Kenazole® Cream - PIC-JO > Home

Kenazole ®
(Ketoconazole)
Pharmacological information
Mode of action:
Kenazole ® (Ketoconazole) is a synthetic imidazole dioxolane derivative
antifungal agent with a broad-spectrum fungicidal activity against
dermatophytes, yeast (Candida pityrosporum, Torulopsis, Cryptococcus),
dimorphic fungi and eumycets.
Kenazole ® blocks the fungal synthesis of ergosterol, triglycerides and
phospholipids.
After oral administration, Kenazole ® is rapidly absorbed from the
gastrointestinal tract and is partially metabolized in the liver then mostly
excreted in faeces via the bile. It is best taken with meals to maximize
absorption. Systemic effects are not expected after topical application of
Kenazole ® cream.
Clinical information
Indications:
Kenazole ® tablets:
• Infections of the skin, hair and nails induced by dermatophytes and/or yeast,
provided these infections can not be treated topically.
• Yeast infections of the GIT.
• Chronic, recurrent vaginal candidiasis, provided this infection fails to
respond to local therapy.
• Systemic fungal infections and as prophylactic treatment in patients with
decreased immunity (inherited, caused by illness or drugs).
Kenazole ® cream:
• Treatment of dermatophyte infections of the skin; Tinea corporis, Tinea
cruris and Tinea pedis (athlete’s foot).
• Treatment of cutaneous candidiasis, Tinea (Pityriasis) versicolor and
seborrheic dermatitis.
Dosage and administration
Usual adult dose:
Kenazole ® tablets: The oral therapeutic dose of Kenazole ® is 200-400mg
daily.

Kenazole ® cream: Apply to the affected skin and surrounding areas topically
once or twice daily. Candidal infections, Tinea corporis and Tinea versicolor,
should be treated for 2-3 weeks. Patients with Tinea pedis require 4-6 weeks of
treatment. Seborrheic dermatitis should be treated for 2-4 weeks or until clinical
clearing.
Contraindications
Kenazole ® should not be administered to patients with acute or chronic liver
disease or with known hypersensitivity to the drug or any of its ingredients.
Warnings and precautions
Liver function: When using oral Ketoconazole, liver function should be
assessed before and at monthly intervals throughout treatment if it is longer
than 2 weeks.
Cross sensitivity: Persons sensitive to miconazole or other imidazoles may be
sensitive to Ketoconazole also.
Pregnancy and lactation: Ketoconazole use during pregnancy depends on the
physicians assessment. Since ketoconazole is probably secreted in the milk, it
is not recommended to be given to nursing mothers.
Ketoconazole cream is not for ophthalmic use.
Topical ketoconazole: To avoid a rebound effect after stopping treatment with
topical corticosteroids, it is recommended to continue applying the topical
steroid in the morning and Kenazole ® cream in the evening then gradually
withdraw the steroid over 2-3 weeks.
Interactions
- During treatment with Kenazole ® tablets: anticholinergics, antacids, and H 2
antagonists should be taken not earlier than two hours after Kenazole ® .
- When Rifampicin, Isoniazid, Cyclosporine, Anticoagulants and
Methylprednisolone are administered concomitantly with Kenazole ® tablets,
their doses should be reduced.
- Terfenadine and Astemizole should not be used by patients using
Kenazole ® .
Side effects
When using oral Ketoconazole, nausea, vomiting, abdominal pain,
constipation and diarrhea can be observed. Treatment should be
withdrawn immediately if there is evidence of severe hepatocellular
damage. Topical Ketoconazole may cause itching, stinging or irritation
not present before therapy.

Overdose
Induction of emesis or gastric lavage should be undertaken in the event of
overdose.
With the shampoo and cream, overdose is not expected because they are
intended for external use.
Pharmaceutical information
How supplied
Kenazole ® 200 mg tablets: Ketoconazole 200 mg/tablet (Pack of 10).
Kenazole ® 2% cream 15gm: Ketoconazole 20mg/1gm.
Kenazole ® 2% shampoo (100ml): Ketoconazole 20mg/1gm.