Nevitrio 30

Rx

Nevitrio 30 is indicated for HIV-infected patients who weigh less than 60 kg, when the patients have been stabilized on the maintenance regimen of nevirapine 200 mg/day and have demonstrated adequate tolerability to lamivudine, stavudine, nevirapine.

Dosage:

Patients weighing ≤ 60 kg: 1 tablet twice daily.

Usage:

Nevitrio 30 is taken orally. The drug may be taken with or without meals. Nevitrio 30 should only be used in case patients completed the initial 2-week of treatment with 3-drug regimen alone: 300 mg of lamivudine daily, 30 mg of stavudine twice daily and 200 mg of nevirapine once daily. After 2 weeks, patients may continue the therapy with Nevitrio 30 (1 tablet twice daily, every 12 hours) without any sign of hypersensitivity reactions (itchy rash on the skin, abnormal liver enzymes).

• Known hypersensitivity to any ingredient in the formulation.
• Patients who have just stopped therapy with nevirapine because of adverse reactions of nevirapine.
• Severe hepatic/ renal disease.

Allergic reaction, fever/chills, fatigue, weight decrease, flu-like syndrome. Rashes, itching, hyperhidrosis. Dizziness, headache, drowsiness, insomnia, nightmares, depression, anxiety, peripheral neuropathy (numbness, tingling, pain in the hands and feet). Anorexia, dysphagia, nausea, vomiting, diarrhea, abdominal pain, dyspepsia, constipation. Nasal signs and symptoms, cough. Nasal signs and symptoms, cough. Lymph node disease, neutropenia, thrombocytopenia. Elevated AST, ALT. Angina.

• Use with caution in:
  • Patients with history of peripheral neuropathy.
  • Patients with renal impairment, mild to moderate hepatic impairment.
  • Patients with a history of pancreatitis.
  • Patients, who with high enzymes of hepatic or are at risk case for liver disease, especially in obese women abused of alcohol or a history of abused alcohol, because of the risk of lactic acidosis.
• Treatment suspended in case of:
  • Developing signs of peripheral neuropathy.
  • Developing signs or symptoms of severe skin reactions or hypersensitivity reactions
  • ALT or AST increase to greater than 5 times the upper limit of normal level.
• Advise the patient that Nevitrio 30 does not reduce the risk of transmission of HIV. Patients must therefore learn to understand that condoms are absolutely needed to protect the sexual partners.
• Hepatic function should be closely monitored in patients with chronic hepatitis B. Prior to lamivudine therapy for the treatment of chronic HBV infection, the patients should be not absolutely co-infected with HIV since use of a lower dose of lamivudine for the treatment of hepatitis may result in rapid emergence of lamivudine-resistance HIV.
• Adipogenic effects have been reported.
• Stavudine cause miscarriage, fetal malformation. Nevitrio 30 should be used during pregnancy only if the potential benefit justifies the potential risk. There is also a high risk of HIV transmission with breast milk. Mothers with HIV infection should not breastfeed.
• Patients should be aware of how they react to drug before driving or operating machinery.