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physicians total care, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - estradiol 1 mg - angeliq is indicated in women who have a uterus for the: 1. treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. progestogens/estrogens should not be used in individuals with any of the following conditions: 1. undiagnosed abnormal genital bleeding. 2. known, suspected, or history of cancer of the breast. 3. known or suspected estrogen-dependent neoplasia. 4. active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. renal insufficiency. 7. liver dysfunction or disease. 8. adrenal insufficiency. 9. angeliq should not be used in patients with known hypersensitivity to its ingredients. 10. known or suspec

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bayer healthcare pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - estradiol 1 mg - angeliq is contraindicated in women with any of the following conditions: angeliq is not indicated for use in pregnancy. there are no data with the use of angeliq in pregnant women, however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies or limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. in reproduction studies in rats, rabbits and monkeys with oral administration of drsp either as single compound or in combination with ee, no non-genital teratogenicity was observed. adverse developmental outcomes like an increase in fetal mortality and a retardation of fetal maturation were seen in rats and rabbits at exposures to drsp exceeding the human exposure by a factor of >15 (in rats) or >60 (rabbits). related to the antiandrogenic activity of drospirenone, a feminization of male fetuses and an impairment of male fertility was observed in rats (>150 times the human exposure to drospirenone) but not in monkeys (at up to more than 300 times the human exposure to drospirenone). due to the large safety margins observed in the animal studies only a low likelihood of an increased risk for human pregnancy was concluded (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. in an embryo-fetal toxicity study in pregnant rats, drsp was given from day 6 to 15 of gestation orally at doses of 5, 15 and 45 mg/kg/day, more than 60 times the human exposure starting from the low dose based on auc of drsp. a slight increase in postimplantational loss and a slight increase in retardation of fetal development (e.g. delayed ossification of bones of the feet) was seen in the two higher doses. no teratogenicity was observed in rats. in an embryo-fetal study in rabbits, drsp was given from day 6 to 18 of gestation orally at doses of 10, 30 and 100 mg/kg/day, about 20, 60 and 250 times the human exposure based on auc. this resulted in a retardation of fetal development (delayed ossification of small bones, multiple fusions of ribs) at the high dose only and in an increase in fetal loss from the mid dose level. no compound-related teratogenicity was seen in rabbits. in a further embryo-fetal toxicity study in pregnant rats, drsp was orally administered in combination with ethinyl estradiol (100:1) from day 6 to 17 of gestation at doses of 1, 3 and 10 mg/kg/day drsp, at about 1, 3 and 23 times the human exposure to drsp on basis of auc. maternal toxicity (decreased body weight gain and food consumption) was seen starting at the low dose and an increase of early resorptions at the high dose level. skeletal variations and retardations were seen in fetuses at the high dose. no malformed fetuses and no effect on the external genitalia of the fetuses were observed. drsp was administered with ethinyl estradiol (100:1) orally to pregnant rats during late pregnancy from day 14 to 21 of gestation (the period of genital development) at doses of 5, 15 and 45 mg/kg of drsp, more than 60 times the human exposure starting from the low dose based on auc of drsp. maternal toxicity (decreased body weight gain) and fetal retardation (decreased fetal body weights) were seen starting at the low dose. there was a dose dependent increase in feminization of male rat fetuses starting at the mid dose level (that is, >150 times the human exposure to drsp). drsp was administered with ethinyl estradiol (100:1) orally to pregnant cynomolgus monkeys at doses up to 10 mg/kg drsp, more than 300 times the human exposure based on auc from day 20 to 90 of gestation. a dose-dependent increase of abortions was observed. no teratogenic or feminization effects were seen in any dose group. drsp was administered with ethinyl estradiol (100:1) in a peri-postnatal study in rats from day 6 to 16 of gestation and day 1 to 22 postpartum at doses of 5, 15 and 45 mg/kg; more than 60 times the human exposure starting from the low dose based on auc of drsp. there was a dose dependent delay in fetal development and an increase in mortality of the f1-generation during the lactational phase. fertility was impaired in the male offspring at the high dose level. estrogens plus progestogens are present in human milk and can reduce milk production in breast-feeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well established. after administration of an oral contraceptive containing drsp about 0.02% of the drsp dose was excreted into the breast milk of postpartum women within 24 hours. this results in a maximal daily dose of about 3 mcg drsp in an infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for angeliq and any potential adverse effects on the breastfed infant from angeliq or from the underlying maternal condition. angeliq is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing angeliq to determine whether those over 65 years of age differ from younger women in their response to angeliq. in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see warnings and precautions (5.1, 5.3) and clinical studies (14.4)] . in the whi estrogen-alone substudy (daily ce [0.625 mg] versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see warnings and precautions (5.1) and clinical studies (14.4)] . in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin or estrogen-alone when compared to placebo [see warnings and precautions (5.4), and clinical studies (14.5)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.4), and clinical studies (14.5)]. angeliq is contraindicated in patients with renal impairment because of the risk of hyperkalemia [see contraindications (4), warnings and precautions (5.2 )  and clinical pharmacology (12.3)]. angeliq is contraindicated in patients with hepatic impairment because of the risk of increased drsp exposure and subsequent hyperkalemia [see contraindications (4), warnings and precautions (5.10)   and clinical pharmacology (12.3)]. angeliq is contraindicated in patients with adrenal insufficiency because of the risk of hyperkalemia [see contraindications (4) and warnings and precautions (5.2)].

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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

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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)

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

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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

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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)]

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physicians total care, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol 1 mg - estradiol/norethindrone acetate tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the: - treatment of moderate to severe vasomotor symptoms associated with menopause. - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin d intake, and when indicated, pharmacologic therapy. postmenopausal women require an average of 1500 mg/day of elemental calcium. therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. vitamin d supplementation of 400-800 iu/day may also be required to ensure adequate daily intake in postmenopausal women. estradiol/norethindrone acetate tablets 1.0 mg/0.5 mg is also in

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breckenridge pharmaceutical, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol 1 mg - estradiol/norethindrone acetate tablets are indicated for:   limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol/norethindrone acetate tablets are contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] - breast cancer or history of breast cancer [see warnings and precautions (5.2)] - estrogen-dependent neoplasia [see warnings and precautions (5.2)] - active dvt, pe, or history of these conditions [see warnings and precautions (5.1)] - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precauti

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teva pharmaceuticals usa, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 10 ug - estradiol vaginal inserts is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.3)]. - breast cancer or a history of breast cancer [see warnings and precautions (5.3)]. - estrogen-dependent neoplasia [see warnings and precautions (5.3)]. - active dvt, pe, or history of these conditions [see warnings and precautions (5.2)]. - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.2)]. - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol vaginal inserts [see warnings and precautions (5.16)]. - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. risk summary estradiol vaginal inserts are not indicated for use in pregnancy. there are no data with the use of estradiol vaginal inserts in pregnant women; however, epidemiologic studies and meta-analyses have