Dermazole Plus Full Prescribing Information, Dosage & Side Effects

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Ketoconazole, zinc pyrithione.

Description

Ketoconazole 2 g (2% w/v), Zinc Pyrithione Suspension (48%) 2.08 g (1% w/v) [equivalent to 1 g of Zinc Pyrithione].

Action

Dermazole Plus contains Ketoconazole which acts against dermatophytes yeast and yeast-like fungi of different strains.
It also contains Zinc Pyrithione which has antimicrobial and antifungal activity.

Indications/Uses

Ketoconazole + Zinc Pyrithione (Dermazole Plus) suspension (shampoo) is used for the prevention and treatment of infection in which Malassezia (previously called Pityrosporum) is likely involved; such as dandruff, seborrheic dermatitis, and tinea (pityriasis) versicolor.

Dosage/Direction for Use

Always use this medicine exactly as the doctor instructed. Check with the doctor or pharmacist if not sure.
How much to use: Wet hair and scalp thoroughly with water. Apply sufficient shampoo to wash the scalp and hair and lather well. Leave for 3-5 minutes before rinsing thoroughly.
The recommended dose for Adults, Elderly and Children: For 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.
What to do if the patient missed a dose: If the patient missed a treatment with Dermazole Plus, use it as soon as remembered.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.

Overdosage

Signs and Symptoms of Overdose: As the shampoo is for external use only, and Ketoconazole is almost unabsorbed into systemic blood flow, the development of overdose symptoms is unlikely. In case of accidental ingestion of shampoo only supportive and symptomatic measures are used. Do not induce vomiting and perform gastric lavage to prevent aspiration.
What to do when the patient has taken more than the recommended dosage: In the event of overdose, supportive and symptomatic measures should be carried out.

Contraindications

Do not use if: Hypersensitivity to Ketoconazole and Zinc Pyrithione or any of the excipients.

Special Precautions

Dermazole Plus 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.

Use In Pregnancy & Lactation

Dermazole Plus is not contraindicated for pregnancy or lactation, but caution should be exercised.

Adverse Reactions

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Skin and subcutaneous tissue: erythema, burning sensation of the skin, itching, acne, contact dermatitis, skin irritation, rash, pustular rash at the application site, urticaria, xerosis, skin flaking enhancement, sense of discomfort, hypersensitivity.
Appendages of skin: folliculitis, hair restructuring, excessive hair dryness or oiliness, hair loss (baldness), change in hair color (generally in patients with chemically damaged or gray hair), nail discoloration. There are known cases of straightening of naturally curly hair.
Nervous system and sense organs: eye irritation, eyelid edema, excessive tearing, taste perversion (dysgeusia), paresthesia, hypersensitivity.
Immune system: hypersensitivity reactions, including anaphylactoid reactions.

View ADR Monitoring Form

Drug Interactions

Please tell the doctor or pharmacist if taking, or has recently taken, any regular medication on prescription or over the counter products.
If patients are taking, Dermazole Plus with locally applied glucocorticoids for a long time, the treatment should be continued and stopped gradually during 2-3 weeks (to avoid withdrawal syndrome).
So make sure the doctor or pharmacist knows if the patient is taking a glucocorticoid.

Storage

Store at temperatures not exceeding 30°C.

Patient Counseling Information

When should you consult your doctor: Consult your doctor: If you experience any first sign of any adverse drug reaction.
If you accidentally ingested the shampoo.

MIMS Class

Psoriasis, Seborrhea & Ichthyosis Preparations

ATC Classification

D11AC - Medicated shampoos ; Used in the treatment of dermatological diseases.

Regulatory Classification

Non-Rx

Presentation/Packing

Form

Dermazole Plus shampoo

Packing/Price

100 mL x 1's;50 mL x 1's

Dermazole Plus

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare