País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25)
Lupin Pharmaceuticals, Inc.
PRESCRIPTION DRUG
Drospirenone and ethinyl estradiol tablet USP is indicated for use by women to prevent pregnancy. Drospirenone and ethinyl estradiol tablet 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
Drospirenone and ethinyl estradiol tablets USP, 3 mg and 0.03 mg are available in a blister pack (NDC 68180-868-71) containing 28 tablets packed in a pouch (NDC 68180-868-71). Such three pouches are packaged in a carton (NDC 68180-868-73). Each blister pack contains 28 tablets in the following order: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DROSPIRENONE AND ETHINYL ESTRADIOL - DROSPIRENONE AND ETHINYL ESTRADIOL LUPIN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP. DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP, 3 MG/0.03 MG, FOR ORAL USE INITIAL U.S. APPROVAL: 2001 _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 Warnings and Precautions (5.3) 4/2022 INDICATIONS AND USAGE Drospirenone and ethinyl estradiol tablets USP 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 consists of 28, biconvex tablets in the following order (3): 21 yellow film-coated tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE), 7 inert white to off-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 (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 major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1) COCs con Leia o documento completo