Shandong Xier Kangtai


Full Prescribing Info
Oxacillin sodium.
Each vial contains: Oxacillin sodium equivalent to 500 mg.
Oxacillin is a semisynthetic penicillin M group, beta-lactam bactericidal antibiotic for parenteral administration.
Pharmacology: Pharmacokinetics: Oxacillin sodium, with normal doses, has insignificant concentrations in the cerebrospinal and ascetic fluids. It is found in therapeutic concentrations in the pleural, bile, and amniotic fluids. Oxacillin sodium is rapidly excreted as unchanged drug in the urine by glomerular filtration and active tubular secretion.
Oxacillin sodium binds to serum protein, mainly albumin. The degree of protein binding reported varies with the method of study and the investigator, but generally has found to be 94.2 ±2.1%.
Intramuscular injections give peak serum levels 30 minutes after injection. A 250 mg dose gives a level of 5.3 μg/mL while a 500 mg dose peaks at 10.9 μg/mL. Intravenous injection gives a peak about 5 minutes after injection is completed. Slow IV dosing with 500 mg gives a 5 minute peak of 43 μg/mL with a half-life of 20 to 30 minutes.
Oxacillin is indicated for the treatment of patients with infections caused by Staphylococci, Streptococci and susceptible organisms in the following diseases: Respiratory tract, ear-nose throat infections; Bone infections; Skin and soft tissue infections; endocarditis; peritonitis (associated with continuous ambulatory peritoneal dialysis); pneumonia.
Dosage/Direction for Use
The usual adult/children dosage: 50-100 mg/kg/day, I.M./I.V.
New born infants: 25-100 mg/kg/day, I.V.
The dose depends on the severity of the infection and the patient's condition.
Administration: Deep I.M. injections of slow IV infusions.
Direction for Reconstitution: For Intramuscular Use: To prepare for intramuscularly use, add 1.4 mL of Sterile Water for Injection USP to each 250 mg vial, 2.7 mL of diluents to each 500 mg vial to provide a concentration of 250 mg of active drug per 1.5 mL of solution. Shake well until a clear solution is obtained.
For Direct Intravenous Use: To prepare initial dilution for direct intravenous use, add 5 mL of Sterile Water for Injection USP or Sodium Chloride injection USP to each 250 or 500 mg vial. The resulting solution should be administered slowly over a 10 minute period.
Single use/Discard any remaining portion after use.
Oxacillin over dosage has occurred in patients with renal failure. Reactions have included seizure activity, asterixis, and neuromuscular excitability. Patients who receive an acute over dosage should be carefully observed and given supportive treatment.
This product is contraindicated in those persons who have shown hypersensitivity to the drug.
It may cause fetal anaphylaxis.
Special Precautions
Monitoring of renal and hematological status during prolonged and high dose therapy. Syphilis. Pregnancy and Lactation.
Adverse Reactions
Oxacillin is generally well tolerated. The incidence of adverse reactions associated with the administration of oxacillin was low in clinical trials. The most common were local reactions following IV injections and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently.
Allergic Reactions: skin rash and fever, Quincke's. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported very rarely.
Gastrointestinal Symptoms: diarrhea, nausea, vomiting and abdominal pain.
CNS: seizures after high doses particularly with impaired renal function.
Drug Interactions
Oxacillin may decrease the efficacy of estrogen-containing contraceptives. Tetracycline, a bacteriostatic antibitotic, may antagonize the bactericidal effect of penicillin and concurrent use of these drugs should be avoided.
Probenicid increase half-life of penicillins. Synegristic effects with aminoglycosides. Erythema multiforme with amoxicillin after MMR vaccination.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01CF04 - oxacillin ; Belongs to the class of beta-lactamase resistant penicillins. Used in the systemic treatment of infections.
Cilvex powd for inj 500 mg
10 × 1's (P275/vial)
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