Country: United States
Language: English
Source: NLM (National Library of Medicine)
DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Nivagen Pharmaceuticals, Inc.
DROSPIRENONE
DROSPIRENONE 3 mg
PRESCRIPTION DRUG
Drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. Do not prescribe drospirenone and ethinyl estradiol tablets 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 (5.5)] Have d
Drospirenone and ethinyl estradiol tablets contain 28 tablets in a blister card (NDC 75834-115-84). Each blister card contains, in the following order, 21 yellow tablets and 7 white tablets. Each round, biconvex, yellow tablet (debossed with "Y2" on one side) contains 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE). Each round, biconvex, white tablet (debossed with "P" on one side and "N " on the other side) contains inert ingredients. Drospirenone and ethinyl estradiol tablets are available in the following packaging configuration: Carton of 3 blister cards NDC 75834-115-29 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DROSPIRENONE AND ETHINYL ESTRADIOL - DROSPIRENONE AND ETHINYL ESTRADIOL NIVAGEN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, 3 MG/0.03 MG, 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 DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS. (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 Drospirenone and ethinyl estradiol tablets are 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 Drospirenone and ethinyl estradiol tablets consist of 28 film-coated, biconvex tablets in the following order (3): 21 yellow tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE) 7 white inert 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 drospirenone and ethinyl estradiol tablets if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after Read the complete document