Lamivudine


Full Generic Medicine Info
Dosage/Direction for Use

Oral
HIV infection
Adult: 150 mg bid or 300 mg once daily, in combination w/ other antiretrovirals.
Child: As soln: >3 mth <14 kg: 4 mg/kg bid. As tab: 14-21 kg: 75 mg bid; 22-30 kg: 75 mg in the morning and 150 mg at night; >30 kg: 150 mg bid. Max: 300 mg daily. Doses are given in combination w/ other antiretrovirals.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<51st dose 50 mg, then 25 mg once daily.
5-141st dose 150 mg, then 50 mg once daily.
15-291st dose 150 mg, then 100 mg once daily.
30-491st dose 150 mg, then 150 mg once daily.


Oral
Chronic hepatitis B
Adult: 100 mg once daily. For patients w/ concomitant HIV infection: 150 mg bid or 300 mg once daily.
Child: 2-17 yr 3 mg/kg once daily. Max: 100 mg daily.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<51st dose 35 mg, then 10 mg once daily.
5-141st dose 35 mg, then 15 mg once daily.
15-291st dose 100 mg, then 25 mg once daily.
30-491st dose 100 mg, then 50 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Lactation.
Special Precautions
Patient w/ hepatomegaly, hepatitis or other risk factors for hepatic disease; childn w/ history or risk factors for pancreatitis. Pregnancy. Monitoring Parameters Monitor amylase, bilirubin, liver enzymes 3 mthly during therapy; haematologic parameters, HIV viral load, CD4 count; signs and symptoms of pancreatitis or hepatonecroinflammation; hepatitis B virus (HBV) DNA regularly during therapy. Monitor hepatic function for several mth following discontinuation of therapy. Perform HIV testing prior to and periodically during treatment.
Adverse Reactions
Abdominal pain, nausea, vomiting, diarrhoea, headache, fever, rash, alopecia, malaise, insomnia, cough, nasal symptoms, arthralgia, musculoskeletal pain, pancreatitis, anaemia, neutropenia, thrombocytopenia, immune reconstitution syndrome, lipodystrophy, metabolic abnormalities (e.g. hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, hyperlactataemia), osteonecrosis; increased creatine phosphokinase, liver enzymes and serum amylase. Rarely, rhabdomyolysis.
Potentially Fatal: Lactic acidosis, hepatomegaly w/ steatosis.
Drug Interactions
Decreased renal excretion w/ high-dose trimethoprim. Severe anaemia may occur when used concomitantly w/ zidovudine. Treatment failure and emergence of resistance may result from once daily triple regimens of lamivudine and tenofovir w/ either abacavir or didanosine. May antagonise the antiviral action of zalcitabine. May enhance the adverse effect of emtricitabine.
Food Interaction
Food decreases rate of absorption.
Action
Lamivudine, a synthetic nucleoside analogue, is phosphorylated into the body to the active 5'-triphosphate metabolite. It inhibits RNA- and DNA-dependent polymerase activities of reverse transcriptase via DNA chain termination.
Absorption: Rapidly absorbed from the GI tract. Delayed absorption by ingestion w/ food. Bioavailability: 80-87%. Time to peak plasma concentration: Approx 1 hr.
Distribution: Crosses the blood-brain barrier and placenta; enters breast milk. Volume of distribution: 1.3 L/kg. Plasma protein binding: Up to 36%.
Metabolism: Metabolised intracellularly to the active metabolite lamivudine triphosphate via phosphorylation.
Excretion: Via urine, mainly as unchanged drug. Elimination half-life: 5-7 hr.
Storage
Oral: Store between 20-25°C.
CIMS Class
Antivirals
ATC Classification
J05AF05 - lamivudine ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Disclaimer: This information is independently developed by CIMS based on lamivudine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 CIMS. All rights reserved. Powered by CIMSAsia.com
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