Indications
Shampoo: Ketoral 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: This 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. Ketoral 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.
Ketoral bar: This bar is indicated for All Kinds of Body
Fungus.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
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: The affected areas of the skin or the scalp should
be washed with ketoconazole 2% shampoo, which should be left on the skin/scalp
for 3 to 5 minutes before rinsing.
Treatment:
Pityriasis versicolor: Once daily for 5 days.
Seborrhoeic dermatitis and pityriasis capitis: Twice weekly
for 2 to 4 weeks.
Prophylaxis:
Pityriasis versicolor: Once daily for 3 days during a single
treatment course before the summer.
Seborrhoeic dermatitis and pityriasis capitis: Once every 1
or 2 weeks.
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 (200 mg) tablet twice daily
for 5 days.
All other indications: 1 tablet (200 mg) once daily until at
least one week after the symptoms have disappeared and the cultures have become
negative.
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.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
Shampoo and Cream: No
information was found.
Tablet: Reduced absorption with antimuscarinics, antacids,
H2-blockers, PPIs and sucralfate. Reduced plasma concentrations with
rifampicin, isoniazid, efavirenz, nevirapine, phenytoin. May also reduce
concentrations of isoniazid and rifampicin. May reduce efficacy of oral
contraceptives. May increase serum levels of CYP3A4 substrates e.g. digoxin,
oral anticoagulants, sildenafil, tacrolimus.
Contraindications
Contraindicated in patients with known hypersensitivity to
ketoconazole.
Side Effects
Shampoo: Topical
treatment with Ketoral 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 Ketoral shampoo 2%.
Cream: Commonly observed adverse reactions to Ketoral 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: Ketoral is very well tolerated. Nausea and itching
may occasionally occur. In some patients, an idosyncratic liver reaction may
occur (incidence 1:10000).
Pregnancy & Lactation
Shampoo: Since ketoconazole is not absorbed through the skin
after topical application, pregnancy and lactation are not a contraindication
for the use of ketoconazole shampoo 2%.
Cream: There are no adequate and well-controlled studies in
pregnant or lactating women. To date, no other relevant epidemiological data
are available. Data on a limited number of exposed pregnancies indicate no
adverse effects of topical Ketoconazole on pregnancy or on the health of the
foetus/newborn child. Animal studies have shown reproductive toxicity following
oral administration of Ketoconazole. No effects on the breastfed newborn/infant
are anticipated.
Tablet: Pregnancy category C. There is no adequate and well
controlled studies in pregnant women. Ketoconazole Tablets should not be used
during pregnancy and lactation.
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 Ketoral 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 Ketoral 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 Ketoral
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, Ketoral therapy
should be stopped immediately
Overdose Effects
Shampoo: Not expected as Ketoral shampoo 2% is intended for
external use only. In the event of accidental ingestion, only supportive
measures should be carried out. To avoid aspiration, emesis or gastric lavage
should not be performed.
Cream: Exaggerated topical application may lead to erythema,
oedema and a burning sensation, which will disappear upon discontinuation of
the treatment. If accidental ingestion of Ketoral 2% w/w cream occurs, no
special measures have to be taken.
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.
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