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Duricef

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Duricef

Indications
Dosage
How Supplied

INDICATIONS

DURICEF (cefadroxil) 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. DURICEF (cefadroxil) is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of DURICEF (cefadroxil) 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.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DURICEF (cefadroxil) and other antibacterial drugs, DURICEF (cefadroxil) 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.

DOSAGE AND ADMINISTRATION

DURICEF (cefadroxil) 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 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.

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

See chart for total daily dosage for children.

DAILY DOSAGE OF DURICEF® SUSPENSION
Child's Weight    
lbs kg 260 mg/5 mL 500 mg/5 mL
10 4.5 ½ tsp  
20 9.1 1 tsp  
30 13.6 1½ tsp  
40 18.2 2 tsp l tsp
50 22.7 2½ tsp 1¼ tsp
60 27.3 3 tsp 1½ tsp
70 & above 31.8+ - 2 tsp

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 DURICEF (cefadroxil) 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-l0 mL/min 36 hours
10-25 mL/min 24 hours
25-50 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.

Reconstitution Directions for Oral Suspension
Bottle Size Reconstitution Directions
l00 mL Suspend in a total of 67 mL water.
Method: Tap bottle lightly to loosen powder. Add 67 mL of water in two portions. Shake well after each addition.
75 mL Suspend in a total of 51 mL water.
Method: Tap bottle lightly to loosen powder. Add 51 mL of water in two portions. Shake well after each addition.
50 mL Suspend in a total of 34 mL water.
Method: Tap bottle lightly to loosen powder.
  Add 34 mL of water in two portions.
Shake well after each addition.
After reconstitution, store in refrigerator. Shake well before using. Keep container tightly closed. Discard unused portion after 14 days.

HOW SUPPLIED

DURICEF® (cefadroxil monohydrate, USP) 500 mg Capsules: opaque, maroon and white hard gelatin capsules, imprinted with "PPP" and "784" on one end and with "DURICEF (cefadroxil) " and "500 mg" on the other end.

Capsules are supplied as follows:

N 0430-0780-19...................Bottle of 50

Store at controlled room temperature 15° - 30° C (59° - 86° F).

DURICEF® (cefadroxil) 1 gram Tablets: white to off white, top bisected, oval shaped, imprinted with "PPP" on one side of the bisect and "785" on the other side of the bisect. Tablets are supplied as follows:

N 0430-0781-19....................Bottle of 50

Store at controlled room temperature 15° - 30° C (59° - 86° F).

DURICEF® (cefadroxil) for Oral Suspension is orange-pineapple flavored, and is supplied as follows:

250mg/5mL................................N 0430-2782-15          50 mL Bottle

500 mg/5 mL N 0430-2782-17
N 0430-2783-16
N 0430-2783-17
100 mL Bottle
75 mL Bottle
100 mL Bottle

Prior to reconstitution: Store at controlled room temperature 15° - 30° C (59° - 86° F).

Manufactured by Bristol-Myers Squibb Co. Princeton, NJ 08543. For Warner Chilcott Company, Inc. Fajardo, PR 00738. Marketed by Warner Chilcott (US), Inc. Rockaway, NJ 07866. Revised April 2007. FDA Rev date: 6/5/2007

Last reviewed on RxList: 3/18/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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