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Antifungals & Antivirals

Nevitrio 30

 

Pack size: 

Box of 1 bottle x 60 tablets.


Composition:

Each tablet contains stavudine 30 mg, lamivudine 150 mg and nevirapine 200 mg.


Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.


 

 
  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • 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.
  • Nevitrio 30 is taken orally regardless to 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 (once daily or 150 mg twice 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).
    Patients weighing not more than 60 kg: 1 tablet twice daily.
    Patients weighing more than 60 kg: The other fixed-combination preparation containing 40 mg of stavudine may be appropriated: 1 tablet twice daily.

 

Or as prescribed by physicians.

 

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

     

Common

  • 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.
  • Arthralgia, myalgia, back pain.
  • Lymph node disease, neutropenia, thrombocytopenia.
  • Elevated AST, ALT.
  • Angina.

Uncommon

  • Neoplasm, fatigue, fat distribution disorders.
  • Mood disorders.
  • Edema swelling of eyelids, around the eyes, lips and tongue, rashes.
  • Pancreatitis, hepatitis, jaundice, diarrhea.
  • Lactic acidosis.
  • Gynaecomastia.
  • Itching accompanied by fever, arthralgia, myalgia, swollen glands.
  • Eosinophilia, granulocytopenia, thrombocytopenia.
  • Renal dysfunction.
  • Hyperbilirubinemia.

Rare

  • Angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN) or Lyell's syndrome.
  • Hepatitis, liver necrolysis.
  • Pancreatitis can be fatal, especially in people with a history of pancreatitis, gallstones or alcohol abuse.

     

  • Stavudine should be used with caution in patients with a history of peripheral neuropathy. Treatment suspended if developing signs of peripheral neuropathy. If symptoms resolve on withdrawal discontinuation of stavudine, stavudine may be resumed at half the previous dose.
  • Severe and life-threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings and visceral involvement such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue nevirapine as soon as possible.
  • Severe and life-threatening hepatotoxicity, including fatal fulminant hepatitis, has occurred in patients treated with nevirapine.
  • Nevirapine should be used with extreme caution in patients with mild to moderate hepatic impairment. Women and patients with high CD4+ cell counts (greater than 250 cells/microliter in women or 400 cells/microlitre in men) at risk of liver toxicity.
  • Patients with a history of pancreatitis should also be observed carefully for signs of pancreatitis during stavudine, lamivudine treatment.
  • Nevitrio 30 should be used with caution in 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.
    Nevitrio 30 should be used with caution in patients with to renal impairment.
  • Advise the patient that Nevitrio 30 does not reduce the risk of transmission of HIV. These patients must therefore learn to understand that condoms are absolutely needed to protect the sexual partners.
  • Hepatic injury: The drug should be stopped if ALT or AST increase to greater than 5 times the upper limit of normal level.
  • Opportunistic infections: Patients receiving Nevitrio 30 or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
  • HIV and HBV coinfection: Patients with HIV and chronic hepatitis B or C coinfection and treated with combination antiretroviral therapy are at higher risk for severe hepatic adverse reactions.
  • Exacerbations after treatment discontinuation: Severe acute exacerbation of hepatitis B has been observed in patients with chronic hepatitis B following discontinuance of lamivudine. Hepatic function should be closely monitored in these patients. Prior to lamivudine therapy for the treatment of chronic HBV infection, the patients should be not absolutely coinfected 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: Lipoatrophy or lipodystrophy has been reported in patients receiving stavudine-containing regimens, the incidence and severity are cumulative over time. Clinicians should assess the benefits versus risks of the drug for each patient and should consider alternative antiretrovirals.
  • Pregnancy: There are no adequate and well-controlled studies in pregnant women. Drug crosses the placenta. Stavudine cause miscarriage, fetal malformation. Nevitrio 30 should be used during pregnancy only if the potential benefit justifies the potential risk.
  • Lactation: Nevitrio 30 is excreted into breast milk. There is also a high risk of HIV transmission with breast milk. Mothers with HIV infection should not breastfeed.
  • There are no specific studies about the ability to drive vehicles and use machinery. However, patients should be advised that they may experience adverse reactions such as fatigue during treatment with Nevitrio 30. Therefore, caution should be recommended when driving a car or operating machinery.

     

Contact us

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