Wednesday, 25 July 2012

Cefaclor


Class: Second Generation Cephalosporins
VA Class: AM116
CAS Number: 53994-73-3

Introduction

Antibacterial; β-lactam antibiotic; second generation cephalosporin.167 168 169 a


Uses for Cefaclor


Acute Otitis Media (AOM)


Treatment of AOM caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, or S. pyogenes (group A β-hemolytic streptococci).167 (See Haemophilus influenzae Infections under Cautions.)


Pharyngitis and Tonsillitis


Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).124 135 152 153 167 168 169 Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.167 168 169


CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;101 102 106 144 oral cephalosporins and oral macrolides considered alternatives.101 102 106 144 Amoxicillin sometimes used instead of penicillin V, especially for young children.101 144


Respiratory Tract Infections


Treatment of lower respiratory tract infections, including pneumonia, caused by susceptible H. influenzae, S. pneumoniae, or S. pyogenes (group A β-hemolytic streptococci).167 (See Haemophilus influenzae Infections under Cautions.)


Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible H. influenzae (β-lactamase negative strains only), Moraxella catarrhalis (including β-lactamase producing strains), or S. pneumoniae.168 169 (See Haemophilus influenzae Infections under Cautions.)


Treatment of secondary bacterial infections of acute bronchitis caused by susceptible H. influenzae (β-lactamase negative strains only) or M. catarrhalis (including β-lactamase producing strains).168 169 (See Haemophilus influenzae Infections under Cautions.)


Skin and Skin Structure Infections


Uncomplicated skin and skin structure infections caused by susceptible Staphylococcus aureus (oxacillin-susceptible strains only)136 167 168 169 or S. pyogenes.136 167


Urinary Tract Infections (UTIs)


Treatment of UTIs (including pyelonephritis and cystitis) caused by susceptible Escherichia coli, Proteus mirabilis, Klebsiella, or coagulase-negative staphylococci.167


Cefaclor Dosage and Administration


Administration


Oral Administration


Administer orally.167 168 169


Conventional capsules or oral suspension: Administer without regard to meals.167


Extended-release tablets: Administer with meals or within 1 hour of eating.168 169 Should not be cut, crushed, or chewed.168 169


Dosage


Available as cefaclor monohydrate; dosage expressed in terms of anhydrous cefaclor.167 168 169


Pediatric Patients


General Pediatric Dosage

Oral

Children ≥1 month of age: AAP recommends 20–40 mg/kg daily in 2 or 3 equally divided doses for treatment of mild or moderate infections.101 AAP states the drug is inappropriate for treatment of severe infections.101


Acute Otitis Media (AOM)

Oral

Children ≥1 month of age: 40 mg/kg daily in divided doses every 8 or 12 hours (as capsules or oral suspension).167


Pharyngitis and Tonsillitis

Oral

Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 or 12 hours for 10 days (as capsules or oral suspension).167 For more severe infections or those caused by less-susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).167


Respiratory Tract Infections

Oral

Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension) for lower respiratory tract infections.167 For more severe infections or those caused by less-susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).167


Skin and Skin Structure Infections

Oral

Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).167 For more severe infections or those caused by less susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).167


Urinary Tract Infections (UTIs)

Oral

Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).167 For more severe infections or those caused by less susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).167


Adults


Acute Otitis Media (AOM)

Oral

250 mg every 8 hours (as capsules or oral suspension).167 For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).167


Pharyngitis and Tonsillitis

Oral

250 mg every 8 hours (as capsules or oral suspension).167 For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).167


375 mg every 12 hours for 10 days (as extended-release tablets).168 169


Respiratory Tract Infections

Lower Respiratory Tract Infections

Oral

250 mg every 8 hours (as capsules or oral suspension).167 For more severe infections (e.g., pneumonia) or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).167


Acute Bacterial Exacerbations of Chronic Bronchitis

Oral

500 mg every 12 hours for 7 days (as extended-release tablets).168 169


Secondary Bacterial Infections of Acute Bronchitis

Oral

500 mg every 12 hours for 7 days (as extended-release tablets).168 169


Skin and Skin Structure Infections

Oral

250 mg every 8 hours (as capsules or oral suspension).167 For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).167


375 mg every 12 hours for 7–10 days (as extended-release tablets).168 169


Urinary Tract Infections (UTIs)

Oral

250 mg every 8 hours (as capsules or suspension).167 For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).167


Prescribing Limits


Pediatric Patients


Maximum 1 g daily.167


Special Populations


Renal Impairment


No dosage adjustments required.167


Close clinical observation and appropriate laboratory tests recommended in those with moderate or severe renal impairment.167 Use with caution in patients with markedly impaired renal function.167


Geriatric Patients


No age-related dosage adjustments required.168 169


Cautions for Cefaclor


Contraindications



  • Known hypersensitivity to cefaclor, any other cephalosporin, or any ingredient in the formulation.167 168 169



Warnings/Precautions


Warnings


Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.167 168 169 Careful observation of the patient is essential.167 168 169 Institute appropriate therapy if superinfection occurs.167 168 169


Treatment with anti-infectives may permit overgrowth of Clostridium difficile.167 168 169 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefaclor, and may range in severity from mild diarrhea to fatal colitis.167 168 169


Consider CDAD if diarrhea develops during or after therapy and manage accordingly.167 168 169 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.


If CDAD is suspected or confirmed, the anti-infective may need to be discontinued. Some mild cases may respond to discontinuance alone.167 168 169 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.167 168 169


Haemophilus influenza Infections

β-lactamase-negative, ampicillin-resistant (BLNAR) strains of H. influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.167 This should be considered when treating infections that may involve these strains (e.g., respiratory tract infections, AOM).167


Efficacy of extended-release tablets in the treatment of bronchitis known, suspected, or potentially caused by β-lactamase-producing H. influenzae has not been established.168 169


Sensitivity Reactions


Hypersensitivity Reactions

Hypersensitivity reactions such as anaphylaxis, angioedema, serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.167 168 169


If an allergic reaction occurs, discontinue cefaclor and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).167 168 169


Cross-hypersensitivity

Partial cross-hypersensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.167 168 169 a


Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.167 168 169 a Cautious use recommended in individuals hypersensitive to penicillins:167 168 169 a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.a


General Precautions


History of GI Disease

Use cephalosporins with caution in patients with a history of GI disease, particularly colitis.167 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)


Specific Populations


Pregnancy

Category B.167 168 169


Lactation

Distributed into milk; use with caution.167 168 169


Pediatric Use

Safety and efficacy of capsules and oral suspension not established in infants <1 month of age.167


Safety and efficacy of extended-release tablets not established in children <16 years of age.168 169


Geriatric Use

Safety and efficacy in geriatric adults similar to that in younger adults.168 169


Renal Impairment

Decreased clearance.167


No dosage adjustment required for patients with renal impairment.167 Close clinical observation and appropriate laboratory tests recommended in those with moderate or severe renal impairment.167 Use with caution in patients with markedly impaired renal function.167


Common Adverse Effects


Diarrhea, genital pruritus or vaginitis, headache, nausea, vomiting, rash.123 125 127 129 130 132 153 167 168 169


Interactions for Cefaclor


Specific Drugs and Laboratory Tests





















Drug or Test



Interaction



Comments



Antacids (aluminum- or magnesium-containing)



Decreased absorption of cefaclor extended-release tablets 168 169



Administer cefaclor extended-release tablets at least 1 hour before aluminum- or magnesium-containing antacids168 169



Anticoagulants, oral



Possible enhanced warfarin effects167 168 169



Histamine H2-receptor antagonists



No effect on rate or extent of absorption of cefaclor extended-release tablets168 169



Probenecid



Decreased renal excretion of cefaclor167 168 169



Tests for glucose



Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution167 168 169



Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)a


Cefaclor Pharmacokinetics


Absorption


Bioavailability


Well absorbed from GI tract following oral administration.167 168 169 Peak plasma concentrations attained within 0.5–1 hour with conventional preparations167 and 1.5–2.7 hours with extended-release tablets.168 169


Food


Peak serum concentrations are lower and attained later when cefaclor capsules are administrated with food, but total amount of drug absorbed is unchanged.167 107 108


When extended-release tablets are administered with food, the extent of absorption and peak plasma concentrations of the drug are increased.168 169


Distribution


Extent


Cephalosporins are widely distributed into tissues and fluids.a


Distributed into milk in low concentrations.167 168 169


Plasma Protein Binding


25%.a


Elimination


Metabolism


Not appreciably metabolized.a


Elimination Route


Excreted unchanged in urine.167 About 60–85% is excreted unchanged in urine within 8 hours; majority is excreted during the first 2 hours.167


Half-life


0.6–1 hour in adults with normal renal function.167 168 169


Special Populations


Renal impairment decreases clearance of cefaclor.167 Serum half-life is 2.3–2.8 hours in anuric patients.167


Stability


Storage


Oral


Capsules

15–30°C; protect from moisture.167


For Suspension

15–30°C.167 After reconstitution, store suspension in tight container in the refrigerator; discard after 14 days.167


Extended-release Tablets

15–30°C.168 169


Actions and SpectrumActions



  • Second generation cephalosporin active against some gram-negative bacteria that generally are resistant to first generation cephalosporins, but has a narrower spectrum of activity than third generation cephalosporins.a Less active against gram-negative bacteria than some other second generation cephalosporins.a




  • Usually bactericidal.167 168 169




  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.167 168 169 a




  • In vitro spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and a few anaerobic bacteria; inactive against fungi and viruses.167 168 169 a




  • Gram-positive aerobes: active in vitro and in clinical infections against staphylococci (including coagulase-positive, coagulase-negative, and penicillinase producing strains), Streptococcus pneumoniae, and S. pyogenes (group A β-hemolytic streptococci).167 168 169 Enterococci (e.g., Enterococcus faecalis) and oxacillin-resistant (methicillin-resistant) staphylococci are resistant.167 168 169 a




  • Gram-negative aerobes: active in vitro and in clinical infections against H. influenzae (except BLNAR strains), Moraxella catarrhalis (including β-lactamase producing strains), Escherichia coli, Klebsiella, and Proteus mirabilis.167 168 169 Also active in vitro against H. parainfluenzae, Citrobacter diversus, and Neisseria gonorrhoeae. Inactive against Acinetobacter, Enterobacter, Morganella morganii, Proteus vulgaris, Providencia, Pseudomonas, and Serratia.167 168 169




  • Anaerobes: active in vitro against Bacteroides (excluding B. fragilis), Peptococcus niger, Peptostreptococcus, and Propionibacterium acnes.167 168 169



Advice to Patients



  • Importance of completing full course of therapy.167




  • Importance of taking cefaclor extended-release tablets at least 1 hour before antacids containing aluminum or magnesium.168 169




  • Importance of taking cefaclor extended-release tablets with meals or within 1 hour of eating.168 169




  • Importance of taking cefaclor extended-release tablets at least 1 hour before antacids containing aluminum or magnesium.168 169




  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.




  • Importance of discontinuing cefaclor and informing clinician if an allergic reaction occurs.167 168 169




  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.167 168 169




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name











































Cefaclor

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



equivalent to anhydrous cefaclor 250 mg*



Cefaclor Capsules



Ranbaxy



equivalent to anhydrous cefaclor 500 mg*



Cefaclor Capsules



Ranbaxy



For suspension



equivalent to anhydrous cefaclor 125 mg/5 mL*



Cefaclor for Suspension



Ranbaxy



equivalent to anhydrous cefaclor 187 mg/5 mL*



Cefaclor for Suspension



Ranbaxy



equivalent to anhydrous cefaclor 250 mg/5 mL*



Cefaclor for Suspension



Ranbaxy



equivalent to anhydrous cefaclor 375 mg/5 mL*



Cefaclor for Suspension



Ranbaxy



Tablets, extended-release



equivalent to anhydrous cefaclor 500 mg



Cefaclor Extended-Release Tablets (with propylene glycol)



Teva


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Cefaclor 125MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 150/$24.99 or 450/$53.98


Cefaclor 125MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 75/$16.99 or 225/$34.97


Cefaclor 250MG Capsules (WEST-WARD): 30/$60.99 or 90/$165.97


Cefaclor 250MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 150/$34.99 or 450/$84.97


Cefaclor 250MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 75/$22.99 or 225/$47.98


Cefaclor 375MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 100/$34.99 or 300/$84.97


Cefaclor 500MG Capsules (RANBAXY PHARMACEUTICALS): 30/$87.99 or 90/$249.98



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




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158. Beghetti M, Wilson GJ, Bohn D et al. Hypersensitivity myocarditis caused by an allergic reaction to cefaclor. J Pediatr. 1998; 132:172-3. [IDIS 401043] [PubMed 9470025]



159. Dowell SF, Marcy SM, Phillips WR et al. Otitis media—principles of judicious use of antimicrobial agents. Pediatrics. 1998; 101:165-71.



160. Stool SE, Berg AO, Berman S et al for the Otitis Media Guideline Panel. Otitis media with effusion in young children. Clinical Practice Guideline. Number 12. AHCPR Publication No. 94-0622. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Resources. July 1994.



161. Perry BP, Zieno SA, Yonkers AJ. Outcome-oriented managed care comparing efficacies of cefaclor and amoxicillin in acute and recurrent acute otitis media. Ear Nose Throat J. 1995; 74:840-4. [PubMed 8556984]



162. Adderson EE. Preventing otitis media: medical approaches. Pediatr Ann. 1998; 27:101-7. [PubMed 9523298]



163. Klein JO. Protecting the therapeutic advantage of antimicrobial agents used for otitis media. Pediatr Infect Dis J. 1998; 17:571-5. [IDIS 408841] [PubMed 9655563]



164. Dowell SF, Marcy SM, Phillips WR et al. Otitis media—principles of judicious use of antimicrobial agents. Pediatrics. 1998; 101:165-71.



165. American Academy of Pediatrics and American Academy of Family Physicians Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics. 2004: 113:1451-65.



166. American Academy of Pediatrics, American Academy of Family Physicians, American Academy of Otolaryngology-Head and Neck Surgery, and American Academy of Pediatrics Subcommittee on Otitis Media with Effusion. Otitis media with effusion. Pediatrics. 2004: 113:1412-29.



167. Ranbaxy. Cefaclor capsules USP and cefaclor for oral suspension USP prescribing information. Princeton, NJ; 2000 Jan.



168. Teva. Cefaclor extended-release tablets USP prescribing information. Sellersville, PA; 2002 May.



169. Ivax. Cefaclor extended-release tablets USP prescribing information. Miami, FL; 2003 Jan.



a. AHFS Drug Information. McEvoy GK, ed. Cephalosporins General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2003: 125-39.



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