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 KETOMAC
WHAT IS KETOMAC? 

Ketomac Shampoo, 2% is a light pinkish brown liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in a shampoo base.

Ketoconazole is an azole antifungal that works by preventing the growth of fungus. It is in the same family of drugs as fluconazole, itraconazole and miconazole. Ketoconazole works by preventing the formation of fungal cell walls, thereby stopping fungal growth. Ketoconazole is (±)-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:

Molecular Formula: C26H28CI2N4O4
Molecular Weight: 531.43

 

HOW DOES KETOMAC WORK?

KETOMAC shampoo contains Ketoconazole that kills fungi and yeasts by interfering with their cell membranes. It works by preventing the fungi from producing a substance called ergosterol, which is an essential component of fungal cell membranes. The disruption in production of ergosterol disrupts the fungal cell membrane, thereby weakening it. The weakened cell membrane allows the contents of the fungal cell to leak out resulting in its death.

The cell membranes of fungi are vital for their survival. They keep unwanted substances from entering the cells and stop the contents of the cells from leaking out. As ketoconazole causes holes to appear in the cell membranes, essential constituents of the fungal cells leak out. This kills the fungi and thereby treats the infection. Ketoconazole works by killing fungi on skin called Malassezia. These fungi occur naturally on the skin, however, people suffering from dandruff seem to have more of Malassezia

 

WHAT IS IT USED FOR?

KETOMAC Shampoo is used for the prevention and treatment of dandruff. It treats flaking, scaling, itching, dandruff and also helps to relieve inflammation due to dandruff. Topical ketoconazole is used for treating ringworm, jock itch, athlete's foot, dandruff, and tinea versicolor.

 

  • DANDRUFF:
Dandruff is a form of skin eczema called seborrhea. Scalp seborrhea and dandruff do not cause permanent hair loss. Often, scalp seborrhea doesn't even itch significantly. Dandruff scale is a cluster of corneocytes, which have retained a large degree of cohesion with one another and detach as such from the surface of the stratum corneum. A corneocyte is a protein complex that is made of tiny threads of keratin in an organised matrix. The size and abundance of scales are heterogeneous from one site to another and over time. Parakeratotic cells often make up part of dandruff. Their numbers are related to the severity of the clinical manifestations, which may also be influenced by seborrhea.

 

A number of antifungal treatments have been found to be effective including: ketoconazole, zinc pyrithione and selenium sulphide. Ketoconazole as a shampoo appears to be the most effective.

  • TINEA (PITYRIASIS) VERSICOLOR:
Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by Pityrosporum Ovale. This commensal organism is part of the normal skin flora. In susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. The rate of recurrence of infection is variable. An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of KETOMAC Shampoo 2% was significantly less than that of 2.5% selenium sulfide shampoo.

 

 

 

HOW TO USE?

Wet hair and scalp thoroughly. Apply a small amount of KETOMAC Shampoo to your scalp and massage into a lather. Leave it on for 5 to 10 minutes and then rinse your scalp thoroughly.

Use twice a week for 4 weeks. After the scalp has cleared, use KETOMAC Shampoo once a week to prevent the reoccurrence of dandruff and to keep the scalp clear. If you stop using KETOMAC Shampoo completely, your symptoms may reappear.

 

FREQUENCY OF USE:

Seborrhoeic dermatitis and dandruff: Use Ketoconazole shampoo 2% twice weekly for 2-4 weeks.

Prophylaxis: Use Ketoconazole shampoo 2% once every 1-2 weeks.

Pityriasis versicolor: Use Ketoconazole shampoo 2% once daily for a maximum of 5 days.

Prophylaxis: As patches of pityriasis versicolor become more apparent on exposure to the sun, Ketoconazole shampoo 2% may be used once daily for a maximum of 3 days in a single treatment course before exposure to sunshine.

 

ADVERSE EFFECTS:

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.

In rare instances, mainly in patients with chemically damaged hair or grey hair, a hair discolouration has been observed.

 

PRECAUTIONS:

Inform your doctor or pharmacist if you are allergic to ketoconazole or to other azole antifungal drugs (such as fluconazole, itraconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. The product should be used with caution in people having liver problems, alcohol use, low testosterone levels, decreased adrenal gland function problems (such as low cortisol levels, Addison's disease, adrenal insufficiency), little or no stomach acid production (achlorhydria).

 

PREGNANCY & LACTATION:

Ketoconazole is not absorbed into the bloodstream from the skin and is not harmful if used during pregnancy and breast-feeding. Ketoconazole is not detected in plasma after continuous shampooing for long period. Nevertheless, caution should be exercised when KETOMAC Shampoo 2% is administered to a nursing woman.

 

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

The dominant lethal mutation test in male and female mice revealed that single oral doses of KETOMAC as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames Salmonella microsomal activator assay was also negative. A long-term study of Ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity, when fed at doses up to 80mg/kg/day.

 

PAEDIATRIC USE:

Safety and effectiveness in children has not been established.

 

WARNINGS:

Do not let ketoconazole cream or shampoo get into your eyes or mouth. Incase this happens, wash with plenty of water.
Do not swallow the medication.

 

STORAGE:

Store at room temperature (25 °C), away from light and moisture.

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