Estados Unidos - inglês - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - 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

Estados Unidos - inglês - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - ethinyl estradiol 0.03 mg - drospirenone and ethinyl estradiol tablets usp 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) ]          

Estados Unidos - inglês - NLM (National Library of Medicine)

nivagen pharmaceuticals, inc. - 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)] have d

Estados Unidos - inglês - 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

Estados Unidos - inglês - 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

Estados Unidos - inglês - 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

Estados Unidos - inglês - NLM (National Library of Medicine)

mayne pharma inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - zarah® (drospirenone/ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. do not prescribe zarah 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 (5.6)] have diabetes mellitus

Estados Unidos - inglês - 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

Estados Unidos - inglês - NLM (National Library of Medicine)

sandoz inc - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - lorynatm (drospirenone and ethinyl estradiol tablets) are indicated for use by women to prevent pregnancy. lorynatm tablets 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 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 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 w

Estados Unidos - inglês - NLM (National Library of Medicine)

sandoz inc - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - syedatm (drospirenone and ethinyl estradiol tablets) are indicated for use by women to prevent pregnancy. do not prescribe syedatm 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 thorombosis 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 fibrilation) [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings