Ethinyl Estradiol, Drospirenone - search results

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

drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium- drospirenone, ethinyl estradiol and levomefol

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

drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium- drospirenone, ethinyl estradiol and levomefol

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

drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium- drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium kit

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, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by females of reproductive potential to prevent pregnancy. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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 phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. diagnosis is made by healthcare providers according to dsm-iv criteria, with symptomatology assessed prospectively over at least two menstrual cycles. in making the diagnosis, care should be taken to rule out other cyclical mood disorders. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been evaluated for the treatment of premenstrual syndrome (pms). drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for the treatment of moderate acne vulgaris in females of reproductive potential at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated in females of reproductive potential 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. drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is contraindicated in females who are known to have or develop the following conditions: - 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 with vascular disease [see warnings and precautions (5.8)] have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions (5.9)] - 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 with vascular disease [see warnings and precautions (5.8)] - have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions (5.9)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.10)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.3)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.4) and use in specific populations (8.7)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir due to the potential for alt elevations [see warnings and precautions (5.5) and drug interactions (7.3)]. risk summary there is no use for contraception in pregnancy; therefore, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium 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. data human data 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 first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight z-scores. post-marketing adverse event data on the use of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. risk summary drsp is present in human milk. after a single oral administration of 3 mg drsp/0.03 mg ee tablets, drsp concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. the estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see data). there is limited information on the effects of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets on the breast-fed infant. chcs can reduce milk production in breast- feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. [see also dosage and administration (2.2)]. increase in folate concentration in milk is not expected (see data). the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets and any potential adverse effects on the breast-fed child from drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets or from the underlying maternal condition. data human data an open-label study evaluated the degree of drsp transfer into milk within 72 hours following a single oral administration of 3 mg drsp/0.03 mg ee tablets to 6 healthy lactating women who were 1 week to 3 months post-partum. drsp was present in breast milk with a mean cmax of 13.5 ng/ml, while the mean cmax in serum of lactating women was 30.8 ng/ml. the drsp concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. based on single dose data, the maximal daily infant dose of drsp was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. a study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416mcg/day [6s]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16 week period. studies to date indicate there is no adverse effect of folate on nursing infants. safety and efficacy of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been studied in postmenopausal women and is not indicated in this population. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are contraindicated in patients with renal impairment [see contraindications (4) and warnings and precautions (5.2)]. in subjects with creatinine clearance (clcr) of 50 to 79 ml/min, serum drsp concentrations were comparable to those in a control group with clcr ≥ 80 ml/min. in subjects with clcr of 30 to 49 ml/min, serum drsp concentrations were on average 37% higher than those in the control group. in addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium-sparing drugs [see clinical pharmacology (12.3)]. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are contraindicated in patients with hepatic disease [see contraindications (4) and warnings and precautions (5.4)]. the mean exposure to drsp in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been studied in women with severe hepatic impairment. no clinically significant difference was observed between the pharmacokinetics of drsp or ee in japanese versus caucasian women [see clinical pharmacology (12.3)].

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

drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium kit

sandoz 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 - drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is indicated for use by females of reproductive potential to prevent pregnancy. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is indicated in females of reproductive potential 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. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in females who are known to have or develop the following conditions: there is no use for contraception in pregnancy; therefore, drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium 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 first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight z-scores. post-marketing adverse event data on the use of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. drsp is present in human milk. after a single oral administration of 3 mg drsp/0.03 mg ee tablets, drsp concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. the estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see data). there is limited information on the effects of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium on the breast-fed infant. chcs can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding [see also dosage and administration (2.2)]. increase in folate concentration in milk is not expected (see data). the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for safyral and any potential adverse effects on the breast-fed child from drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium or from the underlying maternal condition. an open-label study evaluated the degree of drsp transfer into milk within 72 hours following a single oral administration of 3 mg drsp/0.03 mg ee tablets to 6 healthy lactating women who were 1 week to 3 months post-partum. drsp was present in breast milk with a mean cmax of 13.5 ng/ml, while the mean cmax in serum of lactating women was 30.8 ng/ml. the drsp concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. based on single dose data, the maximal daily infant dose of drsp was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. a study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416 mcg/day [6s]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16-week period. studies to date indicate there is no adverse effect of folate on nursing infants. safety and efficacy of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has not been studied in postmenopausal women and is not indicated in this population. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in patients with renal impairment [see contraindications (4) and warnings and precautions (5.2)] . in subjects with creatinine clearance (clcr) of 50–79 ml/min, serum drsp concentrations were comparable to those in a control group with clcr ≥ 80 ml/min. in subjects with clcr of 30–49 ml/min, serum drsp concentrations were on average 37% higher than those in the control group. in addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium-sparing drugs [see clinical pharmacology (12.3)] . drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in patients with hepatic disease [see contraindications (4) and warnings and precautions (5.4)] . the mean exposure to drsp in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has not been studied in women with severe hepatic impairment. no clinically significant difference was observed between the pharmacokinetics of drsp or ee in japanese versus caucasian women [see clinical pharmacology (12.3)] .

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

drospirenone and ethinyl estradiol- drospirenone and ethinyl estradiol kit

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) ]

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

drospirenone and ethinyl estradiol- drospirenone and ethinyl estradiol kit

lupin limited - 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 • 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) ]

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

drospirenone and ethinyl estradiol- drospirenone and ethinyl estradiol kit

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

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

drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium kit

sandoz inc - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is indicated for use by females of reproductive potential to prevent pregnancy. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium 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 drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium 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 or school, or with usual social activities and relationships with others. diagnosis is made by healthcare providers according to dsm-iv criteria, with symptomatology assessed prospectively over at least two menstrual cycles. in making the diagnosis, care should be taken to rule out other cyclical mood disorders. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has not been evaluated for the treatment of premenstrual syndrome (pms). drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is indicated for the treatment of moderate acne vulgaris in females of reproductive potential at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is indicated in females of reproductive potential 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. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in females who are known to have or develop the following conditions: there is no use for contraception in pregnancy; therefore, drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium 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 first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight z-scores. post-marketing adverse event data on the use of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. drsp is present in human milk. after a single oral administration of 3 mg drsp/0.03 mg ee tablets, drsp concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. the estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see data). there is limited information on the effects of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium on the breast-fed infant. chcs can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. [see also dosage and administration (2.2)]. increase in folate concentration in milk is not expected (see data). the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium and any potential adverse effects on the breast-fed child from drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium or from the underlying maternal condition. an open-label study evaluated the degree of drsp transfer into milk within 72 hours following a single oral administration of 3 mg drsp/0.03 mg ee tablets to 6 healthy lactating women who were 1 week to 3 months post-partum. drsp was present in breast milk with a mean cmax of 13.5 ng/ml, while the mean cmax in serum of lactating women was 30.8 ng/ml. the drsp concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. based on single dose data, the maximal daily infant dose of drsp was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. a study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416mcg/day [6s]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16 week period. studies to date indicate there is no adverse effect of folate on nursing infants. safety and efficacy of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has not been studied in postmenopausal women and is not indicated in this population. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in patients with renal impairment [see contraindications (4) and warnings and precautions (5.2)] . in subjects with creatinine clearance (clcr) of 50–79 ml/min, serum drsp concentrations were comparable to those in a control group with clcr ≥ 80 ml/min. in subjects with clcr of 30–49 ml/min, serum drsp concentrations were on average 37% higher than those in the control group. in addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium-sparing drugs [see clinical pharmacology (12.3)] . drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in patients with hepatic disease [see contraindications (4) and warnings and precautions (5.4)] . the mean exposure to drsp in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has not been studied in women with severe hepatic impairment. no clinically significant difference was observed between the pharmacokinetics of drsp or ee in japanese versus caucasian women [see clinical pharmacology (12.3)] .

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

drospirenone and ethinyl estradiol kit

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

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

drospirenone and ethinyl estradiol kit

glenmark pharmaceuticals inc., usa - 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 females of reproductive potential to prevent pregnancy. drospirenone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary 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. data human data a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol