Zilarvir

Zilarvir

lamivudine + zidovudine

Manufacturer:

GPO

Distributor:

GPO
Full Prescribing Info
Contents
Zidovudine, lamivudine.
Description
Each tablet contains: Zidovudine 300 mg and Lamivudine 150 mg.
Action
Zidovudine and lamivudine, synthetic antiretroviral drugs, are thymidine and cytidine nucleoside analogs reverse transcriptase inhibitors, respectively. Zidovudine and lamivudine are intracellularly phosphorylated to their respective active metabolites, zidovudine triphosphate and lamivudine triphosphate. Zidovudine triphosphate compete with the natural substrates for interacting with reverse transcriptase and thus inhibit HIV DNA synthesis.
Zidovudine and lamivudine are well absorbed from the GI tract following oral administration. The bioavailability of zidovudine in adults is 65% and for lamivudine is 80-88%. Zidovudine and lamivudine combination tablet is bioequivalent to zidovudine 300 mg tablet and lamivudine 150 mg tablet taken together. Zidovudine and lamivudine cross the blood-brain barrier and distribute into the cerebrospinal fluid (CSF). The elimination half-life of zidovudine and lamivudine are 0.5-3 hours and 5-7 hours, respectively. Zidovudine is metabolized in the liver to 3-azido-3-deoxy-5-O-beta-D-glucopyranunosylthymidine. This major metabolite, accounting for approximately 50-80% of administered dose, is eliminated by renal excretion. The majority of lamivudine is eliminated unchanged in urine. Zidovudine and lamivudine cross the placenta.
Indications/Uses
Zilarvir are indicated in the treatment of HIV infection in adult and children over 12 years of age.
Dosage/Direction for Use
Adults and adolescents 50 kg of body weight and over: Oral, 1 tablet two times a day.
Adults and adolescents less than 50 kg of body weight: Use is not recommended.
Children up to 12 years of age: Use is not recommended.
Contraindications
It is contraindicated in patients with known hypersensitivity to zidovudine and/or lamivudine.
Special Precautions
Patients with renal function impairment or creatinine clearance ≤50 ml per minute should not receive Zilarvir.
Should not be used in children younger than 12 years of age, patients who weigh less than 50 kg or patients who require reduced dose.
Use with extreme caution in patients with bone marrow depression, hepatic function impairment, hapatitis B virus infection, pancreatitis, and peripheral neuropathy.
Blood cell counts and indices of anemia should be performed prior to initiation and during therapy to detect the hematologic toxicity from the drug.
Concurrent use with nephrotoxic of bone marrow suppressive drugs may increase toxic effects of zidovudine.
Use in Pregnancy & Lactation: Should be used in pregnancy only if clearly needed. Nursing women who treated with Zilarvir should be instructed to discontinue nursing.
Use In Pregnancy & Lactation
Should be used in pregnancy only if clearly needed. Nursing women who treated with Zilarvir should be instructed to discontinue nursing.
Adverse Reactions
The serious effects are bone marrow depression, anemia, neutropenia, hepatotoxicity, myopathy or myositis, neuropathy and pancreatitis.
Headache, nausea, abdominal pain, anorexia, diarrhea, dizziness, insomnia and skin rash have also been reported.
Storage
In well-closed container, below 25°C.
MIMS Class
ATC Classification
J05AR01 - zidovudine and lamivudine ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Tab 60's.
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