DUOVIR-N Tablets
Each film-coated tablet contains:
Lamivudine ……… 150 mg
Zidovudine ………. 300 mg BP
Nevirapine ………. 200 mg

DUOVIR-N Tablets are indicated for the treatment of HIV infection, once patients have been stabilized on the maintenance regimen of nevirapine 200 mg b.i.d., and have demonstrated adequate tolerability to nevirapine.

Additional important information regarding the use of nevirapine for the treatment of HIV infection:

• Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled studies, DUOVIR-N Tablets should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm 3 or in adult males with CD4+ cell counts greater than 400 cells/mm 3 unless the benefit outweighs the risk (see WARNINGS AND PRECAUTION ).
• The 14-day lead-in period with nevirapine 200 mg daily dosing has been demonstrated to reduce the frequency of rash (see WARNINGS AND PRECAUTIONS; DOSAGE AND ADMINISTRATION ).
• If rash persists beyond the 14 day lead-in period, do not dose escalate to 200 mg twice daily. The 200 mg once daily dosing regimen should not be continued beyond 28 days, after which an alternative regimen should be sought.

Adults
One tablet twice daily.

DUOVIR-N Tablets 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, along with the standard doses of lamivudine + zidovudine twice daily is recommended. Following this lead-in dose, a dose escalation (maintenance dose) to DUOVIR-N Tablets twice daily may be carried out in the absence of any hypersensitivity reactions (e.g. rash, liver function test abnormalities) (see Warnings and Precautions ).

Monitoring of p atients
Intensive clinical and laboratory monitoring, including liver function tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver function tests at baseline, prior to dose escalation, and at 2 weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment (see Warnings and Precautions ). In some cases, hepatic injury has progressed despite discontinuation of treatment.

Dosage Adjustment
Because DUOVIR-N Tablets are a fixed-dose combination, they should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance <50 mL/min), or hepatic impairment, or those experiencing dose-limiting adverse events.

DUOVIR-N Tablets should be discontinued if patients experience severe rash or a rash accompanied by constitutional findings (see Warnings and Precautions ). 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 DUOVIR-N Tablets until the rash has resolved (see Warnings and Precautions ). If rash persists beyond the 14-day lead-in period, do not dose escalate to DUOVIR-N Tablets twice daily. The DUOVIR-N Tablets once-daily dosing regimen should not be continued beyond 28 days, after which an alternative regimen should be sought.

If a clinical (symptomatic) hepatic event occurs, nevirapine should be permanently discontinued and not be restarted after recovery (see WARNINGS AND PRECAUTIONS ).

Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing, using one 200 mg nevirapine tablet daily for the first 14 days (lead-in) in combination with the lamivudine + zidovudine, followed by DUOVIR-N Tablets twice daily in the absence of any signs of hypersensitivity.

DUOVIR-N Tablets are contraindicated in patients with clinically significant hypersensitivity (eg, anaphylaxis, Stevens-Johnson syndrome) to any of the components contained in the formulation.

DUOVIR-N Tablets are contraindicated in patients with moderate or severe (Childs Pugh Class B or C, respectively) hepatic impairment (see WARNINGS AND PRECAUTIONS ).

DUOVIR-N Tablets are 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.i.d. (see Indications ).

DUOVIR-N Tablets………………………… Container of 60 tablets