NEXESTA FE- norethindrone and ethinyl estradiol and ferrous fumarate kit

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Aurobindo Pharma Limited

INN (Mezinárodní Name):

NORETHINDRONE

Složení:

NORETHINDRONE 0.4 mg

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Nexesta Fe is indicated for use by females of reproductive potential to prevent pregnancy. Nexesta Fe is contraindicated in females who are known to have or develop the following conditions:  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:       o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]       o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]       o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]       o Have cerebrovascular disease [see Warnings and Precautions (5.1)]       o Have coronary artery disease [see Warnings and Precautions (5.1)]       o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]       o Have uncontrolled hypertension [see Warnings and Precaution

Přehled produktů:

Nexesta Fe (norethindrone and ethinyl estradiol tablets USP (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets (chewable)) is available in blister packs: The Blister Packs are packed in Pouches (NDC 65862-926-87) and the pouches are packaged in cartons Carton of 1 Pouch                  NDC 65862-926-87 Carton of 3 Pouches               NDC 65862-926-88 Carton of 5 Pouches              NDC 65862-926-58 Carton of 72 Pouches            NDC 65862-926-97 Each blister pack contains 28 tablets in the following order: Keep out of the reach of children.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

NEXESTA FE- NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEXESTA FE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEXESTA FE.
NEXESTA FE (NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS (CHEWABLE) AND
FERROUS FUMARATE
TABLETS (CHEWABLE)) FOR ORAL USE
INITIAL U.S. APPROVAL: 1975
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
NEXESTA FE IS 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
Warnings and Precautions (5.11) 11/2021
INDICATIONS AND USAGE
Nexesta Fe is a progestin/estrogen COC indicated for use by females of
reproductive potential to prevent
pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet by mouth at the same time every day. Tablets may be
chewed or swallowed. (2.1)
Take tablets in the order directed on the blister pack. (2.1)
DOSAGE FORMS AND STRENGTHS
Nexesta Fe consists of 28 tablets in the following order (3):
21 white to off-white tablets (active), each containing 0.4 mg
norethindrone USP and 0.035 mg ethinyl
estradiol USP
7 brown tablets (non-hormonal placebo), each containing 75 mg ferrous
fumarate USP. The ferrous
fumarate tablets do not serve any therapeutic purpose.
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Current diagnosis of, or history of, breast cancer, which may be
hormone-sensitive (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Thrombotic Disorders and Other Vascular Problems: Stop Nexesta Fe if a
thrombotic event occurs.
Stop at least 4 weeks before through 2 week