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, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Norgestimate and ethinyl estradiol tablets are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)] . Do not prescribe norgestimate and ethinyl estradiol tablets to women who are known to have the following conditions: There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects

Product summary:

Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg are available in carton of 3 pouches (NDC 0378-7293-53); 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)
Norgestimate and ethinyl estradiol tablets are also indicated for the
treatment of moderate acne vulgaris in females at least
15 years of age, who have no known contraindications to oral
contraceptive therapy and have achieved menarche.
Norgestimate and ethinyl estradiol tablets should be used for the
treatment of acne only if the patient desires an oral
contraceptive for birth control. (1.2)
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:
Norgestimate and ethinyl estradiol tablets: headache/migraine, breast
issues (including breast pain, enlargement, and
discharge), vaginal infection, abdominal/gastrointestinal pain, mood
disorders (including mood alteration and depression),
genital discharge, changes in weight (including weight increased or
decreased). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088