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

bayer healthcare pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone 3 mg - beyaz® is indicated for use by females of reproductive potential to prevent pregnancy. beyaz is 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 beyaz 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 phase and remit within a few days following onset of m

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

bayer healthcare pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - yaz® is indicated for use by females of reproductive potential to prevent pregnancy.  yaz is 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 yaz 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 phase and remit within a few days following onset of mense

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

teva pharmaceuticals usa inc - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - gianvi® is indicated for use by women to prevent pregnancy. gianvi 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 gianvi 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 phase and remit within a few days following onset of menses; the disturbance markedly interferes with work

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

lupin pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone 3 mg - tydemytm is indicated for use by women to prevent pregnancy. tydemy is indicated in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. do not prescribe tydemy 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

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

aurobindo pharma limited - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - lo-zumandiminetm is indicated for use by females of reproductive potential to prevent pregnancy. lo-zumandimine is 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 lo-zumandimine 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

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

lupin australia pty limited - drospirenone; ethinylestradiol; ethinyloestradiol -

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

lupin australia pty limited - drospirenone; ethinylestradiol; ethinyloestradiol -

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

alphapharm pty ltd - ethinylestradiol, quantity: 0.02 mg; drospirenone, quantity: 3 mg - tablet - excipient ingredients: polacrilin potassium; magnesium stearate; lactose monohydrate - drospirenone/ethinyloestradiol-alphapharm 3/20 is indicated for use as: ? an oral contraceptive. ? treatment of moderate acne vulgaris in women who seek oral contraception ? treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of drospirenone 3 mg/ethinyloestradiol 20 ?g tablets for pmdd was not assessed beyond 3 cycles. drospirenone 3 mg/ethinyloestradiol 20 ?g tablets has not been evaluated for treatment of pms (premenstrual syndrome) (see clinical trials).