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

strides pharma science pty ltd - isotretinoin, quantity: 5 mg - capsule, soft - excipient ingredients: gelatin; dl-alpha-tocopherol; soya oil; titanium dioxide; purified water; yellow beeswax; sorbitol solution (70 per cent) (non-crystallising); butylated hydroxyanisole; partially hydrogenated soya oil; hydrogenated vegetable oil; disodium edetate; glycerol - dermatane is indicated for the treatment of patients with severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

strides pharma science limited - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 12 years of age and older pediatric use information is approved for gilead sciences, inc.'s viread® (tenofovir disoproxil fumarate) tablets. however, due to gilead sciences, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the

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

strides pharma science limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8) - efavirenz 600 mg - efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg. - efavirenz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. - coadministration of efavirenz with elbasvir and grazoprevir is contraindicated [see warnings and precautions (5.1) and drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263. risk summary there are retrospective case reports of neural tube defects in infants whose mothers were exposed to efavirenz-containing regimens in the first trimester of pregnancy. prospective pregnancy data from the antiretroviral pregnancy registry are not sufficient to adequately assess this risk. available data from the antiretroviral pregnancy registry show no difference in the risk of overall major birth defects compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp). although a causal relationship has not been established between exposure to efavirenz in the first trimester and neural tube defects, similar malformations have been observed in studies conducted in monkeys at doses similar to the human dose. in addition, fetal and embryonic toxicities occurred in rats, at a dose ten times less than the human exposure at recommended clinical dose. because of the potential risk of neural tube defects, efavirenz should not be used in the first trimester of pregnancy. advise pregnant women of the potential risk to a fetus. data human data there are retrospective postmarketing reports of findings consistent with neural tube defects, including meningomyelocele, all in infants of mothers exposed to efavirenz-containing regimens in the first trimester. based on prospective reports from the antiretroviral pregnancy registry (apr) of approximately 1000 live births following exposure to efavirenz-containing regimens (including over 800 live births exposed in the first trimester), there was no difference between efavirenz and overall birth defects compared with the background birth defect rate of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program. as of the interim apr report issued december 2014, the prevalence of birth defects following first-trimester exposure was 2.3% (95% ci: 1.4%-3.6%). one of these prospectively reported defects with first-trimester exposure was a neural tube defect. a single case of anophthalmia with first-trimester exposure to efavirenz has also been prospectively reported. this case also included severe oblique facial clefts and amniotic banding, which have a known association with anophthalmia. animal data effects of efavirenz on embryo-fetal development have been studied in three nonclinical species (cynomolgus monkeys, rats, and rabbits). in monkeys, efavirenz 60 mg/kg/day was administered to pregnant females throughout pregnancy (gestation days 20 through 150). the maternal systemic drug exposures (auc) were 1.3 times the exposure in humans at the recommended clinical dose (600 mg/day), with fetal umbilical venous drug concentrations approximately 0.7 times the maternal values. three of 20 fetuses/infants had one or more malformations; there were no malformed fetuses or infants from placebo-treated mothers. the malformations that occurred in these three monkey fetuses included anencephaly and unilateral anophthalmia in one fetus, microphthalmia in a second, and cleft palate in the third. there was no noael (no observable adverse effect level) established for this study because only one dosage was evaluated. in rats, efavirenz was administered either during organogenesis (gestation days 7 to 18) or from gestation day 7 through lactation day 21 at 50, 100, or 200 mg/kg/day. administration of 200 mg/kg/day in rats was associated with increase in the incidence of early resorptions; and doses 100 mg/kg/day and greater were associated with early neonatal mortality. the auc at the noael (50 mg/kg/day) in this rat study was 0.1 times that in humans at the recommended clinical dose. drug concentrations in the milk on lactation day 10 were approximately 8 times higher than those in maternal plasma. in pregnant rabbits, efavirenz was neither embryo lethal nor teratogenic when administered at doses of 25, 50, and 75 mg/kg/day over the period of organogenesis (gestation days 6 through 18). the auc at the noael (75 mg/kg/day) in rabbits was 0.4 times that in humans at the recommended clinical dose. risk summary the centers for disease control and prevention recommend that hiv-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. because of the potential for hiv transmission in breastfed infants, advise women not to breastfeed. because of potential teratogenic effects, pregnancy should be avoided in women receiving efavirenz [see use in specific populations (8.1)]. pregnancy testing females of reproductive potential should undergo pregnancy testing before initiation of efavirenz. contraception females of reproductive potential should use effective contraception during treatment with efavirenz and for 12 weeks after discontinuing efavirenz due to the long half-life of efavirenz. barrier contraception should always be used in combination with other methods of contraception. hormonal methods that contain progesterone may have decreased effectiveness [see drug interactions (7.1)]. the safety, pharmacokinetic profile, and virologic and immunologic responses of efavirenz were evaluated in antiretroviral-naive and -experienced hiv-1 infected pediatric patients 3 months to 21 years of age in three open-label clinical trials [see adverse reactions (6.2), clinical pharmacology (12.3), and clinical studies (14.2)]. the type and frequency of adverse reactions in these trials were generally similar to those of adult patients with the exception of a higher frequency of rash, including a higher frequency of grade 3 or 4 rash, in pediatric patients compared to adults [see warnings and precautions (5.8) and adverse reactions (6.2)]. use of efavirenz in patients younger than 3 months of age or less than 3.5 kg body weight is not recommended because the safety, pharmacokinetics, and antiviral activity of efavirenz have not been evaluated in this age group and there is a risk of developing hiv resistance if efavirenz is underdosed. see dosage and administration (2.2) for dosing recommendations for pediatric patients. clinical studies of efavirenz did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other therapy. efavirenz is not recommended for patients with moderate or severe hepatic impairment because there are insufficient data to determine whether dose adjustment is necessary. patients with mild hepatic impairment may be treated with efavirenz without any adjustment in dose. because of the extensive cytochrome p450-mediated metabolism of efavirenz and limited clinical experience in patients with hepatic impairment, caution should be exercised in administering efavirenz to these patients [see warnings and precautions (5.9) and clinical pharmacology (12.3)].

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

strides pharma science limited - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (hpt) in adult patients with chronic kidney disease (ckd) on dialysis [see clinical studies (14.1)]. limitations of use: cinacalcet tablets are not indicated for use in patients with ckd who are not on dialysis because of an increased risk of hypocalcemia [see warnings and precautions (5.1)] cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies (14.2)].   cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary hpt who are unable to undergo parathyroidectomy [see clinical studies (14.3)].   cinacalcet tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see warnings and precautions (5.1)]. risk summary limited case reports of cinacalcet tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmenta

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

strides pharma science limited - losartan potassium (unii: 3st302b24a) (losartan - unii:jms50mpo89) - losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and myocardial infarction. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive

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

strides pharma science limited - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets, 5 mg and 10 mg are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate tablets are contraindicated in patients:   • with urinary retention [see warnings and precautions (5.2)], • with gastric retention [see warnings and precautions (5.3)]. • with uncontrolled narrow-angle glaucoma [see warnings and precautions (5.5)], and • who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions (6.2)].   risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (mrhd) of 10 mg/day. however, administration of doses 3.6 times and greater than the mrhd during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see data ] . in the u.s. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data oral administration of 14 c-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier. in pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the mrhd of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality. administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the mrhd, resulted in reduced fetal body weights and reduced maternal body weight gain. no embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the mrhd). administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (< 1 times and 1.8 times the systemic exposure at the mrhd, respectively), resulted in no findings of embryo-fetal toxicity. oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the mrhd) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency). an increase in the percentage of male offspring was also observed in litters from offspring (f2 generation) exposed to maternal doses of 250 mg/kg/day. there were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the mrhd. risk summary there is no information on the presence of solifenacin in human milk, the effects on the breastfed child, or the effects on milk production. solifenacin is present in mouse milk [see data]. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for solifenacin succinate and any potential adverse effects on the breastfed child from solifenacin succinate or from the underlying maternal condition. data animal data oral administration of 14 c-solifenacin succinate to lactating mice resulted in the recovery of radioactivity in maternal milk. lactating female mice orally administered solifenacin succinate at a maternally toxic dose of 100 mg/kg/day (3.6 times the systemic exposure at the mrhd) had increased postpartum pup mortality, pups with reduced body weights, or delays in the onset of reflex and physical development. pups from lactating dams orally administered solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the mrhd) had no discernible adverse findings. the concentrations of solifenacin in animal milk does not necessarily predict the concentration of drug in human milk. the safety and effectiveness of solifenacin succinate tablets have not been established in pediatric patients. in placebo-controlled clinical studies, similar safety and effectiveness were observed between geriatric patients (623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger adult patients (1188 patients < 65 years) treated with solifenacin succinate [see clinical pharmacology (12.3)] . solifenacin plasma concentrations are greater in patients with severe renal impairment compared to subjects with normal renal function [see clinical pharmacology (12.3)] . because increased solifenacin plasma concentrations increase the risk of antimuscarinic adverse reactions, the maximum recommended dose of solifenacin succinate in patients with severe renal impairment (clcr < 30 ml/min/1.73 m2 ) is 5 mg once daily [see dosage and administration (2.2)] . the recommended dose in patients with mild or moderate renal impairment is the same as in patients with normal renal function. solifenacin plasma concentrations are greater in patients with moderate hepatic impairment compared to subjects with normal hepatic function [see clinical pharmacology (12.3)] . because increased solifenacin plasma concentrations increase the risk of antimuscarinic adverse reactions, the maximum recommended dose of solifenacin succinate in patients with moderate hepatic impairment (child-pugh b) is 5 mg once daily [see dosage and administration (2.3)] and solifenacin succinate is not recommended for use in patients with severe hepatic impairment (child-pugh c). the pharmacokinetics of solifenacin is not significantly influenced by gender.

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

strides pharma science limited - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride tablets are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria). oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

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

strides pharma science pty ltd - oseltamivir phosphate, quantity: 39.4 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; gelatin; titanium dioxide; purified talc; sodium stearylfumarate; purified water; iron oxide yellow; croscarmellose sodium; povidone; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - oseltamivir str is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,oseltamivir str is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

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

strides pharma science pty ltd - oseltamivir phosphate, quantity: 98.5 mg - capsule, hard - excipient ingredients: purified talc; gelatin; purified water; croscarmellose sodium; povidone; iron oxide red; sodium stearylfumarate; titanium dioxide; iron oxide yellow; pregelatinised maize starch; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - oseltamivir str is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,oseltamivir str is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

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

strides pharma science pty ltd - oseltamivir phosphate, quantity: 39.4 mg - capsule, hard - excipient ingredients: gelatin; purified water; povidone; titanium dioxide; croscarmellose sodium; pregelatinised maize starch; purified talc; sodium stearylfumarate; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - osmivir is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,osmivir is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.