Each capsule contains: Cloxacillin (as Sodium), USP 500 mg.
Each 5 mL (1 teaspoonful) contains: Cloxacillin (as Sodium), USP 125 mg & 250 mg.
Cloxacillin (Solaze) Capsule: White to off-white crystalline powder encapsulated in empty gelatin capsule size #0 with black opaque cap and yellow opaque body, each containing 500 mg Cloxacillin.
Cloxacillin (Solaze) Powder for Solution: White to off-white powder. Prepared by adding water to the powder to give Banana flavored and clear solution containing 250 mg Cloxacillin in each 5 mL.
Cloxacillin (Solaze) Powder for Solution: Off-white to yellowish white powder. Prepared by adding water to the powder to give Melon flavored and orange solution containing 125 mg Cloxacillin in each 5 mL.
Pharmacology: Pharmacodynamics: Cloxacillin is an isoxazolyl penicillin used similarly to flucloxacillin in the treatment of infections due to staphylococci resistant to benzylpenicillin.
Pharmacokinetics: Cloxacillin is incompletely absorbed from the gastrointestinal tract, and absorption is reduced by the presence of food in the stomach. After an oral dose of 500 mg, a peak plasma concentration of 7 to 15 micrograms/mL is attained in fasting subjects in 1 to 2 hours. Absorption is more complete when given by intramuscular injection and peak plasma concentrations of about 15 micrograms/mL have been observed 30 minutes after a dose of 500 mg. Doubling the dose can double the plasma concentration. About 94% of cloxacillin in the circulation is bound to plasma proteins. Cloxacillin has been reported to have a plasma half-life of 0.5 to 1 hour. The half-life is prolonged in neonates.
Cloxacillin crosses the placenta and is distributed into breast milk. There is little diffusion into the CSF except when the meninges are inflamed. Therapeutic concentrations can be achieved in pleural and synovial fluids and in bone.
Cloxacillin is metabolized to a limited extent, and the unchanged drug is excreted in the urine by glomerular filtration and renal tubular secretion. About 35% of an oral dose is excreted in the urine and up to 10% in the bile. Cloxacillin is not removed by haemodialysis.
Cloxacillin is an isoxazolyl penicillin used primarily for the treatment of infections due to staphylococci resistant to benzylpenicillin, including infections of the skin and soft tissues, bones and joints, respiratory tract and urinary tract; otitis media, endocarditis, septicemia and meningitis. It is also used for mixed streptococcal infections when the staphylococci are penicillin resistant. It is also used for the prophylaxis of staphylococcal infections during major procedures, particularly in the cardiothoracic and orthopedic surgery.
Capsule: 250 to 500 mg taken four times a day for adults or as prescribed by the physician.
125 mg/5 mL Solution: Children up to 2 years of age: 5 mL (1 teaspoonful).
3 years up to 10 years old: 10 mL (2 teaspoonfuls).
To be taken every 4 to 6 hours of as prescribed by the physician.
250 mg/5 mL Solution: Children: Usual dose is 50 mg to 100 mg per kg body weight daily in divided doses every 6 hours or as prescribed by the physician.
Symptoms: With high parenteral doses of penicillins, neurotoxicity (e.g. convulsions, encephalopathy), blood disorders (e.g. neutropenia, haemolytic anaemia, prolongation of bleeding time, defective platelet function) or electrolyte disturbances may occur.
Treatment: Treatment is symptomatic. Flucloxacillin is not removed from the circulation by haemodialysis.
Cloxacillin sodium has been reported to be incompatible with aminoglycosides and a number of other antimicrobials.
Patients known to be hypersensitive to penicillin should be given an antibiotic of another class. However, sensitized patients may also react to cephalosporin. Penicillin should be given with caution to patients with a history of allergy, especially to other drugs.
Pregnancy: There has been no evidence of a teratogenic effect in animals or untoward effect in humans. However, use in pregnancy should be reserved for essential cases.
Breastfeeding: Trace quantities of penicillin can be detected in breast milk with the potential for hypersensitivity reactions (e.g. drug rashes) in the breastfed neonate or acute alterations in the neonatal bowel flora with resultant diarrhoea.
Hepatitis and cholestatic jaundice have been reported occasionally with flucloxacillin and may be delayed in onset for up to 2 months after treatment has been stopped; older patients and those receiving flucloxacillin for more than 2 weeks are at greater risk. Fatalities have occurred, usually in patients with serious underlying hepatic disease. There have been rare reports of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis associated with flucloxacillin. Agranulocytosis and neutropenia have been associated rarely with isoxazolyl penicillins such as flucloxacillin. Phlebitis has followed intravenous infusion.
Probenecid prolongs the half-life of benzylpenicillin by competing with it for renal tubular secretion and may be used therapeutically for this purpose. Benzylpencillin may also interact with bacteriostatic antibacterials such as chloramphenicol and tetracyclines and may be incompatible in vitro with other drugs, including some other antibacterials. The possibility of a prolonged bleeding time after oral treatment with a broad-spectrum drug like ampicillin should be borne in mind patients receiving anticoagulants.
Powder for Solution: Direction for Reconstitution: To make 60 mL reconstituted solution mix thoroughly the contents with 40 mL water and shake well until the powder is evenly suspended. The reconstituted solution is stable for 7 days at temperatures not exceeding 30°C and 14 days when refrigerated (2-8°C).
Store at temperatures not exceeding 30°C.
J01CF02 - cloxacillin ; Belongs to the class of beta-lactamase resistant penicillins. Used in the systemic treatment of infections.
Solaze powd for soln 125 mg/5 mL
60 mL x 1's
Solaze powd for soln 250 mg/5 mL
60 mL x 1's
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