NORGESTIMATE AND ETHINYL ESTRADIOL kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

Mylan Pharmaceuticals Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norgestimate and ethinyl estradiol tablets, 0.25 mg/0.035 mg are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Do not prescribe norgestimate and ethinyl estradiol tablets to women who are known to have the following conditions: ● A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:     ○ Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]     ○ Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]     ○ Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]     ○ Have cerebrovascular disease [see Warnings and Precautions (5.1)]     ○ Have coronary artery disease [see Warnings and Precautions (5.1)]     ○ Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]   

Product summary:

Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg are available in carton of 3 pouches (NDC 0378-7286-53); each pouch contains a blister pack of 28 tablets. Each blister pack contains 28 tablets in the following order: Keep this and all medications out of the reach of children.

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
COCs, 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
(greater than or equal to 2%) were:
Norgestimate and ethinyl estradiol tablets: headache/migraine,
abdominal/gastrointestinal pain, vaginal infection, genital
discharge, breast issues (including breast pain, discharge, and
enlargement), mood disorders (including depression and
mood altered), flatulence, nervousness, rash. (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
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 9