Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - abacavir sulfate; lamivudine - film-coated tablet - 600 mg/300 milligram(s) - antivirals for treatment of hiv infections, combinations; lamivudine and abacavir

Canada - English - Health Canada

mylan pharmaceuticals ulc - abacavir (abacavir sulfate); lamivudine - tablet - 600mg; 300mg - abacavir (abacavir sulfate) 600mg; lamivudine 300mg - nucleoside and nucleotide reverse transcriptase inhibitors

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

a-s medication solutions - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - epzicom, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (hiv‑1) infection. epzicom is contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to epzicom 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 abacavir or 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 miscarria

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

sun pharma anz pty ltd - abacavir sulfate,lamivudine -

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

sun pharma anz pty ltd - abacavir sulfate,lamivudine -

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

lupin australia pty limited - abacavir hydrochloride monohydrate,lamivudine -

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

lupin australia pty limited - abacavir hydrochloride monohydrate,lamivudine -

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

lupin australia pty limited - abacavir hydrochloride monohydrate,lamivudine -

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

remedyrepack inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - abacavir tablets usp 300 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv-1) infection. abacavir tablet is contraindicated in patients: - who have the hla-b*5701 allele [see warnings and precautions ( 5.1)] . - with prior hypersensitivity reaction to abacavir [see warnings and precautions ( 5.1)] . - with moderate or severe hepatic impairment [see use in specific populations ( 8.6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir sulfate 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 abacavir 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 abacavir to pregnant rats during organogenesis resulted in fetal malformations and other embryonic and fetal toxicities at exposures 35 times the human exposure (auc) at the recommended clinical daily dose. however, no adverse developmental effects were observed following oral administration of abacavir to pregnant rabbits during organogenesis, at exposures approximately 9 times the human exposure (auc) at the recommended clinical dose (see data) . data human data: based on prospective reports to the apr of exposures to abacavir during pregnancy resulting in live births (including over 1,300 exposed in the first trimester and over 1,300 exposed in second/third trimester), there was no difference between the overall risk of birth defects for abacavir 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 3.2% (95% ci: 2.3% to 4.3%) following first trimester exposure to abacavir-containing regimens and 2.9% (95% ci: 2.1% to 4.0%) following second/third trimester exposure to abacavir-containing regimens. abacavir 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)] . animal data: abacavir was administered orally to pregnant rats (at 100, 300, and 1,000 mg per kg per day) and rabbits (at 125, 350, or 700 mg per kg per day) during organogenesis (on gestation days 6 through 17 and 6 through 20, respectively). fetal malformations (increased incidences of fetal anasarca and skeletal malformations) or developmental toxicity (decreased fetal body weight and crown-rump length) were observed in rats at doses up to 1,000 mg per kg per day, resulting in exposures approximately 35 times the human exposure (auc) at the recommended daily dose. no developmental effects were observed in rats at 100 mg per kg per day, resulting in exposures (auc) 3.5 times the human exposure at the recommended daily dose. in a fertility and early embryo-fetal development study conducted in rats (at 60, 160, or 500 mg per kg per day), embryonic and fetal toxicities (increased resorptions, decreased fetal body weights) or toxicities to the offspring (increased incidence of stillbirth and lower body weights) occurred at doses up to 500 mg per kg per day. no developmental effects were observed in rats at 60 mg per kg per day, resulting in exposures (auc) approximately 4 times the human exposure at the recommended daily dose. studies in pregnant rats showed that abacavir is transferred to the fetus through the placenta. in pregnant rabbits, no developmental toxicities and no increases in fetal malformations occurred at up to the highest dose evaluated, resulting in exposures (auc) approximately 9 times the human exposure at the recommended dose. 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. abacavir is present in human milk. there is no information on the effects of abacavir 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 abacavir tablets. the safety and effectiveness of abacavir sulfate have been established in pediatric patients aged 3 months and older. use of abacavir sulfate is supported by pharmacokinetic trials and evidence from adequate and well-controlled trials of abacavir sulfate in adults and pediatric subjects [see dosage and administration ( 2.3), adverse reactions ( 6.2), clinical pharmacology ( 12.3), clinical studies ( 14.2)] . clinical trials of abacavir sulfate 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 abacavir sulfate in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. a dose reduction is required for patients with mild hepatic impairment (child-pugh class a) [see dosage and administration ( 2.4)] . the safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate or severe hepatic impairment; therefore, abacavir sulfate is contraindicated in these patients [see contraindications ( 4), clinical pharmacology ( 12.3)] .

Canada - English - Health Canada

apotex inc - abacavir (abacavir sulfate); lamivudine; zidovudine - tablet - 300mg; 150mg; 300mg - abacavir (abacavir sulfate) 300mg; lamivudine 150mg; zidovudine 300mg - nucleoside and nucleotide reverse transcriptase inhibitors