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INDICATIONS

Shampoo: Ketoconazole shampoo is indicated for the treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff).Cream: ... Read moreShampoo: Ketoconazole shampoo is indicated for the treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff).Cream: Cream is used for topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris (dhobie itch), tinea manus and tinea pedis (athlete’s foot) infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Ketoconazole 2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), candidal intertrigo (sweat rash), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.Tablet: Treatment of superficial and deep mycoses:

Infections of the skin, hair and nails by dermatophytes and/or yeasts (dermatomycosis, onychomycosis, perionyxis, pityriasis versicolor, chronic mucocutaneous candidiasis etc.) especially when topical treatment is difficult or not very effective, owing to involvement of large skin surfaces or to lesions affecting deeper dermal layers, nails and hairs
Yeast infection of the mouth (oral thrush, perleche) and the gastrointestinal tract
Vaginal candidiasis, especially chronic recurrent cases or cases responding poorly to topcial treatment
Systemic mycotic infections such as systemic candidiasis, paracoccidioidomycosis, histoplasmosis, coccidioidomycosis etc.

Maintenance treatment to prevent recurrence in systemic mycotic infections and in chronic mucocutaneous candidiasis.Prophylactic treatment to prevent mycotic infection in patients with reduced host defenses, e.g., patients with cancer, organ transplant and burns.Medicated bar: Medicated bar is indicated for All Kinds of Body Fungus.

PHARMACOLOGY

Ketoconazole interacts with 14-α-sterol demethylase, a cytochrome P-450 enzyme necessary for the conversion of lanosterol to ergosterol. This results in inhibition of ergosterol synthesis and increased fungal cellular permeability due to reduced amounts of ergosterol present in the fungal cell membrane. This metabolic inhibition also results in accumulation of 14α-methyl-3,6-diol, a toxic metabolite. The increase in membrane fluidity is also thought to produce impairment of membrane-bound enzyme systems as components become less closely packed.

DOSAGE & ADMINISTRATION

Shampoo: To use the Ketoconazole 2% shampoo, follow these steps:

Shake the bottle well before use
Use a small amount of water to wet the area where Ketoconazole 2% shampoo is to be applied
Apply the shampoo to the affected skin/scalp and a large area around it
Use fingers to rub the shampoo until it forms lather
Leave the shampoo on skin/scalp for 5 minutes
Rinse the shampoo off skin/scalp with water

Treatment-

Seborrheic dermatitis and Dandruff: twice weekly for 2 to 4 weeks.
Pityriasis versicolor: once daily for 5 days.

Prophylaxis-

Seborrheic dermatitis and Dandruff: once every 1 or 2 weeks.
Pityriasis versicolor: once daily for 3 days during a single treatment course before the summer.

Cream:

Tinea pedis: Ketoconazole cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (e.g. involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse.
For other infections: Ketoconazole cream should be applied to the affected areas once or twice daily, depending on the severity of the infection. The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment is: tinea versicolor 2-3 weeks, tinea corporis 3-4 weeks. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection. Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.

Tablet:

Vaginal candidiasis: 1 tablet b.i.d. for 5 days.
All other indications: Adults: 1 tablet (200 mg) once daily until at least one week after the symptoms have disappeared and the cultures have become negative.
Children: 3 to 5 mg/kg/day

Duration of treatment

Pityriasis versicolor: 1 to 6 weeks
Dermatomycoses: 2 to 8 weeks
Onychomycoses: 1 to 12 months
Mycoses of hair and scalp: 1 to 2 months
Chronic mucocutaneous candidiasis: 1 to 12 months
Oral mycoses: 5 to 10 days
Systemic candidiasis: 1 to 2 months
Paracoccidioidomycosis,histoplasmosis and other systemic mycosis: 1 month to 2 years

Ketoconazole bar: Body Fungus: rub gently on the overall body to produce lather. Leave for 4-5 minutes. Rinse of thoroughly with water.

INTERACTION

No drug interaction in case of Shampoo and Cream. Drugs that reduce gastric acidity (eg.; acid neutralizing medicines such as aluminium hydroxide, suppressors such as H2 receptor antagonist and proton pump inhibitors) impair the absorption of Tablets.

SIDE EFFECTS

Shampoo:  Topical treatment with ketoconazole shampoo 2% is generally well tolerated. As with other shampoos, a local burning sensation, itching or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hair have been reported rarely with the use of ketoconazole shampoo 2%.Cream: Commonly observed adverse reactions to Ketoconazole cream in clinical trials were skin application site burning sensation, erythema and pruritus. Uncommon adverse reactions are application site bleeding, discomfort, dryness, inflammation, irritation, paraesthesia and reaction; bullous eruption, dermatitis contact, rash, skin exfoliation and sticky skin.Tablet: Nausea, Headache, Diarrhea, abdominal pain, vomiting may be associated with the active components of Ketoconazole Tablet.

PREGNANCY & LACTATION

Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Animal studies have shown reproductive toxicity. Since Ketoconazole is not absorbed through the skin after topical application, Ketoconazole 2% shampoo and cream is not contraindicated in pregnancy and lactation. Ketoconazole has been shown to be excreted in the milk. Mothers who are under treatment with Dancel Tablets should not breast feed.

PRECAUTIONS & WARNINGS

Shampoo: In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using ketoconazole shampoo 2%, to prevent any potential rebound effect. Increased hair shedding is often associated with seborrhoeic dermatitis and dandruff, and has been rarely reported with the use of ketoconazole shampoo 2%. Avoid contact with the eyes. If the shampoo should get into the eyes, they should be bathed with water.Cream: Not for ophthalmic use. If a potent topical corticosteroid has been used previously in the treatment of seborrhoeic dermatitis, a recovery period of 2 weeks should be allowed before using Ketoconazole 2% w/w cream, as an increased incidence of steroid induced skin sensitisation has been reported when no recovery period is allowed.Tablet: In patients with a previous history of liver disease, liver enzyme levels should be monitored during treatment. When patients develop symptoms indicative of liver reaction, such as nausea or fatigue, accompanied with pale faeces, dark urine or jaundice, Ketoconazole therapy should be stopped immediately

THERAPEUTIC CLASS

Drugs for subcutaneous and mycoses

STORAGE CONDITIONS

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.