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Drug Catalog - Product Detail

CEFADROXIL FOR ORAL SUSP 250MG /100ML

NDC Mfr Size Str Form
00143-9767-01 HIKMA 100 250MG/5ML SUSPENSION
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Description
DESCRIPTION Cefadroxil monohydrate is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable. 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-[6 α (,7β (R*)]]-. It has the formula C 16 H 17 N 3 O 5 S•H 2 O and the molecular weight of 381.40. It has the following structural formula: Cefadroxil for oral suspension, USP contains cefadroxil monohydrate, USP. After reconstitution, each 5 mL contains Cefadroxil monohydrate, USP equivalent to 250 mg or 500 mg of cefadroxil. In addition, cefadroxil for oral suspension, USP contains the following inactive ingredients: FD&C Yellow No. 6, orange powder flavor, pineapple powder flavor, polysorbate 80, sodium benzoate, sugar (sucrose), and xanthan gum. Cefadroxil for oral suspension, USP is off-white yellow powder, forming an orange colored suspension on constitution. Chemical Structure
How Supplied
HOW SUPPLIED Cefadroxil for oral suspension, USP is an off-white to yellow powder with orange and pineapple flavor, and is supplied as follows: 250 mg/5 mL 50 mL Bottle with child-resistant closure 100 mL Bottle with child-resistant closure 500 mg/5 mL 75 mL Bottle with child-resistant closure 100 mL Bottle with child-resistant closure Prior to reconstitution: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. After reconstitution: Store in refrigerator. Shake well before using. Keep container tightly closed. Discard unused portion after 14 days. Distributed By: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 USA. Manufactured By: Jazeera Pharmaceutical Industries (JPI) AL-Kharj Road P.O Box 106229 Riyadh 11666 Saudi Arabia. An Affiliate of: Hikma Pharmaceuticals P.O Box 182400 Amman 11118-Jordan Revised: October 2020
Indications & Usage
INDICATIONS AND USAGE Cefadroxil for oral suspension 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 monohydrate is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil monohydrate 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 cefadroxil for oral suspension and other antibacterial drugs, cefadroxil for oral suspension 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
DOSAGE AND ADMINISTRATION Cefadroxil for oral suspension 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 cefadroxil for oral suspension should be administered for at least 10 days. See chart for total daily dosage for children. DAILY DOSAGE OF CEFADROXIL FOR ORAL SUSPENSION Child's Weight 250 mg/5 mL 500 mg/5 mL lbs kg 10 4.5 ½ tsp - 20 9.1 1 tsp - 30 13.6 1½ tsp - 40 18.2 2 tsp 1 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 cefadroxil monohydrate and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 m 2 ]) 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. Reconstitution Directions for Oral Suspension Bottle Size Reconstitution Directions 100 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.