Dermazole/Dermazole Plus Dosage & Drug Information

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

Concise Prescribing Info

Contents

Per mL Dermazole Ketoconazole 20 mg (2% w/v). Per 100 mL Dermazole Plus Ketoconazole 2 g (2% w/v), Zn pyrithione 2.08 g (1% w/v) (equiv to 1 g of Zn pyrithione)

Indications/Uses

Dermazole Fungal infections caused by yeast fungi on greasy, reddish, inflamed scalp in adults & adolescents. Dermazole Plus Prevention & treatment of infection in which Malassezia is likely involved eg, dandruff, seborrheic dermatitis, & tinea (pityriasis) versicolor.

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Dosage/Direction for Use

Wash infected area w/ shampoo & rinse after 3-5 min. Dermazole Adult & adolescent Treatment of fungal infection in scalp Twice wkly for 2-4 wk. Prevention of fungal infection in scalp Once wkly or once every 2nd wk. Dermazole Plus Adult, elderly & childn Treatment of dandruff & seborrheic dermatitis Twice wkly for 2-4 wk, tinea versicolor Once daily for max of 5 days. Prophylaxis of dandruff & seborrheic dermatitis Once every 1-2 wk, tinea versicolor Once daily for max of 3 days before exposure to sunshine.

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Overdosage

View Dermazole/Dermazole Plus overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity.

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Special Precautions

May be irritating to mucous membranes of the eyes. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dermazole Plus Hypersensitivity. Erythema, burning sensation of the skin, itching, acne, contact dermatitis, skin irritation, rash, pustular rash at application site, urticaria, xerosis, skin flaking enhancement, sense of discomfort; folliculitis, hair restructuring, excessive hair dryness or oiliness, hair loss (baldness), change in hair color (generally in patients w/ chemically damaged or gray hair), nail discoloration, known cases of straightening of naturally curly hair; eye irritation, eyelid edema, excessive tearing, taste perversion (dysgeusia), paresthesia; anaphylactoid reactions.

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Drug Interactions

When using in patients treated w/ locally applied glucocorticoids for a long time, continue glucocorticoid treatment & cancel gradually during 2-3 wk to avoid w/drawal syndrome.

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Storage

View Dermazole/Dermazole Plus storage conditions for details to ensure optimal shelf-life.

Description

View Dermazole/Dermazole Plus description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Psoriasis, Seborrhea & Ichthyosis Preparations

ATC Classification

D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.

Regulatory Classification

Non-Rx

Patient Counseling Information

View Dermazole/Dermazole Plus patient counselling information

Presentation/Packing

Form

Dermazole Plus shampoo

Packing/Price

100 mL x 1's (P672/bottle);50 mL x 1's (P337/bottle)

Form

Dermazole shampoo

Packing/Price

100 mL x 1's (P619/bottle);50 mL x 1's (P325.5/bottle);8 mL x 20 × 1's (P1,237.6/box)

Dermazole/Dermazole Plus

ketoconazole

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare