pharmacopeia
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/api/v1/drug/oxacillin

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Enzyme Activators; Transpeptidase Inhibitors.

EnzymeTranspeptidase

Indications

Sourced from openFDA
  • Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (See CLINICAL PHARMACOLOGY - Susceptibility Test Methods ).

Contraindications

Sourced from openFDA
  • A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.contraindicated

Dosage & administration

Sourced from openFDA

The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only. Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis. RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP Drug Adults Infants and Children <40 kg (88 lbs) Other Recommendations Oxacillin 250 to 500 mg IV every 4 to 6 hours (mild to moderate infections) 50 mg/kg/day IV in equally divided doses every 6 hours (mild to moderate infections) 1 gram IV every 4 to 6 hours (severe infections) 100 mg/kg/day IV in equally divided doses every 4 to 6 hours (severe infections) Premature and Neonates 25 mg/kg/day IV Directions for Use For Administration by Intravenous Drip Reconstitute as directed below ( Pharmacy Bulk Package ) prior to further dilution.

Warnings & precautions

Sourced from openFDA

Serious and occasionally fatal hypersensitivity (anaphylactic shock with collapse) reactions have occurred in patients receiving penicillin. The incidence of anaphylactic shock in all penicillin-treated patients is between 0.015 and 0.04 percent. Anaphylactic shock resulting in death has occurred in approximately 0.002 percent of the patients treated. When oxacillin therapy is indicated, it should be initiated only after a comprehensive patient drug and allergy history has been obtained. If an allergic reaction occurs, oxacillin should be discontinued and appropriate therapy instituted. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Oxacillin for Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

Adverse reactions

Sourced from openFDA

Body as a Whole The reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent (see WARNINGS ). Sensitization is usually the result of treatment but some individuals have had immediate reactions when first treated. In such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk and vaccines. Two types of allergic reactions to penicillins are noted clinically, immediate and delayed. Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioneurotic edema, laryngospasm, bronchospasm, hypotension, vascular collapse and death. Such immediate anaphylactic reactions are very rare (see WARNINGS ) and usually occur after parenteral therapy but have occurred in patients receiving oral therapy. Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus, and fever. Although laryngeal edema, laryngospasm, and hypotension occasionally occur, fatality is uncommon. Delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as 2 to 4 weeks after initiation of therapy. Manifestations of this type of reaction include serum sickness-like symptoms (i.e ., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Reproduction studies performed in the mouse, rat, and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to the penicillinase-resistant penicillins. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate or well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

The signs and symptoms of oxacillin overdosage are those described in the ADVERSE REACTIONS section. If signs or symptoms occur, discontinue use of the medication, treat symptomatically, and institute appropriate supportive measures.

Approval history

Sourced from openFDA
  • Oct 26, 1989NDANDA050640Baxter Hlthcare
  • Jan 18, 2013ANDAANDA201539Eugia Pharma Speclts
  • Jan 18, 2013ANDAANDA201538Eugia Pharma Speclts
  • Aug 25, 2014ANDAANDA091486Onesource Specialty
  • Jul 31, 2017ANDAANDA207147Wockhardt Bio Ag
  • Nov 24, 2017ANDAANDA207148Wockhardt Bio Ag
  • Jul 20, 2020ANDAANDA206198Fresenius Kabi Usa
  • Jul 27, 2020ANDAANDA206199Fresenius Kabi Usa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,100 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective908.2%
  2. 2Drug Reaction With Eosinophilia And Systemic Symptoms686.2%
  3. 3Acute Kidney Injury625.6%
  4. 4Pyrexia595.4%
  5. 5Rash555.0%
  6. 6Off Label Use444.0%
  7. 7Drug Interaction423.8%
  8. 8Toxic Epidermal Necrolysis423.8%
  9. 9Pneumonia413.7%
  10. 10Renal Failure403.6%
  11. 11Staphylococcal Infection393.5%
  12. 12Alanine Aminotransferase Increased312.8%
  13. 13Thrombocytopenia312.8%
  14. 14Hypotension302.7%
  15. 15Condition Aggravated292.6%

Literature

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Recent PubMed references pinned to Oxacillin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 60 ClinicalTrials.gov registrations naming Oxacillin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Oxacillin work?
Mechanism-of-action classes: Enzyme Activators; Transpeptidase Inhibitors.
What is Oxacillin used for?
According to FDA labeling, Oxacillin carries indications including: Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (See CLINICAL PHARMACOLOGY - Susceptibility Test Methods ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Oxacillin?
Oxacillin is classified as Beta-lactamase resistant penicillins, Penicillin-class Antibacterial, Enzyme Activators, Transpeptidase Inhibitors, Decreased Cell Wall Integrity, Decreased Cell Wall Synthesis & Repair.
What are the contraindications for Oxacillin?
Oxacillin labeling lists contraindications including: A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.. Always consult the full prescribing information and a clinician.
Note. Data for oxacillin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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