Cefaclor

Cefaclor
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

• Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes

Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.

• Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes.

Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.

Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes

Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.

• Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci

• Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes

Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor and other antibacterial drugs, cefaclor should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cefaclor in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefaclor in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Cefaclor in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cefaclor in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefaclor in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Cefaclor in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Cefaclor in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefaclor in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cefaclor during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cefaclor with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cefaclor with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cefaclor with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Cefaclor with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cefaclor with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cefaclor in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cefaclor in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cefaclor in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cefaclor in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Cefaclor in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Cefaclor in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cefaclor in the drug label.

Pharmacology

There is limited information regarding Cefaclor Pharmacology in the drug label.

Mechanism of Action

Structure

File:Cefaclor01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cefaclor in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cefaclor in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cefaclor in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cefaclor in the drug label.

How Supplied

Storage

There is limited information regarding Cefaclor Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Cefaclor in the drug label.

Precautions with Alcohol

• Alcohol-Cefaclor interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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