NORGESTIMATE AND ETHINYL ESTRADIOL

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.18 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL ESTRADIOL
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORGESTIMATE AND ETHINYL
ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR NORGESTIMATE AND
ETHINYL ESTRADIOL TABLETS.
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.3) 08/2017
INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets are estrogen/progestin COC,
indicated for use by women to prevent pregnancy.
(1.1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Norgestimate and ethinyl estradiol tablets consist of 28 round,
flat-faced, beveled edge tablets in the following order (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions reported during clinical trials
(≥2%) were: headache/migraine, nausea/vomiting,
breast issues, abdominal pain, menstrual disorders, mood disorders,
acne, vulvovaginal infection, abdominal distension,
weight increased, fatigue. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes including CYP3A4,
may decrease the effectiveness of COCs or
increase breakthrough bleeding. Counsel patients to use a back-up or
alternative method of contraception when enzyme
inducers are used with COCs. (7.1)
USE IN SPECIFIC POPULATIONS
Nursing mothers: Not recommended; can decrease milk production. (8.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2018
FULL PRESCRIBI