Plan B One-Step (Levonorgestrel Tablet)
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Plan B One-Step (Levonorgestrel Tablet)

Plan B One-Step
(levonorgestrel) Tablet, 1.5 mg, for Oral Use

DRUG DESCRIPTION

The Plan B One-Step (levonorgestrel tablet) tablet contains 1.5 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17 α)-(-)-], a totally synthetic progestogen. The inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc.

Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:

Plan B One-Step (levonorgestrel)  Structural Formula Illustration

What are the possible side effects of levonorgestrel emergency contraceptive (Next Choice, Plan B, Plan B One-Step)?

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 stomach pain;
  • dizziness, tired...

Read All Potential Side Effects and See Pictures of Plan B One-Step »

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Plan B® One-Step is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.

Plan B One-Step is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.

Plan B One-Step is not indicated for routine use as a contraceptive.

DOSAGE AND ADMINISTRATION

Take Plan B One-Step orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. Plan B One-Step can be used at any time during the menstrual cycle.

If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.

HOW SUPPLIED

Dosage Forms And Strengths

The Plan B One-Step tablet is supplied as an almost white, round tablet containing 1.5 mg of levonorgestrel and is marked G00 on one side.

Storage And Handling

The Plan B One-Step (levonorgestrel) tablet 1.5 mg is available in a PVC/aluminum foil blister package. The tablet is almost white, round, and marked G00 on one side.

NDC 51285-088-88 (1 tablet unit of use package)

Store Plan B One-Step at 20°to 25°C (68°to 77°F) [see USP Controlled Room Temperature].

Mfg. by Gedeon Richter, Ltd., Budapest, Hungary for Duramed Pharmaceuticals, Inc., Subsidiary of Barr Pharmaceuticals, Inc., Pomona, New York 10970. Phone: 1-800-330-1271. Website: www.PlanBOneStep.com. Revised: July 2009.

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Plan B One-Step (levonorgestrel tablet) was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the Plan B One-Step (levonorgestrel tablet) group, and 1,377 women in the Plan B group (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given Plan B One-Step was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the Plan B One-Step (levonorgestrel tablet) group and 1.4% in Plan B group were lost to follow-up.

The most common adverse events ( > 10%) in the clinical trial for women receiving Plan B One-Step (levonorgestrel tablet) included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of Plan B One-Step (levonorgestrel tablet) users.

Table 1 : Adverse Events in > 4% of Women, by % Frequency

Most Common Adverse Events (MedDRA) Plan B One-Step
N = 1359 (%)
Heavier menstrual bleeding 30.9
Nausea 13.7
Lower abdominal pain 13.3
Fatigue 13.3
Headache 10.3
Dizziness 9.6
Breast tenderness 8.2
Delay of menses ( > 7 days) 4.5

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Plan B (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders

Abdominal Pain, Nausea, Vomiting

General Disorders and Administration Site Conditions

Fatigue

Nervous System Disorders

Dizziness, Headache

Reproductive System and Breast Disorders

Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain

Read the Plan B One-Step (levonorgestrel tablet) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:

  • barbiturates
  • bosentan
  • carbamazepine
  • felbamate
  • griseofulvin
  • oxcarbazepine
  • phenytoin
  • rifampin
  • St. John's wort
  • topiramate

Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin-only pills or the potential for enzyme alterations.

Drug Abuse And Dependence

Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of Plan B One-Step (levonorgestrel tablet) .

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Ectopic Pregnancy

Ectopic pregnancies account for approximately 2% of all 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 is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B One-Step (levonorgestrel tablet) . A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One-Step (levonorgestrel tablet) .

Existing Pregnancy

Plan B One-Step (levonorgestrel tablet) is not effective in terminating an existing pregnancy.

Effects on Menses

Some women may experience spotting a few days after taking Plan B One-Step (levonorgestrel tablet) . Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception.

If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.

STI/HIV

Plan B One-Step (levonorgestrel tablet) does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

Physical Examination and Follow-up

A physical examination is not required prior to prescribing Plan B One-Step (levonorgestrel tablet) . A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One-Step (levonorgestrel tablet) .

Fertility Following Discontinuation

A rapid return of fertility is likely following treatment with Plan B One-Step (levonorgestrel tablet) for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Plan B One-Step (levonorgestrel tablet) to ensure ongoing prevention of pregnancy.

Patient Counseling Information

  • Take Plan B One-Step (levonorgestrel tablet) as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure.
  • If you vomit within two hours of taking the tablet, immediately contact your healthcare provider to discuss whether to take another tablet.
  • Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Plan B One-Step (levonorgestrel tablet) , in order to be evaluated for an ectopic pregnancy.
  • After taking Plan B One-Step (levonorgestrel tablet) , consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period.
  • Do not use Plan B One-Step (levonorgestrel tablet) as routine contraception.
  • Plan B One-Step (levonorgestrel tablet) is not effective in terminating an existing pregnancy.
  • Plan B One-Step (levonorgestrel tablet) does not protect against HIV-infection (AIDS) and other sexually transmitted diseases/infections.
  • For women younger than age 17 years, Plan B One-Step (levonorgestrel tablet) is available only by prescription.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins. There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 μg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for 10 years at up to 250 μg/kg/day. In another 7 year dog study, administration of levonorgestrel at 0.5 mg/kg/day did increase the number of mammary adenomas in treated dogs compared to controls. There were no malignancies.

Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an in vivo micronucleus assay in mice.

Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins in general.

Use In Specific Populations

Pregnancy

Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects.

Nursing Mothers

In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma.

Pediatric Use

Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older. Use of Plan B One-Step (levonorgestrel tablet) emergency contraception before menarche is not indicated.

Geriatric Use

This product is not intended for use in postmenopausal women.

Race

No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of emergency contraception). There was a non-statistically significant increased rate of pregnancy among Chinese women in the Plan B One-Step (levonorgestrel tablet) trial. The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown.

Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One-Step (levonorgestrel tablet) .

Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One-Step (levonorgestrel tablet) .

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There are no data on overdosage of Plan B One-Step (levonorgestrel tablet) , although the common adverse event of nausea and associated vomiting may be anticipated.

CONTRAINDICATIONS

Plan B One-Step (levonorgestrel tablet) is contraindicated for use in the case of known or suspected pregnancy.

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Emergency contraceptive pills are not effective if a woman is already pregnant. Plan B One-Step (levonorgestrel tablet) 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

Following a single dose administration of Plan B One-Step (levonorgestrel tablet) in 30 women under fasting conditions, maximum plasma concentrations of levonorgestrel of 19.1 ng/mL were reached at 1.7 hours. See Table 2.

Table 2 : Pharmacokinetic Parameter Values Following Single Dose Administration of Plan B One-Step (levonorgestrel) tablet 1.5 mg to 30 Healthy Female Volunteers under Fasting Conditions

  Mean ± SD
Cmax
(ng/mL)
AUCτ
(ng•hr/mL)*
AUCinf
(ng•hr/mL)*
Tmax
(hr)**
t½(hr)
Levonorgestrel 19.1
( 9.7)
294.8
( 208.8)
307.5
( 218.5)
1.7
(1.0-4.0)
27.5
( 5.6)
Cmax = maximum concentration
AUCτ = area under the drug concentration curve from time 0 to time of last determinable concentration
AUCinf = area under the drug concentration curve from time 0 to infinity
Tmax = time to maximum concentration
t½ = elimination half life
* N=29
**median (range)

Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of Plan B One-Step (levonorgestrel tablet) has not been evaluated.

Distribution

The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. It is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin.

Metabolism

Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5αtetrahydrolevonorgestrel and 16βhydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.

Excretion

About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.

Specific Populations

Pediatric

This product is not intended for use in the premenarcheal population, and pharmacokinetic data are not available for this population.

Geriatric

This product is not intended for use in postmenopausal women, 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 Chinese women with both Plan B and the Yuzpe regimen (another form of emergency contraception). There was a non-statistically significant increased rate of pregnancy among Chinese women in the Plan B One-Step (levonorgestrel tablet) trial. The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown [see Use In Specific Populations].

Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One-Step (levonorgestrel tablet) .

Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One-Step (levonorgestrel tablet) .

Drug-Drug Interactions

No formal drug-drug interaction studies were conducted with Plan B One-Step [see DRUG INTERACTIONS].

Clinical Studies

A double-blind, randomized, multicenter, multinational study evaluated and compared the efficacy and safety of three different regimens for emergency contraception. Subjects were enrolled at 15 sites in 10 countries; the racial/ethnic characteristics of the study population overall were 54% Chinese, 34% Caucasian, and 12% Black or Asian (other than Chinese). 2,381 healthy women with a mean age of 27 years, who needed emergency contraception within 72 hours of unprotected intercourse were involved and randomly allocated into one of the two levonorgestrel groups. A single dose of 1.5 mg of levonorgestrel (Plan B One-Step (levonorgestrel tablet) ) was administered to women allocated into group 1. Two doses of 0.75 mg levonorgestrel 12 hours apart (Plan B) were administered to women in group 2. In the Plan B One-Step (levonorgestrel tablet) group, 16 pregnancies occurred in 1,198 women and in the Plan B group, 20 pregnancies occurred in 1,183 women. The number of pregnancies expected in each group was calculated based on the timing of intercourse with regard to each woman's menstrual cycle. Among women receiving Plan B One-Step (levonorgestrel tablet) , 84% of expected pregnancies were prevented and among those women taking Plan B, 79% of expected pregnancies were prevented. The expected pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with Plan B One-Step (levonorgestrel tablet) .

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 INDICATIONS AND USAGE].

In the clinical study, bleeding disturbances were the most common adverse event reported after taking the levonorgestrel-containing regimens. More than half of the women had menses within two days of the expected time; however, 31% of women experienced change in their bleeding pattern during the study period; 4.5% of women had menses more than 7 days after the expected time.

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Plan B One-Step
(levonorgestrel) Tablet, 1.5 mg, for Oral Use

What is Plan B® One-Step?

Plan B® One-Step is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and is not to be used routinely.

Plan B® One-Step can reduce your chance of pregnancy after unprotected sex (if your regular birth control was used incorrectly or fails, or if you have had sex without birth control). For example, if you were using a condom and it broke or slipped, if you did not use your regular birth control as you should have, or if you did not use any birth control, Plan B® One-Step may work for you.

What Plan B® One-Step is not.

Plan B® One-Step will not work if you are already pregnant and will not affect an existing pregnancy. Plan B® One-Step should not be used as regular birth control. It is important to have another reliable source of birth control that is right for you. Plan B® One-Step will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases.

When is the appropriate time to use Plan B® One-Step?

You can use Plan B® One-Step after you have had unprotected sex in the last 72 hours (3 days), and you do not want to become pregnant.

Plan B® One-Step can be used as a backup or emergency method to regular birth control if, for example,

  • Your regular birth control method was used incorrectly or failed (your partner's condom broke or slipped)
  • You made a mistake with your regular method
  • You did not use any birth control method

When is it not appropriate to use Plan B® One-Step?

  • Plan B® One-Step 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® One-Step is a backup or emergency method of contraception.
  • Plan B® One-Step should not be used if you are already pregnant because it will not work.
  • Plan B® One-Step should not be used if you are allergic to levonorgestrel or any other ingredients in Plan B® One-Step.
  • Plan B® One-Step 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 does Plan B® One-Step work?

Plan B® One-Step is one pill with levonorgestrel, a hormone that has been used in many birth control pills for over 35 years. Plan B® One-Step contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Plan B® One-Step 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).

How can I get the best results from Plan B® One-Step?

You have only a few days to try to prevent pregnancy after unprotected sex. The sooner you take Plan B® One-Step, the better it works. Plan B® One-Step should be taken as soon as possible within 72 hours (3 days) after unprotected sex.

How effective is Plan B® One-Step?

The sooner you take Plan B® One-Step, the better it will work. Take Plan B® One-Step as soon as possible after unprotected sex. If it is taken as soon as possible within 72 hours (3 days) after unprotected 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.

How will I know if Plan B® One-Step 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. You should get a pregnancy test and follow up with your healthcare professional.

What if I am already pregnant and use Plan B® One-Step?

There is no medical evidence that Plan B® One-Step would harm a developing baby. If you take Plan B® One-Step (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. The pregnancy will continue. Plan B® One-Step will not work if you are already pregnant.

What should I do if my menstrual period is delayed beyond 1 week and I have severe lower stomach (abdominal) pain?

If you have severe lower stomach (abdominal) pain about 3 to 5 weeks after taking Plan B® One-Step, you may have a pregnancy outside the uterus, which is called a tubal pregnancy. A tubal pregnancy requires immediate medical treatment, so you should see a healthcare professional right away.

Can I use Plan B® One-Step for regular birth control?

No. Plan B® One-Step should not be used for regular birth control. It is an emergency or backup method to be used if your regular birth control fails or is used incorrectly or if you have sex without birth control. You should protect yourself against STDs and pregnancy every time you have sex. If you have unprotected sex again after taking Plan B® One-Step, it will not help protect you from getting pregnant.

How often can I use Plan B® One-Step?

Plan B® One-Step is meant for emergency protection only, and is not designed to be used frequently. If you find that you need to use emergency contraception often, talk to your healthcare professional and learn about methods of birth control and STD prevention that are right for you.

Will I experience any side effects from Plan B® One-Step?

When used as directed, Plan B® One-Step is safe for women. Some women will have mild, temporary side effects, such as menstrual changes, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, breast pain and vomiting. These are similar to the side effects that some women have when taking regular birth control pills. Some women taking Plan B® One-Step will 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.

What warnings should I know about when using Plan B® One-Step?

Plan B® One-Step does not protect against the AIDS virus (HIV) or other sexually transmitted diseases (STDs).

Do not use:

  • If you are already pregnant (because it will not work)
  • If you are allergic to levonogestrel or any of the ingredients in Plan B® One-Step
  • For regular birth control

When using this product, you may have:

  • Menstrual changes
  • Nausea
  • Lower stomach (abdominal) pain
  • Tiredness
  • Headache
  • Dizziness
  • Breast pain
  • Vomiting

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

What are the directions for using Plan B® One-Step?

Women 17 years of age and older:

  • Take Plan B® One-Step as soon as possible within 72 hours (3 days) after unprotected sex.
  • If you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

Prescription only for women younger than age 17. If you are younger than age 17, see a healthcare professional.

What should I do if I have questions about Plan B® One-Step?

If you have questions or need more information about this product, call our toll-free number, 1-800-330-1271, visit our website at www.PlanBOneStep.com, or ask a healthcare professional.

Other information

Tablet is enclosed in a blister seal. Do not use if the blister seal is broken.

Store at room temperature 20 –25 °C (68 –77 °F).

You may report side effects to FDA at 1-800-FDA-1088.

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, potato starch, magnesium stearate, talc, corn starch, lactose monohydrate

Protect yourself in more ways than one!

If you are sexually active, but you are not ready for a pregnancy, it is important to use regular pregnancy protection. There are many types of birth control. Whichever type you choose, it is important to use your regular birth control method as directed. This ensures that you have effective protection against pregnancy every time you have sex.

But things do not always go as planned. For example, if you were using a condom and it broke or slipped, or if you did not use your regular birth control as you should have, or if you did not use any birth control, Plan B® One-Step may work for you. Plan B® One-Step is an emergency contraceptive that helps prevent pregnancy after unprotected sex or when your birth control fails or is not used correctly.

Remember, Plan B® One-Step is only for emergency pregnancy prevention. There are many other products that work for regular birth control that are available by prescription or over-the-counter.

There is also another form of protection to think about when you have sex: protection against sexually transmitted diseases (STDs). Some common STDs are HIV/AIDS, chlamydia, genital herpes, gonorrhea, hepatitis, human papilloma virus (HPV), genital warts, syphilis, and trichomonas. Some of these STDs can be very serious and can lead to infertility (inability to have a baby), problems during pregnancy, chronic illness, and even death.

All sexually active women are at risk of catching STDs because they may not know that their partner has an STD (the partner himself may not know). If your partner uses a latex condom correctly each and every time you have sex with him, this will help reduce, but not eliminate, the chance that you will catch an STD.

No other birth control methods will effectively protect you from STDs. The female condom may give you some STD protection, but it is not as effective as a male latex condom.

For more information on STDs, call the Centers for Disease Control and Prevention (CDC) AIDS/STD Hotline. The CDC phone numbers are 1-800-342-AIDS (2437) for English, 1-800-344-7432 for Spanish, or 1-800-243-7889 for hearing impaired, TDD.

Be sure to protect yourself against pregnancy and STDs by using some form of birth control plus a latex condom. Of course, not having sex is the most effective way to prevent pregnancy and stay free of STDs.

Plan B® One-Step is used to prevent pregnancy after unprotected sex.

Plan B® One-Step should not be used for regular birth control, if you are already pregnant (because it will not work), or if you are allergic to levonorgestrel or any of the ingredients in Plan B® One-Step.

The sooner you take Plan B® One-Step, the better it will work.

Plan B® One-Step does not protect against the AIDS virus (HIV) or other sexually transmitted diseases (STDs)

Common side effects associated with the use of Plan B® One-Step include menstrual changes, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, breast pain and vomiting.

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Plan B One-Step
(levonorgestrel) Tablet, 1.5 mg, for Oral Use

What is Plan B® One-Step?

Plan B® One-Step is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and is not to be used routinely.

Plan B® One-Step can reduce your chance of pregnancy after unprotected sex (if your regular birth control was used incorrectly or fails, or if you have had sex without birth control). For example, if you were using a condom and it broke or slipped, if you did not use your regular birth control as you should have, or if you did not use any birth control, Plan B® One-Step may work for you.

What Plan B® One-Step is not.

Plan B® One-Step will not work if you are already pregnant and will not affect an existing pregnancy. Plan B® One-Step should not be used as regular birth control. It is important to have another reliable source of birth control that is right for you. Plan B® One-Step will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases.

When is the appropriate time to use Plan B® One-Step?

You can use Plan B® One-Step after you have had unprotected sex in the last 72 hours (3 days), and you do not want to become pregnant.

Plan B® One-Step can be used as a backup or emergency method to regular birth control if, for example,

  • Your regular birth control method was used incorrectly or failed (your partner's condom broke or slipped)
  • You made a mistake with your regular method
  • You did not use any birth control method

When is it not appropriate to use Plan B® One-Step?

  • Plan B® One-Step 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® One-Step is a backup or emergency method of contraception.
  • Plan B® One-Step should not be used if you are already pregnant because it will not work.
  • Plan B® One-Step should not be used if you are allergic to levonorgestrel or any other ingredients in Plan B® One-Step.
  • Plan B® One-Step 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 does Plan B® One-Step work?

Plan B® One-Step is one pill with levonorgestrel, a hormone that has been used in many birth control pills for over 35 years. Plan B® One-Step contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Plan B® One-Step 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).

How can I get the best results from Plan B® One-Step?

You have only a few days to try to prevent pregnancy after unprotected sex. The sooner you take Plan B® One-Step, the better it works. Plan B® One-Step should be taken as soon as possible within 72 hours (3 days) after unprotected sex.

How effective is Plan B® One-Step?

The sooner you take Plan B® One-Step, the better it will work. Take Plan B® One-Step as soon as possible after unprotected sex. If it is taken as soon as possible within 72 hours (3 days) after unprotected 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.

How will I know if Plan B® One-Step 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. You should get a pregnancy test and follow up with your healthcare professional.

What if I am already pregnant and use Plan B® One-Step?

There is no medical evidence that Plan B® One-Step would harm a developing baby. If you take Plan B® One-Step (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. The pregnancy will continue. Plan B® One-Step will not work if you are already pregnant.

What should I do if my menstrual period is delayed beyond 1 week and I have severe lower stomach (abdominal) pain?

If you have severe lower stomach (abdominal) pain about 3 to 5 weeks after taking Plan B® One-Step, you may have a pregnancy outside the uterus, which is called a tubal pregnancy. A tubal pregnancy requires immediate medical treatment, so you should see a healthcare professional right away.

Can I use Plan B® One-Step for regular birth control?

No. Plan B® One-Step should not be used for regular birth control. It is an emergency or backup method to be used if your regular birth control fails or is used incorrectly or if you have sex without birth control. You should protect yourself against STDs and pregnancy every time you have sex. If you have unprotected sex again after taking Plan B® One-Step, it will not help protect you from getting pregnant.

How often can I use Plan B® One-Step?

Plan B® One-Step is meant for emergency protection only, and is not designed to be used frequently. If you find that you need to use emergency contraception often, talk to your healthcare professional and learn about methods of birth control and STD prevention that are right for you.

Will I experience any side effects from Plan B® One-Step?

When used as directed, Plan B® One-Step is safe for women. Some women will have mild, temporary side effects, such as menstrual changes, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, breast pain and vomiting. These are similar to the side effects that some women have when taking regular birth control pills. Some women taking Plan B® One-Step will 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.

What warnings should I know about when using Plan B® One-Step?

Plan B® One-Step does not protect against the AIDS virus (HIV) or other sexually transmitted diseases (STDs).

Do not use:

  • If you are already pregnant (because it will not work)
  • If you are allergic to levonogestrel or any of the ingredients in Plan B® One-Step
  • For regular birth control

When using this product, you may have:

  • Menstrual changes
  • Nausea
  • Lower stomach (abdominal) pain
  • Tiredness
  • Headache
  • Dizziness
  • Breast pain
  • Vomiting

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

What are the directions for using Plan B® One-Step?

Women 17 years of age and older:

  • Take Plan B® One-Step as soon as possible within 72 hours (3 days) after unprotected sex.
  • If you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

Prescription only for women younger than age 17. If you are younger than age 17, see a healthcare professional.

What should I do if I have questions about Plan B® One-Step?

If you have questions or need more information about this product, call our toll-free number, 1-800-330-1271, visit our website at www.PlanBOneStep.com, or ask a healthcare professional.

Other information

Tablet is enclosed in a blister seal. Do not use if the blister seal is broken.

Store at room temperature 20 –25 °C (68 –77 °F).

You may report side effects to FDA at 1-800-FDA-1088.

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, potato starch, magnesium stearate, talc, corn starch, lactose monohydrate

Protect yourself in more ways than one!

If you are sexually active, but you are not ready for a pregnancy, it is important to use regular pregnancy protection. There are many types of birth control. Whichever type you choose, it is important to use your regular birth control method as directed. This ensures that you have effective protection against pregnancy every time you have sex.

But things do not always go as planned. For example, if you were using a condom and it broke or slipped, or if you did not use your regular birth control as you should have, or if you did not use any birth control, Plan B® One-Step may work for you. Plan B® One-Step is an emergency contraceptive that helps prevent pregnancy after unprotected sex or when your birth control fails or is not used correctly.

Remember, Plan B® One-Step is only for emergency pregnancy prevention. There are many other products that work for regular birth control that are available by prescription or over-the-counter.

There is also another form of protection to think about when you have sex: protection against sexually transmitted diseases (STDs). Some common STDs are HIV/AIDS, chlamydia, genital herpes, gonorrhea, hepatitis, human papilloma virus (HPV), genital warts, syphilis, and trichomonas. Some of these STDs can be very serious and can lead to infertility (inability to have a baby), problems during pregnancy, chronic illness, and even death.

All sexually active women are at risk of catching STDs because they may not know that their partner has an STD (the partner himself may not know). If your partner uses a latex condom correctly each and every time you have sex with him, this will help reduce, but not eliminate, the chance that you will catch an STD.

No other birth control methods will effectively protect you from STDs. The female condom may give you some STD protection, but it is not as effective as a male latex condom.

For more information on STDs, call the Centers for Disease Control and Prevention (CDC) AIDS/STD Hotline. The CDC phone numbers are 1-800-342-AIDS (2437) for English, 1-800-344-7432 for Spanish, or 1-800-243-7889 for hearing impaired, TDD.

Be sure to protect yourself against pregnancy and STDs by using some form of birth control plus a latex condom. Of course, not having sex is the most effective way to prevent pregnancy and stay free of STDs.

Plan B® One-Step is used to prevent pregnancy after unprotected sex.

Plan B® One-Step should not be used for regular birth control, if you are already pregnant (because it will not work), or if you are allergic to levonorgestrel or any of the ingredients in Plan B® One-Step.

The sooner you take Plan B® One-Step, the better it will work.

Plan B® One-Step does not protect against the AIDS virus (HIV) or other sexually transmitted diseases (STDs)

Common side effects associated with the use of Plan B® One-Step include menstrual changes, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, breast pain and vomiting.

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

Plan B One-Step
(levonorgestrel) Tablet, 1.5 mg, for Oral Use

DRUG DESCRIPTION

The Plan B One-Step (levonorgestrel tablet) tablet contains 1.5 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17 α)-(-)-], a totally synthetic progestogen. The inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc.

Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:

Plan B One-Step (levonorgestrel)  Structural Formula Illustration

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

Plan B One-Step
(levonorgestrel) Tablet, 1.5 mg, for Oral Use

DRUG DESCRIPTION

The Plan B One-Step (levonorgestrel tablet) tablet contains 1.5 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17 α)-(-)-], a totally synthetic progestogen. The inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc.

Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:

Plan B One-Step (levonorgestrel)  Structural Formula Illustration

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

Plan B One-Step
(levonorgestrel) Tablet, 1.5 mg, for Oral Use

DRUG DESCRIPTION

The Plan B One-Step (levonorgestrel tablet) tablet contains 1.5 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17 α)-(-)-], a totally synthetic progestogen. The inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc.

Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:

Plan B One-Step (levonorgestrel)  Structural Formula Illustration

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

Plan B One-Step Patient Information Including Side Effects

Brand Names: Next Choice, Plan B, Plan B One-Step

Generic Name: levonorgestrel emergency contraceptive (Pronunciation: LEE voe nor jes trel)

What is levonorgestrel emergency contraceptive (Plan B One-Step)?

Levonorgestrel is a female hormone that prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Levonorgestrel emergency contraceptive is used to prevent pregnancy after unprotected sex or failure of other forms of birth control (such as condom breakage, or missing 2 or more birth control pills).

Levonorgestrel emergency contraceptive may also be used for other purposes not listed in this medication guide.

What are the possible side effects of levonorgestrel emergency contraceptive (Plan B One-Step)?

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 stomach pain;
  • dizziness, tired feeling;
  • breast pain or tenderness;
  • changes in your menstrual periods; 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 1-800-FDA-1088.

Read the Plan B One-Step (levonorgestrel tablet) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about levonorgestrel emergency contraceptive (Plan B One-Step)?

Do not use this medication if you are already pregnant. Levonorgestrel emergency contraceptive will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Levonorgestrel emergency contraceptive is not intended for use as a routine form of birth control and should not be used in this manner. Talk with your doctor about the many forms of birth control available.

Do not give this medication to anyone younger than 17 years old. Contact a doctor for medical advice.

Side Effects Centers

Plan B One-Step Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking levonorgestrel emergency contraceptive (Plan B One-Step)?

Levonorgestrel emergency contraceptive is not intended for use as a routine form of birth control and should not be used in this manner. Talk with your doctor about the many forms of birth control available.

Do not use this medication if you are already pregnant. Levonorgestrel emergency contraceptive will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have diabetes. You may not be able to use levonorgestrel emergency contraceptive, or you may need special tests during treatment.

Levonorgestrel can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to anyone younger than 17 years old. Contact a doctor for medical advice.

How should I take levonorgestrel emergency contraceptive (Plan B One-Step)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

The first dose of levonorgestrel emergency contraceptive must be taken as soon as possible after unprotected sex (no later than 72 hours afterward). The second dose must be taken 12 hours after the first dose. The timing of these doses is very important for this medication to be effective.

Call your doctor right away if you vomit within 1 hour after taking either dose of levonorgestrel emergency contraceptive. Do not take another dose until you talk with your doctor.

You should be examined by your doctor within 3 weeks after taking levonorgestrel emergency contraceptive. The doctor will need to confirm that you are not pregnant and that this medication has not caused any harmful effects.

If your period is late by 1 week or longer after the expected date, you may be pregnant. Get a pregnancy test and contact your doctor if you are pregnant. Levonorgestrel emergency contraceptive will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Store levonorgestrel emergency contraceptive at room temperature away from moisture and heat.

Side Effects Centers

Plan B One-Step Patient Information including If I Miss a Dose

What happens if I miss a dose (Plan B One-Step)?

Missing a dose of this medication increases your risk of being pregnant.

Contact your doctor if you miss a dose of levonorgestrel emergency contraceptive. The timing of these doses is very important for this medication to be effective.

What happens if I overdose (Plan B One-Step)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea and vomiting.

What should I avoid while taking levonorgestrel emergency contraceptive (Plan B One-Step)?

Levonorgestrel emergency contraceptive will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases. Avoid having unprotected sex.

What other drugs will affect levonorgestrel emergency contraceptive (Plan B One-Step)?

Before using this medication, tell your doctor if you are using any of the following drugs:

  • rifampin (Rifadin, Rifater, Rifamate, Rimactane);
  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
  • seizure medicines such as phenytoin (Dilantin), or carbamazepine (Tegretol).

This list is not complete and there may be other drugs that can affect levonorgestrel emergency contraceptive. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about levonorgestrel emergency contraceptive.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.08. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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