Active Ingredient: Zidovudine
Zidovudine is indicated in anti-retroviral combination therapy for Human Immunodeficiency Virus (HIV) infected adults and children.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 30 kg, oral, 250 milligrams zidovudine, 2 times daily.
Regimen B: In case that patient weight is ≥ 30 kg, oral, 300 milligrams zidovudine, 2 times daily.
The usual recommended dose of zidovudine in combination with other anti-retroviral agents is 250 or 300 mg twice daily.
For:
Regimen A: In case that patient weight is ≥ 8 kg and patient weight is ≤ 13 kg, oral, 100 milligrams zidovudine, 2 times daily.
Regimen B: In case that patient weight is ≥ 14 kg and patient weight is ≤ 21 kg, oral, 300 milligrams zidovudine, divided 2 times daily.
Regimen C: In case that patient weight is ≥ 22 kg and patient weight is ≤ 30 kg, oral, 200 milligrams zidovudine, 2 times daily.
Regimen D: In case that patient weight is ≥ 28 kg and patient weight is ≤ 30 kg, oral, 250 milligrams zidovudine, 2 times daily.
Regimen E: In case that patient weight is ≥ 9 kg and patient weight is ≤ 30 kg, oral, 9 milligrams zidovudine per kilogram of body weight, 2 times daily.
Regimen F: In case that patient weight is ≥ 4 kg and patient weight is ≤ 9 kg, oral, 12 milligrams zidovudine per kilogram of body weight, 2 times daily.
| Weight (kg) | In the morning | In the evening | Daily dose (mg) |
|---|---|---|---|
| 8-13 | 100 mg | 100 mg | 200 |
| 14-21 | 100 mg | 200 mg | 300 |
| 22-30 | 200 mg | 200 mg | 400 |
| Alternatively children weighing at least 28 kg to 30 kg (included) could take: | |||
| 28-30 | 250 mg | 250 mg | 500 |
Children weighing at least 9 kg and less than 30 kg: The recommended dose of zidovudine is 9 mg/kg twice daily in combination with other antiretroviral agents. The maximum dosage should not exceed 300 mg twice daily.
Children weighing at least 4 kg and less than 9 kg: The recommended dose of zidovudine is 12 mg/kg twice daily in combination with other antiretroviral agents.
Available data are insufficient to propose specific dosage recommendations for children weighing less than 4 kg.
For:
Regimen A: Intravenous, 1 milligrams zidovudine per kilogram of body weight, once every 4 hours.
Regimen B: Intravenous, 2 milligrams zidovudine per kilogram of body weight, once every 4 hours.
A dose for zidovudine IV for infusion of 1 or 2 mg zidovudine/kg bodyweight every 4 hours provides similar exposure (AUC) to an oral dose of 1.5 or 3.0 mg zidovudine/kg every 4 hours (600 or 1200 mg/day for a 70 kg patient). The current recommended oral dose of zidovudine is 250 or 300 mg twice daily. This current dose is used as part of a multi-drug treatment regimen.
Patients should receive zidovudine IV for infusion only until oral therapy can be administered.
For:
Intravenous, between 80 milligrams zidovudine per square meter of body surface and 160 milligrams zidovudine per square meter of body surface, once every 6 hours.
Limited data are available on the use of zidovudine IV for infusion in children. A range of intravenous dosages between 80-160 mg/m² every 6 hours (320-640 mg/m²/day) have been used. Exposure following the 120 mg/m² dose every 6 hours approximately corresponds to an oral dose of 180 mg/m² every 6 hours. An oral dose of zidovudine of 360 to 480 mg/m² per day approximately corresponds to an intravenous dose of 240-320 mg/m²/day.
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