NORGESTIMATE AND ETHINYL ESTRADIOL- norgestimate and ethinyl estradiol

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:

Preferred 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, 0.25 mg/0.035 mg and 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)]. Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg 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, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg 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

Product summary:

NDC 68788-7302-2 1 blister card of 28 tablets Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are available in blister packs containing 28 tablets, as follows:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL ESTRADIOL
PREFERRED 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, 0.25 MG/0.035 MG, FOR ORAL
USE
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, 0.18 MG/0.035 MG, 0.215
MG/0.035 MG, 0.25 MG/0.035 MG,
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 0.18 mg/0.035 mg, 0.215
mg/0.035 mg, 0.25 mg/0.035 mg 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 0.18 mg/0.035 mg, 0.215
mg/0.035 mg, 0.25 mg/0.035 mg 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 USP, 0.25 mg/0.035 mg,
consist of 28 round, flat faced beveled edged,
uncoated tablets in the following order (3):
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•
Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg,
0.215 mg/0.035 mg, 0.25 mg/0.035 mg, consist of 28
round, flat faced beveled edged, uncoated tablets in the following
order (3):
•
•
•
•
CONTRAINDICATIONS
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•
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Norgestimate and ethinyl estradiol tablets are contraindicated in
women over 35 years old who smoke. (4)
Cigarette smokin