Monograph Details
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Infections & Infestations
> Viral infections
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ZIAGEN |
| 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) 300mg; tabs. |
| Also |
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• ZIAGEN ORAL SOLUTION
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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, regardless of HLA-B*5701 status. Moderate or severe hepatic impairment. |
| Precautions |
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Evaluate for presence of HLA-B*5701 allele prior to starting therapy or reinitiation; if positive, abacavir is not recommended; discontinue permanently if hypersensitivity cannot be ruled out. Decompensated liver disease or risk factors for liver disease. Suspend if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Cardiovascular disease. Smoking. 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. 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, headache, malaise, fatigue, dreams/sleep disorders, diarrhea, fever, rash (may be severe, eg, Stevens-Johnson), ear/nose/throat infections, mild hyperglycemia, elevated triglycerides, pancreatitis; hypersensitivity reactions (may be fatal); lactic acidosis, severe hepatomegaly with steatosis, immune reconstitution syndrome, fat redistribution. |
| 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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