Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
Drospirenone (UNII: N295J34A25) (Drospirenone - UNII:N295J34A25), Ethinyl Estradiol (UNII: 423D2T571U) (Ethinyl Estradiol - UNII:423D2T571U)
Pharmaceutics International, Inc. (Pii)
Drospirenone
Drospirenone 3 mg
ORAL
PRESCRIPTION DRUG
Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are indicated for use by women to prevent pregnancy. Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Do not prescribe Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg 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 Warnin
Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are available in packages of three blister packs (NDC 61916- 090- 30). The film- coated tablets are rounded with “P” debossed on one side. Each blister pack (28 film- coated tablets) contains in the following order: Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DROSPIRENONE AND ETHINYL ESTRADIOL- DROSPIRENONE AND ETHINYL ESTRADIOL PHARMACEUTICS INTERNATIONAL, INC. (PII) ---------- 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, 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, USP 3 MG/0.02 MG (4). CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4) RECENT MAJOR CHANGES Warnings and Precautions, Hyperkalemia (5.2) 6/2015 INDICATIONS AND USAGE Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are an estrogen/progestin COC, indicated for use by women to: Prevent pregnancy. (1.1) Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3) 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, USP 3 mg/0.02 mg consist of 28 film-coated, biconvex tablets in the following order (3): 24 pink tablets, each containing 3 mg drospirenone, USP (DRSP) (micronized) and 0.02 mg ethinyl estradiol, USP (EE) (micronize d) 4 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) WARNINGS AND PRECAUTIONS Vascular risks: Stop Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 m Leggi il documento completo