Each film-coated tablet contains Lamivudine 150 mg and Zidovudine USP 300 mg
Each film-coated tablet contains Lamivudine 150 mg, Zidovudine USP 300 mg, Nevirapine 200 mg
Without a Prescription
Combivir is prescribed for the treatment of:
Combivir is prescribed for the treatment of HIV infection, as part of combination therapy.
Combivir-N is prescribed for the treatment of HIV infection, once patients have been stabilized on the maintenance regimen of nevirapine 200 mg bd, and have demonstrated adequate tolerability to nevirapine.
The recommended oral dose of Combivir for adults and adolescents (at least 12 years of age) is one tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) twice daily with or without food.
Dose Adjustment: Because it is a fixed dose combination, Combivir 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.
1 tablet twice daily
Combivir-N should not be administered to patients who have just initiated therapy with nevirapine.
This is because an initial lead-in dosing of 200 mg nevirapine once daily for 2 weeks is recommended.
Following this lead-in dose, a dose escalation (maintenance dose) to 200 mg nevirapine bd may be carried out in the absence of any hypersensitivity reactions (e.g. rash, liver function test abnormalities).
Monitoring of patients
Clinical chemistry tests, which include liver function tests, should be performed prior to initiating lead-in nevirapine therapy and at appropriate intervals during therapy.
Because it is a fixed-dose combination, Combivir-N should not be prescribed for patients requiring dosage adjustment, such as those with low body weight (<50 kg), reduced renal function (creatinine clearance < 50 ml/min) or those experiencing dose-limiting adverse events.
Combivir-N should be discontinued if patients experience severe rash or a rash accompanied by constitutional findings.
Patients experiencing mild to moderate rash during the 14-day lead-in period of 200 mg/day should not have their nevirapine dose increased or start therapy with Combivir-N until the rash has resolved Combivir-N administration should be interrupted in patients experiencing moderate or severe liver function tests abnormalities (excluding GGT), until the liver function test elevations have returned to baseline.
Nevirapine (using Nevimune Tablets) may then be restarted at 200 mg per day.
Increasing the daily dose to 200 mg twice daily (using Combivir-N) should be done with caution, after extended observation.
Nevirapine should be permanently discontinued if moderate or severe liver function test abnormalities recur.
Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing, using one 200 mg Nevimune tablet daily for the first 14 days (lead-in) in combination with the other antiretrovirals, followed by 200 mg twice daily using Combivir-N in the absence of any signs of hypersensitivity.
Impaired renal and hepatic function
No data are available to recommend a dosage of nevirapine in patients with hepatic dysfunction, renal insufficiency or undergoing dialysis.
Combivir is contraindicated if you have any of the following conditions:
Combivir tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product.
Combivir-N is contraindicated in patients with clinically significant hypersensitivity to any of the components contained in the formulation.
Combivir-N is also contraindicated for patients who are just initiating therapy with nevirapine.
These patients require a lead-in dose of nevirapine 200 mg o.d., whereas this formulation contains the maintenance dose of nevirapine 200 mg b.d..
- Blister pack of 10 tablets;
- Container of 30 tablets;
- Container of 60 tablets;