Cefadroxil

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Cefadroxil
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: Alberto Plate [2]

Disclaimer

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Overview

Cefadroxil is a cephalosporin that is FDA approved for the treatment of urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species, skin and skin structure infections caused by staphylococci and/or 4streptococci, pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Urinary Tract Infections
  • For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).
  • For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).
Skin and Skin Structure Infections

For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).

Pharyngitis and Tonsillitis

Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis-1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of Cefadroxil should be administered for at least 10 days.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Cefadroxil monohydrate is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Warnings

Before therapy with Cefadroxil monohydrate is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefadroxil, cephalosporins, penicillins, or other drugs. if this product is to be given to penicillin-sensitive patients, caution should be exercised because cross-sensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefadroxil monohydrate occurs, discontinue the drug. serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefadroxil, and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicated that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis’’. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against Clostridium difficile.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Cefadroxil Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Cefadroxil Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Cefadroxil in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefadroxil in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Cefadroxil in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Cefadroxil in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Cefadroxil in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Cefadroxil Administration in the drug label.

Monitoring

There is limited information regarding Cefadroxil Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Cefadroxil and IV administrations.

Overdosage

There is limited information regarding Cefadroxil overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

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

Mechanism of Action

There is limited information regarding Cefadroxil Mechanism of Action in the drug label.

Structure

There is limited information regarding Cefadroxil Structure in the drug label.

Pharmacodynamics

There is limited information regarding Cefadroxil Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Cefadroxil Pharmacokinetics in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Cefadroxil How Supplied in the drug label.

Storage

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

Precautions with Alcohol

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

Brand Names

There is limited information regarding Cefadroxil Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Cefadroxil Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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


Cefadroxil
DURICEF® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [4]

Overview

Cefadroxil (formerly trademarked as Duricef) is a broad-spectrum antibiotic of the cephalosporin type, effective in Gram-positive and Gram-negative bacterial infections. It is a bactericidal antibiotic.

Category

Cephalosporin, First-Generation

US Brand Names

DURICEF®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Overdosage | Dosage and Administration | How Supplied

Mechanism of Action

Cefadroxil belongs to the first-genaration Cephalosporins.Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin-binding proteins (PBPs).

References