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Name:Levonorgestrelemergency Contraceptive
Manufacturer:Perrigo New York Inc
Category:Prescription Marketed Drugs


These highlights do not include all the information needed to use Levonorgestrel tablets, 0.75 mg safely and effectively. See full prescribing information for Levonorgestrel tablets, 0.75 mg. Levonorgestrel Tablets, 0.75 mg, for oral use Initial U.S. Approval: 1982

LEVONORGESTREL EMERGENCY CONTRACEPTIVE - levonorgestrel tablet 
Perrigo New York Inc

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HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use Levonorgestrel tablets, 0.75 mg safely and effectively. See full prescribing information for Levonorgestrel tablets, 0.75 mg.

Levonorgestrel Tablets, 0.75 mg, for oral use

Initial U.S. Approval: 1982


INDICATIONS AND USAGE

Levonorgestrel tablets, 0.75 mg is a progestin-only emergency contraceptive, indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Levonorgestrel tablets, 0.75 mg is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Levonorgestrel tablets, 0.75 mg is not intended for routine use as a contraceptive. (1)


DOSAGE AND ADMINISTRATION

The first tablet is 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 Levonorgestrel tablets, 0.75 mg is taken as soon as possible after unprotected intercourse. (2)


DOSAGE FORMS AND STRENGTHS

A total of two 0.75 mg tablets taken 12 hours apart as a single course of treatment. (3)


CONTRAINDICATIONS

Known or suspected pregnancy. (4)


WARNINGS AND PRECAUTIONS

  • Ectopic Pregnancy: Women who become pregnant or complain of lower abdominal pain after taking Levonorgestrel tablets, 0.75 mg should be evaluated for ectopic pregnancy. (5.1)
  • Levonorgestrel tablets, 0.75 mg is not effective in terminating an existing pregnancy. (5.2)
  • Effect on menses: Levonorgestrel tablets, 0.75 mg may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be considered. (5.3)
  • STI/HIV: Levonorgestrel tablets, 0.75 mg does not protect against STI/HIV. (5.4)

ADVERSE REACTIONS

The most common adverse reactions (> 10%) in the clinical trial included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%), and breast tenderness (11%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Call 1-800-719-9260, or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch


DRUG INTERACTIONS

Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of progestin-only pills. (7)


USE IN SPECIFIC POPULATIONS

  • Nursing Mothers: Small amounts of progestin pass into the breast milk of nursing women taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma. (8.3)
  • Levonorgestrel tablets, 0.75 mg is not intended for use in premenarcheal (8.4) or postmenopausal females. (8.5)
  • Clinical trials demonstrated a higher pregnancy rate in the Chinese population. (8.6)


See 17 for PATIENT COUNSELING INFORMATION

Revised: 03/2011

FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Ectopic Pregnancy

5.2 Existing Pregnancy

5.3 Effects on Menses

5.4 STI/HIV

5.5 Physical Examination and Follow-Up

5.6 Fertility Following Discontinuation

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Race

8.7 Hepatic Impairment

8.8 Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

PRINCIPAL DISPLAY PANEL


FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Levonorgestrel tablets, 0.75 mg 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.

Levonorgestrel tablets, 0.75 mg is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.

Levonorgestrel tablets, 0.75 mg is not indicated for routine use as a contraceptive.

2 DOSAGE AND ADMINISTRATION

Take one tablet of Levonorgestrel tablets, 0.75 mg 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. The second tablet should be taken 12 hours after the first dose. Levonorgestrel tablets, 0.75 mg 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.

3 DOSAGE FORMS AND STRENGTHS

Each Levonorgestrel tablets, 0.75 mg tablet is supplied as a white to off-white circular, flat beveled, uncoated tablet debossed with “L840” on one side and plain on the other side.

4 CONTRAINDICATIONS

Levonorgestrel tablets, 0.75 mg is contraindicated for use in the case of known or suspected pregnancy.

5 WARNINGS AND PRECAUTIONS

5.1 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 Levonorgestrel tablets, 0.75 mg. 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 Levonorgestrel tablets, 0.75 mg.

5.2 Existing Pregnancy

Levonorgestrel tablets, 0.75 mg is not effective in terminating an existing pregnancy.

5.3 Effects on Menses

Some women may experience spotting a few days after taking Levonorgestrel tablets, 0.75 mg. 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.

5.4 STI/HIV

Levonorgestrel tablets, 0.75 mg does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

5.5 Physical Examination and Follow-Up

A physical examination is not required prior to prescribing Levonorgestrel tablets, 0.75 mg. 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 Levonorgestrel tablets, 0.75 mg.

5.6 Fertility Following Discontinuation

A rapid return of fertility is likely following treatment with Levonorgestrel tablets, 0.75 mg for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Levonorgestrel tablets, 0.75 mg to ensure ongoing prevention of pregnancy.

6 ADVERSE REACTIONS

6.1 Clinical Trial 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.

A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and safety of levonorgestrel tablets, 0.75 mg (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 levonorgestrel tablets, 0.75 mg 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 levonorgestrel tablets, 0.75 mg users.

Table 1: Adverse Events in ≥ 5% of Women, by % Frequency
levonorgestrel tablets, 0.75 mg
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
Vomiting 5.6
Diarrhea 5.0

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of levonorgestrel tablets, 0.75 mg. 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

7 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 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.

8 USE IN SPECIFIC POPULATIONS

8.1 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.

8.3 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 progestins-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma.

8.4 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 Levonorgestrel tablets, 0.75 mg emergency contraception before menarche is not indicated.

8.5 Geriatric Use

This product is not intended for use in postmenopausal women.

8.6 Race

No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both levonorgestrel tablets, 0.75 mg 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.

8.7 Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets, 0.75 mg.

8.8 Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets, 0.75 mg.

9 DRUG ABUSE AND DEPENDENCE

Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of levonorgestrel tablets, 0.75 mg.

10 OVERDOSAGE

There are no data on overdosage of levonorgestrel tablets, 0.75 mg, although the common adverse event of nausea and associated vomiting may be anticipated.

11 DESCRIPTION

Each 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, corn starch, lactose monohydrate, magnesium stearate, and povidone. Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:

Levonorgestre molecular formula

C21H28O2

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Emergency contraceptive pills are not effective if a woman is already pregnant. Levonorgestrel tablets, 0.75 mg 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.

12.3 Pharmacokinetics

Absorption

No specific investigation of the absolute bioavailability of levonorgestrel tablets, 0.75 mg 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 levonorgestrel tablets, 0.75 mg administered to 16 women under fasting conditions, the mean maximum serum concentration of levonorgestrel was 14.1 ng/mL at an average of 1.6 hours. See Table 2.

Table 2: Pharmacokinetic Parameter Values Following Single Dose Administration of Levonorgestrel Tablets, 0.75 mg to Healthy Female Volunteers under Fasting Conditions
Mean (± SD)
Cmax (ng/mL) Tmax (h) CL
(L/h)
Vd (L) t½ (h) AUCinf (ng•hr/mL)
levonorgestrel 14.1 (7.7) 1.6 ( 0.7) 7.7 (2.7) 260.0 24.4 (5.3) 123.1 (50.1)

Cmax = maximum concentration

Tmax = time to maximum concentration

CL = clearance

Vd = volume of distribution

t1/2 = elimination half life

AUCinf = area under the drug concentration curve from time 0 to infinity

Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of levonorgestrel tablets, 0.75 mg 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 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 on pharmacokinetics of levonorgestrel tablets, 0.75 mg. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both levonorgestrel tablets, 0.75 mg 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 USE IN SPECIFIC POPULATIONS(8.6)].

Hepatic Impairment: No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets, 0.75 mg.

Renal Impairment: No formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets, 0.75 mg.

Drug-Drug Interactions

No formal drug-drug interaction studies were conducted with levonorgestrel tablets, 0.75 mg [see DRUG INTERACTIONS (7)].

13 NONCLINICAL TOXICOLOGY

13.1 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.

14 CLINICAL STUDIES

A double-blind, randomized, multinational controlled clinical trial in 1,955 evaluable women (mean age 27) compared the efficacy and safety of levonorgestrel tablets, 0.75 mg (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 levonorgestrel tablets, 0.75 mg.

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 INDICATIONS AND USAGE (1) ].

At the time of expected menses, approximately 74% of women using levonorgestrel tablets, 0.75 mg 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

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 to off-white, circular, flat beveled, uncoated tablet debossed with “L840” on one side and plain on the other side.

Available as: Unit-of-use NDC 45802-840-54

Store Levonorgestrel tablets, 0.75 mg 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].

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

  • Take Levonorgestrel tablets, 0.75 mg 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 either 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 Levonorgestrel tablets, 0.75 mg, in order to be evaluated for an ectopic pregnancy.
  • After taking Levonorgestrel tablets, 0.75 mg, consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period.
  • Do not use Levonorgestrel tablets, 0.75 mg as routine contraception.
  • Levonorgestrel tablets, 0.75 mg is not effective in terminating an existing pregnancy.
  • Levonorgestrel tablets, 0.75 mg does not protect against HIV-infection (AIDS) and other sexually transmitted diseases/infections.
  • For women younger than age 17 years, Levonorgestrel tablets, 0.75 mg is available only by prescription.

Phone: 1-800-719-9260          Website: www.Levo4U.com

Product Made in India

DISTRIBUTED BY
PERRIGO®
ALLEGAN, MI 49010

Rev 10/09

PRINCIPAL DISPLAY PANEL

Compare to Plan B® active ingredient

Levonorgestrel tablets, 0.75 mg

Rx only for women younger than age 17

Emergency Contraceptive

Reduces the chance of pregnancy after unprotected sex (if a regular birth control method fails or after sex without birth control).

Not for regular birth control

Tablet 1

Tablet 2

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 Levonorgestrel tablets, 0.75 mg will work. Take the second tablet 12 hours later.

Levonorgesterl Tablet 0.75 mg Carton

Levonorgestrel Tablet 0.75mg Carton


LEVONORGESTREL  EMERGENCY CONTRACEPTIVE
levonorgestrel tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-840
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 0.75 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE  
STARCH, CORN  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
POVIDONE  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (circular, flat, beveled) Size 6mm
Flavor Imprint Code L840
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-840-54 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 2 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (45802-840-54)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090740 03/10/2011

Labeler - Perrigo New York Inc (078846912)

Revised: 03/2011 Perrigo New York Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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