Cloxacillin sodium BP

FICLOX

Presentation

FICLOX 500 mg Capsules: Yellow and black capsules imprinted with company logo and ‘FICLOX 500 mg’; each capsule contains cloxacillin sodium BP equivalent to 500 mg cloxacillin. FICLOX Syrup: Bottles containing powder for preparation of 100 ml of yellow coloured, orange flavoured syrup; when reconstituted each 5 ml contains cloxacillin sodium BP equivalent to 125 mg cloxacillin. FICLOX Paediatric Drops: Bottles containing powder for preparation of 15 ml of yellow coloured, orange flavoured drops; when reconstituted each 1.25 ml contains cloxacillin sodium BP equivalent to 125 mg cloxacillin. A dropper to measure the 1.25 ml dose is provided. FICLOX 250 mg Injection: Powder in vials containing cloxacillin sodium BP equivalent to 250 mg cloxacillin. FICLOX 500 mg Injection: Powder in vials containing cloxacillin sodium BP equivalent to 500 mg cloxacillin.

Uses

FICLOX is indicated for the treatment of infections due to staphylococci resistant to benzylpenicillin; it is also used for mixed streptococcal and staphylococcal infections when the staphylococci are penicillin resistant. The following are typical indications: skin and soft tissue infections: Boils; Abscesses; Carbuncles: Furunculosis; Cellulitis; Infected Wounds; infected burns; Protection for skin grafts; Otitis media and externa; Infected skin conditions; e.g., ulcer, eczema and acne. Respiratory tract infections: Pneumonia; Lung Abscess; Empyema; Sinusitis; Pharyngitis; Tonsillitis; Quinsy. other infections caused by FICLOx sensitive organisms: Osteomyelitis; Enteritis; Endocarditis; Urinary tract infections; and Septicaemia.

Dosage and administration

Usual adult dosage: Oral: 500 mg four times daily. Intramuscular: 250 mg four to six hourly. Intravenous: 500 mg four to six hourly. Systemic dosages may be doubled where Necessary; oral doses should be administered half to one hour before meals. Intrapleural: 500 mg once daily. Intra articular: 500 mg once daily. Usual children’s dosage: 2 to 10 years: ½ adult dose. Under 2 years: ¼ adult dose. Administration: Intramuscular: 250 mg dissolved in 1.5 ml or 500 mg in 2 ml Water for Injection BP. Intravenous: 500 mg dissolved in 5 ml Water for Injection BP. The 5 ml solution is administered by slow intravenous injection (three to four minutes). FICLOX Injection may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes. Intrapleural: 500 mg dissolved in 5 to 10 ml Water for Injection BP. Intra articular: 500 mg dissolved in up to 5ml Water for Injection BP or 0.5% lignocaine hydrochloride solution.

Contra-indications, warnings, etc

Contra-indications: Contra-indicated in patients with penicillin hypersensitivity. Precautions: Cloxacillin should be given with caution to patients with known histories of allergy. It should not be given by subconjunctival injection, or used in eye drops. Side-effects: Side-effects are those encountered with other penicillins and are usually of a mild transitory nature; they may include fever, diarrhea, indigestion, or rash, either urticarial or erythematous. In cases of rash of either type, treatment should be Discontinued.

Pharmaceutical precautions

FICLOX Syrup and Drops should be freshly prepared, stored in a cool place preferably in a refrigerator. Reconstituted syrup and drops should be used within 5 days if kept at room temperature, or within 7 days if kept in a refrigerator. Solutions for iM and direct IV injection should normally be used within 30 minutes of preparation. However, aqueous solution of FICLOX retain their activity for up to 24 hours at room temperature (25°C). FICLOX may be added to most intravenous fluids but should not be mixed with blood products or other proteinaceous fluids (e.g., protein hydrolysates). Storage: All the dosage forms of FICLOX should be stored in airtight containers and kept in a cool dry place. FICLOX injection vials should be stored at a temperature not exceeding 25° C.

Package quantities

FICLOX 500 mg Capsules: Cartons of 100 capsules in strip. FICLOX Syrup: Bottles containing powder to produce 100 ml of syrup when reconstituted. FICLOX Paediatric Drops: Bottles containing powder to produce 15 ml of drops when reconstituted. FICLOX 250 mg Injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 250 mg and 1 ampoule of 5 ml Water for Injection BP for dilution. FICLOX 500 mg Injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 500 mg and 1 ampoule of 5 ml Water for Injection BP for dilution.

Ref: FISONS (BANGLADESH) LIMITED