KETOCONAZOLE
·
COMPOSITION:
Each
ml contains: Ketoconazole, USP
20mg
(Manufacturer's
Specifications)
PHARMACEUTICAL
FORM:
METOWIN
is a shampoo based lotion for topical application to scalp and body skin. When
KETO WIN Lotion mixed with clean water it forms gentle lather to treat the
disease, KETOWIlI Lotion is cosmetically attractive and acceptable.
DESCRIPTION:
KETOWIN
Lotion is for topical application and contains Ketoconazole 20mg/ml as a broad
spectrum synthetic antifungal agent in shampoo based aqueous suspension.
methoxy]
phenyll piperazine.
CLINICAL
PHARMACOLOGY:
PHARMACODYNAMICS:
Ketoconazole,
a synthetic imidazole dioxolane derivative, has a potent antimycotic activity
against dermatophytes such as Trichophyton sp., and against yeasts. Especially
the effect on Pityrosporum sp. or Malassezia furfur is very pronounced. Usually
Ketoconazole lotion acts very rapidly on pruritus which is commonly seen in
dermatophyte and yeast infections, as well as skin conditions associated with
the presence of Pityrosporum sp.
PHARMACOKINETICS:
hErbul
Lotion does not produce detectable blood levels after topical application.
INDICATIONS:
HETOWIN
Lotion (Ketoconazole 20mg/ml) is indicated for the treatment and prophylaxis of
dermal infections caused by Pityrosporum ovale or Malassezia furfur, as well as
it is also indicated in candida albicans infections.
NETOWIN
Lotion indications are:
Dandruff
(Pityriasis capitis)
Seborrhoeic
dermatitis
Flaking,
Scaling and itching associated with dandruff.
Pityriasis
versicolor / Tinea versicolor
KETOWIM
Lotion may also be used for other fungal infections of the skin as determined
by the doctor.
TREATMENT:
Dandruff
and seborhoeic dermatitis: Twice weekly application for 4 to 6 weeks.
Pityriasis
versicolor: Once daily application for 5 to 7 days.
PROPHYLAXIS:
*
Dandruff and seborrhoeic dermatitis: Once every 1 or 2 week or as needed to
keep hairs shiny, manageable and finally dandruff free. This use is only needed
to keep dandruff under
control.
Pityriasis
versicolor: Once daily application for 3 days during a single treatment course
before exposing to sun light.
METHOD
OF ADMINISTRATION:
1.
Moisten
scalp and hair or affected parts of the skin thoroughly with water.
2.
Apply
as small amount (5 to 10ml) of lotion to wet hair or body and work it into good
lather, like we would do with any shampoo, leave it over theentire area for
approximately 3 -5 minutes then rinse thoroughly with clean
3.
Repeat the same application
1.
After
the second thorough rinse, dry the hair / body with a towel or warm air flow.
2.
For
prophylaxis follow the same instruction
3.
Note: In case of dandruff and seborrheic dermatitis, on non KETOWIM Lotion
days, freely use regular shampoo or conditioner but do no the any anti-dandruff
shampoo or product. In children use and dosage must be determined by the
doctor.
4.
MISSED DOSE:
5.
Ita dose of this medicine has been missed, apply it as soon as possible However
fitis almost
6.
time for your next dose, skip the missed dose and go back to your regular
dosing schedule.
7.
CONTRA- INDICATIONS:
8.
WETOWIN Lotion is contraindicated in individuals who have shown
hypersensitivity to any of its ingredients.
9.
WARNINGS AND PRECAUTIONS:
10.
KETOWIN Lotion is not for ophthalmic use. Irritation may occur when KETOWIN
Lotion is used immediately after prolonged treatment with topical
corticosteroids. Therefore, it is recommended to continue applying the topical
corticosteroid in the mornings and to apply KETOWIN Lotion in the evenings, and
to subsequently and gradually withdraw the steroid therapy over a period of 2-3
weeks. In case a potent steroid is used, replace it by a mild steroid and
withdraw therapy over the same period.
11.
PREGNANCY: Teratogenic effects:
12.
pregnancy Category C: Ketoconazole is not detected in plasma level. There are
no adequate and well-controlled studies on Ketoconazole in pregnant women.
Ketoconazole should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
15.
ADVERSE REACTIONS:
16.
A few instances of irritation and burning sensation have been observed during
treatment with
17.
KETOWIN Lotion. Also in rare circumstances allergic local skin phenomena, such
as contact dermatitis, have been associated with KETOWIN Lotion or one of its
components.
18.
OVER DOSAGE:
19.
Exaggerated topical application may lead to erythema, oedema and a burning
sensation, which will disappear upon discontinuation of the treatment.
20.
METOWIN Lotion is intended for external use only. In case of accidental
ingestion, supportive measures including gastric lavage with sodium bicarbonate
should be applied.
21.
INSTRUCTIONS:
22.
Protect from heat, light & moisture. Store at 15°C-30°C. Avoid contact with
eyes. Medicine should bé kept out of the reach of children. To be sold on the
prescription of a registered
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