Description

Cefadroxil Oubari (cefadroxil monohydrate) is a semisynthetic cephalosporin antibiotic intended for oral administration.

Composition

Each Cefadroxil Oubari 500 mg capsule contains:

• Cefadroxil monohydrate equivalent to cefadroxil: 500 mg.

• Excipient : S.Q. for one capsule .

Indications

Cefadroxil Oubari 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).

Cefadroxil is generally effective in the eradication of streptococci from the oropharynx.

Dosage & Administration

Cefadroxil Oubari (cefadroxil monohydrate) 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.).
• Skin and Skin Structure Infections: the usual dosage is 1 g per day in single (q.d.) or divided dose (b.i.d.).
• Pharyngitis and Tonsillitis: for the treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis the dosage is (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 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 Oubari should be administered for at least 10 days.

Dosage 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 Oubari and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73M2]) is 500 mg at the time intervals listed below:

Creatinine Clearances & Dosage Intervals

• 0 – 10 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.