Monograph Details
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Infections & Infestations
> Viral infections
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ZERIT for ORAL SOLUTION |
| Manufacturer |
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Bristol-Myers Squibb Virology |
| 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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Stavudine 1mg/mL after constitution; pwd; dye-free; fruit-flavored. |
| Also |
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• ZERIT
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| Indications |
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HIV-1 infection. |
| Children |
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<30kg: initially 1mg/kg every 12 hours. ≥30kg: as adult. Withdraw drug if peripheral neuropathy occurs; after complete resolution, may restart at ½ recommended dose; if neuropathy recurs consider discontinuing permanently. Renal impairment: reduce dose or increase dosing interval. |
| Adults |
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≥60kg: 40mg every 12hrs; <60kg: 30mg every 12 hrs. Withdraw drug if peripheral neuropathy occurs; after complete resolution, may restart at 20mg every 12 hrs for patients ≥60kg, or 15mg every 12 hrs for patients <60kg; if neuropathy recurs consider discontinuing permanently. Renal impairment: ≥60kg (CrCl 26–50mL/min): 20mg every 12 hrs; (CrCl 10–25mL/min): 20mg every 24 hrs. <60kg (CrCl 26–50mL/min): 15mg every 12 hrs; (CrCl 10–25mL/min): 15mg every 24 hrs. Hemodialysis: ≥60kg: 20mg every 24 hrs; <60kg: 15mg every 24 hrs. Coincide dose for end of dialysis and give at same time of day on non-dialysis days. |
| Precautions |
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Suspend therapy if symptoms of lactic acidosis (eg, motor weakness, fatigue, dyspnea, GI disturbances) or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Suspend if pancreatitis suspected; may restart if ruled out, monitor closely (do not give with didanosine or hydroxyurea after restarted). Monitor for peripheral neuropathy. Advanced HIV disease, history of peripheral neuropathy, or concomitant neurotoxic drugs: consider reducing dose or discontinuing if neuropathy occurs; may attempt rechallenge at 1/2 dose. Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity. Renal dysfunction. Risk of liver disease. Elderly. Pregnancy (Cat.C): monitor for lactic acidosis if used with didanosine. Nursing mothers: not recommended. |
| Interactions |
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Zidovudine: not recommended. Increased risk of toxicity with neurotoxic, hepatotoxic, or pancreatotoxic drugs (eg, didanosine and/or hydroxyurea). |
| Adverse Reactions |
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Headache, GI upset, peripheral neuropathy, rash, elevated liver enzymes, elevated amylase, pancreatitis, lactic acidosis or severe hepatomegaly with steatosis, fat redistribution, anorexia, myalgia. |
| Extra Text |
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Note: Register pregnant patients exposed to stavudine by calling (800) 258-4263. |
| How Supplied |
Caps—60
Soln—200mL |
| Additional Resources |
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• Related Prescribing Note |
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