NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE kit

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Mylan Pharmaceuticals Inc.

DCI (Dénomination commune internationale):

ETHINYL ESTRADIOL

Composition:

ETHINYL ESTRADIOL 0.025 mg

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets (chewable) 75 mg are indicated for use by women to prevent pregnancy. The efficacy of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets (chewable) 75 mg in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated. Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are contraindicated in females who are known to have or develop 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. Women who do not breastfeed may start COCs no earlier than four weeks postpartum. When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing OCs 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 and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) 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 and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) have not been studied in postmenopausal women and is not indicated in this population. The pharmacokinetics of norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) have not been studied in subjects with renal impairment. No studies have been conducted to evaluate the effect of hepatic disease on the disposition of norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable). However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal [see Contraindications (4), and Warnings and Precautions (5.3)]. The safety and efficacy of norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) in women with a BMI > 35 kg/m2 have not been evaluated.

Descriptif du produit:

Norethindrone and Ethinyl Estradiol Tablets (chewable) 0.8 mg/0.025 mg and Ferrous Fumarate Tablets (chewable) 75 mg are available in cartons of 3 pouches (NDC 0378-7308-53); each pouch contains a blister pack of 28 tablets. Each blister pack contains 24 dark yellow, round, flat-faced tablets debossed with 259 on one side and plain on the other side and 4 brown, round, flat-faced, tablets debossed with 310 on one side and plain on the other side. Each dark yellow tablet contains 0.8 mg norethindrone and 0.025 mg ethinyl estradiol and each brown tablet contains 75 mg ferrous fumarate.sss Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]   Keep out of reach of children.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE-
NORETHINDRONE 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 AND
ETHINYL ESTRADIOL TABLETS (CHEWABLE) AND FERROUS FUMARATE TABLETS
(CHEWABLE)
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
NORETHINDRONE AND ETHINYL
ESTRADIOL TABLETS (CHEWABLE) AND FERROUS FUMARATE TABLETS (CHEWABLE).
NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS (CHEWABLE) AND FERROUS
FUMARATE TABLETS
(CHEWABLE)
INITIAL U.S. APPROVAL: 1974
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 4/2022
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Norethindrone and Ethinyl Estradiol Tablets (chewable) and Ferrous
Fumarate Tablets (chewable) consists
of 28 tablets in the following order (3):
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•
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE NORETHINDRONE AND
ETHINYL
ESTRADIOL TABLETS (CHEWABLE) AND FERROUS FUMARATE TABLETS (CHEWABLE).
(4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
Norethindrone and ethinyl estradiol tablets (chewable) and ferrous
fumarate tablets (chewable) are
an estrogen/progestin COC indicated for use by women to prevent
pregnancy. (1)
The efficacy in women with a body mass index (BMI) of > 35 kg/m has
not been evaluated. (1, 8.8)
2
Chew one tablet without water at the same time every day. (2.1)
Take tablets in the order directed on the blister pack. (2.1)
24 dark yellow, round tablets (active) each containing 0.8 mg
norethindrone and 0.025 mg ethinyl
estradiol.
4 brown, round tablets (non-hormonal placebo) each containing 75 mg
ferrous fumarate, which does
not serve any therapeutic purpo