Label: DICLOXACILLIN SODIUM capsule

  • NDC Code(s): 59651-565-01, 59651-566-01
  • Packager: Aurobindo Pharma Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 27, 2023

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  • SPL UNCLASSIFIED SECTION
    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 ...
  • DESCRIPTION
    Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase resistant, acid resistant semisynthetic penicillin suitable for oral ...
  • CLINICAL PHARMACOLOGY
    Microbiology - Mechanism of Action - Penicillinase-resistant penicillins exert a bactericidal action against penicillin-susceptible microorganisms during the state of active multiplication ...
  • INDICATIONS AND USAGE
    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 ...
  • CONTRAINDICATIONS
    Dicloxacillin sodium capsules are contraindicated in persons who have shown hypersensitivity to any of the penicillins or any component of the formulations.
  • WARNINGS
    Serious and occasionally fatal hypersensitivity (anaphylactic shock with collapse) reactions have occurred in patients receiving penicillin. The incidence of anaphylactic shock in all ...
  • PRECAUTIONS
    General - Prescribing dicloxacillin sodium capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient ...
  • ADVERSE REACTIONS
    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 ...
  • DOSAGE AND ADMINISTRATION
    Concurrent administration of the penicillinase-resistant penicillins and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and ...
  • HOW SUPPLIED
    Dicloxacillin Sodium Capsules USP are available as follows: 250 mg: Each capsule contains dicloxacillin sodium USP monohydrate equivalent to 250 mg dicloxacillin (anhydrous), with blue opaque ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 250 mg (100 Capsules Bottle)
    NDC 59651-565-01 - Rx only - Dicloxacillin - Sodium Capsules, USP - 250 mg* AUROBINDO     100 Capsules - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 500 mg (100 Capsules Bottle) NDC ...
  • INGREDIENTS AND APPEARANCE
    Product Information