Trade Names:Ceclor- Powder for Oral Suspension 125 mg/5 mL- Powder for Oral Suspension 187 mg/5 mL- Powder for Oral Suspension 250 mg/5 mL- Powder for Oral Suspension 375 mg/5 mL
Trade Names:Ceclor Pulvules- Capsules 250 mg- Capsules 500 mg
Trade Names:Cefaclor- Tablets, extended-release 375 mg- Tablets, extended-release 500 mg
Trade Names:Raniclor- Tablets, chewable 125 mg- Tablets, chewable 187 mg- Tablets, chewable 250 mg- Tablets, chewable 375 mgApo-Cefaclor (Canada)
Inhibits mucopeptide synthesis in bacterial cell wall.
C max is 3.7 to 8.2 mcg/mL, T max is 2.5 to 2.7 h, AUC is 9.9 to 18.1 mcg•h/mL.Immediate-Release (500 mg without food)
C max is 16.8 mcg/mL, T max is 0.9 h, AUC is 19.2 mcg•h/mL.Food
The AUC and C max are greater when the extended-release tablets are taken with food. The C max is decreased when the immediate-release capsules are taken with food.
Cefaclor is 25% protein bound.
No evidence of metabolism.
Plasma t ½ is about 1 h. About 60% to 85% is excreted unchanged in the urine within 8 h.
The t ½ is slightly prolonged. In those with complete absence of renal function, t ½ is 2.3 to 2.8 h.
Treatment of infections of respiratory tract, urinary tract, skin and skin structures; treatment of otitis media caused by susceptible strains of specific microorganisms.
Hypersensitivity to cephalosporins.
PO 250 to 500 mg every 8 h.Children
PO 20 to 40 mg/kg/day in divided doses every 8 h (for otitis media and pharyngitis, every 12 h) (max 1 g/day).Acute Bacterial Exacerbations of Chronic BronchitisAdults Extended-release
PO 500 mg/day for 7 days.Secondary Bacterial Infection of Acute BronchitisAdults
PO 500 mg/12 h for 7 days.Pharyngitis or TonsillitisAdults
PO 375 mg/12 h for 10 days.Uncomplicated Skin and Skin Structure InfectionsAdults
PO 375 mg/12 h for 7 to 10 days.
Administer with food or milk if GI upset occurs.Tablets, extended-release
Administer with food to enhance absorption. Do not crush or chew.
After reconstitution, oral suspension must be refrigerated and will remain stable for up to 14 days. Do not freeze. Shake well before use.
Inhibition of renal excretion of cefaclor.
May cause false-positive urine glucose test results with Benedict solution, Fehling solution, or Clinitest tablets but not with enzyme-based tests (eg, Clinistix , Tes-tape ); false-positive test results for proteinuria with acid and denaturization-precipitation tests; false-positive direct Coombs test results in certain patients (eg, those with azotemia); false elevations in urinary 17-ketosteroid values.
Nausea; vomiting; diarrhea; anorexia; abdominal pain or cramps; flatulence; colitis, including pseudomembranous colitis.
Pyuria; renal dysfunction; dysuria; reversible interstitial nephritis; hematuria; toxic nephropathy.
Eosinophilia; neutropenia; lymphocytosis; leukocytosis; thrombocytopenia; decreased platelet function; anemia; aplastic anemia; hemorrhage.
Hepatic dysfunction, abnormal LFT results.
Hypersensitivity, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis; serum sickness–like reactions (eg, skin rash, polyarthritis, arthralgia, fever); candidal overgrowth.
MonitorResponse to therapy
Monitor patient's response to therapy. Notify health care provider if infection does not improve or appears to worsen.Side effects
Monitor patient for GI, DERM, and general body side effects, and signs of superinfection. Inform health care provider if noted and significant. Immediately report severe diarrhea, diarrhea containing blood or pus, or severe abdominal cramping.
Category B .
Excreted in breast milk.
In infants, consider benefits relative to risks. Safety and efficacy in children under 1 mo not established.
Reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible cross-reactivity.
Use drug with caution in patients with renal impairment. Dosage adjustment based on renal function may be required.
May result in bacterial or fungal overgrowth of nonsusceptible microorganisms.
Consider in patients in whom diarrhea develops.
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