|ZIDINE ORAL SOLUTION|
|Each 5 ml contains:||Zidovudine USP - 50 mg|
Zidovudine in combination with other antiretroviral agents is indicated for the treatment of HIV infection. Zidovudine is also indicated for the prevention of maternal-fetal HIV transmission as part of a regimen that includes oral Zidovudine beginning between 14 and 34 weeks of gestation, IV Zidovudine during labor, and administration of Zidovudine oral solution to the neonate after birth.
Hypersensitivity to any of the components of the formulation.
Zidovudine oral solution should not be administered concomitantly with fixed dose combination products that also contain Zidovudine as one of their components. Zidovudine should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count <1000 cells/mm3 or hemoglobin <9.5 g/dL. Frequent blood counts are strongly recommended in patients with advanced HIV disease who are treated with Zidovudine. For patients with asymptomatic or early HIV disease, periodic blood counts are recommended. If anaemia or neutropenia develops, dosage adjustments may be necessary. Therapy with Zidovudine should be suspended until the diagnosis of lactic acidosis has been excluded.
Concomitant use of Zidovudine with stavudine and Zidovudine with doxorubicin should be avoided since an antagonistic relationship has been demonstrated. Some nucleoside analogues affecting DNA replication, such as ribavirin, antagonize the in vitro antiviral activity of Zidovudine against HIV; concomitant use of such drugs should be avoided. Coadministration of ganciclovir, interferon-alpha, and other bone marrow suppressive or cytotoxic agents may increase the hematological toxicity of Zidovudine. For patients experiencing pronounced anemia or other severe Zidovudine-associated events while receiving chronic administration of Zidovudine and some of the drugs (e.g., fluconazole, valproic acid), Zidovudine dose reduction may be considered.
Headache, insomnia, nausea, GI upset, myalgia, malaise, neutropenia, anemia, occasional hepatotoxicity, peripheral neuropathy, myositis
The recommended dose in pediatric patients 6 weeks to 12 years of age is 160 mg/m2 every 8 hours (480 mg/m2/day up to a maximum of 200 mg every 8 hours) in combination with other antiretroviral agents.
Maternal-fetal HIV transmission: The recommended dosing regimen for administration to pregnant women (>14 weeks of pregnancy) and their neonates is:
Maternal Dosing: 100 mg orally five times per day until the start of labor. During labor and delivery, IV Zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous IV infusion of 1 mg/kg/h (total body weight) until clamping of the umbilical cord.
Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered Zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.elimination half-life after a single dose of Lamivudine ranges 3-7 hours.
Dose adjustment: Significant anaemia (hemoglobin of <7.5 g/dL or reduction of >25% of baseline) and/or significant granulocytopenia (granulocyte count of <750 cells/mm 3 or reduction of >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed. For less severe anaemia or neutropenia, a reduction in daily dose may be adequate. In patients who develop significant anaemia, dose modification does not necessarily eliminate the need for transfusion. If marrow recovery occurs following dose modification, gradual increases in dose may be appropriate depending on hematological indices and patient tolerance. There are insufficient data to recommend dose adjustment of Zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.
Since Zidovudine is primarily eliminated by hepatic metabolism, a reduction in the daily dose may be necessary in these patients. In patients with poor bone marrow reserve, particularly in patients with advanced symptomatic HIV disease, frequent monitoring of hematological indices is recommended to detect serious anaemia or granulocytopenia.