ZUMANDIMINE- drospirenone and ethinyl estradiol kit

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Prieinama:

Aurobindo Pharma Limited

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Zumandimine® (drospirenone and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy. Zumandimine is contraindicated in females who are known to have or develop the following conditions: - 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 hyper

Produkto santrauka:

Zumandimine (drospirenone and ethinyl estradiol) tablets, USP are light pink to pink, round, flat faced, beveled-edge tablets, debossed with “S” on one side and “76” on other side. Each green, round, mottled, flat faced beveled-edge, uncoated tablets are debossed with “S” on one side and “37” on other side. They are available in blister packs of 28 tablets each. The blister packs are available in the following packages:                 Carton of 1 Pouch                               NDC 59651-030-87                 Carton of 3 Pouches                           NDC 59651-030-88                 Carton of 1 Blister Pack                  NDC 59651-030-28                 Carton of 3 Blister Packs                 NDC 59651-030-85 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ZUMANDIMINE- DROSPIRENONE AND ETHINYL ESTRADIOL
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZUMANDIMINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZUMANDIMINE.
ZUMANDIMINE (DROSPIRENONE AND 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 ZUMANDIMINE. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Dosage and Administration (2.3) 5/2023
Contraindications, Pregnancy (4) Removed 5/2023
Warnings and Precautions, (5.11) Removed 5/2023
INDICATIONS AND USAGE
Zumandimine (drospirenone and ethinyl estradiol tablets) is a
combination of drospirenone, a progestin,
and ethinyl estradiol, an estrogen, indicated for use by females of
reproductive potential 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
Zumandimine (drospirenone and ethinyl estradiol tablet, USP) consists
of 28 tablets in the following order
(3):
21 light pink to pink tablets, each containing 3 mg drospirenone
(DRSP) and 0.03 mg ethinyl estradiol
(EE)
7 inert green 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 (4)
Liver tumors or liver disease (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir, paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop Zumandimine if a thrombotic event occurs. Stop at
least 4 weeks before and
through 2 weeks after major surgery. Start no earlier than 4 weeks