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When will epivir come off patent
Pharmacological / chemical class ATX.
Antiviral direct action – nucleoside reverse transcriptase inhibitor.
ATC therapeutic class.
Antiviral for systemic use.
The mechanism of action. Inhibits reverse transcriptase of HIV. The suppression of HIV replication.
Pharmacological effects.
Antivirus, is active against HIV.
Pharmacokinetics.
Rapid absorption from the gastrointestinal tract.
Indications for use and dosing.
• HIV infection in adults and children (solution for internal use of 10 mg / ml and 150 mg tablets). Inside adults and adolescents (12 years and older) – 150 mg 2 times a day in combination with other antiretroviral drugs. Children: from 3 months. to 12 years – 4 mg / kg 2 times per day, maximum dose of 300 mg (30 ml) per day, in combination with other antiretroviral drugs; newborns aged 1 week. – 2 mg / kg 2 times per day. In mild renal failure (spacecraft more than 50 ml / min) initial dose of 150 mg, maintenance – 150 mg 2 times a day with CC 50-30 ml / min, the first dose of 150 mg, maintenance – 150 mg / day. (for 1 admission), with CC 30-15 ml / min, the first dose of 150 mg, further course of therapy is not recommended. Children from 3 months. to 12 years with impaired renal function, dose calculated according to the scheme: with CC 30-50 ml / min initial dose of 4 mg / kg and maintenance – 4 mg / kg 1 time a day, with CC 15-30 ml / min, the first dose of 4 mg / kg, maintenance – 2,6 mg / kg 1 time a day, with CC 5-15 ml / min the first dose of 4 mg / kg, maintenance – 1,3 mg / kg 1 time a day at least 5 ml of QA / mines the first dose of 1.3 mg / kg, maintenance – 0,7 mg / kg 1 time a day.
• Chronic viral hepatitis B in the background of viral replication (solution for internal use of 5 mg / ml and 100 mg tablets). Inside adults and adolescents (16 years and over) – regardless of food intake of 100 mg 1 time per day. In moderate to severe chronic renal failure the concentration of lamivudine in serum was increased by the reduction of its renal clearance, therefore, patients with CC than 50 ml / min dose of lamivudine should be lower: in QA 50-30 ml / min initial dose of 100 mg, maintenance 50 mg, with Page 30-15 ml / min – 100 mg and 25 mg, respectively, with CC 15.5 ml / min – 35 mg and 15 mg, respectively, with CC of less than 5 ml / min – 35 mg and 10 mg respectively. In the appointment of less than 100 mg dose of the drug used as a solution for oral administration. Patients on hemodialysis (2-3 sessions a week lasting at least 4 h), after the initial dose reduction in accordance with the spacecraft in the future for the entire period of dialysis dose adjustment is required. When liver failure and compensated renal function dosage adjustment of lamivudine is not required.
• Chemoprophylaxis of HIV transmission from mother to child during pregnancy and childbirth.
Chemoprophylaxis of HIV infection after contact with HIV-contaminated material (sex with patients with HIV infection, punctures and cuts while working with HIV-contaminated material, the material from falling on the mucous membranes or broken skin).
Side effects.
• Anemia, neutropenia.
• Hepatotoxic pancreatitis.
• myopathy, myositis, neuropathy.
Overdose.
Clinical manifestations are not identified. The effectiveness of hemodialysis is unknown.
Contraindications.
Hypersensitivity. Precautions – renal failure, pancreatitis (including history), peripheral neuropathy (including history), pregnancy, lactation period.
Pregnancy.
FDA category C. passes through the placenta. The preferred drug for use in pregnant women.
Breastfeeding.
Passes into breast milk. HIV-positive mothers is recommended to refrain from breastfeeding to prevent postnatal transmission of HIV.
Clinically meaningful interactions.
Fluconazole, methadone, nelfinavir, ritonavir, probenitsid, trimethoprim, valproic acid – an increased concentration of lamivudine (competitive effect). Dose not change.
Summary and additional information.
Systematic monitoring of peripheral blood.
Trade names, forms of production and producers.
• Zeffiks, solution for oral administration of 5 mg / ml 240 ml, coated tablets 100 mg № 14, Glaxo Vellkom Opereyshens United Kingdom;
• Epivir TriTiSi, solution for oral administration of 10 mg / ml 240 ml number 1, GlaxoSmithKline Inc., Canada;
• Epivir TriTiSi, solution for oral administration of 10 mg / ml 240 ml, coated tablets 150 mg № 60, Glaxo Vellkom Opereyshens UK Limited, United Kingdom.
