Professional Information

Cefaclor

Pronouncation: (SEFF-uh-klor)
Class: Antibiotic, Cephalosporin

Trade Names:
Ceclor
- Powder for Oral Suspension 125ߙmg/5ߙmL
- Powder for Oral Suspension 187ߙmg/5ߙmL
- Powder for Oral Suspension 250ߙmg/5ߙmL
- Powder for Oral Suspension 375ߙmg/5ߙmL

Trade Names:
Ceclor Pulvules
- Capsules 250ߙmg
- Capsules 500ߙmg

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 mg

Apo-Cefaclor (Canada)
Novo-Cefaclor (Canada)
Nu-Cefaclor (Canada)
PMS-Cefaclor (Canada)

Pharmacology

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Compare with other drugs.

Inhibits mucopeptide synthesis in bacterial cell wall.

Pharmacokinetics

Absorption

Extended-Release (375 to 500 mg with food)

C _max is 3.7 to 8.2 mcg/mL, T _max is 2.5 to 2.7ߙh, 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.

Distribution

Cefaclor is 25% protein bound.

Metabolism

No evidence of metabolism.

Elimination

Plasma t _½ is about 1 h. About 60% to 85% is excreted unchanged in the urine within 8 h.

Special Populations

Renal 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.

Contraindications

Hypersensitivity to cephalosporins.

Dosage and Administration

Adults

PO 250 to 500 mg everyߙ8ߙh.

Children

PO 20 to 40 mg/kg/day in divided doses every 8 h (for otitis media and pharyngitis, every 12 h) (max 1ߙg/day).

Acute Bacterial Exacerbations of Chronic Bronchitis
Adults Extended-release

PO 500ߙmg/day for 7 days.

Secondary Bacterial Infection of Acute Bronchitis
Adults

PO 500 mg/12 h for 7 days.

Pharyngitis or Tonsillitis
Adults

PO 375 mg/12 h for 10 days.

Uncomplicated Skin and Skin Structure Infections
Adults

PO 375 mg/12 h for 7 to 10ߙdays.

General Advice

Administer with food or milk if GI upset occurs.

Tablets, extended-release

Administer with food to enhance absorption. Do not crush or chew.

Storage/Stability

After reconstitution, oral suspension must be refrigerated and will remain stable for up to 14 days. Do not freeze. Shake well before use.

Drug Interactions

Probenecid

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.

Adverse Reactions

GI

Nausea; vomiting; diarrhea; anorexia; abdominal pain or cramps; flatulence; colitis, including pseudomembranous colitis.

Genitourinary

Pyuria; renal dysfunction; dysuria; reversible interstitial nephritis; hematuria; toxic nephropathy.

Hematologic

Eosinophilia; neutropenia; lymphocytosis; leukocytosis; thrombocytopenia; decreased platelet function; anemia; aplastic anemia; hemorrhage.

Hepatic

Hepatic dysfunction, abnormal LFT results.

Miscellaneous

Hypersensitivity, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis; serum sickness–like reactions (eg, skin rash, polyarthritis, arthralgia, fever); candidal overgrowth.

Precautions

Monitor

Response 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.

Pregnancy

Category B .

Lactation

Excreted in breast milk.

Children

In infants, consider benefits relative to risks. Safety and efficacy in children under 1ߙmo not established.

Hypersensitivity

Reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible cross-reactivity.

Renal Function

Use drug with caution in patients with renal impairment. Dosage adjustment based on renal function may be required.

Pseudomembranous colitis

Consider in patients in whom diarrhea develops.

Superinfection

May result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Overdosage

Symptoms

Seizures.

Patient Information

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.