Malasiya 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:

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:

GIT:
nausea, vomiting, heartburn, diarrhea.

CNS:
hyperexcitability of CNS, headache.

Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue: allergic reactions.

Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

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?

Ascozin® increases salicylates (increases a risk of crystalluria), ethynilestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases per oral contraceptives concentration in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron drugs absorption in intestine. It increases general clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylate, corticosteroid decrease vitamin C reserve when used for a long term. Corticosteroids (cortisone and prednisolone), which are administered in concrete diseases (arthritis, bronchial astma etc), also reduce vitamin C and zinc levels.
Concurrent usage of ascorbic acid and deferoxamine enhances tissue toxicity of iron, especially in cardiac muscle that can cause decompensation of blood circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term administration of high doses in patients, who are treated by disulfiram, inhibits disulfamide-alcohol reaction.
High doses of the preparation decrease efficacy of tricyclic depressants.

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

Symptoms:
nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.

Treatment:
It is symptomatic.

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:

Store in a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Drug Description

COMPOSITION:

1 ml of shampoo contains: Ketoconazole USP 20 mg Other ingredients: Cocodiethanolamide, Sodium lauryl ether sulfate, Disodium monolauryl ether sulfosuccinate, Macrogol 120 methyl glucose dioleate, Propylene glycol, Conc. hydrochloric acid, Sodium chloride, Sodium hydroxide, Butylated hydroxytoluene, Imidurea, Colour Ponceau 4R, Fragrance CK D00923, Purified water.

Indications and dosage.

INDICATIONS:
Ketoconazole Shampoo is indicated for the prevention and treatment of dandruff.

DOSAGE:
Use shampoo every 3-4 days for 2-4 weeks. There should be a minimum of 3 days between applications. Prophylaxis: Use shampoo once every 1-2 weeks

Side effects and drug interactions.

ADVERSE REACTIONS:

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 shampoo. In rare instances, mainly in patients with chemically damaged hair or grey hair, a discolouration of the hair has been observed.


Drug 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 shampoo is not contraindicated for pregnancy or lactation, but caution should be exercised.


PRECAUTIONS:
Dermazole 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. On rare occasions when using Dermazole Shampoo to treat pityriasis capitis (dandruff), an increase in normal hair loss and irritation associated with this condition may occur. If the scalp is not cleared within 4 weeks of treatment a doctor or pharmacist should be consulted.

Overdosage and Contraindications

Overdose:

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.

CONTRAINDICATIONS: Hypersensitivity to Ketoconazole or any of the excipients.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics:
Pharmacotherapeutic (ATC) Classification: D01A C08 Ketoconazole is a synthetic imidazole-dioxolane derivative. It is a broad spectrum antifungal agent which inhibits the growth of common dermatophytes and yeasts by altering the permeability of the cell membrane: Dermatophytes: Trichophyton rubrum, T. mentagrophytes, T.tonsurans, Microsporum canis, M. audouinii, M. gypseum and Epidermophyton floccosum. Yeasts: Candida albicans, C tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur).

PHARMACEUTICAL CHARACTERISTICS:
General physic-chemical properties:
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

Shelf-life:
3 years.

Storage:
Store at the temperature not more than 25° C. in a place protected from sunlight. Keep it out of reach of children

Package:
White High-density polyethylene (HDPE) multi dose bottles with polypropylene flip top closures available in pack of 50 ml and 100 ml. Each bottle is packed in a carton. Laminated aluminium foil sachet containing 8 ml shampoo. 20 sachets are packed in a carton.

Conditions of supply:
By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575