Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Mylan Pharmaceuticals Inc.
DROSPIRENONE
DROSPIRENONE 3 mg
PRESCRIPTION DRUG
Drospirenone and ethinyl estradiol tablets, 3 mg/0.03 mg are indicated for use by females of reproductive potential to prevent pregnancy. Drosperinone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: There is no use for contraception in pregnancy; therefore, drospirenone and ethinyl estradiol tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the fir
Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg are available in a carton of three pouches, each pouch contains a blister of 28 tablets. Each blister pack contains 28 uncoated tablets in the following order: NDC 0378-7300-53, carton of 3 pouches, each pouch containing a blister of 28 tablets. 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 MYLAN 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, FOR ORAL USE INITIAL U.S. APPROVAL: 2001 WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ • • 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 Drospirenone and ethinyl estradiol tablets are 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 • • DOSAGE FORMS AND STRENGTHS Drospirenone and ethinyl estradiol tablets consist of 28 uncoated, biconvex tablets in the following order (3): • • CONTRAINDICATIONS • • • • • • • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS The most frequent adverse reactions (≥ 2%) are premenstrual syndrome (13.2%), headache /migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%), abdominal pain/tenderness/discomfort (2.3%), mood changes (2.3%). (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679 (1-877-4-INFO- RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH DRUG INTERACTIONS Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. (7.1) USE IN SPECIFIC POPULATIONS Lactation: Can reduce milk production in breast-feeding females (8.2) SEE 17 FOR PATIEN Olvassa el a teljes dokumentumot