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:

Akorn

INN (International Name):

Norgestimate

Composition:

Norgestimate 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norgestimate and Ethinyl Estradiol Tablets USP are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)]. 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 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 USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 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 USP 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

Product summary:

Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg) Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg) are available in a blister card: (NDC 17478-260-28). Each blister card (28 tablets) contains in the following order: Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg) are packaged in a carton (NDC 17478-260-06) containing 6 blister cards. 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) 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 a blister card (NDC 17478-261-28). Each blister card (28 tablets) contains in the following order: 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 packaged in a carton containing 6 blister cards: (NDC 17478-261-06).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL
ESTRADIOL
AKORN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORGESTIMATE AND ETHINYL
ESTRADIOL TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP.
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP ARE CONTRAINDICATED IN
WOMEN OVER
35 YEARS OLD WHO SMOKE. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVES (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications (4)
09/2017
Warnings and Precautions (5.3)
09/2017
INDICATIONS AND USAGE
Norgestimate and Ethinyl Estradiol Tablets USP are estrogen/progestin
COCs, indicated for use by women
to prevent pregnancy. (1.1)
Norgestimate and Ethinyl Estradiol Tablets USP 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 USP should be used for the
treatment of acne only if the
patient desires an oral contraceptive for birth control. (1.2)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.2)
Take tablets in the order directed on the blister pack. (2.2)
Do not skip or delay tablet intake. (2.2)
DOSAGE FORMS AND STRENGTHS
Norgestimate and Ethinyl Estradiol Tablets USP (0.25 mg/0.035 mg)
consist of 28 round tablets in the
following order (3):
21 dark blue tablets each containing 0.25 mg norgestimate and 0.035 mg
ethinyl estradiol
7 white tablets (inert)
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) consist of 28 round tablets in the following o