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:

A-S Medication Solutions

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:

Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg are available in blister packs containing 28 tablets, as follows: NDC 68462-309-29 1 carton containing 3 blister cards 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: NDC 68462-565-29 1 carton containing 3 blister cards of 28 tablets

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL
ESTRADIOL
A-S MEDICATION SOLUTIONS
----------
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._
•
•
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
•
•
•
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):
•
•
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
Norgestimate and ethinyl estradiol tablets are contraindicated in
women over 35 years old who
smoke. (4)
Cigarette smoking increases the ri