ZARAH- drospirenone and ethinyl estradiol kit

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Drospirenone (UNII: N295J34A25) (Drospirenone - UNII:N295J34A25), Ethinyl Estradiol (UNII: 423D2T571U) (Ethinyl Estradiol - UNII:423D2T571U)

Disponible desde:

Mayne Pharma Inc.

Designación común internacional (DCI):

Drospirenone

Composición:

Drospirenone 3 mg

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Zarah® (drospirenone/ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. Do not prescribe Zarah to women who are known to have the following: - Renal impairment - Adrenal insufficiency - 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 cerebrovascular disease [see Warnings and Precautions (5.1)] Have coronary artery disease [see Warnings and Precautions (5.1)] 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)] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] Have uncontrolled hypertension [see Warnings and Precautions (5.6)] Have diabetes mellitus

Resumen del producto:

Zarah (drospirenone/ethinyl estradiol tablets) is available in packages of three blister packs (NDC 51862-036-03). The tablets are round and unscored, one side is embossed with "981 " or "983 ". Each blister pack contains 28 round, unscored tablets in the following order: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ZARAH- DROSPIRENONE AND ETHINYL ESTRADIOL
MAYNE PHARMA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZARAH SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZARAH.
ZARAH® (DROSPIRENONE/ETHINYL ESTRADIOL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE ZARAH. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications (4)
08/2017
Warnings and Precautions (5.5)
08/2017
INDICATIONS AND USAGE
Zarah is an estrogen/progestin COC indicated for use by women to
prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the blister pack. (2.1)
DOSAGE FORMS AND STRENGTHS
Zarah consists of 28 round, unscored tablets in the following order
(3):
21 blue tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg
ethinyl estradiol (EE)
7 inert peach tablets
CONTRAINDICATIONS
Renal impairment (4)
Adrenal insufficiency (4)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Pregnancy (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir, paritaprevir/ritonavir, with or without
dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop Zarah if a thrombotic event occurs. Stop at least
4 weeks before and through 2 weeks after major
surgery. Start no earlier than 4 weeks after delivery, in women who
are not breastfeeding. (5.1) COCs containing DRSP
may be associated with a higher risk of venous thromboembolism (VTE)
than COCs containing levonorgestrel or some
other progestins. Before initiating Zarah i