USA - engelska - NLM (National Library of Medicine)

bryant ranch prepack - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine and zidovudine tablets, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. lamivudine and zidovudine tablets 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 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 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 (cmax ) 35 times the recommended clinical dose. 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: lamivudine : 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 a u.s. reference population of the macdp. the prevalence of birth 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 trial 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). zidovudine: 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. 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 trial drug [see clinical studies (14.2) ]. 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: lamivudine : 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 (cmax ) 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 (cmax ) 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. zidovudine: 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 days 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 recommends that hiv-1-infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. lamivudine and zidovudine are present in human milk. there is no information on the effects of lamivudine or zidovudine 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 similar to those seen in adults, instruct mothers not to breastfeed if they are receiving lamivudine and zidovudine tablets. lamivudine and zidovudine tablets are not recommended for use in pediatric patients who weigh less than 30 kg because it is a fixed-dose combination tablet that cannot be adjusted for this patient population [see dosage and administration ( 2.2 )]. clinical trials of lamivudine and zidovudine 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 and zidovudine tablets in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology ( 12.3 )]. lamivudine and zidovudine tablets are not recommended for patients with creatinine clearance less than 50 ml per min because lamivudine and zidovudine tablets are a fixed-dose combination and the dosage of the individual components cannot be adjusted. if a dose reduction of the lamivudine or zidovudine components of lamivudine and zidovudine tablets are required for patients with renal impairment then the individual components should be used [see dosage and administration ( 2.3 ), clinical pharmacology ( 12.3 )]. lamivudine and zidovudine tablets are a fixed-dose combination and the dosage of the individual components cannot be adjusted. zidovudine is primarily eliminated by hepatic metabolism and zidovudine concentrations are increased in patients with impaired hepatic function, which may increase the risk of hematologic toxicity. frequent monitoring of hematologic toxicities is advised.

Malaysia - engelska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - zidovudine -

USA - engelska - NLM (National Library of Medicine)

a-s medication solutions - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine and zidovudine tablet, usp a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (hiv-1) infection.    lamivudine and zidovudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. pregnancy category c. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine tablets during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263. fetal risk summary: there are no adequate and well-controlled trials of lamivudine and zidovudine tablet in pregnant women. clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of hiv-1 infection to the fetus. animal reproduction studies performed with lamivudine and zidovudine showed incre

Belgien - engelska - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - zidovudine 300 mg; lamivudine 150 mg - film-coated tablet - zidovudine and lamivudine

Malta - engelska - Medicines Authority

a.m. mangion limited - zidovudine; lamivudine - film-coated tablet - zidovudine 300 mg; lamivudine 150 mg - antivirals for systemic use

Kenya - engelska - Pharmacy and Poisons Board

anhui biochem bio-pharmaceutical co., ltd no. 30 hongfeng road, hi-tech development zone, - zidovudine 300mg and lamivudine 150mg tablets - film-coated tablet - zidovudine 300mg and lamivudine 150mg tablets - antivirals for systemic use: combinations of

Kenya - engelska - Pharmacy and Poisons Board

mylan laboratories limited c/o surgilinks ltd mylan laboratories limited r&d centre plot no. - zidovudine usp - modified-release tablet - zidovudine usp 300mg - antivirals for systemic use:

Israel - engelska - Ministry of Health

glaxo smith kline (israel) ltd - zidovudine - capsules - zidovudine 100 mg - zidovudine - zidovudine - retrovir oral formulations are indicated in anti-retroviral combination therapy for human immunodeficiency virus (hiv) infected adults and children.retrovir chemoprophylaxis is indicated for use in hiv-positive pregnant women (over 14 weeks of gestation) for prevention of maternal-foetal hiv transmission and for primary prophylaxis of hiv infection in newborn infants.

Israel - engelska - Ministry of Health

glaxo smith kline (israel) ltd - zidovudine - capsules - zidovudine 250 mg - zidovudine - zidovudine - retrovir oral formulations are indicated in anti-retroviral combination therapy for human immunodeficiency virus (hiv) infected adults and children.retrovir chemoprophylaxis is indicated for use in hiv-positive pregnant women (over 14 weeks of gestation) for prevention of maternal-foetal hiv transmission and for primary prophylaxis of hiv infection in newborn infants.

Israel - engelska - Ministry of Health

glaxo smith kline (israel) ltd - zidovudine - solution for infusion - zidovudine 200 mg / 20 ml - zidovudine - zidovudine - retrovir iv for infusion is indicated for the short term management of serious manifestations of human immunodeficiency virus (hiv) infection in patients with acquired immuno deficiency syndrome (aids) or aids who are unable to take retrovir oral formulations.retrovir chemoprophylaxis, is indicated for use in hiv-positive pregnant women (over 14 weeks of gestation) for prevention of maternal-foetal hiv transmission and for primary prophylaxis of hiv infection in newborn infants. retrovir i.v. should only be used when oral treatment is not possible (except during labour and delivery).