Description
- Bactericidal and resistant to staphylococcal penicillinase.
- Active against most gram positive cocci including beta-hemolytic streptococci, pneumococci and nonpenicillinase producing staphylococci.
- It is also active against penicillinase producing staphylococci.
PHARMACOKINETICS
ABSORPTION
- The intramuscular injection of 500 mg peak plasma concentrations of up to 15 µg per mL have been achieved after 30 minutes.
- Doubling the dose can double the plasma concentration.
DISTRIBUTION
- Plasma half-life of 0.5 to 1 hour. The half-life is prolonged in neonates.
- About 93% of the oxacillin in the circulation is bound to plasma proteins.
- Crosses the placenta and is excreted in breast milk.
METABOLISM
- Oxacillin undergoes some metabolism.
EXCRETION
- The unchanged drug and metabolites are excreted in the urine by glomerular filtration and renal tubular secretion.
- More than 40% of an intramuscular dose is rapidly excreted in the urine.
- Oxacillin is also excreted in the bile.
INDICATIONS
Oxacillin (Wydox®) is an isoxazolyl penicillin used primarily for the treatment of infections due to staphylococci resistant to benzylpenicillin. These include:
- Bone and joint infections
- Endocarditis
- Peritonitis (associated with continuous ambulatory peritoneal dialysis)
- Pneumonia
- Skin disorders (including soft-tissue infections)
- Surgical infection (prophylaxis)
- Toxic shock syndrome
DOSE
DOSAGE AND ADMINISTRATION
TREATMENT DOSAGE
- For mild and moderate upper respiratory and localized skin and soft tissue infections
| Age Group | Dose | Frequency |
| Adults & children weighing 40 kg or more Children weighing less than 40 kg |
250 mg to 500 mg50mg/kg/day in equally divided doses | Every 4 to 6 hoursEvery 6 hours |
- For more severe infections, such as those of the lower respiratory tract or disseminated infections
| Age Group | Dose | Frequency |
| Adults & children weighing 40 kg or more Children weighing less than 40 kg |
1 g or higher100mg/kg/day or higher in equally divided doses | Every 4 to 6 hoursEvery 4 to 6 hours |
PREPARATION AND ADMINISTRATION
INTRAMUSCULAR USE
- For 250 mg vial: add 1.4 mL of Sterile Water for Injection USP.
- For 500 mg vial: add 2.8 mL of Sterile Water for Injection USP.
- Shake well until a clear solution is obtained.
- After reconstitution, solution retains its potency for 3 days at 25°C for one week under refrigeration.
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.
CONTRAINDICATIONS
- Contraindicated in those persons who have shown a hypersensitivity to the drug.
PRECAUTIONS
- WYDOX® should be given with caution to patients with a history of allergy, especially to drugs.
- Care is necessary if very high doses of WYDOX® are given, especially if renal function is poor.
- Renal and hematological status should be monitored during prolonged and high dose therapy.
USE IN PREGNANCY
- There are no controlled studies in pregnant women.
NURSING MOTHERS
- WYDOX® is excreted in human milk. Caution should be exercised if use is indicated.
DRUG INTERACTION
- WYDOX® may decrease the efficacy of estrogen-containing oral contraceptives.
- Certain antibiotics given by injection
- Probenecid
- Rifampin
ADVERSE EFFECTS
Most Common Adverse Effects:
- Hypersensitivity reactions, especially skin rashes
Other Adverse Effects:
- Anaphylaxis (occasionally occurs and has sometimes been fatal)
- Hemolytic anemia and neutropenia
- Prolongation of bleeding time and defective platelet function
- Convulsions and other signs of central nervous system toxicity.
- Jarisch-Herxheimer reaction (some patients with syphilis)
Symptoms include:
- Fever
- Chills
- Headache
- Reactions at the site of the lesions
◘ Hypersensitivity to Oxacillin sodium gives rise to a wide variety of clinical syndromes.
Immediate Reactions Include:
- Anaphylaxis
- Angioedema
- Urticaria
- Some maculopapular rashes
Late Reactions Include:
- Serum sickness-like reactions
- Hemolytic anemia
- Acute interstitial nephritis
STORAGE RECOMMENDATION
- Store at temperature not exceeding 30°C.
PHARMACEUTICAL INFORMATION
DRUG SUBSTANCE
Proper Name : Oxacillin Sodium
Chemical Name : C19H18N3NaO5S · H2O
Structural Formula :
Molecular Formula : 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3.3-dimethyl-6-[[(5-methyl-3-phenyl-4-isoxazolyl) carbonyl] amino]-7-oxo-,monosodium salt, monohydrate, [2S (2a, 5a, 6b)]-.
Molecular Weight : 441.3
Description : Fine, white, crystalline powder, odorless or having a slight odor. Freely soluble in water, in methanol, and in dimethyl sulfoxide; slightly soluble in absolute alcohol, in chloroform, in pyridine, and in methyl acetate; insoluble in ethyl acetate, in ether, in benzene, and in ethylene chloride.
DRUG PRODUCT
Oxacillin (as Sodium) 250 mg Powder for Injection I.M. / I.V. (Wydox)
BFAD Registration No.: DRP-480
Oxacillin (as Sodium) 500 mg Powder for Injection I.M. / I.V. (Wydox)
BFAD Registration No.: DRP-404
- Oxacillin Sodium (Wydox®) 250 mg and 500 mg Powder for Injection
Description:
- Dry Product
a.1. Color : White crystalline powder
a.2. Odor : Odorless to practically so
- Reconstituted Product
➟ Clear, colorless solution
AVAILABILITY
- WYDOX® is supplied in sterilized rubber-stoppered vials containing 250 mg and 500 mg. Box of 10 vials.
REFERENCES
- Reynolds, James EF, Martindale 31st edition, (London, 1996).
- The United States Pharmacopeia 27th ed. and The National Formulary 22nd ed. (Asian edition, 2004).
- www.DrugDigest.org.
FORMULATION:
ACTIVE INGREDIENTS
- Oxacillin sodium
INACTIVE INGREDIENT/ EXCIPIENTS
- No added excipients
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