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