Dermazole/Dermazole Plus

Dermazole: Clear viscous liquid of pink colour with specific odour.
Ketoconazole 20 mg/mL (2% w/v).
Dermazole Plus: Clear, pink coloured viscous liquid with specific odour.
Ketoconazole 2 g (2% w/v), Zinc Pyrithione Suspension (48%) 2.08 g (1% w/v) [equivalent to 1 g of Zinc Pyrithione].

Dermazole: Ketoconazole (Dermazole) contains the active substance ketoconazole, which is used to treat dandruff caused by fungal infections.
Dermazole Plus: 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.

Dermazole: It can be used to treat fungal infections caused for example by yeast fungi, on greasy, reddish, inflamed scalp in adults and adolescents.
Dermazole Plus: 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.

Always use this medicine exactly as the doctor has told. Check with the doctor or pharmacist if not sure.
Dermazole: The recommended dose is for: Adults and adolescents: Fungal infections in the scalp: Wash the infected area with the shampoo and rinse after 3-5 minutes.
Treatment: Twice weekly for 2-4 weeks.
Preventive treatment: Once weekly or once every second week.
Dermazole Plus: 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 should the patient do if they miss a dose: If the patient misses a treatment with Dermazole or Dermazole Plus, they should use it as soon as they remember.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.

Dermazole: In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.
What to do when the patient has taken more than the recommended dosage: There is no risk in using more shampoo than the patient should on the skin. If the patient or a child accidentally swallows the gel, seek medical advice immediately.
Dermazole Plus: 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.

Dermazole: Do not use Ketoconazole (Dermazole) if the patient is allergic to ketoconazole or any of the other ingredients of this medicine.
Dermazole Plus: Do not use if: Hypersensitivity to Ketoconazole and Zinc Pyrithione or any of the excipients.

Dermazole: Talk to the doctor or pharmacist before using Ketoconazole shampoo.
If Ketoconazole shampoo gets in the eyes gently wash the eyes in cold water.
Dermazole Plus: 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.

Dermazole: There are no risks known for the use of ketoconazole shampoo in pregnancy or lactation.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Dermazole Plus: Dermazole Plus is not contraindicated for pregnancy or lactation, but caution should be exercised.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dermazole: Stop using Ketoconazole shampoo and tell the doctor straight away if patient notices or suspects any of the following. The patient may need urgent medical treatment.
Uncommon (may affect up to 1 in 100 people): Severe irritation or reddening of the skin where the shampoo has been used, or other signs of allergy during the first few days of treatment.
Rare (may affect up to 1 in 1,000 people): Allergic reaction, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
Peeling or blistering of the skin.
Tell the doctor or pharmacist if the patient notices or suspects any of the following side effects: Uncommon (may affect up to 1 in 100 people): Infection of the hair roots.
Increase in production of tears.
Unusual hair loss or thinning.
Dry skin, rash, burning feeling.
Changes in how your hair feels.
Rare (may affect up to 1 in 1,000 people): Taste impairment; Irritation of the eyes; Acne; Flaking skin.
Not known (frequency cannot be estimated from the available data): Hives (also known as nettle rash or urticaria); Hair colour changes.
Dermazole Plus: 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.

Tell the doctor or pharmacist if the patient is taking, or has recently taken, any regular medication on prescription or over the counter products.
Dermazole: If cortisone ointments, such as betamethasone or hydrocortisone, are being used on the same area, for a long period and they decide to stop this treatment: reduce the cortisone therapy gradually over 2-3 weeks while also using Ketoconazole.
Other medicines and Ketoconazole shampoo: No interactions with other medicines are known.
Dermazole Plus: 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.

Store at temperatures not exceeding 30°C.

When should you consult your doctor: Consult your doctor if you experience any first sign of any adverse drug reaction; if you accidentally swallow any shampoo.

Psoriasis, Seborrhea & Ichthyosis Preparations

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

Non-Rx