Philippines Product

Dermazole Shampoo

Dermazole Shampoo

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

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 hairs have been reported rarely with the use of (Dermazole) Ketoconazole Shampoo.
In rare instances, mainly in patients with chemically damaged hair or grey hair, a discoloration of the hair has been observed.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Hypersensitivity to Ketoconazole or any of the excipients.

What to do if you accidentally take too much (overdose) of the medicine?

In the event of accidental ingestion, only supportive measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

STORAGE CONDITION:
Store at temperatures not exceeding 30°C.

Drug Description

FORMULATION:
Each mL contains:
Ketoconazole ……….. 20 mg

DESCRIPTION:
Clear viscous liquid of pink colour with specific odor.

Indications and dosage.

INDICATIONS:
Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.

RECOMMENDED DOSE:
For topical administration:
Adults, Elderly and Children: Wash affected areas and leave for 3-5 minutes before rinsing.

Treatment:
Dandruff and seborrhoeic dermatitis: Wash hair twice weekly for 2-4 weeks.

Tinea versicolor:
Once daily for a maximum of 5 days.

Prophylaxis:
Dandruff and seborrhoeic dermatitis: Use once every 1-2 weeks.
Tinea versicolor:
Once daily for a maximum of 3 days before exposure to sunshine.

MODE OF ADMINISTRATION:
For topical administration.
Adults including the elderly and children Wet hair and scalp thoroughly with water.
Apply sufficient shampoo to wash the scalp and hair

Side effects and drug interactions.

UNDESIRABLE EFFECTS:
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 hairs have been reported rarely with the use of (Dermazole) Ketoconazole Shampoo.
In rare instances, mainly in patients with chemically damaged hair or grey hair, a discoloration of the hair has been observed.


INTERACTIONS
Long-term treatment with steroids. Stopping prolonged treatment with steroids requires the gradual reduction of application of the steroid over a period of 2-3 weeks while simultaneously using Ketoconazole. This is to prevent the condition flaring up.

Warnings and precautions

Pregnancy and lactation: Ketoconazole is not detected in plasma after chronic shampooing or topical application.
(Dermazole) Ketoconazole Shampoo is not contraindicated for pregnancy or lactation, but caution should be exercised.

Precautions (Dermazole) Ketoconazole Shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided. If the shampoo does get into the eyes, they should be bathed gently with cold water.

Overdosage and Contraindications

OVERDOSE AND TREATMENT:
In the event of accidental ingestion, only supportive measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

CONTRAINDICATION:
Hypersensitivity to Ketoconazole or any of the excipients.

Clinical pharmacology.

PHARMACOKINETICS:
Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months or in patients who shampooed 2-3 times per week for 3-26 months. Twelve hours after a single shampoo, hair samples taken from six patients showed that high amounts of ketoconazole were present on the hair; only about 5% had penetrated into the hair keratin. There were no detectable plasma levels after chronic shampooing twice weekly for two months with ketoconazole.

STORAGE CONDITION:
Store at temperatures not exceeding 30°C.
CAUTION:
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
AVAILABILITY:
In box of 1-HDPE Bottle (50 ml in 60 ml; 100 ml in 120 ml)
MANUFACTURED BY:
Kusum Healthcare Private Limited
SP-289(A) RIICO Indl. Area
Chopanki (Bhiwadi), Distt- Alwar,
Rajasthan, INDIA
IMPORTED & DISTRIBUTED BY:
Kusum Healthcare Pvt Ltd
Branch Office:
Peninsula Court Bldg
8735 Paseo de Roxas
Makati City.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780