Plan B Information
Plan b (Levonorgestrel) Indications And Usage
Plan b (Levonorgestrel) ® 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 first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet should be taken 12 hours later.
Plan b (Levonorgestrel) 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 (Levonorgestrel) is not indicated for routine use as a contraceptive.
Plan b (Levonorgestrel) Dosage And Administration
Take one tablet of Plan b (Levonorgestrel) orally 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. The second tablet should be taken 12 hours after the first dose. Plan b (Levonorgestrel) can be used at any time during the menstrual cycle.
If vomiting occurs within two hours of taking either dose of medication, consideration should be given to repeating the dose.
Plan b (Levonorgestrel) Dosage Forms And Strengths
Each Plan b (Levonorgestrel) tablet is supplied as a white, round tablet containing 0.75 mg of levonorgestrel and is marked with INOR on one side.
Plan b (Levonorgestrel) Contraindications
Plan b (Levonorgestrel) is contraindicated for use in the case of known or suspected pregnancy.
Plan b (Levonorgestrel) Warnings And Precautions
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 (Levonorgestrel) . 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 (Levonorgestrel) .
Some women may experience spotting a few days after taking Plan b (Levonorgestrel) . 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.
Plan b (Levonorgestrel) Adverse Reactions
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.
A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and safety of Plan b (Levonorgestrel) (one 0.75 mg tablet of levonorgestrel taken within 72 hours of unprotected intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets each containing 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two tablets taken 12 hours later).
The most common adverse events (>10%) in the clinical trial for women receiving Plan b (Levonorgestrel) included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%), and breast tenderness (11%). Table 1 lists those adverse events that were reported in ≥ 5% of Plan b (Levonorgestrel) users.
The following adverse reactions have been identified during post-approval use of Plan b (Levonorgestrel) . 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
General Disorders and Administration Site Conditions
Nervous System Disorders
Reproductive System and Breast Disorders
Plan b (Levonorgestrel) 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:
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.
Plan b (Levonorgestrel) Drug Abuse And Dependence
Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of Plan b (Levonorgestrel) .
Plan b (Levonorgestrel) Overdosage
There are no data on overdosage of Plan b (Levonorgestrel) , although the common adverse event of nausea and associated vomiting may be anticipated.
Plan b (Levonorgestrel) Description
Each Plan b (Levonorgestrel) 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:
Plan b (Levonorgestrel) Clinical Pharmacology
Absorption
No specific investigation of the absolute bioavailability of Plan b (Levonorgestrel) 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 (Levonorgestrel) (0.75 mg) administered to 16 women under fasting conditions, maximum serum concentrations of levonorgestrel were 14.1 + 7.7 ng/mL (mean + SD) at an average of 1.6 + 0.7 hours.
Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of Plan b (Levonorgestrel) 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, 5α-tetrahydrolevonorgestrel 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 pediatric (pre-menarcheal) 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 on pharmacokinetics of Plan b (Levonorgestrel) . However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan b (Levonorgestrel) and the Yuzpe regimen (another form of emergency contraception). The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown [see ].
Hepatic Impairment: No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan b (Levonorgestrel) .
Renal Impairment: No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan b (Levonorgestrel) .
Drug-Drug Interactions
No formal drug-drug interaction studies were conducted with Plan b (Levonorgestrel) [see ].
Plan b (Levonorgestrel) Clinical Studies
A double-blind, randomized, multinational controlled clinical trial in 1,955 evaluable women (mean age 27) compared the efficacy and safety of Plan b (Levonorgestrel) (one 0.75 mg tablet of levonorgestrel taken within 72 hours of unprotected intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets each containing 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two additional tablets taken 12 hours later). After a single act of intercourse occurring anytime during the menstrual cycle, the expected pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with Plan b (Levonorgestrel) .
Emergency contraceptives are not as effective as routine hormonal contraception since their failure rate, while low based on a single use, would accumulate over time with repeated use [see ].
At the time of expected menses, approximately 74% of women using Plan b (Levonorgestrel) had vaginal bleeding similar to their normal menses, 14% 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.
Plan b (Levonorgestrel) How Supplied/storage And Handling
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 on one side.
Available as: Unit-of-use NDC 51285-769-93
Store Plan b (Levonorgestrel) 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].
Plan b (Levonorgestrel)
Plan b (Levonorgestrel) Principal Display Panel
Plan b (Levonorgestrel) (LEVONORGESTREL)tablets 0.75 mg
2 Levonorgestrel Tablets0.75 mg each
Not for regular birth control.
1 Take as soon as possible, within 72 hours (3 days) after unprotected sex.
2 Take 12 hours after taking .
AM/PM (circle one)
Reduces the chance of pregnancy after unprotected sex (if a regular birth control method fails or after sex without birth control).
Take the first tablet as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take the first tablet, the better Plan b (Levonorgestrel) ® will work. Take the second tablet 12 hours later.
Levonorgestrel 0.75mg......................Emergency contraceptive
colloidal silicon dioxide, corn starch, gelatin, lactose monohydrate, magnesium stearate, potato starch, talc
For more information or to speak to a healthcare professional,call , 24 hours a day/7 days a week.
Visit our Web site at www.go2planb.com
Plan b (Levonorgestrel) Principal Display Panel - Clinic Pack
Plan b (Levonorgestrel) (LEVONORGESTREL)tablets 0.75 mg
2 Levonorgestrel Tablets0.75 mg each
Not for regular birth control.
1 Take as soon as possible, within 72 hours (3 days) after unprotected sex.
2 Take 12 hours after taking .
AM/PM (circle one)
Reduces the chance of pregnancy after unprotected sex (if a regular birth control method fails or after sex without birth control).
Take the first tablet as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take the first tablet, the better Plan b (Levonorgestrel) ® will work. Take the second tablet 12 hours later.
Levonorgestrel 0.75mg......................Emergency contraceptive
colloidal silicon dioxide, corn starch, gelatin, lactose monohydrate, magnesium stearate, potato starch, talc
For more information or to speak to a healthcare professional,call , 24 hours a day/7 days a week.
Visit our Web site at www.go2planb.com
