Kenya - English - Pharmacy and Poisons Board

sun pharmaceutical industries limited sun house 201 b/1, goregaon, mumbai, india - drospirenone usp and ethinyl estradiol usp - coated tablet - drospirenone usp - 3.0 mg; ethinyl estradiol usp… - hormonal contraceptives: fixed combinations of

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

a-s medication solutions - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only etonogestrel/ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. etonogestrel/ethinyl estradiol vaginal ring is contraindicated in females who are known to have or develop the following conditions: - 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 diabetes mellitus with vascular disease [see warnings and precautions (5.9)] have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - 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 diabetes mellitus with vascular disease [see warnings and precautions (5.9)] - have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.10)] women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - women over age 35 with any migraine headaches [see warnings and precautions (5.10)] - liver tumors, benign or malignant or liver disease [see warnings and precautions (5.3) and use in specific populations (8.6)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.11)] - pregnancy, because there is no reason to use chcs during pregnancy [see use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.14)] - hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of etonogestrel/ethinyl estradiol vaginal ring [see warnings and precautions (5.6) and adverse reactions (6)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for alt elevations [see warnings and precautions (5.4)] risk summary etonogestrel/ethinyl estradiol vaginal ring is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose chcs prior to conception or during early pregnancy. no adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day). no adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). discontinue etonogestrel/ethinyl estradiol vaginal ring use if pregnancy is confirmed. data animal data in rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic. co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). no adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose. when desogestrel/ethinyl estradiol was given to pregnant rabbits, pre-implantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. no adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose. risk summary small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. harmful effects have not been observed in breastfed infants exposed to chcs through breast milk. chcs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. when possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for etonogestrel/ethinyl estradiol vaginal ring and any potential adverse effects on the breastfed child from etonogestrel/ethinyl estradiol vaginal ring or from the underlying maternal condition. safety and efficacy of etonogestrel/ethinyl estradiol vaginal ring have 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. etonogestrel/ethinyl estradiol vaginal ring has not been studied in postmenopausal women and is not indicated in this population. the effect of hepatic impairment on the pharmacokinetics of etonogestrel/ethinyl estradiol vaginal ring has not been studied. steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of chc use until markers of liver function return to normal. [see contraindications (4) and warnings and precautions (5.3).] the effect of renal impairment on the pharmacokinetics of etonogestrel/ethinyl estradiol vaginal ring has not been studied. instructions for use etonogestrel/ethinyl estradiol vaginal ring read these instructions for use before you start using etonogestrel/ethinyl estradiol vaginal ring and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your treatment. how should i start using etonogestrel/ethinyl estradiol vaginal ring? if you are not currently using hormonal birth control, you have 2 ways to start using etonogestrel/ethinyl estradiol vaginal ring. choose the best way for you: - first day start: insert etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. you will not need to use another birth control method since you are using etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start etonogestrel/ethinyl estradiol vaginal ring on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of etonogestrel/ethinyl estradiol vaginal ring use in the first cycle. if you are changing from a birth control pill or patch to etonogestrel/ethinyl estradiol vaginal ring: if you have been using your birth control method correctly and are certain that you are not pregnant, you can change to etonogestrel/ethinyl estradiol vaginal ring any day. do not start etonogestrel/ethinyl estradiol vaginal ring any later than the day you would start your next birth control pill or apply your patch. if you are changing from a progestin-only birth control method, such as a minipill, implant or injection or from an intrauterine system (ius): - you may switch from a minipill on any day. start using etonogestrel/ethinyl estradiol vaginal ring on the day that you would have taken your next minipill. - you should switch from an implant or the ius and start using etonogestrel/ethinyl estradiol vaginal ring on the day that you remove the implant or ius. - you should switch from an injectable and start using etonogestrel/ethinyl estradiol vaginal ring on the day when your next injection would be due. if you are changing from a minipill, implant or injection or from an intrauterine system (ius), you should use an extra method of birth control, such as a male condom with spermicide during the first 7 days of using etonogestrel/ethinyl estradiol vaginal ring. if you start using etonogestrel/ethinyl estradiol vaginal ring after an abortion or miscarriage: - following a first trimester abortion or miscarriage: you may start etonogestrel/ethinyl estradiol vaginal ring within 5 days following a first trimester abortion or miscarriage (the first 12 weeks of pregnancy). you do not need to use an additional birth control method. - if you do not start etonogestrel/ethinyl estradiol vaginal ring within 5 days after a first trimester abortion or miscarriage, use a non-hormonal birth control method, such as male condoms and spermicide, while you wait for your period to start. begin etonogestrel/ethinyl estradiol vaginal ring at the time of your next menstrual period. count the first day of your menstrual period as "day 1" and start etonogestrel/ethinyl estradiol vaginal ring one of the following 2 ways below. first day start: insert etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. you will not need to use another birth control method since you are using etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. day 2 to day 5 cycle start: you may choose to start etonogestrel/ethinyl estradiol vaginal ring on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of etonogestrel/ethinyl estradiol vaginal ring use in the first cycle. - first day start: insert etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. you will not need to use another birth control method since you are using etonogestrel/ethinyl estradiol vaginal ring on the first day of your menstrual period. - day 2 to day 5 cycle start: you may choose to start etonogestrel/ethinyl estradiol vaginal ring on days 2 to 5 of your menstrual period. make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of etonogestrel/ethinyl estradiol vaginal ring use in the first cycle. - following a second trimester abortion or miscarriage: you may start using etonogestrel/ethinyl estradiol vaginal ring no sooner than 4 weeks (28 days) after a second trimester abortion (after the first 12 weeks of pregnancy). if you are starting etonogestrel/ethinyl estradiol vaginal ring after childbirth: - you may start using etonogestrel/ethinyl estradiol vaginal ring no sooner than 4 weeks (28 days) after having a baby if you are not breastfeeding. - if you have not gotten your menstrual period after childbirth, you should talk to your healthcare provider. you may need a pregnancy test to make sure you are not pregnant before you start using etonogestrel/ethinyl estradiol vaginal ring. - use another birth control method such as male condoms with spermicide for the first 7 days in addition to etonogestrel/ethinyl estradiol vaginal ring. if you are breastfeeding you should not use etonogestrel/ethinyl estradiol vaginal ring. use other birth control methods until you are no longer breastfeeding. step 1. choose a position for insertion of etonogestrel/ethinyl estradiol vaginal ring. - choose the position that is comfortable for you. for example, lying down, squatting, or standing with 1 leg up (see figures a, b, and c) . positions for etonogestrel/ethinyl estradiol vaginal ring insertion step 2. open the pouch to remove your etonogestrel/ethinyl estradiol vaginal ring. - each etonogestrel/ethinyl estradiol vaginal ring comes in a re-sealable foil pouch. - wash and dry your hands before removing etonogestrel/ethinyl estradiol vaginal ring from the foil pouch. - open the foil pouch at either notch near the top. - keep the foil pouch so you can place your used etonogestrel/ethinyl estradiol vaginal ring in it before you throw it away in your household trash. step 3. prepare etonogestrel/ethinyl estradiol vaginal ring for insertion. - hold etonogestrel/ethinyl estradiol vaginal ring between your thumb and index finger and press the sides of the ring together (see figures d and e) . step 4. insert etonogestrel/ethinyl estradiol vaginal ring into your vagina. - insert the folded etonogestrel/ethinyl estradiol vaginal ring into your vagina and gently push it further up into your vagina using your index finger (see figures f and g) . - when you insert etonogestrel/ethinyl estradiol vaginal ring it may be in different positions in your vagina, but etonogestrel/ethinyl estradiol vaginal ring does not have to be in an exact position for it to work (see figures h and i) . - etonogestrel/ethinyl estradiol vaginal ring may move around slightly within your vagina. this is normal. although some women may be aware of etonogestrel/ethinyl estradiol vaginal ring in the vagina, most women do not feel it when it is in place. inserting etonogestrel/ethinyl estradiol vaginal ring (figure f, figure g) and positioning etonogestrel/ethinyl estradiol vaginal ring (figure h, figure i) note: - if the etonogestrel/ethinyl estradiol vaginal ring feels uncomfortable, you may not have pushed the ring into your vagina far enough. use your finger to gently push the etonogestrel/ethinyl estradiol vaginal ring as far as you can into your vagina. there is no danger of etonogestrel/ethinyl estradiol vaginal ring being pushed too far up in the vagina or getting lost (see figure g). - some women have accidentally inserted etonogestrel/ethinyl estradiol vaginal ring into their bladder. if you have pain during or after insertion and you cannot find etonogestrel/ethinyl estradiol vaginal ring in your vagina, call your healthcare provider right away. - regularly check that etonogestrel/ethinyl estradiol vaginal ring is in your vagina (for example, before and after intercourse) to ensure you are protected from pregnancy. step 5. how do i remove etonogestrel/ethinyl estradiol vaginal ring? - wash and dry your hands. - choose the position that is most comfortable for you (see figures a, b, and c). - put your index finger into your vagina and hook it through the etonogestrel/ethinyl estradiol vaginal ring. gently pull downward and forward to remove the etonogestrel/ethinyl estradiol vaginal ring and pull it out (see figure j).                                     figure j step 6. throw away the used etonogestrel/ethinyl estradiol vaginal ring. - place the used etonogestrel/ethinyl estradiol vaginal ring in the re-sealable foil pouch and put it in a trash can out of the reach of children and pets. - do not throw etonogestrel/ethinyl estradiol vaginal ring in the toilet. what else should i know about using etonogestrel/ethinyl estradiol vaginal ring? what if i leave etonogestrel/ethinyl estradiol vaginal ring in too long? - if you leave etonogestrel/ethinyl estradiol vaginal ring in your vagina for up to 4 weeks (28 days) you will still be getting pregnancy protection. remove your old etonogestrel/ethinyl estradiol vaginal ring for 1 week (7 days) and insert a new etonogestrel/ethinyl estradiol vaginal ring 1 week (7 days) later (see steps 1 through 4) . - if you leave etonogestrel/ethinyl estradiol vaginal ring in your vagina longer than 4 weeks (28 days), remove the ring and check to make sure you are not pregnant. if you are not pregnant, insert a new etonogestrel/ethinyl estradiol vaginal ring (see steps 1 through 4) . you must use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row. what should i do if my etonogestrel/ethinyl estradiol vaginal ring comes out of my vagina? etonogestrel/ethinyl estradiol vaginal ring can slip or accidentally come out (expelled) of your vagina, for example, during sexual intercourse, bowel movements, use of tampons, or if it breaks. - etonogestrel/ethinyl estradiol vaginal ring may break causing the ring to lose its shape. if the ring stays in your vagina this should not lower etonogestrel/ethinyl estradiol vaginal ring's effectiveness at preventing pregnancy. if etonogestrel/ethinyl estradiol vaginal ring breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. insert a new etonogestrel/ethinyl estradiol vaginal ring (see steps 1 through 4). - if etonogestrel/ethinyl estradiol vaginal ring breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. - insert a new etonogestrel/ethinyl estradiol vaginal ring (see steps 1 through 4). - you should pay attention when removing a tampon to be sure that your etonogestrel/ethinyl estradiol vaginal ring is not accidentally pulled out. be sure to insert etonogestrel/ethinyl estradiol vaginal ring before inserting a tampon. if you accidentally pull out your etonogestrel/ethinyl estradiol vaginal ring while using tampons, rinse your etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. - be sure to insert etonogestrel/ethinyl estradiol vaginal ring before inserting a tampon. - if you accidentally pull out your etonogestrel/ethinyl estradiol vaginal ring while using tampons, rinse your etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. - etonogestrel/ethinyl estradiol vaginal ring can be pushed out of (expelled from) your vagina, for example, during sexual intercourse or during a bowel movement. if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. if the expelled etonogestrel/ethinyl estradiol vaginal ring has been out of your vagina for more than 3 continuous hours: during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. during week 3, do not reinsert the etonogestrel/ethinyl estradiol vaginal ring that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day etonogestrel/ethinyl estradiol vaginal ring use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used etonogestrel/ethinyl estradiol vaginal ring for 7 days in a row, prior to the day that your previous etonogestrel/ethinyl estradiol vaginal ring was accidentally removed or expelled. - if the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled etonogestrel/ethinyl estradiol vaginal ring in cool to lukewarm (not hot) water and insert it again right away. - if the expelled etonogestrel/ethinyl estradiol vaginal ring has been out of your vagina for more than 3 continuous hours: during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. during week 3, do not reinsert the etonogestrel/ethinyl estradiol vaginal ring that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day etonogestrel/ethinyl estradiol vaginal ring use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used etonogestrel/ethinyl estradiol vaginal ring for 7 days in a row, prior to the day that your previous etonogestrel/ethinyl estradiol vaginal ring was accidentally removed or expelled. - during weeks 1 and 2, you may not be protected from pregnancy. reinsert the ring as soon as you remember (see steps 1 through 4) . use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. - during week 3, do not reinsert the etonogestrel/ethinyl estradiol vaginal ring that has been out of your vagina; but throw it away in your household trash away from children and pets. use another birth control method, such as male condoms with spermicide, until the new etonogestrel/ethinyl estradiol vaginal ring has been used for 7 days in a row, following one of the two options below: - option 1. insert a new ring right away to start your next 21 day etonogestrel/ethinyl estradiol vaginal ring use cycle. you may not have your regular period, but you may have spotting or vaginal bleeding. - option 2. insert a new ring no later than 7 days from the time the previous ring was removed or expelled. during this time, you may have your period. note: you should only choose to do option 2 if you used etonogestrel/ethinyl estradiol vaginal ring for 7 days in a row, prior to the day that your previous etonogestrel/ethinyl estradiol vaginal ring was accidentally removed or expelled. - if etonogestrel/ethinyl estradiol vaginal ring was out of the vagina for an unknown amount of time, you may not be protected from pregnancy. perform a pregnancy test prior to inserting a new ring and consult your healthcare provider. this patient information and instructions for use have been approved by the u.s. food and drug administration.

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

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)].

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

physicians total care, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - ocella is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an accidental pregnancy % of women continuing use at one year method typical use perfect use in clinical efficacy studies of ocella of up to 2 years duration, 2,629 subjects completed 33,160 cycles of use without any other contraception. the mean age of the subjects was 25.5 ± 4.7 years. the age range was 16 to 37 years. the racial demographic was: 83% caucasian, 1% hispanic, 1% black, <1% asian, <1% other, <1% missing data, 14% not inquired and <1% unspecified. pregnancy rates in the clinical trials were less than one p

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

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

teva pharmaceuticals usa, inc. - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - for vaginal use only etonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. etonogestrel and ethinyl estradiol vaginal ring is contraindicated in females who are known to have or develop the following conditions: - 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 [

Israel - English - Ministry of Health

bayer israel ltd - drospirenone; ethinylestradiol - film coated tablets - drospirenone 3 mg; ethinylestradiol 0.03 mg - drospirenone and estrogen - drospirenone and estrogen - oral contraception.

Israel - English - Ministry of Health

bayer israel ltd - drospirenone; ethinylestradiol - film coated tablets - drospirenone 3 mg; ethinylestradiol 0.02 mg - drospirenone and estrogen - drospirenone and estrogen - - oral contraception. - 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 yaz for pmdd was not assessed beyond 3 cycles. yaz has not been evaluated for treatment of pms ( premenstrual syndrome ).

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

bayer australia ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, uncoated - excipient ingredients: magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; purified talc; microcrystalline cellulose - yvette 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 yvette for pmdd was not assessed beyond 3 cycles. yvette has not been evaluated for treatment of pms (premenstrual syndrome), see clinical trials.

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

bayer australia ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, uncoated - excipient ingredients: magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; purified talc; microcrystalline cellulose - leah 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 leah for pmdd was not assessed beyond 3 cycles. leah has not been evaluated for treatment of pms (premenstrual syndrome), see clinical trials.