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

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - ethinyl estradiol 0.02 mg - nikki™ (drospirenone and ethinyl estradiol tablets usp), 3 mg/0.02 mg is indicated for use by women to prevent pregnancy. nikki (drospirenone and ethinyl estradiol tablets usp), 3 mg/0.02 mg is 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. nikki (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 nikki 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:           о smoke, if over age 35 [see boxed warning and warnings and precautions (5.1) ]           о have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1) ]           о have cerebrovascular disease [se

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - ethinyl estradiol 0.02 mg - nikki™ (drospirenone and ethinyl estradiol tablets usp), 3 mg/0.02 mg is indicated for use by women to prevent pregnancy. nikki (drospirenone and ethinyl estradiol tablets usp), 3 mg/0.02 mg is 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 nikki (drospirenone and ethinyl estradiol tablets usp), 3 mg/0.02 mg 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 we

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

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

camber 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 females of reproductive potential to prevent pregnancy. drospirenone and ethinyl estradiol tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in females of reproductive potential 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

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

theramex australia pty ltd - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: lactose; hypromellose; microcrystalline cellulose; magnesium stearate; polysorbate 80; titanium dioxide; macrogol 400; allura red ac aluminium lake; brilliant blue fcf aluminium lake - seasonique is indicated for use as an oral contraceptive.

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

bryant ranch prepack - 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 lut

Kenya - English - Pharmacy and Poisons Board

sun pharmaceutical industries limited acme plaza andheri - kurla road andheri (e) - drospirenone and ethinyl estradiol - tablet - drospirenone : 3 mg ethinyl estradiol : 0.02 mg - hormonal contraceptives: fixed combinations of

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone; ethinylestradiol - film-coated tablet - 0.02 mg/ 3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - drospirenone ; ethinyl estradiol - film coated tablet - 0.02/3.0 milligram - drospirenone and ethinylestradiol

Malta - English - Medicines Authority

bayer limited 1st floor the grange offices the grange brewery road stillorgan co. dublin, a94 h2k7 , ireland - drospirenone, ethinylestradiol - film-coated tablet - drospirenone 3 mg ethinylestradiol 0.02 mg - sex hormones and modulators of the genital system