Insufficient data are available to recommend a dosage of Lamivir in patients undergoing dialysis.

Contraindications
Lamivir is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product.

Warnings and Precautions
In paediatric patients with a history of pancreatitis or other significant risk factors for the development of pancreatitis, the combination of lamivudine and zidovudine should be used with extreme caution and only if there is no satisfactory alternative therapy. Treatment with lamivudine should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur.
The complete prescribing information for zidovudine should be consulted before combination therapy with lamivudine and zidovudine is initiated.

LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination, including lamivudine. A majority of these cases have been in women. Caution should be exercised when administering lamivudine to any patient, and particularly to those with known risk factors for liver disease. Treatment with lamivudine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity.

IMPAIRED RENAL FUNCTION
Reduction of the dose of Lamivir is recommended for patients with impaired renal function (See Dosage and Administration)

PATIENTS WITH HIV AND HEPATITIS B VIRUS COINFECTION
In clinical trials, some patients with HIV infection who have chronic liver disease due to hepatitis B virus infection experienced clinical or laboratory evidence of recurrent hepatitis upon discontinuation of lamivudine. Consequences may be more severe in patients with decompensated liver disease.

DRUG INTERACTIONS
Trimethoprim 160 mg and sulfamethoxazole
800 mg once daily has been shown to increase lamivudine exposure (AUC). The effect of higher doses of trimethoprim and sulfamethoxazole on lamivudine pharmacokinetics has not been investigated.

PREGNANCY
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Lamivudine should be used during pregnancy only if the potential benefits outweigh the risks.

LACTATION
It is recommended that HIV-infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV infection. Although it is not known if lamivudine is excreted in human milk, there is the potential for adverse effects from lamivudine in nursing infants. Mothers should be instructed to discontinue nursing if they are receiving lamivudine.

PAEDIATRIC USE
The safety and effectiveness of lamivudine in combination with other antiretroviral agents have been established in paediatric patients three months of age and older.

Side Effects
Adults
Selected clinical adverse events with a > 5% frequency during therapy with lamivudine 150 mg twice daily plus zidovudine 200 mg thrice daily compared with zidovudine are: headache, malaise, fatigue, nausea, anorexia and/or decreased appetite, abdominal cramps, neuropathy, insomnia and sleep disorders, dizziness, depressive disorders, nasal signs and symptoms, cough and skin rashes. Pancreatitis was observed in less than 0.5% of patients who received lamivudine in controlled clinical trials.
The incidence of neutropenia (ANC
< 750/mm3) was greater in patients during therapy with lamivudine 150 mg plus zidovudine 200 mg tid (7.2%) versus zidovudine alone (5.4%). Likewise, anaemia (Hb < 8.0 g/dl) was reported in 2.9% of patients on the combination, as compared to 1.8% of patients on zidovudine alone. Levels of bilirubin > 2.5 the upper limit of normal (ULN) were observed in 0.8% of patients receiving the combination, versus 0.4% on zidovudine monotherapy. Levels of amylase
(> 2.0 ULN) were observed in 4.2% of patients receiving the combination versus 1.5% in patients on zidovudine monotherapy. (ULN* = Upper limit of normal).

Paediatric patients
Of 97 paediatric patients enrolled in one open-label, uncontrolled study, 14% developed pancreatitis while receiving monotherapy with lamivudine (See Warnings). Paraesthesias and peripheral neuropathies were reported in 13 patients (13%) in this study and resulted in treatment discontinuation in 3 patients. Selected laboratory abnormalities included neutropenia, anaemia, thrombocytopenia, and elevated ALT, AST and amylase levels.

Overdosage
There is no known antidote for lamivudine. One case of an adult ingesting 6 g of lamivudine was reported; there were no clinical signs or symptoms noted and haematologic tests remained normal. It is not known whether lamivudine can be removed by peritoneal dialysis or haemodialysis.

Presentation
Lamivir Tablets Blister pack of 10 tablets and container of 60 tablets
Lamivir Oral Solution Bottle of 100 ml with syringe