Monograph Details
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Infections & Infestations
> Viral infections
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HEPSERA |
| Manufacturer |
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Gilead Sciences, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nucleotide analogue (reverse transcriptase inhibitor). |
| Generic Name |
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Adefovir dipivoxil 10mg; tabs. |
| Indications |
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Chronic hepatitis B with viral replication and either elevated serum ALT/AST or histologically active disease. |
| Children |
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Not recommended. |
| Adults |
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10mg once daily. Renal impairment: CrCl 20–49mL/min: 10mg every 48 hours; CrCl 10–19mL/min: 10mg every 72 hours; CrCl <10mL/min (on hemodialysis): 10mg every 7 days after dialysis; (not on hemodialysis): not recommended. |
| Precautions |
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Unrecognized or untreated HIV co-infection (test for HIV before and during treatment). Monitor renal function. Monitor hepatic function during and for several months after treatment. Discontinue if lactic acidosis or hepatotoxicity occurs. Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity (eg, lactic acidosis, steatosis). Reevaluate periodically. Elderly. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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May potentiate or be potentiated by drugs that reduce renal function or compete for renal tubular secretion (monitor). Caution with other nephrotoxic drugs (eg, cyclosporine, tacrolimus, aminoglycosides, vancomycin, NSAIDs). |
| Adverse Reactions |
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Asthenia, headache, abdominal pain, GI upset, pruritus, lactic acidosis, severe hepatomegaly with steatosis, post-treatment exacerbation of hepatitis, elevated creatinine, hypophosphatemia; nephrotoxicity (prolonged use). |
| Extra Text |
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Note: Register pregnant patients exposed to adefovir by calling (800) 258-4263. |
| How Supplied |
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Tabs—30 |
| Additional Resources |
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• Related Prescribing Note |
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