Therapeutic Category:

Anti-retroviral reverse transcriptase inhibitor


Composition:

LAZID
Each tablet contains: Lamivudine 150 mg + Zidovudine 300 mg

Indications:

Treatment of HIV infection in combination with NNRTIs or PIs.


Contraindications:

Hypersensitivity to any of the components of the formulation.


Adverse Reactions:

Headache, Malaise and fatigue, nausea/vomiting, diarrhea, anorexia, abdominal pain, abdominal cramps and dyspepsia. Lactic acidosis and severe hepatomegaly with steatosis and recurrent hepatitis following discontinuation of therapy have also been reported Hematological adverse events include neutropenia, anemia, and thrombocytopenia. Chills or fever were reported in 10% of patients treated with combined lamivudine/zidovudine therapy.


Precautions:

Should be used with caution in patients with hepatic disease or in those with known risk factors for liver disease, patients with impaired renal function, including renal failure and patients who have bone marrow suppression. Treatment should be discontinued in any patient who develops lactic acidosis or pronounced hepatotoxicity which may include hepatomegaly and steatosis. Patients should be closely monitored for several months after stopping lamivudine+zidovudine therapy for hepatitis B. Frequent blood counts are strongly recommended in patients with advanced HIV disease who are treated with combination. Myopathy and myositis have been associated with prolonged use of zidovudine and therefore may occur with therapy with the combination.


Pregnancy and Lactation:

There have been no studies of lamivudine in pregnant women and no data regarding effect on vertical transmission. It is not known if lamivudine is excreted into human milk but zidovudine is excreted in the milk. Mothers should be instructed to discontinue breast-feeding if they are receiving lamivudine and zidovudine.


Drug Interactions:

No significant differences were observed in AUC or total clearance for lamivudine or zidovudine when the two drugs were administered together in HIV-infected adults; however, zidovudine Cmax was increased by 39% ± 62% (mean ± SD). Concurrent dosing with sulfamethoxazole; trimethoprim, SMX-TMP increased exposure (AUC) lamivudine by 44% after 5 days of concomitant therapy. Hypertensive crisis in patient taking a phenylpropanolamine-containing product was reported with triple therapy of indinavir, lamivudine, 3TC, and stavudine.Coadministration of ganciclovir, interferon-alpha, and other bone marrow suppressive or cytotoxic agents may increase the hematologic toxicity of zidovudine.


Dosage And Administration:

Adults and adolescents (at least 12 years of age): Lazid one tablet twice daily The combination should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance £50 mL/min), those with low body weight(<50 kg or 110 lb), or those experiencing dose-limiting adverse events.


Storage:

Store in a cool, dry and dark place.