NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE kit

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Glenmark Pharmaceuticals Inc., USA

INN (International namn):

NORETHINDRONE ACETATE

Sammansättning:

NORETHINDRONE ACETATE 1 mg

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 pregnancy to treat threatened or habitual abortion. When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. Safety and efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets have been established in women of reproductive age. Efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets has not been studied in postmenopausal women and is not indicated in this population. The pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets has not been studied in subjects with renal impairment. The pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [see Contraindications (4) and Warnings and Precautions (5.2)]. The safety and efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) greater than 35 kg/m2 has not been evaluated [see Clinical Studies (14)].

Produktsammanfattning:

Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets USP are available in blister cards (dispensers) containing 28 tablets: NDC 68462-376-29 Cartons of 3 blister cards (dispensers) Each blister card contains 28 tablets in the following order: Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Keep this drug and all drugs out of the reach of children.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE-
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
GLENMARK PHARMACEUTICALS INC., USA
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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
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 USP 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)
Contraindications (4) 08/2017
Warnings (5.3) 08/2017
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/m has
not been evaluated (1, 8.8)
2
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 chewable tablets (active), each containing 1 mg norethindrone
acetate, USP and 20 mcg ethi