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Cefadroxil

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Cefadroxil

INDICATIONS

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefadroxil (cefadroxil hemihydrate) Tablets and Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) Capsules and other antibacterial drugs, Cefadroxil (cefadroxil hemihydrate) Tablets and Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) capsules 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.

Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:

Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.

Skin and skin structure infections caused by staphylococci and/or streptococci.

Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic Streptococci).

Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) for the prophylaxis of subsequent rheumatic fever are not available.

Note: Culture and susceptibility tests should be initiated prior to and during therapy.

Renal function studies should be performed when indicated.

DOSAGE AND ADMINISTRATION

Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.

Adults

Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in 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.

Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) oral suspension may be more suitable for pediatric patients

Children

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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) should be administered for at least 10 days.

Renal Impairment

In patients with renal impairment, the dosage of cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 M2]) is 500 mg at the time intervals listed below.

Creatinine Clearances Dosage Interval
0 to 10 mL/min 36 hours
10 to 25 mL/min 24 hours
25 to 50 mL/min 12 hours

Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function

HOW SUPPLIED

Cefadroxil tablets contain cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) hemihydrate equivalent to 1 gram of cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) and are supplied as follows:

Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) 1 gram Tablets: white, oblong, biconvex film-coated tablets, debossed on one side with ‘CF 512’ and scored on the other side.

(50s) NDC 63304-512-50

(100s) NDC 63304-512-01

(unit-dose 100s) NDC 63304-512-80

Cefadroxil capsules contain cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) hemihydrate equivalent to 500 mg of cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) and are supplied as follows:

Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) 500 mg Capsules: white opaque body and brown opaque cap imprinted with ‘C’ on the cap and ‘582’ on the body.

(50s) NDC 63304-582-50

(100s) NDC 63304-582-01

Dispense in a tight container as defined in the USP.

Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature).

Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32216 USA by: Ranbaxy Laboratories Ltd. New Delhi - 110 019, India March 2007
FDA rev date: 3/2007

Last reviewed on RxList: 7/31/2007
This monograph has been modified to include the generic and brand name in many instances.

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