Norgestrel and Ethinyl estradiol

Norgestrel and Ethinyl estradiol
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: Deepika Beereddy, MBBS [2]

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Overview

Norgestrel and Ethinyl estradiol is an oral contraceptive agent that is FDA approved for the {{{indicationType}}} of contraception. Common adverse reactions include weight changes, abdominal pain, bloating symptom, nausea, vomiting, muscle cramps, headache, mood swings, amenorrhea, break-through bleeding, breast tenderness, discharge from nipple, disorder of menstruation, pain of breast, scanty vaginal bleeding.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Norgestrel and Ethinyl estradiol FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Norgestrel and Ethinyl estradiol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Norgestrel and Ethinyl estradiol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Norgestrel and Ethinyl estradiol 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 Norgestrel and Ethinyl estradiol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Norgestrel and Ethinyl estradiol in pediatric patients.

Contraindications

There is limited information regarding Norgestrel and Ethinyl estradiol Contraindications in the drug label.

Warnings

There is limited information regarding Norgestrel and Ethinyl estradiol Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Norgestrel and Ethinyl estradiol Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Norgestrel and Ethinyl estradiol Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Norgestrel and Ethinyl estradiol Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Norgestrel and Ethinyl estradiol during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Norgestrel and Ethinyl estradiol in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Norgestrel and Ethinyl estradiol in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Norgestrel and Ethinyl estradiol in geriatric settings.

Gender

There is no FDA guidance on the use of Norgestrel and Ethinyl estradiol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Norgestrel and Ethinyl estradiol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Norgestrel and Ethinyl estradiol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Norgestrel and Ethinyl estradiol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Norgestrel and Ethinyl estradiol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Norgestrel and Ethinyl estradiol in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Norgestrel and Ethinyl estradiol Administration in the drug label.

Monitoring

There is limited information regarding Norgestrel and Ethinyl estradiol Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Norgestrel and Ethinyl estradiol and IV administrations.

Overdosage

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

Pharmacology

File:Norgestrel and Ethinyl estradiol image.png

Mechanism of Action

Combination oral contraceptives act by suppression of gonadotrophins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which may reduce the likelihood of implantation).

Structure

Low-Ogestrel ® Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) provide an oral contraceptive regimen consisting of 21 white tablets followed by 7 peach tablets.

Each white tablet, for oral administration contains 0.3 mg of norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.

Each inactive peach tablet, for oral administration, in the 28 day regimen contains the following inactive ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

Norgestrel is a totally synthetic progestogen, insoluble in water, freely soluble in chloroform, sparingly soluble in alcohol with the chemical name (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in water, soluble in alcohol, in chloroform, in ether, in vegetable oils, and in solutions of fixed alkali hydroxides with the chemical name 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulae follow:

Therapeutic class: Oral contraceptive.

Pharmacodynamics

There is limited information regarding Norgestrel and Ethinyl estradiol Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Norgestrel and Ethinyl estradiol Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Norgestrel and Ethinyl estradiol Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Norgestrel and Ethinyl estradiol Clinical Studies in the drug label.

How Supplied

There is limited information regarding Norgestrel and Ethinyl estradiol How Supplied in the drug label.

Storage

There is limited information regarding Norgestrel and Ethinyl estradiol 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 Norgestrel and Ethinyl estradiol Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Norgestrel and Ethinyl estradiol 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 Norgestrel and Ethinyl estradiol Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Norgestrel and Ethinyl estradiol 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.