Monograph Details
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Infections & Infestations
> Viral infections
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ZIAGEN ORAL SOLUTION |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nucleoside analogue (reverse transcriptase inhibitor). |
| Generic Name |
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Abacavir (as sulfate) 20mg/mL; strawberry-banana flavor; contains parabens, propylene glycol. |
| Also |
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• ZIAGEN
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| Indications |
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HIV-1 infection. |
| Children |
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<3 months: not recommended. ≥3 months–16 years: 8mg/kg twice daily; max 300mg twice daily. |
| Adults |
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>16 years: 300mg twice daily or 600mg once daily. Mild hepatic impairment: 200mg twice daily. |
| Contraindications |
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See literature regarding fatal hypersensitivity reactions (which may include fever, rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, or respiratory symptoms); discontinue as soon as suspected; do not restart. Moderate or severe hepatic impairment. |
| Precautions |
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Decompensated liver disease or risk factors for liver disease. Suspend if lactic acidosis or hepatotoxicity (e.g., hepatomegaly, steatosis) occurs. Women, obesity, prolonged nuceloside exposure: increased risk of toxicity. Do not add as a single agent to a failing regimen. If stopped for reasons other than hypersensitivity, restart only if medical care can be readily accessed by patient or caregiver; monitor for hypersensitivity. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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May antagonize methadone. May be potentiated by ethanol. Triple therapy (once daily regimen) with lamivudine + tenofovir: high rate of early viral non-response (see literature). |
| Adverse Reactions |
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Nausea, vomiting, fever, headache, diarrhea, rash (may be severe, eg, Stevens-Johnson), anorexia, insomnia, fat redistribution, mild hyperglycemia, elevated triglycerides, pancreatitis; hypersensitivity reactions (may be fatal); lactic acidosis, severe hepatomegaly with steatosis, immune reconstitution syndrome. |
| Extra Text |
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Note: Register pregnant patients exposed to abacavir by calling (800) 258-4263. Register patients who have had a hypersensitivity reaction to abacavir by calling (800) 270-0425. |
| How Supplied |
Tabs—60
Soln—240mL |
| Additional Resources |
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• Related Prescribing Note |
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