NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE- norethindrone acetate and ethinyl estradiol and ferrous fumara

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

ETHINYL ESTRADIOL

Composition:

ETHINYL ESTRADIOL 20 ug

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)] . The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated. Do not prescribe norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate 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) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during preg

Product summary:

Norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fumarate tablets, 75 mg are available in blister packs containing 28 tablets: NDC 0378-7315-53 Carton of 3 blister packs Each blister pack contains 28 tablets in the following order: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep this drug and all drugs out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE-
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORETHINDRONE ACETATE AND
ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NORETHINDRONE ACETATE AND ETHINYL
ESTRADIOL TABLETS AND
FERROUS FUMARATE TABLETS.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS
FUMARATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1968
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 (5.3) 08/2017
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Norethindrone acetate and ethinyl estradiol tablets, USP and ferrous
fumarate tablets consist of 28 tablets in the following
order (3):
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CONTRAINDICATIONS
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WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE NORETHINDRONE ACETATE
AND ETHINYL ESTRADIOL
TABLETS AND FERROUS FUMARATE TABLETS (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE (4)
Norethindrone acetate and ethinyl estradiol tablets and ferrous
fumarate tablets are an estrogen/progestin COC
indicated for use by women to prevent pregnancy (1)
The efficacy in women with a body mass index of more than 35 kg/m2 has
not been evaluated (1, 8.8)
One tablet daily chewed and swallowed or swallowed whole taken at the
same time of day. Follow with 8 ounces of
water (2.1)
Take one tablet by mouth at the same time every day for 28 days (2.1)
Take tablets in the order directed on the blister pack (2.1)
Tablets may be administered without regard to meals (12.3)
24 white to off-white chewable tablets (active), each containing 1 mg
norethindrone acetate and 20 mcg ethi