Plan B®

(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 totally synthetic progestogen. The inactive ingredients present are colloidal silicon dioxide, potato starch, gelatin, magnesium stearate, talc, corn starch, and lactose monohydrate. Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:

C21H28O2
Last reviewed on RxList: 5/24/2007
Plan B Indications & Dosage

INDICATIONS
For women age 17 and younger, Plan B® is a prescription-only emergency contraceptive that can be used to prevent pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet must be taken 12 hours later.
DOSAGE AND ADMINISTRATION
One tablet of Plan B® should be taken orally as soon as possible within 72 hours after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Efficacy is better if Plan B® is taken as directed as soon as possible after unprotected intercourse. Plan B® can be used at any time during the menstrual cycle.
The user should be instructed that if she vomits within one hour of taking either dose of medication she should contact her health care professional to discuss whether to repeat that dose.
HOW SUPPLIED
Plan B® (levonorgestrel) tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. The tablet is white, round, and marked: INOR.
Available as:
Unit-of-use NDC 51285-038-93
Store Plan B® tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].
Mfg. by Gedeon Richter, Ltd., Budapest, Hungary
for Duramed Pharmaceuticals, Inc.
Subsidiary of Barr Pharmaceuticals, Inc.
Pomona, NY 10970
Phone: 1-800-330-1271 begin_of_the_skype_highlighting 1-800-330-1271 end_of_the_skype_highlighting Web site: www.go2planb.com
Revised August 2006
BR- 038 / 21000382503
Last reviewed on RxList: 5/24/2007
Plan B Side Effects & Drug Interactions

SIDE EFFECTS
The most common adverse events in the clinical trial for women receiving Plan B® included nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), and menstrual changes. The table below shows those adverse events that occurred in ≥5% of Plan B® users.
Table 3
Adverse Events in ≥ to 5% of Women, by % Frequency
Most Common
Adverse Events Plan B®
Levonorgestrel
N = 977 (%)
Nausea 23.1
Abdominal Pain 17.6
Fatigue 16.9
Headache 16.8
Heavier Menstrual Bleeding 13.8
Lighter Menstrual Bleeding 12.5
Dizziness 11.2
Breast Tenderness 10.7
Other complaints 9.7
Vomiting 5.6
Diarrhea 5.0
Plan B® demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events:
Nausea: Occurred in 23% of women taking Plan B® (compared to 50% with Yuzpe)
Vomiting: Occurred in 6% of women taking Plan B® (compared to 19% with Yuzpe)
DRUG ABUSE AND DEPENDENCE
There is no information about dependence associated with the use of Plan B®.
DRUG INTERACTIONS
Theoretically, the effectiveness of low-dose progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics. It is not known whether the efficacy of Plan B® would be affected by these or any other medications.
Last reviewed on RxList: 5/24/2007
Plan B Warnings & Precautions

WARNINGS
Plan B® is not recommended for routine use as a contraceptive.
Plan B® is not effective in terminating an existing pregnancy.
Effects on Menses
Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and in clinical studies of levonorgestrel for postcoital and emergency contraceptive use. Some women may experience spotting a few days after taking Plan B®. At the time of expected menses, approximately 75% of women using Plan B® had vaginal bleeding similar to their normal menses, 12-13% bled more than usual, and 12% bled less than usual. The majority of women (87%) had their next menstrual period at the expected time or within ± 7 days, while 13% had a delay of more than 7 days beyond the anticipated onset of menses. If there is a delay in the onset of menses beyond 1 week, the possibility of pregnancy should be considered.
Ectopic Pregnancy
Ectopic pregnancies account for approximately 2% of reported pregnancies (19.7 per 1,000 reported pregnancies). Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. A history of ectopic pregnancy need not be considered a contraindication to use of this emergency contraceptive method. Health providers, however, should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B®.
PRECAUTIONS
Pregnancy
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins (POPs). The few studies of infant growth and development that have been conducted with POPs have not demonstrated significant adverse effects.
STD/HIV
Plan B®, like progestin-only contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Physical Examination and Follow-up
A physical examination is not required prior to prescribing Plan B®. A follow-up physical or pelvic examination, however, is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B®.
Carbohydrate Metabolism
The effects of Plan B® on carbohydrate metabolism are unknown. Some users of progestin-only oral contraceptives (POPs) may experience slight deterioration in glucose tolerance, with increases in plasma insulin; however, women with diabetes mellitus who use POPs do not generally experience changes in their insulin requirements. Nonetheless, diabetic women should be monitored while taking Plan B®.
Nursing Mothers
Small amounts of progestin pass into the breast milk in women taking progestin-only pills for long-term contraception resulting in steroid levels in infant plasma of 1-6% of the levels of maternal plasma. However, no adverse effects due to progestin-only pills have been found on breastfeeding performance, either in the quality or quantity of the milk, or on the health, growth or development of the infant.
Pediatric Use
Safety and efficacy of progestin-only pills have been established in women of reproductive age for long-term contraception. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of Plan B® emergency contraception before menarche is not indicated.
Fertility Following Discontinuation
The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only pills for emergency contraception and long-term contraception.
Last reviewed on RxList: 5/24/2007
Plan B Overdosage & Contraindications

OVERDOSE
There are no data on overdosage of Plan B®, although the common adverse event of nausea and its associated vomiting may be anticipated.
CONTRAINDICATIONS
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B® regimen consisting of the emergency use of two progestin pills. POPs however, are not recommended for use in the following conditions:
Known or suspected pregnancy
Hypersensitivity to any component of the product
Last reviewed on RxList: 5/24/2007
Plan B Clinical Pharmacology

CLINICAL PHARMACOLOGY
Emergency contraceptives are not effective if the woman is already pregnant. Plan B® is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.
Pharmacokinetics
Absorption
No specific investigation of the absolute bioavailability of Plan B® in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first pass metabolism. After a single dose of Plan B® (0.75 mg) administered to 16 women under fasting conditions, maximum serum concentrations of levonorgestrel are 14.1 ± 7.7 ng/mL (mean ± SD) at an average of 1.6 ± 0.7 hours. No formal study of the effect of food on the absorption of levonorgestrel has been undertaken.
Table 1
Pharmacokinetic Parameter Values Following Single Dose Administration of Plan B (Levonorgestrel 0.75 mg) to Healthy Female Volunteers

Mean (± S.D.)
N Cmax
(ng/mL) Tmax
(h) CL
(L/h) Vd
(L) T1/2
(h) AUC
(ng/mL/h)
16 14.1 ± 7.7 1.6 ± 0.7 7.7 ± 2.7 260.0 24.4 ± 5.3 123.1 ± 50.1
Distribution
Levonorgestrel in serum is primarily protein bound. Approximately 50% is bound to albumin and 47.5% is bound to sex hormone binding globulin (SHBG).
Metabolism
Following a single oral dosage, levonorgestrel does not appear to be extensively metabolized by the liver. The primary metabolites are 3α,5β- and 3α,5β-tetrahydrolevonorgestrel with 16β-hydroxynorgestrel also identified. Together, these account for less than 10% of parent plasma levels. Urinary metabolites hydroxylated at the 2α and 16β positions have also been identified. Small amounts of the metabolites are present in plasma as sulfate and glucuronide conjugates.
Excretion
The elimination half-life of levonorgestrel following single dose administration as Plan B® (0.75 mg) is 24.4 ± 5.3 hours. Excretion following single dose administration as emergency contraception is unknown, but based on chronic, low-dose contraceptive use, levonorgestrel and its metabolites are primarily excreted in the urine, with smaller amounts recovered in the feces.
Special Populations
Geriatric: This product is not intended for use in geriatric (age 65 years or older) populations and pharmacokinetic data are not available for this population.
Pediatric: This product is not intended for use in pediatric (premenarchal) populations, and pharmacokinetic data are not available for this population.
Race: No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in the Chinese population with both Plan B® and the Yuzpe regimen (another form of emergency contraception consisting of two doses of ethinyl estradiol 0.1 mg + levonorgestrel 0.5 mg). The reason for this apparent increase in the pregnancy rate of emergency contraceptives in Chinese women is unknown.
Hepatic Insufficiency and Renal Insufficiency: No formal studies have evaluated the effect of hepatic insufficiency or renal insufficiency on the disposition of emergency contraceptive tablets.
Drug-Drug Interactions: No formal studies of drug-drug interactions were conducted.
CLINICAL STUDIES
A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and safety of Plan B® (one 0.75 mg tablet of levonorgestrel taken within 72 hours of intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets of 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two tablets taken 12 hours later). Plan B® was at least as effective as the Yuzpe regimen in preventing pregnancy. After a single act of intercourse, the expected pregnancy rate of 8% (with no contraception) was reduced to approximately 1% with Plan B®.
Emergency contraceptives are not as effective as routine contraception since their failure rate, while low based on a single use, would accumulate over time with repeated use (see WARNINGS). See Table 2 below.
Table 2
Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception, and the Percentage Continuing Use at the End of the first Year- United States

% of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3
Method
(1) Typical Use1
(2) Perfect Use2
(3) (4)
Chance4 85 85
Spermicide5 26 6 40
Periodic Abstinence 25 63
Calendar 9
Ovulation Method 3
Symptom-thermal6 2
Post-ovulation 1
Withdrawal 19 4
Cap7
Parous Women 40 26 42
Nulliparous Women 20 9 56
Sponge
Parous Women 40 20 42
Nulliparous Women 20 9 56
Diaphragm7 20 6 56
Condom8
Female (Reality) 21 5 56
Male 14 3 61
Pill 5 71
Progestin Only 0.5
Combined 0.1
IUD
Progesterone T 2.0 1.5 81
Copper T 380A 0.8 0.6 78
LNg 20 0.1 0.1 81
Depo Provera 0.3 0.3 70
Norplant and Norplant-2 0.05 0.05 88
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method: LAM is a highly effective temporary method of contraception.10
Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology; Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.
1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an unintended pregnancy during the first year if they do not stop use for any other reason.
2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an unintended pregnancy during the first year if they do not stop use for any other reason.
3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4. The percentages of women becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5. Foams, creams, gels, vaginal suppositories, and vaginal film.
6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phase.
7. With spermicidal cream or jelly.
8. Without spermicides.
9. The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced or the baby reaches six months of age.
Last reviewed on RxList: 5/24/2007
Plan B Medication Guide

PATIENT INFORMATION
Plan B®
(levonorgestrel) Tablets 0.75 mg
Emergency Contraceptive
What is Plan B®?
Plan B® is emergency contraception. Emergency contraception is a backup method of preventing pregnancy and is not for routine use. Drugs used for emergency contraception are called emergency contraceptive pills, postcoital pills, or morning after pills. Plan B® can reduce your chance of pregnancy after unprotected sex (if your regular birth control method fails or if you have had sex without birth control). For example, if you were using a condom and it broke, or if you forgot to take 2 or more of your birth control pills this month, or if you did not use any birth control method, Plan B® may work for you.
How does Plan B® work?
Plan B® contains a dose of the hormone levonorgestrel that is higher than in a single birth control pill. Levonorgestrel has been used in birth control pills for over 35 years. Plan B® works like a birth control pill to prevent pregnancy mainly by stopping the release of an egg from the ovary. It is possible that Plan B® may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb), which usually occurs beginning 7 days after release of an egg from the ovary. Plan B® will not do anything to a fertilized egg already attached to the uterus. The pregnancy will continue.
When is it appropriate to use Plan B®?
You can use Plan B® after you have had unprotected sex 1 or more times in the last 3 days (72 hours), and you don’t want to become pregnant.
Plan B® can be used as a backup method to birth control if, for example,
Your regular birth control failed (your partner’s condom broke or slipped)
You made a mistake with your regular method (you missed 2 or more birth control pills this month)
You did not use any birth control method
When is it not appropriate to use Plan B®?
Plan B® should not be used as a regular birth control method. It does not work as well as most other forms of birth control when they are used consistently and correctly. Plan B® is a backup or emergency method of contraception
Plan B® should not be used if you are already pregnant because it will not work
Plan B® should not be used if you are allergic to levonorgestrel
Plan B® does not protect against HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs). The best ways to protect yourself against getting HIV or other STDs are to use a latex condom correctly with every sexual act or not to have sex at all
How can I get the best results from Plan B®?
You have only a few days to prevent pregnancy after unprotected sex. Plan B® works better the sooner you take it. Take the first Plan B® tablet as soon as possible but not later than 3 days (72 hours) after unprotected sex. Take the second tablet 12 hours later.
How effective is Plan B®?
Plan B® works best the sooner you use it. If it is taken within 72 hours (3 days) after sex, it will significantly decrease the chance that you will get pregnant. Seven out of every 8 women who would have gotten pregnant will not become pregnant. Plan B® works even better than this if taken within the first 24 hours after sex.
How will I know if Plan B® worked?
Most women will have their next menstrual period at the expected time or within a week of the expected time. If your menstrual period is delayed beyond 1 week, you may be pregnant and you should get a pregnancy test and follow up with your healthcare professional.
What if I am already pregnant and use Plan B®?
There is no medical evidence that Plan B® would harm a developing baby. If you take Plan B® accidentally after you are already pregnant, or it does not work and you become pregnant, it is not likely to cause any harm to you or your pregnancy. Plan B® should not have any effect on a pregnancy after implantation.
What should I do if my menstrual period is delayed beyond 1 week and I have severe lower stomach pain?
If you have severe lower stomach pain about 3 to 5 weeks after taking Plan B®, you may have a pregnancy outside the uterus (a tubal pregnancy). See a healthcare professional right away because a tubal pregnancy requires immediate medical treatment.
Can I use Plan B® for regular birth control?
Plan B® should not be used for regular birth control. Plan B® is not as effective as using a regular birth control method correctly and consistently. It is a backup method to be used if your regular birth control fails or if you have sex without birth control. You should not have unprotected sex following treatment because Plan B® will not protect you from getting pregnant.
How often can I use Plan B®?
Plan B® is meant for infrequent emergency protection. If you need to use emergency contraception often, you should consult with your healthcare professional for your best methods of birth control and STD prevention.
Will I experience any side effects from Plan B®?
When used as directed, Plan B® is safe for women. Plan B® has no serious or lasting medical side effects. Some women will experience non-serious side effects, such as nausea, stomach pain, headache, dizziness, or breast tenderness. These are similar to the side effects of regular birth control pills. Some women have menstrual changes such as spotting or bleeding before their next period. Some women may have a heavier or lighter next period, or a period that is early or late. If your period is more than a week late, you should get a pregnancy test.