Monograph Details
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Infections & Infestations
> Bacterial infections
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KETEK |
| Manufacturer |
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Sanofi Aventis |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Ketolide (macrolide deriv.). |
| Generic Name |
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Telithromycin 300mg, 400mg; tabs. |
| Indications |
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Susceptible mild to moderate community-acquired pneumonia. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: 800mg once daily for 7–10days. Severe renal impairment (CrCl <30mL/min): 600mg once daily; renal and hepatic impairment: 400mg once daily. Hemodialysis: give dose after dialysis session. |
| Contraindications |
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Concomitant cisapride, pimozide. History of telithromycin or macrolide-related hepatitis and/or jaundice. Myasthenia gravis. |
| Precautions |
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Avoid use in patients with congenital QTc prolongation or proarrhythmic conditions (eg, hypokalemia, bradycardia). Hepatic dysfunction; monitor and discontinue if hepatotoxicity occurs; do not re-administer. Elderly. Pregnancy (Cat.C). Nursing mothers. |
| Interactions |
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See Contraindications. Do not use with Class IA (eg, quinidine, procainamide) or Class III (eg, dofetilide) antiarrhythmics. Avoid rifampin, ergots, simvastatin, lovastatin, atorvastatin (suspend during therapy). Potentiates metoprolol. May potentiate oral anticoagulants (monitor). May be potentiated by CYP3A4 inhibitors (eg, itraconazole, ketoconazole). Antagonized by CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbital). GI upset with theophylline (separate dosing by 1 hour). Monitor digoxin, midazolam, CYP450 substrates. |
| Adverse Reactions |
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GI upset, headache, dysgeusia, dizziness, visual disturbances (esp. focusing difficulties, blurred vision, diplopia; may be severe), fainting; rarely: hepatic dysfunction (usually reversible), QTc prolongation. |
| How Supplied |
Tabs 300mg—20
Tabs 400mg—60 |
| Additional Resources |
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• Related Prescribing Note |
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