Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets)

1. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) © The Swiss Pharmacy

2. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets), a combination of 2 nucleoside analogue reverse transcriptase inhibitors (Lamivudine and Zidovudine) and one non-nucleoside analogue reverse transcriptase inhibitor (Nevirapine), is used alone as a complete regimen or in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. © The Swiss Pharmacy

3. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Duovir-N Tablets are manufactured by Cipla Limited, India in the strength of 650 mg (Lamivudine 150mg, Zidovudine 300mg and Nevirapine 200mg). © The Swiss Pharmacy

4. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Chemical Structure - Lamivudine © The Swiss Pharmacy

5. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Chemical Structure - Zidovudine © The Swiss Pharmacy

6. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Chemical Structure - Nevirapine © The Swiss Pharmacy

7. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) The active ingredients contained in Duovir-N tablets are Lamivudine, Zidovudine and Nevirapine. Each film-coated Duovir-N tablet contains 150 mg of Lamivudine, 300 mg of Zidovudine and 200 mg of Nevirapine. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

8. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Uses of Duovir-N 650 mg tablets: The combination of Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) is used alone or along with other medications for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 35 kg. Lamivudine and Zidovudine are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). They work by lowering the amount of HIV in the blood. Duovir-N will not cure HIV infection or AIDS, however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. © The Swiss Pharmacy

9. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Uses of Duovir-N 650 mg tablets: Duovir-N will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease. Duovir-N also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. The decision to use Duovir-N (Lamivudine, Zidovudine and Nevirapine Tablets) should take into account liver and skin toxicity, potentially fatal, especially in patients with higher CD4 counts and in women, due to the Nevirapine component. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

10. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Recommended Adult Dosage The recommended dosage of Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) in HIV-1 infected adults and adolescents weighing greater than or equal to 35 kg is 1 tablet (containing 150 mg of Lamivudine, 300 mg of Zidovudine and 200 mg of Nevirapine) taken orally once daily followed by a daily oral dose of Lamivudine and Zidovudine (Duovir tablets) 12 hours later for the first 14 days. After 14 days, One Duovir-N (Lamivudine, Zidovudine and Nevirapine Tablets) fixed-dose tablet twice daily. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

11. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Recommended Adult Dosage The 14-day lead-in period with Nevirapine 200 mg once daily must be strictly followed; it has been demonstrated to reduce the frequency of rash. If any patient experiences rash during the 14-day lead-in period, do not dose escalate to 200 mg twice daily until the rash has resolved. Do not continue the lead-in dosing regimen beyond 28 days. If dosing is interrupted for greater than 7 days, restart 14-day Nevirapine lead-in period. Because Lamivudine, Zidovudine and Nevirapine tablets is a fixed dose combination and cannot be dose adjusted, Lamivudine, Zidovudine and Nevirapine tablets is not recommended in pediatric patients weighing less than 35 kg, patients with creatinine clearance less than 50 mL per minute, patients with hepatic impairment or experiencing dose-limiting adverse reactions. © The Swiss Pharmacy

12. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Contraindications ➔Duovir-N is contraindicated in patients with a known hypersensitivity to Lamivudine, Zidovudine, Nevirapine or any other component of the tablet. ➔In patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment. ➔Use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens, an unapproved use. ➔Duovir-N is contraindicated in patients who have been discontinued for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to Nevirapine. © The Swiss Pharmacy

13. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Contraindications ➔Duovir-N is contraindicated in patients who previously had AST or ALT greater than 5X Upper Limit of Normality (ULN) during Nevirapine therapy. ➔Coadministration of Duovir-N with herbal preparations containing St John’s wort (Hypericum perforatum) is contraindicated due to the risk of potentially significant decreases of plasma concentrations and reduced clinical effects of Nevirapine. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

14. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Storage Instructions Duovir-N Tablets (Generic Lamivudine, Zidovudine and Nevirapine Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

15. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Warnings Zidovudine, a component of DUOVIR-N Tablets, has been associated with hematologic toxicity, including neutropenia and anemia, particularly in patients with advanced HIV-1 disease. Lamivudine/Zidovudine containing tablets should be used with caution in patients who have bone marrow compromise. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) must not be administered with other Lamivudine, Zidovudine Or Nevirapine containing products or Emtricitabine containing products. Hepatic decompensation, some fatal, has occurred in HIV -1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with/without Ribavirin. Discontinue Duovir-N as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and Zidovudine. Coadministration of Ribavirin and Zidovudine is not advised. © The Swiss Pharmacy

16. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Warnings Pancreatitis: Use with caution in patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue Duovir-N therapy as clinically appropriate. Immune reconstitution syndrome and redistribution/accumulation of body fat have been reported in patients treated with combination antiretroviral therapy. Myopathy and myositis, with pathological changes similar to that produced by HIV-1 disease, have been associated with prolonged use of Zidovudine and, therefore, may occur with therapy with Lamivudine/Zidovudine Tablet. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine. Patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. © The Swiss Pharmacy

17. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Warnings Treatment with zidovudine, a component of DUOVIR-N, has been associated with loss of subcutaneous fat. The incidence and severity of lipoatrophy are related to cumulative exposure. Severe and life-threatening skin reactions, including fatal cases, have been reported, occurring most frequently during the first 6 weeks of therapy. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterized by rash, constitutional findings and organ dysfunction, including hepatic failure. Rhabdomyolysis has been observed in some patients experiencing skin and/or liver reactions associated with nevirapine use. Severe, life-threatening and, in some cases, fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, have been reported in patients treated with nevirapine. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

18. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Warnings In controlled clinical trials, symptomatic hepatic events regardless of severity occurred in 4% (range, 0% to 11%) of subjects who received Nevirapine and 1% of subjects in control groups. Severe and life-threatening skin reactions, including fatal cases, have been reported, occurring most frequently during the first 6 weeks of therapy. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterized by rash, constitutional findings and organ dysfunction, including hepatic failure. Rhabdomyolysis has been observed in some patients experiencing skin and/or liver reactions associated with Nevirapine use. Nevirapine must not be used as a single agent to treat HIV-1 or added on as a sole agent to a failing regimen. Resistant virus emerges rapidly when nevirapine is administered as monotherapy. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

19. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Possible Side Effects Most commonly reported Side effects of Lamivudine and Zidovudine tablets with an incidence greater than or equal to 15% during clinical trials of combination Lamivudine and Zidovudine were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. The most serious side effects associated with Nevirapine are hepatitis/hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure may be isolated or associated with signs of hypersensitivity which may include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

20. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Overdosage Lamivudine: Because a negligible amount of Lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a Lamivudine overdose event. Zidovudine: Acute overdoses of Zidovudine have been reported in pediatric patients and adults. These involved exposure up to 50 grams. No specific symptoms or signs have been identified following acute overdosage with Zidovudine apart from those listed as adverse events such as fatigue, headache, vomiting, and occasional reports of hematological disturbances. Patients recovered without permanent sequelae. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

21. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Overdosage Hemodialysis and peritoneal dialysis appear to have a negligible effect on the removal of Zidovudine, while elimination of its primary metabolite, 3'- azido-3'-deoxy-5'-O-ß-D glucopyranuronosythymidine (GZDV), is enhanced. Nevirapine: There is no known antidote for Nevirapine overdosage. Cases of Nevirapine overdose at doses ranging from 800 to 1,800 mg per day for up to 15 days have been reported. Patients have experienced adverse events, including edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, and weight decrease. All events subsided following discontinuation of Nevirapine. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

22. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Duovir-N During Pregnancy Lamivudine and Zidovudine tablets are classified by the US FDA as Pregnancy Category C. Nevirapine has been classified by the US FDA as Pregnancy Category B. There are no adequate and well-controlled studies of Lamivudine / Zidovudine in pregnant women. Lamivudine / Zidovudine should be used during pregnancy only if the potential benefits outweigh the risks. Clinical trial data demonstrate that maternal Zidovudine treatment during pregnancy reduces vertical transmission of HIV-1 infection to the fetus. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

23. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Duovir-N During Pregnancy No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits with Nevirapine. The maternal and developmental no-observable-effect level dosages produced systemic exposures approximately equivalent to or approximately 50% higher in rats and rabbits, respectively, than those seen at the recommended daily human dose (based on AUC). There are no adequate and well-controlled studies of Nevirapine in pregnant women. The Antiretroviral Pregnancy Registry, has not found an increased risk of birth defects following first trimester exposures to Nevirapine. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy

24. Duovir-N (Generic Lamivudine, Zidovudine and Nevirapine Tablets) Duovir-N Tablets are manufactured by Cipla Limited, India. URL: https://www.theswisspharmacy.com/product_info.php?info=p9544_Duovir-N-Pills.html © The Swiss Pharmacy