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]

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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 GI upset, nausea, vomiting, diarrhea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Urinary Tract Infections
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

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

Osteomyelitis[1]

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 Group A beta-hemolytic streptococci 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

Osteomyelitis[1]

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Gastrointestinal
Hypersensitivity
Other

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): B

  • Reproduction studies have been performed in mice and rats at doses up to 11 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefadroxil monohydrate. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.


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

Labor and Delivery

Cefadroxil monohydrate has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.

Nursing Mothers

Caution should be exercised when cefadroxil monohydrate is administered to a nursing mother.

Pediatric Use

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

Geriatic Use

  • Of approximately 650 patients who received cefadroxil for the treatment of urinary tract infections in three clinical trials, 28% were 60 years and older, while 16% were 70 years and older. Of approximately 1000 patients who received cefadroxil for the treatment of skin and skin structure infection in 14 clinical trials, 12% were 60 years and older while 4% were 70 years and over. No overall differences in safety were observed between the elderly patients in these studies and younger patients. Clinical studies of cefadroxil for the treatment of pharyngitis or tonsillitis did not include sufficient numbers of patients 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience with cefadroxil has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
  • Cefadroxil is substantially excreted by the kidney, and dosage adjustment is indicated for patients with renal impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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

  • In patients with renal impairment, the dosage of cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of cefadroxil monohydrate and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 m2]) is 500 mg at the time intervals listed below.
Renal Impairment - Cefadroxil.png
  • Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.

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

  • A study of children under six years of age suggested that ingestion of less than 250 mg/kg of cephalosporins is not associated with significant outcomes. No action is required other than general support and observation. For amounts greater than 250 mg/kg, induce gastric emptying.
  • In five anuric patients, it was demonstrated that an average of 63% of a 1 g oral dose is extracted from the body during a 6 to 8 hour hemodialysis session.

Pharmacology

Cefadroxil Structurew.png
Cefadroxil
Systematic (IUPAC) name
(6R,7R)-7-{[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Identifiers
CAS number 66592-87-8
ATC code J01DB05
PubChem 47964
DrugBank DB01140
Chemical data
Formula C16H17N3O5S 
Mol. mass 363.389 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Protein binding plasma protein
Metabolism unknown
Half life 1.5 hours
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status

Rx Only

Routes Oral

Mechanism of Action

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

Structure

  • It is chemically designated as 5-Thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid, 7-[[amino (4-hydroxyphenyl) acetyl] amino]-3-methyl-8-oxo-, monohydrate, [6R-[6α, 7β(R*)]]-. It has the molecular formula C16H17N3O5S•H2O and the molecular weight of 381.40. It has the following structural formula:
Cefadroxil Structurew.png

Pharmacodynamics

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

Pharmacokinetics

  • Cefadroxil monohydrate is rapidly absorbed after oral administration. Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 16 and 28 mcg/mL, respectively. Measurable levels were present 12 hours after administration. Over 90% of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1800 mcg/mL during the period following a single 500 mg oral dose. Increases in dosage generally produce a proportionate increase in cefadroxil urinary concentration. The urine antibiotic concentration, following a 1 g dose, was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours.

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

Cefadroxil Tablets, USP 1 gram: White to off-white, film-coated, oval shaped tablets with ‘416’ and ‘par’ on either side of the breakline on one side and plain on the other side. Tablets are supplied as follows:

  • NDC 49884-416-03: Bottle of 50
  • NDC 49884-416-01: Bottle of 100
  • NDC 49884-416-05: Bottle of 500
  • NDC 49884-416-74: Carton of 100 [10 x 10s (2 x 5 cards)]

Storage

Store at 20° – 25° C (68° – 77° F)

Images

Drug Images

Cefadroxil NDC 00933196.jpg

Drug Name: Cefadroxil
Ingredient(s): CEFADROXIL[CEFADROXIL ANHYDROUS]
Imprint: 93;3196
Dosage: 500 mg
Color(s): Orange, White, Red
Shape: Capsule
Size (mm): 22
Score: 1
NDC:00933196

Drug Label Author: Teva Pharmaceuticals USA Inc

This pill image is provided by the National Library of Medicine's PillBox.
Cefadroxil NDC 00934059.jpg

Drug Name: Cefadroxil
Ingredient(s): CEFADROXIL[CEFADROXIL ANHYDROUS]
Imprint: 9;3;4059
Dosage: 1000 mg
Color(s): White
Shape: Oval
Size (mm): 19
Score: 2
NDC:00934059

Drug Label Author: Teva Pharmaceuticals USA Inc

This pill image is provided by the National Library of Medicine's PillBox.
Cefadroxil NDC 01439947.jpg

Drug Name: Cefadroxil
Ingredient(s): CEFADROXIL[CEFADROXIL ANHYDROUS]
Imprint: WW;947;West;ward;947
Dosage: 500 mg
Color(s): Brown, White
Shape: Capsule
Size (mm): 18
Score: 1
NDC:01439947

Drug Label Author: West-ward Pharmaceutical Corp

This pill image is provided by the National Library of Medicine's PillBox.
Cefadroxil NDC 07812938.jpg

Drug Name: Cefadroxil
Ingredient(s): CEFADROXIL[CEFADROXIL]
Imprint: Sandoz611
Dosage: 500 mg
Color(s): Blue, Black
Shape: Capsule
Size (mm): 22
Score: 1
NDC:07812938

Drug Label Author: Sandoz Inc

This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

Cefadroxil Appearance .png

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

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.

  1. 1.0 1.1 Schwob MF, Jimenez-Shehab M (1980). "Cefadroxil in the treatment of osteomyelitis in children". J Int Med Res. 8 (Suppl 1): 106–10. PMID 7439498.







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