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ORBENIN

CLOXACILLIN · by GSK

BETA-LACTAMASE SENSITIVE PENICILLINS Betalactamas-Sensitive Penicillin GSK

Composition

Cap 250 mg/500 mg: Cloxacillin (as sodium salt) 250 mg/500 mg. Inj 250 mg/500 mg/1 gm: Cloxacillin 250 mg/500 mg/1 gm; vial. Susp 125 mg/250 mg: Per 5 ml: Cloxacillin (as sodium salt) 125 mg/

Indications & Dosage

Infections caused by Gram-positive organism (including resistant staphylococci): ORAL: Adults: 500 mg six hourly. Children below 2 yrs: 125 mg six hourly; above 2 yrs: 250 mg six hourly. BY IM OR IV INJ: Adults: 250 mg four to six hourly. Children below 2 yrs: 62.5 mg 4-6 hourly; above 2 yr:125 mg four to six hourly.

Administration

For IM Injection: 250 mg vial/500 mg vial: Add 1.5 ml SWFI in 250 mg vial or 2 ml SWFI in 500 mg. For IV Injection: Add 5 ml SWFI in 250 mg vial or 10 ml SWFI in 500 mg vial, then administer by Direct IV Injection or by IV Intermittent Infusion after addition of appropriate infusion fluid.

Stability

Store at controlled room temperature not exceeding 25C. Reconstituted solution is stable for up to 24 hours at controlled room temperature and 48 hours under refrigeration.

Contraindications

Hypersensitivity to penicillins.

Precautions

Avoid small ineffective doses of penicillin as resistant organisms are more likely to emerge, therapy must be sufficient to eliminate the streptococcal organism (a minimum of ten days), otherwise the sequela of streptococcal disease (endocarditis, rheumatic fever) may occur. Serious fatal immediate hypersensitivity (anaphylactoid) reactions have been reported. Do not inject par-enteral solutions into or near an artery or nerve

Pregnancy

Caution advised

Lactation

Caution advised

Side Effects

GI disturbances, anaemias, anaphylaxis, glossitis, stomatitis, gastritis, sore throat, dry mouth, furry tongue, Hemorrhagic manifestation, interstitial nephritis (e.g oliguria, hematuria), nephrotoxicity, accumulation of sodium from injection can occur in renal failure. High doses may cause neurotoxicity, including cerebral irritation, convulsions, or coma.