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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

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

camber pharmaceuticals, 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. 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 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 popu

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lannett company, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 10 mg in 1 ml - lamivudine oral solution, usp 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 oral solution 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. 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 gene

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state of florida doh central pharmacy - 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 products. pregnancy category c there are no adequate and well-controlled studies of lamivudine tablets 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 tablets 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 week

United States - English - 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)] .

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camber pharmaceuticals, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 100 mg - lamivudine tablets (hbv) are indi cat ed for the t r e atm ent of ch ronic h ep atitis b vi rus ( h b v) in f ection asso ci at ed with evid e n ce of h ep atitis b vi ral r epli c ation and active liv er in f l amm ation [s ee clini cal studi es (14.1, 14.2 ) ] . the follo wing points sh ould be consid ered wh en initi ating th era py with lamivudine tablets (hbv): - due to hi gh rat es of resi st an ce d e v elopm ent in t r e at ed p ati ents, initi ation of t reatm ent with lamivudine tablets (hbv) should only be consid e r ed wh en the use of an alt e rn ative ant ivi ral a g ent with a hi gh er g en etic b arri er to r esist an ce is not av ail able or app rop ri a t e. - lamivudine tablets (hbv) h ave not b e en ev alu a t ed in p ati ents co -in fect ed with h i v, h e p atitis c vi rus (hc v), or h e p atitis d elta vi rus. - lamivudine tablets (hbv) h ave not b e en ev alu a t ed in liv er t ra nspl ant recipi ents or in p a ti ents with ch ronic h ep atiti

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marlex pharmaceuticals inc - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 10 mg in 1 ml - lamivudine oral solution, usp is 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 oral solution is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis) to any of the components of the products. teratogenic effects 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 i

United States - English - 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

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

apotex corp. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 100 mg - lamivudine tablets (hbv) are indicated for the treatment of chronic hepatitis b virus (hbv) infection associated with evidence of hepatitis b viral replication and active liver inflammation [see clinical studies (14.1, 14.2) ]. the following points should be considered when initiating therapy with lamivudine tablets (hbv): - due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (hbv) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. - lamivudine tablets (hbv) have not been evaluated in patients co-infected with human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis delta virus. - lamivudine tablets (hbv) have not been evaluated in liver transplant recipients or in patients with chronic hepatitis b virus infection with decompensated liver disease. lamivudine tablets (hbv) 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 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 substantial difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% reported in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp). the apr uses the macdp as a 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 occur at less than 20 weeks’ gestation. of over 12,900 women exposed to lamivudine in the apr, less than 2% were hbv mono-infected. the majority of women exposed to lamivudine in the apr were hiv-1-infected and were treated with higher doses of lamivudine compared with hbv mono-infected women. in addition to lamivudine, hiv-1-infected women were also treated with other concomitant medications for hiv-1 infection [see data]. the estimated rate of miscarriage for women exposed to lamivudine in the indicated population is unknown. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15% to 20%. 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 developmental effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (cmax ) 60 times the recommended clinical dose [see data] . data human data based on prospective reports from the apr of over 12,900 exposures to lamivudine during pregnancy resulting in live births (including over 5,400 exposed in the first trimester and over 7,500 exposed in the second/third trimester), there was no difference between the overall risk of birth defects with lamivudine compared with the background birth defect rate of 2.7% observed in the u.s. reference population of the macdp.the prevalence of birth defects in live births was 3.1% (95% ci: 2.7% to 3.6%) following first trimester exposure to lamivudine-containing regimens and 2.9% (95% ci: 2.5% to 3.3%) following second/third trimester exposure to lamivudine-containing regimens. the pharmacokinetics of lamivudine in patients with hbv or hiv-1 infection and in healthy volunteers are similar at similar doses. lamivudine pharmacokinetics were studied in pregnant women with hiv-1 infection 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 (3 times the recommended daily dosage for hbv) with zidovudine, 10 women at 38 weeks gestation using 150 mg lamivudine twice daily (3 times the recommended daily dosage for hbv) with zidovudine, and 10 women at 38 weeks gestation using lamivudine 300 mg twice daily (6 times the recommended daily dosage for hbv) without other antiretrovirals. 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 concentrations (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 (cmax ) approximately 53 or more times higher than human exposure at the recommended daily dose. evidence of early embryolethality in the absence of maternal toxicity was seen in the rabbit at systemic exposures (auc) similar to those observed in humans, but there was no indication of this effect in the rat at plasma concentrations (cmax ) 60 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 at plasma concentrations (cmax ) 104 times higher than human exposure. risk summary lamivudine is present in human milk. there is no information available regarding lamivudine concentrations in milk from lactating women receiving lamivudine for treatment of hbv infection. however, in lactating women with hiv-1 infection being treated with lamivudine at 3 or 6 times the recommended daily dose for hbv, lamivudine concentrations in milk were similar to those observed in serum [see data]. the lamivudine dose received by a breastfed infant of a mother being treated for hiv-1 infection was estimated to be approximately 6% of the recommended daily lamivudine dose for hbv in children over 2 years of age. there is no information available regarding the effects of the drug on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lamivudine tablets (hbv) and any potential adverse effects on the breastfed infant from lamivudine or from the underlying maternal condition. data in mothers with hiv receiving lamivudine monotherapy (300 mg twice daily [6 times the recommended daily dosage for hbv]) or combination therapy (150 mg lamivudine twice daily [3 times the recommended daily dosage for hbv] with 300 mg zidovudine twice daily), the median breast milk to plasma lamivudine concentration ratio was 0.6 to 3.3, and the estimated infant daily dose was approximately 6% of the recommended 3-mg-per-kg daily lamivudine dose for treatment of hbv in children over 2 years of age. in breastfed infants of mothers with hiv-1 infection receiving lamivudine therapy, the blood concentrations of lamivudine decreased after delivery and were undetectable at 6 months despite constant milk concentrations. this is consistent with increased lamivudine renal clearance in the first 6 months of life. lamivudine tablets (hbv) is indicated for the treatment of chronic hepatitis b virus infection in pediatric patients aged 2 to 17 years [see indications and usage (1) , clinical pharmacology (12.3) , clinical studies (14.2) ]. the safety and efficacy of lamivudine tablets (hbv) in pediatric patients younger than 2 years have not been established. clinical trials of lamivudine tablets (hbv) 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 tablets (hbv) 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 (2.4), clinical pharmacology (12.3)] . reduction of the dosage of lamivudine tablets (hbv) is recommended for patients with impaired renal function [see dosage and administration (2.4) , clinical pharmacology (12.3) ]. no dose adjustment for lamivudine is required for patients with impaired hepatic function.

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american health packaging - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablets, 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 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 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 p