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)
Physicians Total Care, Inc.
DROSPIRENONE
DROSPIRENONE 3 mg
PRESCRIPTION DRUG
Yasmin is indicated for use by women to prevent pregnancy. Do not prescribe Yasmin 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)] - 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 hypercoagulopa
Yasmin (drospirenone/ethinyl estradiol) tablets are available in blister packs (54868-4590-0). The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with DO or DP. Each blister pack contains 28 film-coated tablets in the following order: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
New Drug Application
YASMIN - DROSPIRENONE AND ETHINYL ESTRADIOL PHYSICIANS TOTAL CARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE YASMIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YASMIN. YASMIN (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 YASMIN. (4) CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4) RECENT MAJOR CHANGES Warnings and Precautions, Thromboembolic Disorders (5.1)2/2012 INDICATIONS AND USAGE Yasmin 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 Yasmin consists 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 inert white 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) WARNINGS AND PRECAUTIONS Vascular risks: Stop Yasmin 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) Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration. (5.2, 7.3) L Read the complete document