LAMIVUDINE 100MG

INTRODUCTION
Alfa interferon (INF) has been the mainstay in the management of Chronic hepatites B since mis-1980s,but only 30 -40% of patients respond to this Therapy. Moreover immunosuppreed patients such as those with HIV infection and organ transplant respond poorly to INF. Patients with perinatal acquisition of infection, patients with normal ALT levels and patients infected with precore mutants also respond poorly. In addition, INF can cause an acute exacerbation of hepatic injury, rendering it unsafe for use in patients with decompensated liver disease. Finally, cumbersome adverse effects may accompany INF therapy.
The development of nucleoside analouges has launched a revolution in the treatment of hepatites B. Unlike INF , LAMIVUDINE blocks replication of the virus by inhibiting the HBV polymerase enzymes and it's activity is thought to be independent of the host immune response to the virus. It is highly bioavailable by oral route and extremely well tolerated .
Results obtained from a Chinese study in patients who where not likely respond to INF:LAMIVUDINE dine 100mg/day given for 52 weeks, resulted in a sustainaed normalisation of ALT levels in 72%of patients and HbeAge to anti-Hbe sero-conversion 16%of patients. In addition, 56 %of patients has significant improvement in necroinflammatory activity and 11%has improvement in inbrosis .After 2 year of therapy52%of patients contained to have undetectable. HBV DNA levels, and cumulative rate of sero-conversion had risen to 27 %. A parallel study with 100mg LAMIVUDINE for 52 % weeks reported similar findings.

Mechanism of Action

LAMIVUDINE is an synthetic nucleoside analuges with activity against HBV and HIV.It is phosphorylated to its active 5- phosphate metabolite intracellularly in the peripherals blood mononucleocytes . It acts by inhibition of the viral polymerase enzymes, which acts as a reverse transcriptase , it also inhibits RNS and DNS dependent viral DNA polymerase activity. It is a weak inhibitor of mammalian DNA polymerase.

PHARMACOKINETICS

LAMIVUDINE is rapidly obsorbed after oral administration. Bioavail ability binding is low <36%>and apparent volume of distribution following 4 administration 1.3 suggesting distribution to extra cellular space.

INDICATION

LAMIVUDINE is indicated for the treatment of Chronic hepatites B infection associated with viral replication and liver flammation.

Contraindication

Hypersensitivity to any of the components of the product.

Special precautions

LAMIVUDINE should be stopped immediately if clinacal signs symptoms or laboratory abnormalities suggestive of pancreataties occur .Reduce dosage in patients with renal dysfunction. Some patients with chronic HBV infection have experienced clinical or laboratory evidence of recurrence of hepatites upon discontinuation of lamivudine therapy

PREGNANCY:Use only if potential benefits outweigh the risk.

LACTATION:Mothers advised to discontinue nursing if they are receiving lamivudine.

Drug interactions

The pharmacokinetics of lamivudine 100mg /day was not altered by coadministration of alfa -interferon 30MU/week for 4 weeks in patients with HIV infection, there is no drug -drug interaction between lamivudine and zidovdine.In patients with asymptomatic HIV infection a single 300mg dose of lamivudine theAUC increased by 44%and clearance increased by 35%after receiving cotrimoxazole 800/160mg /day for 4 days.

Adverse Effects

LAMIVUDINE is an extremely well tolerated drug . Advice events includes headache, malaise,fatigue, nausea, anorexia, abdominal, cramps , neuropathy, insomnia, dizziness, depressive disorders, cough skin rashas , Musculo-Skeletal , pain and myalgia. Pancreatitis was reported in >5%of patients a abnormalities observed include neutropenia , an anaemia and eveltated serum bilirubin and serum amylase levels.

Dosage and administration

Adults and children above 12 years :100mg /day

Presentation

Blister packs of 10

BRAND AVAILABLE

LAMIDAC-100

Zydus alidac