Dermoket

Properties

Dermoket is a powerful broad-spectrum antifungal that works against dermatophytes, yeasts, dimorphic fungi and other fungi, effectively altering the function of its membrane.

Indications

Dermoket tablets are indicated for superficial mycosis, dermatomycosis, ringworm, pityriasis versicolor, mycosis of the skin, nails, hair, mucous membranes, deep mycoses, oral yeast infections, candidiasis of the digestive and intestinal tracts, vaginal yeast infections, prophylactic treatment for immunosuppressed patients.

Dermoket cream and soap are indicated as the medicine of first choice in the treatment of: Tinea corporis (ringworm of the body) and tinea cruris (ringworm of the groin, rider itch) produced by Trichophophyton rubrum, T. mentagrophytes.

They are also indicated in the treatment of onychomycosis and tinea pedis (ringworm of the foot; athlete’s foot); tinea barbae and tinea capitis. They are used as the medicine of first choice in the treatment of cutaneous candidiasis (moniliasis) caused by species of candida (monilia).

Dermoket Shampoo is indicated for the treatment and prophylaxis of infections in which yeast (Pityrosporum ovale) is involved. Dermoket Shampoo quickly eliminates scales and itching, diseases normally associated with pityriasis versicolor, seborrheic dermatitis and tinea capitis (dandruff).

Side effects

Dermoket Tablets: The most frequently reported adverse reactions in association with the use of Ketoconazole were of gastrointestinal origin: dyspepsia, nausea, abdominal pain and diarrhea. Less frequently reported adverse reactions include headache, reversible increase in liver enzymes, menstrual disorders, vertigo, photophobia, paraesthesia, and allergic reactions. Adverse reactions reported with very low frequency are: thrombocytopenia, alopecia, impotence and reversible increase in intracranial pressure (for example: papilledema, bulging of the fontanelle in infants). Isolated cases of gynecomastia and reversible oligospermia have been reported with doses higher than the recommended therapeutic doses of 200 to 400 mg daily. At the therapeutic level of 200 mg once daily, a transient decrease in plasma testosterone levels can be observed. Testosterone levels return to normal within 24 hours after oral administration of ketoconazole. In long-term treatments at this dose, testosterone levels are not significantly different from controls. Hepatitis (most likely idiosyncratic) (observed in 1 / 12,000 patients) has very rarely developed during Ketoconazole tablet treatment, this adverse reaction is reversible if treatment is discontinued in time.

Dermoket Cream and Soap: Some cases of irritation and burning sensation have been reported during treatment with Dermoket cream and soap.

Dermoket Shampoo: Topical treatment with Shampoo is generally tolerated. As with other Shampoos, a local burning sensation, itching, irritation and oily / dry hair may occur, but they are very rare during the period of Shampoo use. On rare occasions, mainly in patients with hair damaged by dyes or gray hair, a discoloration of the hair has been observed.


Drug and other interactions

Known examples of potential serious interactions:

  1. Terfenadine, astemizole cisapride, midazolam and triazolam by mouth. Interaction with HMG-CoA reductase inhibitors such as lovastatin may also occur. These drugs should not be administered to patients during treatment with oral Ketoconazole. If midazolam is administered intravenously, special care is required because the sedative effect may be prolonged.
  2. Cyclosporine, methylprednisolone anticoagulants, and possibly busulfan and tacrolimus. The dose of such drugs, if administered concomitantly with Ketoconazole, should be reduced if necessary.
  3. Medicines that reduce heartburn such as: cholinergic agents, antacids, cimetidine and ranitidine, since these reduce the absorption of Ketoconazole.

Isolated cases of alcohol reactions similar to that of disulfiram have been reported, characterized by facial redness, rash, peripheral edema, nausea and headache. These symptoms disappear completely in a few hours.

Posology

 

Dermoket tablets.

Adults:

Mycosis of the skin caused by dermatophytes: 1 tablet of 200mg once a day with food. When the dose is insufficient, it should be increased to 2 tablets (400mg) once a day for 4 weeks.

Vaginal yeast infection: 2 tablets (400mg) once a day during food for 5 consecutive days.

Prophylactic treatment for immunodeficient patients: 2 tablets (400mg) once a day for 4 months or more.

Pityriasis versicolor: 1 tablet (200mg) once a day for 10 days.

Oral and skin mycosis caused by candida: 1 to 2 tablets of 200 mg once a day for 2-3 weeks.

Hair infections: 1 tablet (200 mg) once a day for 4 weeks.

Nail infections: 200 mg to 400 mg once a day for 6-12 months or depending on the growth and speed of the affected nail.

Systemic candidiasis: 200 mg to 400 mg once daily for 1-2 months.

Dermoket Cream, Soap and Shampoo:

Dermoket Soap: Wash the affected area 2 or 3 times a day for 2 or 3 weeks.

Dermoket Cream: Apply 1 or 2 times a day to the affected area depending on the severity of the infection.

Dermoket Shampoo: Wash the affected area (skin or hair) leaving the Shampoo to work for 5 to 10 minutes and then rinse.

Treatment: Pityriasis versicolor: Once a day for a maximum of 5 days. Seborrheic dermatitis and tinea capitis; Once every 1 to 2 weeks.

Composition

Dermoket Tablets

Ketoconazole     200 mg

C.S.P. excipients     1 coated tablet

Dermoket Cream

Ketoconazole     2 g

C.S.P. excipients      100 g

Dermoket Soap

Ketoconazole     2.0 g

C.S.P. excipients      100 g

Dermoket Shampoo

Ketoconazole     2 g

C.S.P. excipients      100 ml


Administration route

Dermoket Tablets: Oral.

Dermoket Cream, Soap and Shampoo: Topical.


Presentation

Dermoket Soap: box containing 100 g paste.

Dermoket Cream: box containing a tube with 20 g of cream.

Dermoket Shampoo: box containing a bottle with 120 ml of Shampoo.

Dermoket Tablets: box containing a blister with 10 coated tablets.


Storage Recommendations

Dermoket Cream, Soap and Shampoo: Store at a temperature of 20 °C to 30 °C. Dermoket Tablets: Store below 30 °C, protect from light and moisture.

Contraindications

Dermoket Tablets is contraindicated in patients with liver disease, it is also contraindicated during pregnancy and lactation. It should not be administered with medications that reduce heartburn such as: anticholinergic agents, antacids, cimetidine and ranitidine, since these reduce the absorption of Ketoconazole. Dermoket cream, soap, shampoo are contraindicated in hypersensitivity to ketoconazole and to the excipients in the formula.