Wydox

OXACILLIN SODIUM

Sterile Powder for Injection
I.M./I.V.

ANTIBACTERIAL

Category:

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

  1. 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
  1. 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:

  1. Dry Product

a.1. Color : White crystalline powder

a.2. Odor : Odorless to practically so

  1. 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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