(cetirizine hydrochloride) Tablets, Chewable Tablets and Syrup Now available Over-The-Counter (OTC); No prescription needed. DRUG DESCRIPTION What are the possible side effects of cetirizine (All Day Allergy, All Day Allergy Children’s, Indoor/Outdoor Allergy Relief, Zyrtec, Zyrtec Hives)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects: fast, pounding, or uneven heartbeat; weakness, tremors (uncontrolled shaking), or sleep problems (insomnia); severe… Read All Potential Side Effects and See Pictures of Zyrtec » Cetirizine hydrochloride, the active component of ZYRTEC® tablets and syrup, is an orally active and selective H1-receptor antagonist. The chemical name is (±) – [2- [4- [ (4-chlorophenyl)phenylmethyl] -1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN2O3•2HCl. The molecular weight is 461.82 and the chemical structure is shown below: Cetirizine hydrochloride is a white, crystalline powder and is water soluble. ZYRTEC tablets are formulated as white, film-coated, rounded-off rectangular shaped tablets for oral administration and are available in 5 and 10 mg strengths. Inactive ingredients…

(olanzapine) Tablet for Oral use ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral use ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ZYPREXA (olanzapine) is not approved for the treatment of patients…

(bupropion hydrochloride) Sustained-Release Tablets WARNING Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking ZYBAN for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking ZYBAN who continued to smoke. All patients being treated with ZYBAN should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking ZYBAN in the postmarketing experience. When symptoms were reported, most were during treatment with ZYBAN, but some were following discontinuation of treatment with ZYBAN. These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive…

(acyclovir) Capsules ZOVIRAX® (acyclovir) Tablets ZOVIRAX® (acyclovir) Suspension DRUG DESCRIPTION What are the possible side effects of acyclovir (Zovirax)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: pain in your lower back; urinating less than usual or not at all; easy bruising or bleeding; or unusual weakness. Less serious side effects may include: nausea, vomiting, diarrhea, loss of appetite,… Read All Potential Side Effects and See Pictures of Zovirax » ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Capsules, Tablets, and Suspension are formulations for oral administration. Each capsule of ZOVIRAX contains 200 mg of acyclovir and the inactive ingredients corn starch, lactose, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 2, and titanium dioxide. May contain one or more parabens. Printed with edible black ink. Each 800-mg tablet of ZOVIRAX contains 800 mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each…

(sertraline hydrochloride) Tablets and Oral Concentrate Suicidality and Antidcprcssant Drugs Antidcprcssants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See WARNINGS: Clinical Worsening and Suicide Risk, PATIENT INFORMATION and PRECAUTIONS: Pediatric Use) DRUG DESCRIPTION What are the possible…

(simvastatin) Tablets DRUG DESCRIPTION What are the possible side effects of simvastatin (Zocor)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using simvastatin and call your doctor at once if you have any of these serious side effects: muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine. Less serious side effects may include: mild stomach pain, gas, bloating, stomach upset, heartburn; … Read All Potential Side Effects and See Pictures of Zocor » ZOCOR (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is: Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and…

(azithromycin) Tablets and Oral Suspension To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zithromax® (azithromycin) and other antibacterial drugs, Zithromax (azithromycin) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DRUG DESCRIPTION What are the possible side effects of azithromycin? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as: diarrhea that is watery or bloody; chest pain, uneven heartbeats; nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or fever, sore throat, and headache with a severe… Read All Potential Side Effects and See Pictures of Zithromax » ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-l3-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-l-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula…

(ezetimibe) Tablets DRUG DESCRIPTION What are the possible side effects of ezetimibe (Zetia)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: unusual muscle weakness, tenderness, or pain; nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); chest pain; or pancreatitis (severe pain in your upper… Read All Potential Side Effects and See Pictures of Zetia » ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is: Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. ZETIA is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate…

ZANTAC® 150 (ranitidine hydrochloride) Tablets, USP ZANTAC® 300 (ranitidine hydrochloride) Tablets, USP ZANTAC® 25 (ranitidine hydrochloride effervescent) EFFERdose® Tablets (ranitidine hydrochloride) Syrup, USP DRUG DESCRIPTION What are the possible side effects of ranitidine (Zantac, Zantac 150, Zantac 300, Zantac 75, Zantac EFFERdose)? Stop using ranitidine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: chest pain, fever, feeling short of breath, coughing up green or yellow mucus; easy bruising or bleeding, unusual weakness; fast or slow heart rate; … Read All Potential Side Effects and See Pictures of Zantac » The active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, ZANTAC 25 EFFERdose Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure: The empirical formula is C13H22N4O3S•HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor. Each ZANTAC 150 Tablet for oral administration…

(tizanidine hydrochloride) PHARMACOKINETIC DIFFERENCES BETWEEN Zanaflex Capsules™AND ZANAFLEX® TABLETS: Zanaflex Capsules™ARE NOT BIOEQUIVALENT TO ZANAFLEX® TABLETS IN THE FED STATE. THE PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH THE COMPLEX EFFECTS OF FOOD ON TIZANIDINE PHARMACOKINETICS (see PHARMACOKINETICS and DOSAGE AND ADMINISTRATION). DRUG DESCRIPTION What are the possible side effects of tizanidine (Zanaflex)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: feeling light-headed, fainting, slow heart rate; hallucinations, confusion, unusual thoughts or behavior; nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or … Read All Potential Side Effects and See Pictures of Zanaflex » Zanaflex® (tizanidine hydrochloride) is a centrally acting α2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8CIN5 S-HCl, its molecular weight is 290.2 and its…

(orlistat) Capsules DRUG DESCRIPTION What are the possible side effects of orlistat (alli, Xenical)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking orlistat and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and a fast heart rate. These could be signs of pancreatitis. The following side effects occur commonly with the use of orlistat. They are the natural effects of orlistat’s fat-blocking action and are… Read All Potential Side Effects and See Pictures of Xenical » XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats. Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2oxetanyl] methyl]-dodecyl ester. Its empirical formula is C29H53NO5, and its molecular weight is 495.7. It is a single diastereomeric molecule that contains four chiral centers, with a negative optical rotation in ethanol at 529 nm. The structure is: Orlistat is a white to off-white crystalline powder. Orlistat is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol. Orlistat has no pKa within…

(CIV alprazolam) Tablets , USP DRUG DESCRIPTION What are the possible side effects of alprazolam (Niravam, Xanax, Xanax XR)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: unusual risk-taking behavior, decreased inhibitions, no fear of danger; depressed mood, thoughts of suicide or hurting yourself; hyperactivity, agitation, hostility, hallucinations; feeling light-headed,… Read All Potential Side Effects and See Pictures of Xanax » XANAX Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-I] [1,4] benzodiazepine. The structural formula is represented to the right: Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each XANAX Tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. XANAX Tablets, 2 mg, are multi-scored and may be divided as shown below: Inactive ingredients: Cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the…

(bupropion hydrochloride) Tablets WARNING Suicidality and Antidepressant Drugs Use in Treating Psychiatric Disorders: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of WELLBUTRIN or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. WELLBUTRIN is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders, PATIENT INFORMATION, and PRECAUTIONS: Pediatric Use.) Use in Smoking Cessation Treatment: WELLBUTRIN®, WELLBUTRIN…

(lisdexamfetamine dimesylate) Capsules WARNING: POTENTIAL FOR ABUSE AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS. DRUG DESCRIPTION What are the possible side effects of lisdexamfetamine (Vyvanse)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using lisdexamfetamine and call your doctor at once if you have any of these serious side effects: fast, pounding, or uneven heartbeats; decreased blood pressure (feeling light-headed, fainting); dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion,… Read All Potential Side Effects and See Pictures of Vyvanse » Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O•(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is: Lisdexamfetamine dimesylate is…

(ezetimibe/simvastatin) Tablets DRUG DESCRIPTION What are the possible side effects of ezetimibe and simvastatin (Vytorin)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using ezetimibe and simvastatin and call your doctor at once if you have any of these serious side effects: muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, and jaundice (yellowing of… Read All Potential Side Effects and See Pictures of Vytorin » VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is: Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7 dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular…

(diclofenac sodium) Enteric-Coated Tablets of 75 mg Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (See WARNINGS.) Voltaren® (diclofenac sodium enteric-coated tablets) is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS.) DRUG DESCRIPTION What are the possible side effects of diclofenac (Cataflam, Voltaren, Voltaren-XR)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking diclofenac and seek medical attention or call your doctor at once if you have any of these serious side effects: chest pain, weakness, shortness of breath, slurred speech, problems…

(hydroxyzine pamoate) Capsules and Oral Suspension DRUG DESCRIPTION What are the possible side effects of hydroxyzine (Vistaril)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using hydroxyzine and call your doctor at once if you have a serious side effect such as: restless muscle movements in your eyes, tongue, jaw, or neck; tremor (uncontrolled shaking); confusion; or seizure (convulsions). Less serious side effects may include: … Read All Potential Side Effects and See Pictures of Vistaril » Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4- [2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1 -methylene bis (2 hydroxy- 3-naphthalene carboxylic acid). Inert ingredients for the capsule formulations are: hard gelatin capsules (which may contain Yellow 10, Green 3, Yellow 6, Red 33, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose. Inert ingredients for the oral suspension formulation are: carboxymethylcellulose sodium; lemon flavor; propylene glycol; sorbic acid; sorbitol solution; water. Last reviewed on RxList: 10/11/2010 Vistaril Indications & Dosage INDICATIONS For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is…

(hydrocodone bitartrate and acetaminophen) Tablets, USP 5 mg/500 mg DRUG DESCRIPTION What are the possible side effects of acetaminophen and hydrocodone? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: shallow breathing, slow heartbeat; feeling light-headed, fainting; confusion, fear, unusual thoughts or behavior; seizure (convulsions); problems with urination; or nausea, stomach pain, loss of… Read All Potential Side Effects and See Pictures of Vicodin » Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: C18H21NO3•C4H6O6•2½H2O M.W. 494.50 Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Each VICODIN tablet contains: Hydrocodone Bitartrate 5 mg Acetaminophen 500 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, starch, croscarmellose…

(sildenafil citrate) Tablets DRUG DESCRIPTION What are the possible side effects of sildenafil (Revatio, Viagra)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil. Stop using sildenafil and call your doctor at once if you have any of these serious side effects: … Read All Potential Side Effects and See Pictures of Viagra » VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA (sildenafil citrate) is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to…

(sildenafil citrate) Tablets DRUG DESCRIPTION What are the possible side effects of sildenafil (Revatio, Viagra)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil. Stop using sildenafil and call your doctor at once if you have any of these serious side effects: … Read All Potential Side Effects and See Pictures of Viagra » VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA (sildenafil citrate) is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to…

(enalapril maleate) USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, VASOTEC should be discontinued as soon as possible. (See WARNINGS, Fetal/Neonatal Morbidity and Mortality). DRUG DESCRIPTION What are the possible side effects of enalapril (Vasotec)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: feeling light-headed, fainting; urinating more or less than usual, or not at all; fever, chills, body aches, flu symptoms; pale skin, easy bruising or bleeding; fast, pounding, or uneven… Read All Potential Side Effects and See Pictures of Vasotec » VASOTEC® (Enalapril Maleate) is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5•C4H4O4, and its structural formula is: Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water,…

(vancomycin hydrochloride) Injection, Solution in GALAXY Plastic Container (PL 2040) For Intravenous Use Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DRUG DESCRIPTION What are the possible side effects of vancomycin (Lyphocin, Vancocin HCl, Vancocin HCl Pulvules)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using vancomycin and call your doctor at once if you have any of these serious side effects: hearing loss, ringing in your ears; urinating less than usual or not at all; fever, chills, body aches, flu symptoms; feeling light-headed,… Read All Potential Side Effects and See Pictures of Vancomycin Hydrochloride » Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) contains vancomycin,added as Vancomycin Hydrochloride, USP. It is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The molecular formula is C66H75Cl2N9O24 •HCl and the molecular weight is 1,485.71. 500 mg of the base is equivalent to 0.34 mmol. Vancomycin hydrochloride has…

(valacyclovir hydrochloride) Caplets DRUG DESCRIPTION What are the possible side effects of valacyclovir (Valtrex)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking valacyclovir and call your doctor right away if you have any of the following signs of a serious side effect that can harm red blood cells: fever, easy bruising or bleeding; red spots on the skin (not related to herpes or chickenpox); bloody diarrhea, vomiting; pale or… Read All Potential Side Effects and See Pictures of Valtrex » VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. VALTREX Caplets are for oral administration. Each caplet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients carnauba wax, colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The blue, film-coated caplets are printed with edible white ink. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula: Valacyclovir hydrochloride is a white to off-white powder with the…

(diazepam) Tablets DRUG DESCRIPTION What are the possible side effects of diazepam (Valium)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: confusion, unusual thoughts or behavior; unusual risk-taking behavior, decreased inhibitions, no fear of danger; depressed mood, thoughts of suicide or hurting yourself; hyperactivity, anxiety, agitation, hostility; … Read All Potential Side Effects and See Pictures of Valium » Valium (diazepam) is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows: Valium is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate with the following dyes: 5-mg tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10; 10-mg tablets contain FD&C Blue No. 1. Valium 2-mg tablets contain…

(tramadol hydrochloride) Tablets DRUG DESCRIPTION What are the possible side effects of tramadol (Ultram, Ultram ER)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using tramadol and call your doctor at once if you have any of these serious side effects: seizure (convulsions); a red, blistering, peeling skin rash; or shallow breathing, weak pulse. Less serious side effects may include: dizziness, drowsiness, weakness; … Read All Potential Side Effects and See Pictures of Ultram » ULTRAM® (tramadol hydrochloride) tablets is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM® tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are pregelatinized corn starch, modified starch (corn), hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide…

(tramadol hydrochloride/acetaminophen) Tablets DRUG DESCRIPTION What are the possible side effects of acetaminophen and tramadol (Ultracet)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using acetaminophen and tramadol and call your doctor at once if you have any of these serious side effects: seizure (convulsions); a red, blistering, peeling skin rash; or shallow breathing, weak pulse. Less serious side effects may include: dizziness,… Read All Potential Side Effects and See Pictures of Ultracet » ULTRACET® (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is: The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. ULTRACET® tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are…

with Codeine (acetaminophen and codeine phosphate) Tablets, USP DRUG DESCRIPTION What are the possible side effects of acetaminophen and codeine (Capital with Codeine Suspension, EZ III, Tylenol with Codeine #3, Tylenol with Codeine #4, Vopac)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: shallow breathing, slow heartbeat; feeling light-headed, fainting; confusion, unusual thoughts or behavior; seizure… Read All Potential Side Effects and See Pictures of Tylenol-Codeine » TYLENOL® with Codeine is supplied in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3•H3PO4•1/2 H2O M.W. 406.37 Each tablet contains: Acetaminophen. . . . . . . . . . . . . . . . . . . 300 mg No. 3 Codeine Phosphate . . . . . . . . ….

(acetaminophen) DRUG DESCRIPTION What are the possible side effects of acetaminophen? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as: low fever with nausea, stomach pain, and loss of appetite; dark urine, clay-colored stools; or jaundice (yellowing of the skin or eyes). This is not a complete list of side effects and others may occur…. Read All Potential Side Effects and See Pictures of Tylenol » American Hospital Formulary Service (Ahfs)* Classification Number 28:08.92 Generic Name USAN: acetaminophen INN: paracetamol CAS#: 103-90-2 Source of Supply (Trade Name and Manufacturer) TYLENOL® (acetaminophen) – McNeil Consumer Healthcare Physical Properties Of The Chemical Entity1 a. Structural Formula b. Molecular Formula C8H9NO2 c. Molecular Weight 151.16 d. Macroscopic Appearance Acetaminophen is a white, crystalline powder. e. Solubility water 1:70 boiling water 1:20 alcohol 1:10 chloroform 1:50 glycerin 1:40 ether slightly soluble Chemical Properties a. Structural Similarities/Differences of the Drug to Other Available Compounds or Groups of Compounds Acetaminophen is a synthetic, nonopiate, centrally acting analgesic derived from p-aminophenol….

(hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension DRUG DESCRIPTION What are the possible side effects of chlorpheniramine and hydrocodone (HyTan, Novasus, S-T Forte 2, TussiCaps, Tussionex PennKinetic)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: weak or shallow breathing; chest tightness; painful urination; urinating less than usual or not at all; or confusion, hallucinations, or… Read All Potential Side Effects and See Pictures of Tussionex » Each teaspoonful (5 mL) of TUSSIONEX Pennkinetic Extended-Release Suspension contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate. TUSSIONEX Pennkinetic Extended- Release Suspension provides up to 12-hour relief per dose. Hydrocodone is a centrally-acting narcotic antitussive. Chlorpheniramine is an antihistamine. TUSSIONEX Pennkinetic Extended- Release Suspension is for oral use only. Hydrocodone Polistirex Sulfonated styrene-divinylbenzene copolymer complex with 4,5α-epoxy-3-methoxy-17- methylmorphinan-6-one. Chlorpheniramine Polistirex Sulfonated styrene-divinylbenzene copolymer complex with 2-[p-chloro-α-[2- (dimethylamino)ethyl]-benzyl]pyridine. Inactive Ingredients Ascorbic acid, D&C Yellow No. 10, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate…

(fenofibrate) Tablets 48 mg and 145 mg DRUG DESCRIPTION What are the possible side effects of fenofibrate? Fenofibrate has been associated with a rare but serious side effect of the muscles. Contact your doctor at once if you have unusual muscle pain, tenderness, or weakness especially if accompanied by fever or flu-like feeling. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using fenofibrate and call your doctor at once if you have any of these serious side effects: severe stomach… Read All Potential Side Effects and See Pictures of Tricor » TRICOR (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoicacid, 1-methylethyl ester with the following structural formula: The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline…

Cream USP, 0.1% DRUG DESCRIPTION What are the possible side effects of triamcinolone topical (Cinolar, Kenalog, Triderm)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing triamcinolone topical through your skin or gums: blurred vision, or seeing halos around lights; uneven heartbeats; mood changes; sleep problems… Read All Potential Side Effects and See Pictures of Triamcinolone Cream » The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include Triamcinolone Acetonide. Triamcinolone Acetonide is designated chemically as 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. With the molecular formula of C24H31FO6 and a molecular weight of 434.51. The structural formula is: Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg Triamcinolone Acetonide in a cream base consisting of cetyl alcohol, glyceryl monostearate, cetyl esters wax, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water. Last reviewed on RxList: 10/11/2010 Triamcinolone Cream Indications & Dosage INDICATIONS Triamcinolone acetonide cream is indicated for…

(sumatriptan and naproxen sodium) Tablets WARNINGS Cardiovascular Risk: TREXIMET may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS: Cardiovascular Effects). Gastrointestinal Risk: TREXIMET contains a nonsteroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS: Risk of Gastrointestinal Ulceration, Bleeding, and Perforation With Nonsteroidal Anti-inflammatory Drug Therapy). DRUG DESCRIPTION What are the possible side effects of sumatriptan and naproxen (Treximet)? Get emergency medical help if you have any of these signs of an allergic reaction: runny or stuffy nose; hives; wheezing or trouble breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you a serious side effect such as: chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or…

(ketorolac tromethamine) Tablets WARNING TORADOLORAL (ketorolac tromethamine), a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of TORADOLORAL and ketorolac tromethamine should not exceed 5 days. TORADOLORAL is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of TORADOLORAL beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events. GASTROINTESTINAL RISK Ketorolac tromethamine, including TORADOL can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, TORADOL is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS). CARDIOVASCULAR RISK NSAIDs may…

(metoprolol succinate) Tablet, Extended Release for Oral Use WARNING: ISCHEMIC HEART DISEASE Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered TOPROL-XL, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 – 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, TOPROL-XL administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Warn patients against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue TOPROL-XL therapy abruptly even in patients treated only for hypertension. DRUG DESCRIPTION What are the possible side effects of metoprolol (Lopressor, Metoprolol Succinate ER, Toprol-XL)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: slow or uneven heartbeats; feeling light-headed, fainting; feeling short…

(topiramate) Tablets TOPAMAX® (topiramate) Capsules DRUG DESCRIPTION What are the possible side effects of topiramate (Topamax, Topamax Sprinkle)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself. Stop taking topiramate and call your doctor at once if you have any of… Read All Potential Side Effects and See Pictures of Topamax » Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX® (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. TOPAMAX® (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform,…

(carbamazepine USP) Chewable Tablets of 100 mg – Red-Speckled, Pink Tablets of 200 mg – Pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine) Extended-Release Tablets 100 mg, 200 mg, 400 mg WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH TEGRETOL. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH TEGRETOL. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH TEGRETOL UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE WARNINGS AND PRECAUTIONS, LABORATORY TESTS). APLASTIC ANEMIA AND AGRANULOCYTOSIS APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE…

(oseltamivir phosphate) Capsules TAMIFLU® (oseltamivir phosphate) for Oral Suspension DRUG DESCRIPTION What are the possible side effects of oseltamivir (Tamiflu)? Stop using oseltamivir and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat; a red and blistering or peeling skin rash. Some people using oseltamivir have had rare side effects of sudden confusion, delirium, hallucinations, unusual behavior, or self-injury. These symptoms have occurred most often in children. It is not known whether oseltamivir was the exact cause of these symptoms. However, anyone… Read All Potential Side Effects and See Pictures of Tamiflu » TAMIFLU (oseltamivir phosphate) is available as capsules containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the form of oseltamivir phosphate, and as a powder for oral suspension, which when constituted with water as directed contains 12 mg/mL oseltamivir base. In addition to the active ingredient, each capsule contains pregelatinized starch, talc, povidone K30, croscarmellose sodium, and sodium stearyl fumarate. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide, and…

(levothyroxine sodium) Tablets, USP DRUG DESCRIPTION What are the possible side effects of levothyroxine (Levothroid, Levoxyl, Synthroid, Unithroid)? Stop using levothyroxine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: headache; sleep problems (insomnia); nervous or irritable feeling; fever, hot flashes, sweating; changes in your menstrual periods; appetite… Read All Potential Side Effects and See Pictures of Synthroid » SYNTHROID® (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3′,5,5′-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 • H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown: Inactive Ingredients: acacia, confectioner’s sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. The following are the color additives by tablet strength: Strength (mcg) Color additive(s) 25 FD&C Yellow No. 6 Aluminum Lake 50 None 75 FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake 88 FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No….

SUMYCIN® ‘500’ TABLETS (tetracycline hydrochloride) Tablets USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sumycin ‘250’ and Sumycin ‘500’ Tablets (Tetracycline Hydrochloride Tablets) and other antibacterial drugs, Sumycin ‘250’ and Sumycin ‘500’ Tablets (Tetracycline Hydrochloride Tablets) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DRUG DESCRIPTION What are the possible side effects of tetracycline (Ala-Tet, Sumycin)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using tetracycline and call your doctor at once if you have any of these serious side effects: severe headache, dizziness, blurred vision; fever, chills, body aches, flu symptoms; severe blistering, peeling, and red skin rash; urinating less than usual or not at all; pale… Read All Potential Side Effects and See Pictures of Sumycin » Sumycin for oral administration contains tetracycline, an antibiotic isolated from Streptomyces aureofaciens. Tetracycline is described chemically as 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octa- hydro-3, 6, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-nap- thacenecarboxamide; its structural formula is: Sumycin ‘250’ and Sumycin ‘500’ Tablets (Tetracycline Hydrochloride Tablets)…

(buprenorphine and naloxone) Sublingual Film for Sublingual Administration DRUG DESCRIPTION What are the possible side effects of buprenorphine and naloxone (Suboxone)? Buprenorphine and naloxone can cause drug dependence. This means that withdrawal symptoms may occur if you stop using the medicine too quickly. Withdrawal symptoms may also occur at the start of treatment due to dependence on another drug. Buprenorphine and naloxone is not for occasional (“as needed”) use. Do not stop taking buprenorphine and naloxone without first talking to your doctor. Your doctor may want to gradually reduce the dose to avoid or minimize withdrawal symptoms. Seek emergency… Read All Potential Side Effects and See Pictures of Suboxone » SUBOXONE (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual administration and is available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual film also contains polyethylene oxide, hydroxypropyl methylcellulose,…

(atomoxetine hydrochloride) Capsules for Oral Use WARNING SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients…

(tiotropium bromide inhalation powder) Capsules for Respiratory Inhalation DRUG DESCRIPTION What are the possible side effects of tiotropium inhalation (Spiriva)? Stop using tiotropium inhalation and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as: tongue swelling or redness; sores or white patches of your mouth, lips, or tongue; or urinating less than usual or not at all. Less serious side effects may include: … Read All Potential Side Effects and See Pictures of Spiriva » SPIRIVA HandiHaler consists of a capsule dosage form containing a dry powder formulation of tiotropium intended for oral inhalation only with the HandiHaler device. Each light green, hard gelatin SPIRIVA capsule contains 18 mcg tiotropium (equivalent to 22.5 mcg tiotropium bromide monohydrate) blended with lactose monohydrate (which may contain milk proteins) as the carrier. The dry powder formulation within the SPIRIVA capsule is intended for oral inhalation only. The active component of SPIRIVA HandiHaler is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described…

(carisoprodol) Tablets for Oral use DRUG DESCRIPTION What are the possible side effects of carisoprodol (Soma, Vanadom)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using carisoprodol and call your doctor at once if you have any of these serious side effects: paralysis (loss of feeling); extreme weakness or lack of coordination; feeling light-headed, fainting; fast heartbeat; seizure (convulsions); vision loss; or … Read All Potential Side Effects and See Pictures of Soma » SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is: Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate. Last reviewed on RxList: 12/8/2009 Soma Indications &…

(metaxalone) Tablets DRUG DESCRIPTION What are the possible side effects of metaxalone (Skelaxin)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using metaxalone and call your doctor at once if you have any of these serious side effects: nausea, stomach pain, loss of appetite; low fever; dark urine, clay-colored stools; or jaundice (yellowing of the skin or eyes). Less serious side effects may include: … Read All Potential Side Effects and See Pictures of Skelaxin » SKELAXIN® (metaxalone) is available as an 800 mg oval, scored pink tablet. Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15N03, which corresponds to a molecular weight of 221.25. The structural formula is: Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: alginic acid, ammonium calcium alginate, B-Rose Liquid, corn starch, and magnesium stearate. Last reviewed on RxList: 11/8/2010 Skelaxin Indications & Dosage INDICATIONS SKELAXIN (metaxalone) is indicated as an adjunct to rest,…

(montelukast sodium) Tablets, Chewable Tablets, and Oral Granules DRUG DESCRIPTION What are the possible side effects of montelukast (Singulair)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: skin rash, bruising, severe tingling, numbness, pain, muscle weakness; mood or behavior changes, anxiety, depression, or thoughts about suicide or hurting yourself; tremors or shaking; severe sinus pain, swelling, or… Read All Potential Side Effects and See Pictures of Singulair » Montelukast sodium, the active ingredient in SINGULAIR, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor. Montelukast sodium is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C35H35CINNaO3S, and its molecular weight is 608.18. The structural formula is: Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg film-coated SINGULAIR tablet contains 10.4 mg montelukast sodium, which is equivalent to 10mg of montelukast, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate,…

(carbidopa-levodopa) Tablets DRUG DESCRIPTION What are the possible side effects of carbidopa and levodopa (Atamet, Parcopa, Sinemet, Sinemet CR)? You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: restless muscle… Read All Potential Side Effects and See Pictures of Sinemet » SINEMET* (Carbidopa-Levodopa) is a combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (—)-L-α¬hydrazino- α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4•H2O, and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with…

(quetiapine fumarate) Tablets WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. SEROQUEL (quetiapine) is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS]. SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal…

(trimethoprim and sulfamethoxazole) Tablets Septra DS Tablets (trimethoprim and sulfamethoxazole) DS Tablets Septra Suspension (trimethoprim and sulfamethoxazole) Suspension Septra Grape Suspension (trimethoprim and sulfamethoxazole) Grape Suspension To reduce the development of drug-resistant bacteria and maintain the effectiveness of SEPTRA and other antibacterial drugs, SEPTRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DRUG DESCRIPTION What are the possible side effects of sulfamethoxazole and trimethoprim (Bactrim, Bactrim DS, Septra, Septra DS, Sulfatrim Pediatric)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as: fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; the first sign of any skin rash, no matter how mild; pale skin, easy bruising or… Read All Potential Side Effects and See Pictures of Septra » SEPTRA (trimethoprim and sulfamethoxazole) is a synthetic antibacterial combination product. Each SEPTRA Tablet contains 80 mg trimethoprim and 400 mg sulfamethoxazole and the inactive ingredients docusate sodium (0.4 mg per tablet), FD&C Red No. 40,…

(methocarbamol) Tablet, Film Coated DRUG DESCRIPTION What are the possible side effects of methocarbamol (Robaxin, Robaxin-750)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using methocarbamol and call your doctor at once if you have any of these serious side effects: slow heart rate; feeling like you might pass out; jaundice (yellowing of your skin or eyes); confusion, spinning sensation, loss of balance; or seizure… Read All Potential Side Effects and See Pictures of Robaxin » robaxin®/robaxin®-750 (methocarbamol tablets, USP), a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-l,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. robaxin® is available as a light orange, round, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, FD&C Yellow 6, hydroxypropyl cellulose, hypromellose,…

(methylphenidate hydrochloride) Tablets USP Ritalin-SR® (methylphenidate hydrochloride) USP Sustained-release tablets DRUG DESCRIPTION What are the possible side effects of methylphenidate? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking methylphenidate and call your doctor at once if you have any of these serious side effects: fast, pounding, or uneven heartbeats; feeling like you might pass out; fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; aggression, restlessness, hallucinations,… Read All Potential Side Effects and See Pictures of Ritalin » Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients. Ritalin tablets: D&C Yellow No. 10…

(risperidone) Tablets RISPERDAL® (risperidone) Oral Solution RISPERDAL® M-TAB® (risperidone) Orally Disintegrating Tablets WARNING INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIARELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL ® (risperidone) is not approved for the treatment of patients with dementia-related psychosis. [See WARNINGS AND PRECAUTIONS] DRUG DESCRIPTION What…

(budesonide) Nasal Spray 32 mcg DRUG DESCRIPTION What are the possible side effects of budesonide nasal (Rhinocort Aqua)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: severe or ongoing nose bleed; sores in the nose that won’t heal; wheezing, trouble breathing; vision problems; or fever, chills, body aches, flu symptoms. Less serious side effects may… Read All Potential Side Effects and See Pictures of Rhinocort Aqua » Budesonide, the active ingredient of RHINOCORT AQUA® Nasal Spray, is an anti-inflammatory synthetic corticosteroid. It is designated chemically as (RS)-11-beta, 16-alpha, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as the mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is: Budesonide is a white to off-white, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 103. RHINOCORT AQUA is an…

(infliximab) Lyophilized Concentrate for Intravenous (IV) Injection WARNINGS SERIOUS INFECTIONS Patients treated with REMICADE® are at increased risk for developing serious infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS] Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. REMICADE should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before REMICADE use and during therapy.1,2 Treatment for latent infection should be initiated prior to REMICADE use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with REMICADE should be carefully considered prior to initiating therapy in patients with chronic or…

(mirtazapine) Tablets Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of REMERON® (mirtazapine) Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. REMERON is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PATIENT INFORMATION and PRECAUTIONS: Pediatric Use) DRUG DESCRIPTION What are the possible side effects of mirtazapine (Remeron, Remeron SolTab)? Get emergency medical…

(nabumetone) Tablets Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at a greater risk (See WARNINGS). RELAFEN is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS). DRUG DESCRIPTION What are the possible side effects of nabumetone (Relafen)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking nabumetone and seek medical attention or call your doctor at once if you have any of these serious side effects: chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance; black, bloody, or tarry stools; coughing up…

(metoclopramide) Tablets, USP WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia. See WARNINGS DRUG DESCRIPTION What are the possible side effects of metoclopramide (Reglan)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using metoclopramide and call your doctor at once if you have any of these serious side effects: tremors, or restless muscle movements in your eyes, tongue, jaw, or neck; mask-like appearance of the face; fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing; … Read All Potential Side Effects and See Pictures of Reglan » For oral…

(budesonide) Inhalation suspension DRUG DESCRIPTION What are the possible side effects of budesonide inhalation (Pulmicort Flexhaler, Pulmicort Respules)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: weakness, tired feeling, nausea, vomiting, feeling like you might pass out; wheezing or breathing problems after using this medication; worsening respiratory symptoms; ear pain with… Read All Potential Side Effects and See Pictures of Pulmicort Respules » Budesonide, the active component of PULMICORT RESPULES®, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is: Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. PULMICORT RESPULES is a sterile suspension for inhalation via jet nebulizer…

(fluoxetine hydrochloride) Pulvule® for Oral Use PROZAC (fluoxetine hydrochloride) Oral Solution PROZAC Weekly™ (fluoxetine hydrochloride) Delayed-Release Capsules for Oral Use WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PROZAC or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PROZAC is approved for use in pediatric patients with MDD and Obsessive Compulsive Disorder (OCD) [see WARNINGS AND PRECAUTIONS and Use…

(modafinil) Tablets DRUG DESCRIPTION What are the possible side effects of modafinil (Provigil)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using modafinil and call your doctor at once if you have any of these serious side effects: fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash; bruising, severe tingling, numbness, pain, muscle weakness; easy bruising or bleeding; white patches or… Read All Potential Side Effects and See Pictures of Provigil » PROVIGIL (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl) sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is: Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate. Last reviewed on RxList: 11/29/2010 Provigil Indications & Dosage INDICATIONS PROVIGIL is…

(medroxyprogesterone acetate) Tablets, USP WARNINGS CARDIOVASCULAR AND OTHER RISKS Estrogens with progestins should not be used for the prevention of cardiovascular disease or dementia. (See Clinical Studies and WARNINGS, Cardiovascular disorders and Dementia.) The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See Clinical Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.) The Women’s Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See Clinical Studies and WARNINGS, Dementia, and PRECAUTIONS, Geriatric Use.) In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens…

(pantoprazole sodium) Delayed-Release Tablets PROTONIX (pantoprazole sodium) for Delayed-Release Oral Suspension DRUG DESCRIPTION What are the possible side effects of pantoprazole (Protonix)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Less serious side effects are more likely to occur, such as: nausea, vomiting; gas, stomach pain; diarrhea; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at… Read All Potential Side Effects and See Pictures of Protonix » The active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane….

(progesterone, USP) Capsules 100 mg & Capsules 200 mg WARNING CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See Clinical Studies and WARNINGS, Cardiovascular disorders and Dementia.) The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism, and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See Clinical Studies and WARNINGS, Cardiovascular disorders.) The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See Clinical Studies and WARNINGS, Malignant neoplasms, Breast cancer.) The Women’s Health Initiative Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older. DRUG DESCRIPTION What are the possible side effects of progesterone (First Progesterone MC10, First Progesterone MC5, Prometrium)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling…

(lisinopril) Tablets USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, PRINIVIL should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality. DRUG DESCRIPTION What are the possible side effects of lisinopril (Prinivil, Zestril)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: feeling light-headed, fainting; urinating more or less than usual, or not at all; fever, chills, body aches, flu symptoms; tired feeling, muscle weakness, and pounding or uneven heartbeats; … Read All Potential Side Effects and See Pictures of Prinivil » PRINIVIL (Lisinopril), a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5•2H2O and its structural formula is: Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol….

(omeprazole) Delayed-Release Capsules PRILOSEC (omeprazole magnesium) For Delayed-Release Oral Suspension DRUG DESCRIPTION What are the possible side effects of omeprazole (Prilosec, Prilosec OTC)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Other less serious side effects are more likely to occur, such as: stomach pain, gas; nausea, vomiting, diarrhea; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA… Read All Potential Side Effects and See Pictures of Prilosec » The active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is: Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in…

(lansoprazole) Delayed-Release Capsules PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets DRUG DESCRIPTION What are the possible side effects of lansoprazole (Prevacid, Prevacid SoluTab)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Less serious side effects may include: headache; nausea, stomach pain; diarrhea; or constipation. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at… Read All Potential Side Effects and See Pictures of Prevacid » The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. PREVACID has the following structure: Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is…

(conjugated estrogens/medroxyprogesterone acetate) Tablets PREMPHASE® (conjugated estrogens plus medroxyprogesterone acetate) Tablets WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER and PROBABLE DEMENTIA Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS, and Clinical Studies]. The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see WARNINGS AND PRECAUTIONS, and Clinical Studies]. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and Clinical Studies]. Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive…

(conjugated estrogens) Tablets, USP WARNINGS ENDOMETRIAL CANCER Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. (See WARNINGS, Malignant neoplasms, Endometrial cancer.) CARDIOVASCULAR AND OTHER RISKS Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See Clinical Studies and WARNINGS, Cardiovascular disorders and Dementia.) The estrogen alone substudy of the Women’s Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with daily oral conjugated estrogens (CE 0.625 mg), relative to placebo. (See Clinical Studies and WARNINGS, Cardiovascular disorders.) The estrogen plus progestin substudy of WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. (See Clinical Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.) The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported an…

(pravastatin sodium) Tablets DRUG DESCRIPTION What are the possible side effects of pravastatin (Pravachol)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using pravastatin and call your doctor at once if you have any of these serious side effects: chest pain; muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; or nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of… Read All Potential Side Effects and See Pictures of Pravachol » PRAVACHOL® (pravastatin sodium) is one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula: Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL),…

(levonorgestrel) Tablets, 0.75 mg Available without a prescription for consumers 18 and older. Rx only for women age 17 and younger For women age 17 and younger, Plan B® is a prescription-only emergency contraceptive. Plan B® is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. Emergency contraceptive pills (like all oral contraceptives) do not protect against infection with HIV (the virus that causes AIDS) and other sexually transmitted diseases. DRUG DESCRIPTION What are the possible side effects of levonorgestrel emergency contraceptive (Plan B)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency. Less serious side effects may include: nausea, diarrhea, or… Read All Potential Side Effects and See Pictures of Plan B » Emergency contraceptive tablet. Each Plan B® tablet contains 0.75 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)- (-)-], a…