RVP

Drug Catalog - Product Detail

CEFACLOR CP 500MG 100

NDC Mfr Size Str Form
00143-9986-01 HIKMA 100 500MG CAPSULE
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Description
DESCRIPTION Cefaclor Capsules, USP are a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The molecular formula for cefaclor is C 15 H 14 ClN 3 O 4 S•H 2 O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain black iron oxide, croscarmellose sodium, FD & C Red No.3, FD & C Blue No.2, gelatin, magnesium stearate, corn starch, and titanium dioxide. The color of the capsule powder is white to off white. Cefaclor Capsules, USP are a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The molecular formula for cefaclor is C15H14ClN3O4S•H2O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain black iron oxide, croscarmellose sodium, FD & C Red No.3, FD & C Blue No.2, gelatin, magnesium stearate, corn starch, and titanium dioxide. The color of the capsule powder is white to off white. Chemical Structure
How Supplied
HOW SUPPLIED Cefaclor Capsules, USP 250 mg: opaque purple and white hard gelatin capsules imprinted with “West-ward 985” in bottles of 15 and bottles of 100. Cefaclor Capsules, USP 500 mg: opaque purple and gray hard gelatin capsules imprinted with “West-ward 986” in bottles of 15 and bottles of 100. Cefaclor Capsules, USP 250 mg and 500 mg (Pack of 15’s and Pack of 100’s) are supplied with child-resistant closures. Store bottles at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP using a child-resistant closure. 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 November 2020
Indications & Usage
INDICATIONS AND USAGE Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae , staphylococci, and Streptococcus pyogenes Lower respiratory tract infections , including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes Pharyngitis and Tonsillitis , caused by Streptococcus pyogenes Note : Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections , including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor and other antibacterial drugs, Cefaclor 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 Cefaclor is administered orally. Adults– The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled. Pediatric patients– The usual recommended daily dosage for children is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day. Cefaclor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (See PRECAUTIONS ). In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.