Therapeutic Category:

Antiretroviral reverse transcriptase inhibitor.


Composition:

ZIDINE-100ZIDINE-300
Each capsule containsEach tablet contains
Zidovudine - 100 mg Zidovudine - 300 mg

Indications And Usage:

Treatment of HIV infection Prevention of maternal-fetal HIV transmission


Contraindications:

Patients with hypersensitivity to any of the components of the formulation


Warnings:

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. There have been reports of pancytopenia associated with the use of zidovudine. Myopathy and myositis with pathological changes, similar to that produced by HIV disease, have been associated with prolonged use of zidovudine. Rare occurrences of potentially fatal lactic acidosis in the absence of hypoxemia, and severe hepatomegaly with steatosis have been reported. Caution should be exercised when administering zidovudine to any patient, particularly obese women, with hepatomegaly, hepatitis, or other known risk factor for liver disease.


Precautions:

Patients with severely impaired hepatic function may be at greater risk of toxicity. No data is available on its teratogenic potential in humans. Zidovudine is excreted in human milk. HIV-infected women should not breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.


Drug Interactions:

Acyclovir, alpha interferon, dipyridamole (increased in vitro antiretroviral activity); amphotericin B, dapsone, pentamidine, TMP/SMX, acyclovir, ganciclovir, pentamidine, sulfadiazine/pyrimethamine (increased bone marrow toxicity); methadone (decreased ZDV metabolism); phenytoin (increased or decreased phenytoin levels); Nephrotoxic drugs or cytotoxic drugs, such as flucytosine, vincristine, or interferon, may increase ZDV toxicity. Acetominophen, probenecid, cimetidine, indomethacin, lorazepam, or aspirin may inhibit excretion and contribute to toxicity.


Adverse reactions:

Minor: headache, insomnia, nausea, GI upset, myalgia, malaise.
Major: Neutropenia, anemia, occasional hepatotoxicity, peripheral neuropathy, myositis


Dosage And Administration:

HIV Infection Adults: 600 mg per day in divided doses i.e. 300 mg bid
Paediatrics: 3 months to 12 years 180 mg/m2 every 6 hours, not to exceed 200 mg every 6 hours
Prophylaxis for maternal transmission:
During pregnancy (after 14 weeks): 100 mg orally 5 times a day till the onset of labour
During labour: Intravenous Zidovudine, 2 mg/kg over 1 hour followed by a continuous IV infusion of 1 mg/kg/h until clamping of the umbilical cord.
To the neonate: Zidovudine syrup 2 mg/kg 6 hourly, beginning 8-12 hours after birth and continuing for 6 weeks


Storage:

Store at 15° to 25° C (59° to 77° F)