United States - English - NLM (National Library of Medicine)

pharmaceutics international, inc. (pii) - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - 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

United States - English - NLM (National Library of Medicine)

apotex corp. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. do not prescribe drospirenone and ethinyl estradiol tablets 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 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 uncontrolled hypertension [see warnings and precautions (5.5)]

United States - English - NLM (National Library of Medicine)

nivagen pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - 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 luteal

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - drospirenone,ethinylestradiol -

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 0.03 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; polacrilin potassium - drospirenone/ethinyloestradiol-alphapharm 3/30 is indicated for use as an oral contraceptive.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone ethinylestradiol - film coated tablet - 0.03 / 3 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone ethinylestradiol - film coated tablet - 0.02 / 3 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - drospirenone ethinylestradiol - film coated tablet - 0.03 / 3 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone ethinylestradiol - film coated tablet - 0.02 / 3 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone ethinylestradiol - film coated tablet - 0.03 / 3 milligram