Levonorgestrel (oral)

Levonorgestrel (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Overview

Levonorgestrel (oral) is an emergency contraceptive that is FDA approved for the prophylaxis 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.. Common adverse reactions include menstrual bleeding, nausea, lower abdominal pain, fatigue, headache, and dizziness..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Emergency Contraceptive

• Dosage: Taken 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. Each round tablet containing 1.5 mg of levonorgestrel.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Levonorgestrel in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levonorgestrel in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Levonorgestrel (oral) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Levonorgestrel in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levonorgestrel in pediatric patients.

Contraindications

There is limited information regarding Levonorgestrel (oral) Contraindications in the drug label.

Warnings

There is limited information regarding Levonorgestrel (oral) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Levonorgestrel (oral) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Levonorgestrel (oral) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Levonorgestrel (oral) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Levonorgestrel (oral) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Levonorgestrel (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Levonorgestrel (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Levonorgestrel (oral) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Levonorgestrel (oral) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Levonorgestrel (oral) in geriatric settings.

Gender

There is no FDA guidance on the use of Levonorgestrel (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Levonorgestrel (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Levonorgestrel (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Levonorgestrel (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Levonorgestrel (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Levonorgestrel (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Levonorgestrel (oral) Administration in the drug label.

Monitoring

There is limited information regarding Levonorgestrel (oral) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Levonorgestrel (oral) and IV administrations.

Overdosage

There is limited information regarding Levonorgestrel (oral) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Levonorgestrel (oral) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Levonorgestrel (oral) Mechanism of Action in the drug label.

Structure

There is limited information regarding Levonorgestrel (oral) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Levonorgestrel (oral) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Levonorgestrel (oral) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Levonorgestrel (oral) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Levonorgestrel (oral) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Levonorgestrel (oral) How Supplied in the drug label.

Storage

There is limited information regarding Levonorgestrel (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Levonorgestrel (oral) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Levonorgestrel interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Levonorgestrel (oral) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Levonorgestrel (oral) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Levonorgestrel (oral)

Clinical data
Pregnancy category	X
Routes of administration	Implant; insert (extended-release); oral
ATC code	G03AC03 (WHO)
Pharmacokinetic data
Bioavailability	~100%
Protein binding	55%
Metabolism	Hepatic
Elimination half-life	36 ± 13 hours
Excretion	Renal: 45%; Fecal:32%
Identifiers
IUPAC name 13-ethyl-17-ethynyl-17-hydroxy- 1,2,6,7,8,9,10,11,12,13,14,15,16, 17- tetradecahydrocyclopenta[a] phenanthren-3-one
CAS Number	797-63-7
PubChem CID	13109
DrugBank	APRD00754
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C21H28O2
Molar mass	312.446 g/mol

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List of terms related to Levonorgestrel (oral)

Levonorgestrel (or l-norgestrel or D-norgestrel) is a synthetic progestogen used as an active ingredient in some hormonal contraceptives.

Chemistry

Chemically, it is a hormonally active levorotatory enantiomer of the racemic mixture norgestrel. It is a gonane progestin derived from 19-nortestosterone.

Its in vitro relative binding affinities at human steroid hormone receptors are: 323% that of progesterone at the progesterone receptor, 58% that of testosterone at the androgen receptor, 17% that of aldosterone at the mineralocorticoid receptor, 7.5% that of cortisol at the glucocorticoid receptor, and <0.02% that of estradiol at the estrogen receptor.

Usage

Main article: birth control

Oral contraceptives

At low doses, levonorgestrel is used in monophasic and triphasic formulations of combined oral contraceptive pills, with available monophasic doses ranging from 100-250 µg, and triphasic doses of 50 µg/75 µg/125 µg.

At very low daily dose of 30 µg, levonorgestrel is used in some progestogen only pill formulations.

Emergency contraception

Levonorgestrel is used in emergency contraceptive pills (ECPs), both in a combined Yuzpe regimen which includes estrogen, and as a levonorgestrel-only method. The levonorgestrel-only method uses levonorgestrel 1500 μg (as a single dose or as two 750 μg doses 12 hours apart) taken within 3 days of unprotected sex. There are many brand names of levonorgestrel-only ECPs, including: Plan B, Levonelle, NorLevo, Postinor-2, and 72-HOURS.

IUD

Levonorgestrel is the active ingredient in Mirena.

Contraceptive implants

Levonorgestrel is the active ingredient in Norplant and Jadelle.

External links

• Levonelle manufacturer's product information from Schering
• Monograph for levonorgestrel - Uk Medicines Information