Dicloxacillin Sodium

Dicloxacillin Sodium

Dicloxacillin Sodium Recall

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Questions & Answers

  • Question

    STANSPHARMACY

    DOES THE DICLOXACILLIN RECALL GO TO THE PATIENT LEVEL

    posted on July 16, 2016
    • Answer

      Risa Blair, M.S. Ed., MHC

      This medication has been recalled at the retail level but not the patient level (medical practitioners, hospitals, supermarkets, and pharmacies are notified but not individual consumers). The FDA determines the recall level according to the known severity of risk. I recommend contacting your doctor and discussing discontinuing this medication if you are still taking it.

      posted on July 20, 2016
  • Side Effects & Adverse Reactions

    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. 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, the drug should be discontinued and the patient should receive supportive treatment, eg, artificial maintenance of ventilation, pressor amines, antihistamines, and corticosteroids. 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. 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. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

    Legal Issues

    There is currently no legal information available for this drug.

    FDA Safety Alerts

    There are currently no FDA safety alerts available for this drug.

    Manufacturer Warnings

    There is currently no manufacturer warning information available for this drug.

    FDA Labeling Changes

    There are currently no FDA labeling changes available for this drug.

    Uses

    The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Testing).

    The penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.

    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. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

    History

    There is currently no drug history available for this drug.

    Other Information

    Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase-resistant, acid resistant semisynthetic penicillin suitable for oral administration.

    Dicloxacillin sodium is chemically designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7-oxo-, monosodium salt, monohydrate, [2S-(2α5α,6β)] and has the following structural formula:

    Dicloxacillin sodium chemical structure

    Each capsule for oral administration contains dicloxacillin sodium equivalent to 250 or 500 mg of dicloxacillin. The inactive ingredient is magnesium stearate. The capsule shells contain FD&C Blue 1, titanium dioxide, and gelatin.

    Dicloxacillin Sodium Manufacturers


    • A-s Medication Solutions Llc
      Dicloxacillin Sodium Capsule [A-s Medication Solutions Llc]
    • A-s Medication Solutions Llc
      Dicloxacillin Sodium Capsule [A-s Medication Solutions Llc]
    • Rebel Distributors Corp
      Dicloxacillin Sodium Capsule [Rebel Distributors Corp]
    • Stat Rx Usa Llc
      Dicloxacillin Sodium Capsule [Stat Rx Usa Llc]
    • Pd-rx Pharmaceuticals, Inc.
      Dicloxacillin Sodium Capsule [Pd-rx Pharmaceuticals, Inc.]
    • Redpharm Drug Inc.
      Dicloxacillin Sodium Capsule [Redpharm Drug Inc.]
    • Pd-rx Pharmaceuticals, Inc.
      Dicloxacillin Sodium Capsule [Pd-rx Pharmaceuticals, Inc.]
    • Pd-rx Pharmaceuticals, Inc.
      Dicloxacillin Sodium Capsule [Pd-rx Pharmaceuticals, Inc.]
    • H.j. Harkins Company, Inc.
      Dicloxacillin Sodium Capsule [H.j. Harkins Company, Inc.]
    • Physicians Total Care, Inc.
      Dicloxacillin Sodium Capsule [Physicians Total Care, Inc.]
    • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
      Dicloxacillin Sodium Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
    • Teva Pharmaceuticals Usa Inc
      Dicloxacillin Sodium Capsule [Teva Pharmaceuticals Usa Inc]
    • A-s Medication Solutions Llc
      Dicloxacillin Sodium Capsule [A-s Medication Solutions Llc]
    • Liberty Pharmaceuticals, Inc.
      Dicloxacillin Sodium Capsule [Liberty Pharmaceuticals, Inc.]
    • Sandoz Inc
      Dicloxacillin Sodium Capsule [Sandoz Inc]
    • Pd-rx Pharmaceuticals, Inc.
      Dicloxacillin Sodium Capsule [Pd-rx Pharmaceuticals, Inc.]
    • Liberty Pharmaceuticals, Inc.
      Dicloxacillin Sodium Capsule [Liberty Pharmaceuticals, Inc.]

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