Class: Antibiotic, Cephalosporin
- 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
- Capsules 250 mg
- Capsules 500 mg
- Tablets, extended-release 375 mg
- Tablets, extended-release 500 mg
- Tablets, chewable 125 mg
- Tablets, chewable 187 mg
- Tablets, chewable 250 mg
- Tablets, chewable 375 mg
Inhibits mucopeptide synthesis in bacterial cell wall.
AbsorptionExtended-Release (375 to 500 mg with food)
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.
Special PopulationsRenal Function Impairment
The t ½ is slightly prolonged. In those with complete absence of renal function, t ½ is 2.3 to 2.8 h.
Indications and Usage
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.
Dosage and AdministrationAdults
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 Bronchitis
PO 500 mg/day for 7 days.Secondary Bacterial Infection of Acute Bronchitis
PO 500 mg/12 h for 7 days.Pharyngitis or Tonsillitis
PO 375 mg/12 h for 10 days.Uncomplicated Skin and Skin Structure Infections
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.
Laboratory Test Interactions
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.
- Instruct patient to complete full course of therapy.
- Instruct patient to check body temperature daily. If fever persists for more than a few days or if high fever (above 102°F) or shaking chills are noted, notify health care provider immediately.
- Advise patient to maintain normal fluid intake while using this medication.
- Advise diabetic patient to use enzyme-based tests (eg, Clinistix , Testape ) for monitoring urine glucose because drug may give false results with other tests.
- Instruct patient to report these symptoms to health care provider: nausea, vomiting, diarrhea, skin rash, hives, muscle or joint pain.
- Advise patient to report signs of superinfection: Black “furry” tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
- Warn patient that diarrhea that contains blood or pus may be a sign of serious disorders. Tell patient to seek medical care and not to treat at home.
- Instruct patient to seek emergency care immediately if wheezing or difficulty in breathing occurs.
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