Plan B One-Step

Plan B One-Step is part of the drug class:

• Emergency contraceptives

This section provides information on the proper use of a number of products that contain progestin contraceptives. It may not be specific to Plan B One-Step. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using this medicine.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

When using levonorgestrel tablet dosage form for emergency contraception:

• The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception:

• Your injection is given by a health care professional every 3 months.
• To stop using medroxyprogesterone injection for contraception, simply do not have another injection.
• Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form:

• Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.
• Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.
• When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.
• Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection. You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Follow your doctor's orders to schedule the proper time to receive an injection of progestins for contraception.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For levonorgestrel
• For oral dosage form (tablets):
  • For emergency contraception for preventing pregnancy:
    • Adults and teenagers—The first dose of 0.75 milligram should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.

For medroxyprogesterone
• For muscular injection dosage form
  • For preventing pregnancy:
    • Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).
• For subcutaneous injection dosage form
  • For preventing pregnancy:
    • Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).

For norethindrone
• For oral dosage form (tablets):
  • For preventing pregnancy:
    • Adults and teenagers—0.35 milligrams every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.

For norgestrel
• For oral dosage form (tablets):
  • For preventing pregnancy:
    • Adults and teenagers—75 micrograms every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.

Missed Dose

Call your doctor or pharmacist for instructions.

For oral dosage form (tablets):

• When you miss 1 day's dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.

For injection dosage form:

• If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.
• If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

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 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 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.

Renal Impairment

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

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

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 51285-942-88  (1 tablet unit of use package)

Store Plan B One-Step at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Plan B One-Step tablets contain levonorgestrel, a female hormone that prevents ovulation (the release of an egg from an ovary). Levonorgestrel 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.

Plan B One-Step 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).

Plan B One-Step may also be used for other purposes not listed in this medication guide.

Do not use Plan B One-Step if you are already pregnant. Plan B One-Step will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus). Plan B One-Step 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 15 years old. Contact a doctor for medical advice.

Plan B One-Step 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. Plan B One-Step 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 Plan B One-Step, or you may need special tests during treatment.

Levonorgestrel can pass into breast milk and may harm a nursing baby. Do not use Plan B One-Step without telling your doctor if you are breast-feeding a baby. Do not give Plan B One-Step to anyone younger than 15 years old. Contact a doctor for medical advice.

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

Contact your doctor if you miss taking your dose of Plan B One-Step. The timing of the doses is very important for this medication to be effective.

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

Overdose symptoms may include nausea and vomiting.

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 Plan B One-Step. 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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.