Patient Information Leaflet
Ketanol 2% Solution
Ketoconazole Solution 2%

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. (see section 4).

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.

100 ml.
Ketoconazole Solution 2%
Ketanol 2% Solution
FOR EXTERNAL USE ONLY
NOT FOR ORAL USE

DESCRIPTION:
Ketanol is broad spectrum antifungal agent each ml containing synthetic Ketoconazole IP 20 mg.

PROPERTIES:
PHARMACODYNAMICS:
Ketoconazole belonging to Imidazole group has potent antifungal activity against wide range of dermatophytes. Ketoconazole is effective in rapid relief from scaling and pruritus, usually associated with pityriasis capistis (Dandruff), pityriasis versicolor and saeborrhoeic dermatitis.

PHARMACOKINETICS:
Even after prolong use the absorption of topical Ketoconazole is almost negligible and hence concern on systemic effects does not arise.

INDICATION:
For the treatment and prophylaxis of infections caused by yeasts of pityrosporum spp such as pityriasis capitis (Dandruff), pityriasis versicolor (localized) and Saeborrhoeic dermatitis.

CONTRA-INDICATIONS:
Hypersensitivity to Ketoconazole or its other ingredients.

WARNING AND PRECAUTIONS:
For prevention of the rebound effect of the abrupt stoppage of prolonged use of topical corticosteroid, continue applying the topical corticosteroid together and gradually withdraw the steroid therapy over a period of 2-3 weeks.
Dandruff and saeborrhoeic dermatitis are often implicated in increased hair shedding and this has also been reported though rarely, with the use of Ketanol.

PREGNANCY AND LACTATION:
The absorption of Ketoconazole through topical application is almost nil and hence the use of Ketanol is not contraindicated in pregnancy and lactation.

DOSAGE AND ADMINISTRATION:
Ketanol Solution should be applied to the affected area of the skin and / or hair and left 3-5 minutes and then thoroughly washed.

TREATMENT:
Pityriasis capitis (Dandruff), Saeborrhoeic dermatitis: twice weekly for 2-4 weeks.
Pityriasis versicolor: once daily for maximum 5 days.

PROPHYLAXIS:
Pityriasis capitis (Dandruff), Saeborrhoeic dermatitis: once every one or two weeks.
Pityriasis versicolor: once daily for maximum 3 days during a single treatment course before the summer.

ADVERSE REACTION:
Generally topical application of Ketanol is well tolerated.
While using Ketanol, local burning sensation, itching, irritation and oily/dry hair may rarely occur, In rare circumstances discolouration of chemically damaged hair or grey hair has been observed.

OVERDOSAGES:
Ketanol is intended for topical use only and hence cases of overdosage is not anticipated. However, in the event of accidental ingestion, only supportive measures should be carried out. So as to avoid aspiration neighter emesis nor gastric lavage is recommended.

STORAGE:
Keep all medicine in dark and dry place and out of the reach of children.

PACKING:
Bottle of 100 ml.

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