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Ketoconazole (Ketoconazole Topical) - Summary

 
 



BOXED WARNING

WARNING
When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. (See WARNINGS and PRECAUTIONS sections.)
Coadministration of terfenadine with ketoconazole tablets is contraindicated. Rare cases of serious cardiovascular adverse events, including death, ventricular tachycardia and torsades de pointes have been observed in patients taking ketoconazole tablets concomitantly with terfenadine, due to increased terfenadine concentrations induced by ketoconazole tablets. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)
Pharmacokinetic data indicate that oral ketoconazole inhibits the metabolism of astemizole, resulting in elevated plasma levels of astemizole and its active metabolite desmethylastemizole which may prolong QT intervals. Coadministration of astemizole with ketoconazole tablets is therefore contraindicated. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)
Coadministration of cisapride with ketoconazole is contraindicated. Serious cardiovascular adverse events including ventricular tachycardia, ventricular fibrillation and torsades de pointes have occurred in patients taking ketoconazole concomitantly with cisapride. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)

 

KETOCONAZOLE SUMMARY

Ketoconazole is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration.

Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebral-spinal fluid.
Ketoconazole tablets are also indicated for the treatment of patients with severe recalcitrant cutaneous dermatophyte infections who have not responded to topical therapy or oral griseofulvin, or who are unable to take griseofulvin.


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NEWS HIGHLIGHTS

Published Studies Related to Ketoconazole (Ketoconazole Topical)

Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp. [2014]
the treatment of scalp seborrheic dermatitis... CONCLUSIONS: Miconazole shampoo is at least as effective and safe as ketoconazole

Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp. [2014]
the treatment of scalp seborrheic dermatitis... CONCLUSIONS: Miconazole shampoo is at least as effective and safe as ketoconazole

Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0.05% combined with ketoconazole shampoo 2%: a randomized, controlled study. [2011.07]
BACKGROUND: Topical antifungals and corticosteroids are the mainstay of treatment for seborrhoeic dermatitis. The short-contact clobetasol propionate 0.05% shampoo (CP) is an efficacious and safe once-daily treatment for scalp psoriasis. OBJECTIVES: To evaluate the efficacy and safety of CP alone and combined with ketoconazole shampoo 2% (KC) in the treatment of moderate to severe scalp seborrhoeic dermatitis... CONCLUSIONS: The combination therapy of twice-weekly CP alternating with twice-weekly KC provided significantly greater efficacy than KC alone and a sustained effect in the treatment of moderate to severe scalp seborrhoeic dermatitis. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists 2011.

Pharmacokinetic interactions between alitretinoin and ketoconazole or simvastatin or ciclosporin A. [2011.04]
BACKGROUND: Based on in vitro data with isolated cytochrome P450 (CYP) isoenzymes, alitretinoin interacts only with CYP3A4, and the potential for drug-drug interactions is considered negligible. AIM: To confirm in humans the lack of potential interactions between CYP3A4 and alitretinoin in vivo... CONCLUSIONS: Single and repeated doses of alitretinoin do not alter the PK of ciclosporin A and ketoconazole. Simvastatin levels were slightly but significantly reduced by co-administration of alitretinoin. Substrates of CYP3A4 did not affect the PK of alitretinoin. However, ketoconazole significantly increased the plasma levels of alitretinoin, therefore, co-administration with CYP3A4 inhibitors such as ketoconazole may require a dose reduction of alitretinoin. (c) 2011 The Author(s). Clinical and Experimental Dermatology (c) 2011 British Association of Dermatologists.

Pharmacokinetics of oral neratinib during co-administration of ketoconazole in healthy subjects. [2011.04]
AIM: The primary objective was to evaluate the pharmacokinetics of a single dose of neratinib, a potent, low-molecular-weight, orally administered, irreversible pan-ErbB (ErbB-1, -2, -4) receptor tyrosine kinase inhibitor, during co-administration with ketoconazole, a potent CYP3A4 inhibitor... CONCLUSION: Co-administration of neratinib with ketoconazole, a potent CYP3A inhibitor, increased neratinib C(max) by 3.2-fold and AUC by 4.8-fold compared with administration of neratinib alone. These results indicate that neratinib is a substrate of CYP3A and is susceptible to interaction with potent CYP3A inhibitors and, thus, dose adjustments may be needed if neratinib is administered with such compounds. (c) 2011 The Authors. British Journal of Clinical Pharmacology (c) 2011 The British Pharmacological Society.

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Reports of Suspected Ketoconazole (Ketoconazole Topical) Side Effects

Drug Interaction (19)OFF Label USE (15)Rhabdomyolysis (12)Prostatic Specific Antigen Increased (12)Pruritus (10)Renal Failure Acute (10)Rash (9)Asthenia (9)Neurotoxicity (8)Fatigue (8)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Ketoconazole has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Ketoconazole review by 52 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Ringworm/Pityriasis
Dosage & duration:   200mg taken 1 per day for the period of 14 days
Other conditions:   none
Other drugs taken:   Lamisil
  
Reported Results
Benefits:   The skin rash was better
Side effects:   I can not be sure it was from the medication but I had mild stomach upset
Comments:   I originally had lamisil cream to treat a pretty bad case of ringworm. After about 4 days the rash was spreading and so I went back and received oral Lamisil. I took that for 14 days and the rash was lighter but still there. The doctor then prescribed Ketoconazole and after 3 days the rash was significantly lighter. By the end of the prescription the rash was almost completely gone.

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Page last updated: 2015-08-10

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