DOSAGE AND ADMINISTRATION
- A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. To facilitate reporting of hypersensitivity reactions and collection of information on each case, an Abacavir Hypersensitivity Registry has been established. Physicians should register patients by calling 1-800-270-0425.
- ZIAGEN may be taken with or without food.
Adult Patients
The recommended oral dose of ZIAGEN for adults is 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.
Pediatric Patients
The recommended oral dose of ZIAGEN Oral Solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg/kg twice daily (up to a maximum of 300 mg twice daily) in combination with other antiretroviral agents.
ZIAGEN is also available as a scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing ZIAGEN Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow ZIAGEN Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of ZIAGEN Tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for ZIAGEN Tablets in Pediatric Patients |
Weight
(kg) | Dosage Regimen Using Scored Tablet |
Total
Daily Dose |
| AM Dose | PM Dose |
| 14 to 21 | ½ tablet (150 mg) | ½ tablet (150 mg) | 300 mg |
| >21 to <30 | ½ tablet (150 mg) | 1 tablet (300 mg) | 450 mg |
| ≥30 | 1 tablet (300 mg) | 1 tablet (300 mg) | 600 mg |
Patients with Hepatic Impairment
The recommended dose of ZIAGEN in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. To enable dose reduction, ZIAGEN Oral Solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, ZIAGEN is contraindicated in these patients.
DOSAGE FORMS AND STRENGTHS
ZIAGEN Tablets, containing abacavir sulfate equivalent to 300 mg abacavir, are yellow, biconvex, scored, capsule-shaped, film-coated, and imprinted with "GX 623" on both sides.
ZIAGEN Oral Solution, each mL containing abacavir sulfate equivalent to 20 mg of abacavir, is a clear to opalescent, yellowish, strawberry-banana-flavored liquid.
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