Cloxacillin Capsules COMPOSITION: Each capsule contains cloxacillin sodium equivalent to 250 mg or 500 mg cloxacillin. PHARMACOLOGICAL ACTION: Cloxacillin is a semi-synthetic penicillin, resistant to penicillinase, and is therefore active against penicillinase-producing staphylococci. Cloxacillin is in general less effective against organisms susceptible to benzylpenicillin, such as streptococci, pneumococci and non-penicillinase-producing staphylococci, and is not useful against gram-negative bacteria. INDICATIONS: Cloxacillin is indicated for the treatment of infections due to penicillinase-producing staphylococci that are resistant to benzylpenicillin. It is used against gram-positive staphylococcus aureus in: skin and soft tissue infections, e. g. abscesses, cellulitis. Pneumonia Endocarditis, Osteomyelitis. CONTRA-INDICATIONS: Cloxacillin should not be given to patients with a history of penicillin allergy or administered to neonates born of mothers hypersensitive to penicillin. Patients allergic to cephalosporins may also be allergic to penicillins. Cloxacillin is incompatible with aminoglycosides, tetracyclines, erythromycin and polymyxin B. DOSAGE AND DIRECTIONS FOR USE: Adults: One 500 mg capsule six hourly, administered one hour before meals. Children (2-10 years): One 250 mg capsule six hourly, administered one hour before meals. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Sensitivity reactions may include skin rashes, angioedema, bronchospasm, serum sickness and anaphylaxis, and sometimes death within minutes. Treatment with adrenaline, corticosteroids, aminophylline or antihistamines may be necessary. A generalized sensitivity reaction can develop within a few hours or weeks of commencing treatment, including urticaria, fever, joint Pains and eosinophilia. Other allergic reactions include exfoliative dermatitis and maculopapular rashes, interstitial nephritis and vasculitis. Haemolytic anaemia, leucopenia prolonged bleeding time and defective platelet function can occur. Oral administration may produce diarrhoea, heartburn and nausea, and hepatitis and cholestatic jaundice have been reported. A sore mouth or tongue, and a black hairy tongue have also been reported. Care should be taken when administering high doses of cloxacillin especially to patients with impaired renal function as there is a risk of neurotoxicity and congestive heart failure. Disturbance of electrolyte balance may occur following administration of large doses. Renal and haematological systems should be monitored during prolonged and high dose therapy, patients with syphilis may exhibit the Jarish-Herxheimer reaction and should also therefore be monitored. A skin test for sensitivity may be used to determine those patients most likely to develop allergic reactions to penicillins. OVERDOSAGE AND TREATMENT: Convulsions and other signs of toxicity to the central nervous system may occur with very high doses. Nephrotoxicity may occur in patients with diminished renal function. Treatment is symptomatic and supportive. STORAGE DIRECTIONS: Store in a dry place below 25ºC. SHELF LIFE: Three years.
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