More Information About Cefaclor, Geniclor


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More information about Cefaclor

Contraindications

Hypersensitivity to cefaclor, any component of the formulation, or other cephalosporins

Warnings/Precautions

Modify dosage in patients with severe renal impairment. Prolonged use may result in superinfection. Use with caution in patients with a history of penicillin allergy especially IgE-mediated reactions (eg, anaphylaxis, urticaria). Beta-lactamase-negative, ampicillin-resistant (BLNAR) strains of H. influenzae should be considered resistant to cefaclor. Extended release tablets are not approved for use in children <16 years of age.

Adverse Reactions

Dermatologic: Rash (maculopapular, erythematous, or morbilliform) (1% to 2%)

Gastrointestinal: Diarrhea (3%)

Genitourinary: Vaginitis (2%)

Hematologic: Eosinophilia (2%)

Hepatic: Transaminases increased (3%)

Miscellaneous: Moniliasis (2%)

<1%: Agitation, agranulocytosis, anaphylaxis, angioedema, aplastic anemia, arthralgia, cholestatic jaundice, CNS irritability, confusion, dizziness, hallucinations, hemolytic anemia, hepatitis, hyperactivity, insomnia, interstitial nephritis, nausea, nervousness, neutropenia, paresthesia, pruritus, pseudomembranous colitis, PT prolonged, seizure, serum-sickness, somnolence, Stevens-Johnson syndrome, urticaria, thrombocytopenia, toxic epidermal necrolysis, vomiting

Reactions reported with other cephalosporins include fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, cholestasis

Overdosage/Toxicology

Symptoms of overdose include diarrhea, epigastric distress, nausea, and vomiting. Many beta-lactam containing antibiotics have the potential to cause neuromuscular hyperirritability or seizures. Hemodialysis may be helpful to aid in removal of the drug from blood; otherwise, treatment is supportive and symptom-directed.

Drug Interactions

Aminoglycosides: May be additive to nephrotoxicity.

Furosemide: May be additive to nephrotoxicity.

Probenecid: May decrease cephalosporin elimination.

Ethanol/Nutrition/Herb Interactions

Food: Cefaclor serum levels may be decreased slightly if taken with food. The bioavailability of cefaclor extended release tablets is decreased 23% and the maximum concentration is decreased 67% when taken on an empty stomach.

Stability

Store at controlled room temperature. Refrigerate suspension after reconstitution. Discard after 14 days. Do not freeze.

Mechanism of Action

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Pharmacodynamics/Kinetics

Absorption: Well absorbed, acid stable

Distribution: Widely throughout the body and reaches therapeutic concentration in most tissues and body fluids, including synovial, pericardial, pleural, peritoneal fluids; bile, sputum, and urine; bone, myocardium, gallbladder, skin and soft tissue; crosses placenta; enters breast milk

Protein binding: 25%

Metabolism: Partially hepatic

Half-life elimination: 0.5-1 hour; prolonged with renal impairment

Time to peak: Capsule: 60 minutes; Suspension: 45 minutes

Excretion: Urine (80% as unchanged drug)

Dosage

Children >1 month: Dosing range: 20-40 mg/kg/day divided every 8-12 hours; maximum dose: 1 g/day

Otitis media: 40 mg/kg/day divided every 12 hours

Pharyngitis: 20 mg/kg/day divided every 12 hours

Adults: Dosing range: 250-500 mg every 8 hours

Extended release tablets:

Acute bacterial exacerbations of or secondary infections with chronic bronchitis: 500 mg every 12 hours for 7 days

Pharyngitis, tonsillitis, uncomplicated skin and skin structure infections: 375 mg every 12 hours for 10 days

Dosing adjustment in renal impairment:

Clcr 10-50 mL/minute: Administer 50% to 100% of dose

Clcr<10 mL/minute: Administer 50% of dose

Hemodialysis: Moderately dialyzable (20% to 50%)

Administration

Administer around-the-clock to promote less variation in peak and trough serum levels.

Chewable tablet: Should be chewed before swallowing; should not be swallowed whole

Extended release tablet: Should not be cut, crushed, or chewed; should be administered with food

Oral suspension: Shake well before using.

Monitoring Parameters

Assess patient at beginning and throughout therapy for infection; monitor for signs of anaphylaxis during first dose

Test Interactions

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest ®. Fehling's solution), false-positive serum or urine creatinine with Jaffe reaction

Dietary Considerations

Capsule, chewable tablet, and suspension may be taken with or without food. Extended release tablet should be taken with food. Raniclor™ contains phenylalanine 2.8 mg/cefaclor 125 mg.

Patient Education

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Do not chew or crush extended release tablets. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Complete full course of medication, even if you feel better. May cause false test results with Clinitest ® ; use of another type of testing is preferable. May cause diarrhea (yogurt, boiled milk, or buttermilk may help). Report rash; respiratory difficulty or swallowing; persistent nausea, vomiting, or abdominal pain; changes in urinary pattern or pain on urination; opportunistic infection (eg, vaginal itching or drainage; sores in mouth; blood in stool or urine, vaginal itching or drainage, unusual fever or chills); or CNS changes (eg, irritability, agitation, nervousness, insomnia, hallucinations). Breast-feeding precaution: Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Dental Comment

Patients allergic to penicillins can use a cephalosporin; the incidence of cross-reactivity between penicillins and cephalosporins is 1% when the allergic reaction to penicillin is delayed. Cefaclor is effective against anaerobic bacteria, but the sensitivity of alpha-hemolytic Streptococcus vary; approximately 10% of strains are resistant. Nearly 70% are intermediately sensitive. If the patient has a history of immediate reaction to penicillin, the incidence of cross-reactivity is 20%; cephalosporins are contraindicated in these patients.

Mental Health: Effects on Mental Status

May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins

Mental Health: Effects on Psychiatric Treatment

May rarely cause neutropenia; use caution with clozapine and carbamazepine

Dosage Forms

Capsule (Ceclor ® ): 250 mg, 500 mg

Powder for oral suspension: 125 mg/5 mL (75 mL, 150 mL); 187 mg/5 mL (50 mL, 100 mL); 250 mg/5 mL (75 mL, 150 mL); 375 mg/5 mL (50 mL, 100 mL)

Ceclor ®. 125 mg/5 mL (150 mL); 187 mg/5 mL (100 mL); 250 mg/5 mL (75 mL, 150 mL); 375 mg/5 mL (100 mL)

Tablet, chewable (Raniclor™): 125 mg [contains phenylalanine 2.8 mg; fruity flavor], 187 mg [contains phenylalanine 4.2 mg; fruity flavor], 250 mg [contains phenylalanine 5.6 mg; fruity flavor], 375 mg [contains phenylalanine 8.4 mg; fruity flavor]

Tablet, extended release (Ceclor ® CD): 375 mg, 500 mg

References

American Thoracic Society, "Guidelines for the Initial Management of Adults With Community-Acquired Pneumonia: Diagnosis, Assessment of Severity, and Initial Antimicrobial Therapy," Am Rev Respir Dis . 1993, 148(5):1418-26.

Boguniewicz M and Leung DYM, "Hypersensitivity Reactions to Antibiotics Commonly Used in Children," Pediatr Infect Dis J . 1995, 14(3):221-31.

Donowitz GR and Mandell GL, "Beta-Lactam Antibiotics," N Engl J Med . 1988, 318(7):419-26 and 318(8):490-500.

Hyslop DL, "Cefaclor Safety Profile: A Ten Year Review," Clin Ther . 1988, 11(Suppl A):83-94.

Levine LR, "Quantitative Comparison of Adverse Reactions to Cefaclor vs Amoxicillin in a Surveillance Study," Pediatr Infect Dis . 1985, 4(4):358-61.

Marshall WF and Blair JE, "The Cephalosporins," Mayo Clin Proc . 1999, 74(2):187-95.

Saxon A, Beall GN, Rohr AS, et al, "Immediate Hypersensitivity Reactions to Beta-Lactam Antibiotics," Ann Intern Med . 1987, 107(2):204-15.

Smith GH, "Oral Cephalosporins in Perspective," DICP . 1990, 24(1):45-51.

Wright AJ, "The Penicillins," Mayo Clin Proc . 1999, 74(3):290-307.

International Brand Names

Adco-Cefaclor ® (ZA); Alfacet ® (YU); Alfatil ® (FR); Altaclor ® (IT); Apo-Cefaclor ® (CA, PL); Bactigram ® (IT); Biocef ® (BD); Capabiotic ® (ID); CEC ® (AT, CZ, DE, DO, LU, RO, ZA); Ceclodyne ® (RO); Ceclor ® (AT, AU, BD, BE, BR, CA, CH, CO, CR, CZ, DO, ES, GT, HN, HR, HU, ID, IL, LU, MX, NL, NZ, PA, PL, PT, RO, RU, SI, SV, TR, ZA); Ceclorbeta ® (DE); Cecloretta ® (HU); Ceclor ® MR (RO); Cefabac ® (BG, JO, KW, LB, MA, MY, SY); Cefaclor 1A Pharma ® (DE); Cefaclor ABC ® (IT); Cefaclor acis ® (DE); Cefaclor Ahimsa ® (AR); Cefaclor AL ® (DE); Cefaclor AZU ® (DE); Cefaclor Basics ® (DE); Cefaclor beta ® (DE); Cefaclor Bexal ® (ES); Cefaclor Biochemie ® (CO, RO); Cefaclor ® (CZ, GB, RO); Cefaclor DOC ® (IT); Cefaclor EG ® (IT); Cefaclor Fabra ® (AR); Cefaclor Heumann ® (DE); Cefaclor K24 ® (IT); Cefaclor Lindo ® (DE); Cefaclor Merck ® (IT); Cefaclor MK ® (CR, DO, GT, HN, PA, SV); Cefaclor Normon ® (ES); Cefaclor PB ® (DE); Cefaclor Pliva ® (IT); Cefaclor Ranbaxy ® (ES); Cefaclor-ratiopharm ® (DE, HU, IT); Cefaclor Richet ® (AR); Cefaclor S250 Stada ® (TH); Cefaclor Sandoz ® (DE); Cefaclor Stada ® (DE); Cefaclor-Teva ® (IL); Cefaclor-Wolff ® (DE); CefaCl ® (SI); Cefager ® (IE); Cefahexal ® (AT); Cefaklor ® (YU); Cefalcor ® (IT); Cefalor ® (IL); Cefaltrex ® (DO); Cefamid ® (DO); Cefastad ® (AT); Cef-Diolan ® (DE); Cefin ® (DO); Cefkor ® (AU); Cefor ® (PL); Cefral ® (AR); Cefulton ® (IT); CEK ® (PL); Celco ® (TH); cephaclor von ct ® (DE); Cephalodoc ® (DE); Citiclor ® (IT); Cleancef ® (SG); Cloracef ® (HK, ID, JO, KW, LB, MT, MY, RO, ZA); Clorad ® (IT); Clorazer ® (IT); Clorotir ® (NZ); DBL Cefaclor ® (AU); Distaclor ® (GB, HK, IE, SG, TH); Dista MR ® (GB); Doccefaclo ® (BE); Dorf ® (IT); Especlor ® (ID); Eurocefix ® (IT); Faclor ® (BR); Falcef ® (DO); Fuclode ® (IT); Geniclor ® (IT); hefa clor ® (DE); Infectocef ® (DE); Kefaclor ® (TH); Keflor ® (AU, CL, IN); Kefolor ® (FI); Kefsid ® (TR); Keftid ® (GB, IE); Kliacef ® (IT); Kloracef ® (PL); KWICap ® (AR); Lafarclor ® (IT); Lilly-Cefaclor ® (ZA); Loracef ® (BD); Losefar ® (TR); Medikoncef ® (ID); Medoclor ® (RO); Navacef ® (BD); Necloral ® (IT); Novacef ® (BR); Novo-Cefaclor (CA); Nu-Cefaclor (CA); Oralcef ® (IT); Panacef ® (IT); Panclor ® (PL); Panoral ® (DE); Performer ® (IT); Pinaclor ® (IE); PMS-Cefaclor (CA); Razicef ® (BG); Remeclor ® (CY); Rolab-Cefaclor ® (ZA); Selviclor ® (IT); Serviclor ® (CZ, PL); Sifaclor ® (TH); Sigacefal ® [caps.] (DE); Sinclor ® (RO); Soficlor ® (SG); Suclor ® (DO); Taracef ® (PL, RU, SI); Tibifor ® (IT); Vercef ® (CZ, HU, PL, RO, RU, SG, TH, ZA); Vercef MR ® (CZ, HU, PL)