-
الفئة العلاجية
- الشكل الصيدلاني :
- التركيب : Each 1 g dermic cream contains: Crotamiton 100 mg
- المادة الفعالة : Crotamiton
النشرة الدوائية :
PROPERTIES:
Crotamiton has a symptomatic action on pruritus and is an acaricide. As an acaricide agent, crotamiton is effective on the motor system of the mites by inducing irreversible cessation of spontaneous movements.
CROTA HEAL 10 % Cream will provide relief from irritation for 6 to 10 hours after each application.
Pharmacokinetic properties:
CROTA HEAL 10% Cream penetrates rapidly into human skin. Low but measurable concentrations of crotamiton are found in plasma, with a maximum level after 4-10 hours, declining rapidly thereafter.
INDICATIONS
-For the relief of itching and skin irritation caused by, for example, sunburn, dry eczema, itchy dermatitis, allergic rashes, hives, nettle rash, chickenpox, insect bites and stings, heat rashes and personal itching.
-The treatment of scabies.
CONTRAINDICATIONS
Acute exudative dermatoses.
Hypersensitivity to the active substance or to any of the excipients
PRECAUTIONS:
For external use only.
CROTA HEAL 10 % Cream can be used for children However for children under three years of age; usage should only be under medical supervision.
Should not be used in buccal mucosa and in or around the eyes since contact with the eyelids may give rise to conjunctival inflammation.
In case of accidental contact with the eyes, or buccal mucosa rinse thoroughly with running water.
Should not be applied in the presence of exudative wounds, acute eczema, broken skin, or very inflamed skin.
In the presence of eczematous scabies, eczema should be treated before the scabies.
CROTA HEAL 10 % cream contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and methyl hydroxybenzoate which may cause allergic reactions (possibly delayed).
Pregnancy
CROTA HEAL 10 % Cream is not recommended during pregnancy, especially in the first three months.
Breastfeeding
Mothers should not use CROTA HEAL 10 % Cream whilst breastfeeding unless directed by a physician. If CROTA HEAL 10 % Cream is used during breastfeeding it should not be applied to the nipple area
SIDE EFFECTS:
Skin and subcutaneous tissue disorders:
Uncommon: pruritus
Rare: contact dermatitis, hypersensitivity (including/like rash, eczema, erythema, skin irritation, angioedema)
Treatment should be discontinued if sever irritation occurs.
DOSES
Pruritus
Adults (including the elderly):
Apply to the affected area 2 to 3 times daily. CROTA HEAL 10 % Cream will provide relief from irritation for 6 to 10 hours after each application. There are no special dosage recommendations in the elderly.
Paediatric population:
CROTA HEAL 10 % Cream can be used in children. However for children under three years of age usage should only be under medical supervision and it should not be applied more than once a day.
Scabies
Adults (including the elderly:
After the patient has taken a warm bath, the skin should be well dried and CROTA HEAL 10 % Cream rubbed into the entire body surface (excluding the face and scalp) until no traces of the preparation remain visible on the surface.
The application should be repeated once daily, preferably in the evening, for a total of 3-5 days.
Depending on the response, special attention should be paid to sites that are particularly susceptible to infestation by the mites (e.g. interdigital spaces, wrists, axillae and genitalia). Areas where there is pus formation should be covered with a dressing impregnated with CROTA HEAL 10 % Cream. While the treatment is in progress the patient may take a bath shortly before the next application.
After completion of the treatment, a cleansing bath should be taken followed by a change of bed linen and underclothing.
There are no special dosage recommendations in the elderly.
Paediatric population:
CROTA HEAL 10 % Cream can be used in children. However for children under three years of age usage should only be under medical supervision and it should not be applied more than once a day.
Method of administration: For cutaneous use.
STORAGE CONDITIONS
Do not store above 25°C.
PACKAGING:
(20-40) g tube.