Ketoconazole Cream

— THERAPEUTIC CATEGORIES —
  • Skin infections (topicals)
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ketoconazole Cream Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Ketoconazole 2%; may contain sulfites.

    Pharmacological Class

    Azole antifungal.

    How Supplied

    Crm—contact supplier

    Storage

    Store at 20° C to 25° C (68° F to 77° F); excursions permitted to 15° C to 30° C (59° F to 86° F.)

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    Ketaconozole is a boad spectrum synthetic anti-fungal agent which inhibits the in vitro growth of certain dermatophytes and yeasts by altering the permeability of the cell membrane. Studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes.

    Ketoconazole Cream Indications

    Indications

    Tinea corporis, t. cruris, t. versicolor, t. pedis, cutaneous candidiasis, seborrheic dermatitis.

    Ketoconazole Cream Dosage and Administration

    Adult

    Apply once daily to affected and adjacent area. Treat for at least 2 weeks. T. pedis: treat for 6 weeks. Seborrheic dermatitis: apply to affected area twice daily for 4 weeks or until clinical clearing. Reevaluate if no improvement after full course of treatment.

    Children

    Not recommended.

    Ketoconazole Cream Contraindications

    Not Applicable

    Ketoconazole Cream Boxed Warnings

    Not Applicable

    Ketoconazole Cream Warnings/Precautions

    Warnings/Precautions

    Asthma. Discontinue if sensitization occurs. Avoid eyes. Pregnancy (Cat.C). Nursing mothers: not recommended.

    Warnings/Precautions

    General

    • Ketoconazole 2% cream is not for ophthalmic use.
    • Some Ketoconazole 2% cream formulations may contain sodium sulfite anhydrous, a sulfite that can cause allergic-type reactions, including anaphylactic symptoms, and life-threatening or less severe asthmatic episodes in certain susceptible patients.
    • Sulfite sensitivity is seen more frequently in asthmatic versus nonasthmatic patients.
    • Discontinue therapy if a reaction suggesting sensitivity or chemical irritation should occur.

    Pregnancy Considerations

    There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mother Considerations

    Given topically, it is not known whether ketoconazole cream could result in sufficient systemic absorption to produce detectable quantities in breast milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

    Pediatric Considerations

    Safety and effectiveness in children have not been established.

    Ketoconazole Cream Pharmacokinetics

    Metabolism

    Hepatic. 

    Elimination

    Renal. 

    Ketoconazole Cream Interactions

    Not Applicable

    Ketoconazole Cream Adverse Reactions

    Adverse Reactions

    Irritation, pruritus, stinging, allergic reaction. 

    Ketoconazole Cream Clinical Trials

    See Literature

    Ketoconazole Cream Note

    Notes

    Formerly known under the brand names Ketozole, Nizoral.

    Ketoconazole Cream Patient Counseling

    See Literature

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