Indications
Shampoo: Ketotab 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. Ketotab 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.
Ketotab 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 Ketotab 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
Ketotab shampoo 2%.
Cream: Commonly observed adverse reactions
to Ketotab 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: Ketotab 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 Ketotab 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 Ketotab 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 Ketotab 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,
Ketotab therapy should be stopped immediately
Overdose Effects
Shampoo: Not expected as Ketotab
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
Ketotab 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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