Xclor Powder For Suspension (PFS): After reconstitution, each 5 ml reconstituted suspension contains Cefaclor 125 mg as Cefaclor Monohydrate USP.

Second Generation Cephalosporin antibiotic 

USP

Xclor® (Cefaclor) is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:Otitis Media,Lower Respiratory Tract Infections including Pneumonia, Bronchitis and Acute Exacerbation of Chronic Bronchitis,Upper Respiratory Tract Infections, including Pharyngitis and Tonsillitis,Skin and Soft Tissue Infections (SSTIs),Skin and Skin Structure Infections (SSSIs),Sinusitis

Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.

Xclor® (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.Pneumonia) or those caused by less susceptible organisms, doses may be doubled.

Pediatric Patients: The usual recommended daily dose for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections (Otitis Media), 40 mg/kg/day are recommended, with a maximum dose of 1 gm/day.

Gastrointestinal symptoms occur in about 2.5 % of patients including diarrhea. Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported rarely. The severity of the colitis may range from mild to life threatening.

In penicillin-sensitive patients, cephalosporin antibiotics should be administered cautiously. There is clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins and there are instances in which patients have had reactions, including anaphylaxis, to both drug classes. Cefaclor should be used with caution in patients with liver disease, impaired renal function.

Xclor® Powder For Suspension (PFS): After reconstitution, each 5 ml reconstituted suspension contains Cefaclor 125 mg as Cefaclor Monohydrate USP.

No studies have shown that cefaclor causes adverse effects to the children.

Pregnancy: Animal studies have shown no evidence of impaired fertility or teratogenicity. However, since there are no adequate or well-controlled studies in pregnant women, caution should be exercised when prescribing for the pregnant women.

Lactation: Small amount of Cefaclor have been detected in breast milk following administration of single 500 mg dose. Caution should be exercised when Cefaclor is administered to a nursing woman.

Xclor® (Cefaclor) suspension: Bottle containing dry powder for 100 ml suspension after reconstitution and a 10 ml measuring cup.

Keep the bottle tightly closed and protected from light. Store in a cool and dry place at 20- 25°C. Bottle should be shaken well before use.