Contains Hydrocortisone 1% w/w.
Excipients/Inactive Ingredients: Cream: White soft paraffin, Liquid paraffin, Chlorocresol, Cetostearyl alcohol, Propylene glycol, Macrogol cetostearyl ether (Cetamacrogol 1000) and Purified water.
Ointment: White soft paraffin and Liquid paraffin.
Pharmacology: Pharmacodynamics: Hydrocortisone is a topically active corticosteroid which has anti-inflammatory, antipruritic and vasoconstrictive actions.
Pharmacokinetics: Corticosteroids are extensively bound to plasma protein. Only unbound corticosteroids has pharmacological effects or is metabolised. They are metabolised mainly in the liver and also in the kidney, and are excreted in the urine.
Suppression of skin diseases in which inflammation is a prominent feature, e.g. eczema, infantile eczema, atopic dermatitis, dermatitis herpetiformis, contact dermatitis, neurodermatitis, psoriasis and intertrigo.
RECOMMENDED DOSAGE: Apply thinly to the affected area one to four times daily, depending on the seriousness of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
ROUTE OF ADMINISTRATION: Topical.
OVERDOSE AND TREATMENT: If hypothalamic-pituitary-adrenal axis suppression is found, then the drug should be withdrawn, frequency of application reduced or weaker steroid used. Supplemental systemic corticosteroids may be required if signs and symptoms of steroid withdrawal occur.
Hypersensitivity to hydrocortisone, other corticosteroids, or any component in the base.
Discontinue use if irritation, sensitivity or other reaction develop and institute appropriate treatment. Corticosteroid applied to the skin can be absorbed in sufficient amount to produce systemic effects such as hypothalamic-pituitary-adrenal axis suppression, manifestation of Cushing's syndrome, hyperglycaemia and glucosuria. Thus suitable precautions should be taken during prolonged treatment, when treating extensive body surface areas, when using the occlusive technique and when treating children (because of a large skin surface area to body weight ratio).
Not suitable for ophthalmic use.
Visual disturbance may be reported with systemic and topical corticosteroids use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR) which may have been reported after use of systemic and topical corticosteroids.
Safety of use of topical corticosteroids during pregnancy and lactation has not been established. Thus it should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It should not be used extensively on pregnant patients in large amounts or for prolonged periods of time. Caution should be exercised when administering it to nursing mothers.
Reported local adverse reactions are burning sensation, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
Keep containers well closed. Protect from strong light. Store below 30°C.
For external use only.
Recommended shelf-life: 3 years.
D07AA02 - hydrocortisone ; Belongs to the class of weak (group I) corticosteroids. Used in the treatment of dermatological diseases.
H-Cort cream 1%
15 g x 1's
H-Cort oint 1%
15 g x 1's
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