pharmacopeia
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/api/v1/drug/dicloxacillin

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Transpeptidase Inhibitors.

Transpeptidase

Indications

Sourced from openFDA
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

Contraindications

Sourced from openFDA
  • Dicloxacillin sodium is contraindicated in persons who have shown hypersensitivity to any of the penicillins or any component of the formulations.contraindicated

Dosage & administration

Sourced from openFDA

Concurrent administration of the penicillinase-resistant penicillins and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary. Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS - General ). Oral therapy with the penicillinase-resistant penicillins may be used to follow up the previous use of a parenteral agent as soon as the clinical condition warrants. RECOMMENDED DOSAGES FOR DICLOXACILLIN SODIUM IN MILD TO MODERATE AND SEVERE INFECTIONS DRUG ADULTS CHILDREN Mild to Moderate Severe Mild to Moderate Severe Dicloxacillin 125 mg every 6 hours 250 mg every 6 hours 12.5 mg/kg/day 1 in equally divided doses every 6 hours 25 mg/kg/day 1 in equally divided doses every 6 hours 1 . Patients weighing less than 40 kg (88 lbs) Dicloxacillin is best absorbed when taken on an empty stomach, and should be administered at least 1 hour before or 2 hours after meals. Dicloxacillin should be taken with at least 4 fluid ounces (120 mL) of water and should not be taken in the supine position or immediately before going to bed (see PRECAUTIONS ).

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%. Anaphylactic shock resulting in death has occurred in approximately 0.002% of the patients treated. Although anaphylaxis is more frequent following a parenteral administration, it has occurred in patients receiving oral penicillins. When penicillin therapy is indicated, it should be initiated only after a comprehensive patient drug and allergy history has been obtained. If an allergic reaction occurs, dicloxacillin should be discontinued and appropriate therapy instituted. Individuals with a history of penicillin hypersensitivity may also experience allergic reactions when treated with a cephalosporin. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including dicloxacillin sodium, 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.

Adverse reactions

Sourced from openFDA

Hypersensitive Reactions The reported incidence of allergic reactions to penicillin ranges from 0.7% to 10% (see WARNINGS ). Sensitization is usually the result of treatment, but some individuals have had immediate reactions to penicillin 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 penicillin 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 two to four 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 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.

Approval history

Sourced from openFDA
  • Jun 3, 1982ANDAANDA062286Teva
  • Sep 23, 2022ANDAANDA216845Aurobindo Pharma

FAERS reports

View JSON
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.
182 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. 1Rash137.1%
  2. 2Suspected Transmission Of An Infectious Agent Via Product137.1%
  3. 3Fatigue126.6%
  4. 4Pruritus126.6%
  5. 5Off Label Use116.0%
  6. 6Abdominal Discomfort105.5%
  7. 7Drug Ineffective105.5%
  8. 8Diarrhoea94.9%
  9. 9Drug Hypersensitivity94.9%
  10. 10Dyspnoea94.9%
  11. 11Headache94.9%
  12. 12Hypersensitivity94.9%
  13. 13Nausea94.9%
  14. 14Back Pain84.4%
  15. 15Acute Kidney Injury73.8%

Literature

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Recent PubMed references pinned to Dicloxacillin 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 17 ClinicalTrials.gov registrations naming Dicloxacillin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dicloxacillin work?
Mechanism-of-action class: Transpeptidase Inhibitors.
What is Dicloxacillin used for?
According to FDA labeling, Dicloxacillin carries indications including: To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dicloxacillin?
Dicloxacillin is classified as Beta-lactamase resistant penicillins, Penicillin-class Antibacterial, Transpeptidase Inhibitors, Decreased Cell Wall Integrity, Decreased Cell Wall Synthesis & Repair.
What are the contraindications for Dicloxacillin?
Dicloxacillin labeling lists contraindications including: Dicloxacillin sodium is contraindicated in persons who have shown hypersensitivity to any of the penicillins or any component of the formulations.. Always consult the full prescribing information and a clinician.
Note. Data for dicloxacillin 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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