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)
Bryant Ranch Prepack
PRESCRIPTION DRUG
Drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. Drospirenone and ethinyl estradiol tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of drospirenone and ethinyl estradiol tablets for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the lut
16.1 How Supplied Drospirenone and ethinyl estradiol tablets, USP are available in packages of three blister packs (NDC 63629-1931-1). The active film-coated tablets are rounded with biconvex faces, one side is debossed with 20. The placebo film-coated tablets are rounded with biconvex faces, one side is debossed with PL. Each blister pack (28 film-coated tablets) contains in the following order: • 24 active pink round, unscored, film-coated tablets debossed with a "20" on one side, each containing 3 mg drospirenone and 0.02 mg ethinyl estradiol • 4 inert white round, unscored, film-coated tablets debossed with a "PL". 16.2 Storage Store at 20° to 25°C (68º-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 BRYANT RANCH PREPACK ---------- 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 (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. (1.1) • Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2) • 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 consists of 28 film-coated, biconvex tablets in the following order (3): • 24 pink tablets, each containing 3 mg drospirenone (DRSP) and 0.02 mg ethinyl estradiol (EE) • 4 white inert tablets (3) 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) Read the complete document