Monograph Details
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Infections & Infestations
> Bacterial infections
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CEDAX |
| Manufacturer |
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Shionogi USA, Inc |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Cephalosporin. |
| Generic Name |
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Ceftibuten (as dihydrate) 400mg; caps. |
| Also |
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• CEDAX SUSPENSION
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| Indications |
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Susceptible mild-to-moderate acute bacterial exacerbations of chronic bronchitis, acute bacterial otitis media, and pharyngitis/tonsillitis. |
| Children |
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Take susp on an empty stomach; caps may be taken without regard to meals. Treat for 10 days. <6 months: not recommended. ≥6 months: (otitis media or pharyngitis/tonsillitis): ≤45kg: 9mg/kg (max 400mg) once daily; >45kg: 400mg once daily. |
| Adults |
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Take susp on an empty stomach; caps may be taken without regard to meals. Treat for 10 days. 400mg once daily. Renal impairment: Creatinine clearance (CrCl) 30–49mL/min: 200mg (or 4.5mg/kg) every 24 hrs; CrCl 5–29mL/min: 100mg (or 2.25mg/kg) every 24 hrs. Coincide a dose for the end of hemodialysis. |
| Precautions |
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Penicillin or other drug allergy. History of GI disease (esp. colitis). Renal dysfunction. Elderly. Labor & delivery. Pregnancy (Cat.B). Nursing mothers. |
| Adverse Reactions |
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GI upset, headache, dizziness. |
| How Supplied |
Caps—20, 100
Susp 90mg/5mL—30mL, 60mL, 90mL, 120mL |
| Additional Resources |
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• Related Prescribing Note |
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