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:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

NORETHINDRONE ACETATE

Composition:

NORETHINDRONE ACETATE 1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by women 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 > 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:     ●    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 pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]         ○    Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]         ○    Have cerebrovascular disease [see Warnings and Precautions (5.1)]         ○    Have coronary artery disease

Product summary:

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets are available in blister packs containing 28 tablets: NDC 0378-7301-53 Cartons of 3 blister packs Each blister pack (28 tablets) contains in the following order:

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
Norethindrone acetate and ethinyl estradiol tablets and ferrous
fumarate tablets are a progestin/estrogen COC indicated
for use by women to prevent pregnancy. (1) The efficacy of
norethindrone acetate and ethinyl estradiol tablets and ferrous
fumarate tablets in women with a body mass index (BMI) of > 35 kg/m
has not been evaluated. (1, 8.8)
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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•
•
•
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 How to Start Norethindrone Acetate and Ethinyl Estradiol Tablets
and