ABD - İngilizce - NLM (National Library of Medicine)

bryant ranch prepack - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablets, usp a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. lamivudine and zidovudine tablets, usp are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine tablets 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 difference in the overall risk of birth defects for lamivudine or zidovudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data) . the apr uses the macdp as the u.s. reference population for birth defects in the g

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

viiv healthcare pty ltd - abacavir sulfate, quantity: 351 mg (equivalent: abacavir, qty 300 mg); zidovudine, quantity: 300 mg; lamivudine, quantity: 150 mg - tablet, film coated - excipient ingredients: magnesium stearate; sodium starch glycollate type a; microcrystalline cellulose; purified water; titanium dioxide; hypromellose; indigo carmine; iron oxide yellow; macrogol 400 - trizivir is indicated in antiretroviral therapy for the treatment of human immunodeficiency virus (hiv) infected adults and adolescents over the age of 12 years. trizivir should not be administered to adults and adolescents who weigh less than 40kg because it is a fixed dose tablet, and the dose cannot be adjusted for this patient population.

Kenya - İngilizce - Pharmacy and Poisons Board

cipla ltd cipla house, peninsula business park, ganpatrao - lamivudine, zidovudine and nevirapine - tablet - lamivudine: 150 mg zidovudine: 300 mg and… - zidovudine lamivudine and nevirapine

ABD - İngilizce - NLM (National Library of Medicine)

remedyrepack inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - lamivudine tablet is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-l) infection.   limitation of use: the dosage of this product is for hiv-1and not for hbv. lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. teratogenic effects pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263.  risk summary available data from the antiretroviral pregnancy registry show no difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% in the us reference population of the metropolitan atlanta congenital defects program (macdp). lamivudine produced embryonic toxicity in rabbits at

ABD - İngilizce - NLM (National Library of Medicine)

cipla ltd. - zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - zidovudine 300 mg - zidovudine, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. zidovudine is indicated for the prevention of maternal-fetal hiv-1 transmission [see dosage and administration (2.3)]. the indication is based on a dosing regimen that included 3 components: - antepartum therapy of hiv-1 infected mothers - intrapartum therapy of hiv-1 infected mothers - post-partum therapy of hiv-1 exposed neonate points to consider prior to initiating zidovudine in pregnant women for the prevention of maternal-fetal hiv-1 transmission include: - in most cases, zidovudine for prevention of maternal-fetal hiv-1 transmission should be  given in combination with other antiretroviral drugs. - prevention of hiv-1 transmission in women who have received zidovudine for a prolonged period before pregnancy has not been evaluated. - because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of ges

ABD - İngilizce - NLM (National Library of Medicine)

aurobindo pharma limited - zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - zidovudine 300 mg - zidovudine tablets, a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. zidovudine tablets are indicated for the prevention of maternal-fetal hiv-1 transmission [see dosage and administration (2.3)].  the indication is based on a dosing regimen that included 3 components:   - antepartum therapy of hiv-1 infected mothers - intrapartum therapy of hiv-1 infected mothers - post-partum therapy of hiv-1 exposed neonate points to consider prior to initiating zidovudine tablets in pregnant women for the prevention of maternal-fetal hiv-1 transmission include:   - in most cases, zidovudine tablets for prevention of maternal-fetal hiv-1 transmission should be given in combination with other antiretroviral drugs. - prevention of hiv-1 transmission in women who have received zidovudine tablets for a prolonged period before pregnancy has not been evaluated. - because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of gestation and the risks of therapy with zidovudine tablets during that period are not fully known, women in the first trimester of pregnancy who do not require immediate initiation of antiretroviral therapy for their own health may consider delaying use; this indication is based on use after 14 week's gestation. zidovudine tablets are contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, stevens-johnson syndrome) to any of the components of the formulation. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to zidovudine 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 difference in the overall risk of birth defects for zidovudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data) . the apr uses the macdp as the u.s. reference population for birth defects in the general population. the macdp evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks' gestation. the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15% to 20%. the background risk for major birth defects and miscarriage for the indicated population is unknown. hyperlactatemia, which may be due to mitochondrial dysfunction, has been reported in infants with in utero exposure to zidovudine-containing products. these events were transient and asymptomatic in most cases. there have been few reports of developmental delay, seizures, and other neurological disease. however, a causal relationship between these events and exposure to zidovudine-containing products in utero or peri-partum has not been established (see data) . in an animal reproduction study, administration of oral zidovudine to female rats prior to mating and throughout gestation resulted in embryotoxicity at doses that produced systemic exposure (auc) approximately 33 times higher than exposure at the recommended clinical dose. however, no embryotoxicity was observed after oral administration of zidovudine to pregnant rats during organogenesis at doses that produced systemic exposure (auc) approximately 117 times higher than exposures at the recommended clinical dose. administration of oral zidovudine to pregnant rabbits during organogenesis resulted in embryotoxicity at doses that produced systemic exposure (auc) approximately 108 times higher than exposure at the recommended clinical dose. however, no embryotoxicity was observed at doses that produced systemic exposure (auc) approximately 23 times higher than exposures at the recommended clinical dose (see data) . data human data: based on prospective reports to the apr of over 13,000 exposures to zidovudine during pregnancy resulting in live births (including over 4,000 exposed in the first trimester), there was no difference between the overall risk of birth defects for zidovudine compared with the background birth defect rate of 2.7% in a u.s. reference population of the macdp. the prevalence of birth defects in live births was 3.2% (95% ci: 2.7% to 3.8%) following first trimester exposure to zidovudine-containing regimens and 2.8% (95% ci: 2.5% to 3.2%) following second/third trimester exposure to zidovudine-containing regimens. a randomized, double-blind, placebo-controlled trial was conducted in hiv-1-infected pregnant women to determine the utility of zidovudine for the prevention of maternal-fetal hiv-1-transmission [see clinical studies (14.3)] . zidovudine treatment during pregnancy reduced the rate of maternal-fetal hiv-1 transmission from 24.9% for infants born to placebo-treated mothers to 7.8% for infants born to mothers treated with zidovudine. there were no differences in pregnancy-related adverse events between the treatment groups. of the 363 neonates that were evaluated, congenital abnormalities occurred with similar frequency between neonates born to mothers who received zidovudine and neonates born to mothers who received placebo. the observed abnormalities included problems in embryogenesis (prior to 14 weeks) or were recognized on ultrasound before or immediately after initiation of study drug. zidovudine has been shown to cross the placenta and concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery [see clinical pharmacology (12.3)] . there have been reports of mild, transient elevations in serum lactate levels, which may be due to mitochondrial dysfunction, in neonates and infants exposed in utero or peri-partum to zidovudine-containing products. there have been few reports of developmental delay, seizures, and other neurological disease. however, a causal relationship between these events and exposure to zidovudine-containing products in utero or peri-partum has not been established. the clinical relevance of transient elevations in serum lactate is unknown. animal data: a study in pregnant rats (at 50, 150, or 450 mg per kg per day starting 26 days prior to mating through gestation to postnatal day 21) showed increased fetal resorptions at doses that produced systemic exposures (auc) approximately 33 times higher than exposure at the recommended daily human dose (300 mg twice daily). however, in an oral embryo-fetal development study in rats (at 125, 250, or 500 mg per kg per day on gestation days 6 through 15), no fetal resorptions were observed at doses that produced systemic exposure (auc) approximately 117 times higher than exposures at the recommended daily human dose. an oral embryo-fetal development study in rabbits (at 75, 150, or 500 mg per kg per day on gestation day 6 through 18) showed increased fetal resorptions at the 500 mg per kg per day dose, which produced systemic exposures (auc) approximately 108 times higher than exposure at the recommended daily human dose; however, no fetal resorptions were noted at doses up to 150 mg per kg per day, which produced systemic exposure (auc) approximately 23 times higher than exposures at the recommended daily human dose. these oral embryo-fetal development studies in the rat and rabbit revealed no evidence of fetal malformations with zidovudine. in another developmental toxicity study, pregnant rats (dosed at 3,000 mg per kg per day from days 6 through 15 of gestation) showed marked maternal toxicity and an increased incidence of fetal malformations at exposures greater than 300 times the recommended daily human dose based on auc. however, there were no signs of fetal malformations at doses up to 600 mg per kg per day. risk summary the centers for disease control and prevention recommend that hiv-1-infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. zidovudine is present in human milk. there is no information on the effects of zidovudine on the breastfed infant or the effects of the drug on milk production. because of the potential for (1) hiv-1 transmission (in hiv negative infants), (2) developing viral resistance (in hiv positive infants), and (3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving zidovudine. zidovudine has been studied in hiv-1-infected pediatric subjects aged at least 6 weeks who had hiv-1-related symptoms or who were asymptomatic with abnormal laboratory values indicating significant hiv-1-related immunosuppression. zidovudine has also been studied in neonates perinatally exposed to hiv-1 [see dosage and administration (2.2), adverse reactions (6.1) , clinical pharmacology (12.3), clinical studies (14.2, 14.3)] . clinical studies of zidovudine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 drug therapy. unchanged zidovudine and its glucuronide metabolite (formed in the liver) are primarily eliminated from the body by renal excretion. in patients with severely impaired renal function (crcl less than 15 ml per min), dosage reduction is recommended [see dosage and administration (2.5), clinical pharmacology (12.3)] . zidovudine is primarily eliminated by hepatic metabolism and zidovudine concentrations appear to be increased in patients with impaired hepatic function, which may increase the risk of hematologic toxicity. frequent monitoring of hematologic toxicities is advised. there are insufficient data to recommend dose adjustment of zidovudine in patients with impaired hepatic function or liver cirrhosis [see dosage and administration (2.6), clinical pharmacology (12.3)] .

ABD - İngilizce - NLM (National Library of Medicine)

golden state medical supply, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: - the dosage of this product is for hiv-1 and not for hbv. lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine tablets 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 difference in the overall risk of birth defects for lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data). the apr uses the macdp as the u.s. reference population for birth defects in the general population. the macdp evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks’ gestation. the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15% to 20%. the background risk for major birth defects and miscarriage for the indicated population is unknown. in animal reproduction studies, oral administration of lamivudine to pregnant rabbits during organogenesis resulted in embryolethality at systemic exposure (auc) similar to the recommended clinical dose; however, no adverse development effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (c max ) 35 times the recommended clinical dose (see data).  data human data based on prospective reports to the apr of over 11,000 exposures to lamivudine during pregnancy resulting in live births (including over 4,500 exposed in the first trimester), there was no difference between  the overall risk of birth defects for lamivudine compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of defects in live births was 3.1% (95% ci: 2.6% to 3.6%) following first trimester exposure to lamivudine-containing regimens and 2.8% (95% ci: 2.5% to 3.3%) following second/third trimester exposure to lamivudine-containing regimens. lamivudine pharmacokinetics were studied in pregnant women during 2 clinical trials conducted in south africa. the trials assessed pharmacokinetics in 16 women at 36 weeks’ gestation using 150 mg lamivudine twice daily with zidovudine, 10 women at 38 weeks’ gestation using 150 mg lamivudine twice daily with zidovudine, and 10 women at 38 weeks’ gestation using lamivudine 300 mg twice daily without other antiretrovirals. these trials were not designed or powered to provide efficacy information. lamivudine concentrations were generally similar in maternal, neonatal, and umbilical cord serum samples. in a subset of subjects, amniotic fluid specimens were collected following natural rupture of membranes and confirmed that lamivudine crosses the placenta in humans.  based on limited data at delivery, median (range) amniotic fluid concentrations of lamivudine were 3.9 (1.2 to 12.8)–fold greater compared with paired maternal serum concentration (n = 8). animal data lamivudine was administered orally to pregnant rats (at 90, 600, and 4,000 mg per kg per day) and rabbits (at 90, 300, and 1,000 mg per kg per day and at 15, 40, and 90 mg per kg per day) during organogenesis (on gestation days 7 through 16 [rat] and 8 through 20 [rabbit]). no evidence of fetal malformations due to lamivudine was observed in rats and rabbits at doses producing plasma concentrations (c max ) approximately 35 times higher than human exposure at the recommended daily dose. evidence of early embryolethality was seen in the rabbit at system exposures (auc) similar to those observed in humans, but there was no indication of this effect in the rat at plasma concentrations (c max ) 35 times higher than human exposure at the recommended daily dose. studies in pregnant rats showed that lamivudine is transferred to the fetus through the placenta. in the fertility/pre-and postnatal development study in rats, lamivudine was administered orally at doses of 180, 900, and 4,000 mg per kg per day (from prior to mating through postnatal day 20). in the study, development of the offspring, including fertility and reproductive performance, was not affected by maternal administration of lamivudine. risk summary the centers for disease control and prevention recommends that hiv-1-infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. lamivudine is present in human milk. there is no information on the effects of lamivudine on the breastfed infant or the effects of the drugs on milk production. because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving lamivudine. the safety and effectiveness of lamivudine tablets in combination with other antiretroviral agents have been established in pediatric patients aged 3 months and older. lamivudine scored tablet is the preferred formulation for hiv-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate because pediatric subjects who received lamivudine oral solution had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving lamivudine tablets in the arrow trial [see dosage and administration ( 2.2), warnings and precautions ( 5.6), adverse reactions ( 6.1), clinical pharmacology ( 12.3), clinical studies ( 14.2)] . clinical trials of lamivudine tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, caution should be exercised in the administration of lamivudine in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see dosage and administration ( 2.3), clinical pharmacology ( 12.3)]. reduction of the dosage of lamivudine tablets are recommended for patients with impaired renal function [ see dosage and administration ( 2.3), clinical pharmacology ( 12.3)] .

ABD - İngilizce - NLM (National Library of Medicine)

bryant ranch prepack - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection. limitation of use: the dosage of this product is for hiv-1 and not for hbv. lamivudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis) to any of the components of the product. pregnancy category c. there are no adequate and well-controlled studies of lamivudine in pregnant women. animal reproduction studies in rats and rabbits revealed no evidence of teratogenicity. increased early embryolethality occurred in rabbits at exposure levels similar to those in humans. lamivudine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. lamivudine pharmacokinetics were studied in pregnant women during 2 clinical studies conducted in south africa. the study assessed pharmacokinetics in: 16 women at 36 weeks gestation usin

ABD - İngilizce - NLM (National Library of Medicine)

remedyrepack inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - lamivudine is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: - the dosage of this product is for hiv-1 and not for hbv. lamivudine is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263. risk summary available data from the antiretroviral pregnancy registry show no difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% in the us reference population of the metropolitan atlanta congenital defects program (macdp). lamivudine produced embryonic toxicity in rabbits at a dose that produced similar human exposur

Tanzanya - İngilizce - Tanzania Medicinces & Medical Devices Authority

aurobindo pharma limited, india - lamivudine , zidovudine , efavirenz - tablets - 150 mg + 300 mg + 600 mg