DAKTACORT HYDROCORTISONE

For topical administration Apply the cream twice a day to the affected area, rubbing in gently until the cream has been absorbed by the skin. The maximum period of treatment is 7 days. Elderly Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time.

The safety of Daktacort Hydrocortisone Cream was evaluated in 480 patients who participated in 13 clinical trials (six double-blind and seven open-label trials) of Daktacort Hydrocortisone Cream. These studies examined patients from 1 month to 95 years of age with infections of the skin caused by dermatophytes or Candida species in which inflammatory symptoms were prominent.

All patients No adverse drug reactions (ADRs) were reported by ≥ 1% of the 480 Daktacort Hydrocortisone Cream-treated patients (adult and paediatric patients combined). The frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to < 1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available clinical trial data).

Of the three ADR’s identified from the 13 clinical trials of Daktacort Hydrocortisone Cream, skin irritation was reported in one clinical trial that included patients aged 17 to 84 years, skin burning sensation in two clinical trials that included patients aged 13 to 84 years, and irritability in one clinical trial of infants aged 1 to 34 months.

Paediatric population The safety of Daktacort Hydrocortisone Cream was evaluated in 63 paediatric patients (1 month to 14 years of age) who were treated with Daktacort Hydrocortisone Cream in 3 of the 13 clinical trials noted above.

One ADR term (irritability) was reported in these 3 trials. 2%). All events of irritability occurred in one clinical trial of infants (aged 1 to 34 months) with napkin dermatitis. The frequency, type and severity of other ADRs in paediatric patients are expected to be similar to those in adults.

4) Skin and Subcutaneous Tissue Disorders Skin irritation, Skin burning sensation. Urticaria, Pruritis Angioedema, Rash, Contact dermatitis, Erythema, Skin inflammation, Skin hypopigmentation, Application site reaction General Disorders and Administration Site Conditions Irritability Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4. Special Warnings and Special Precautions for Use When Daktacort Hydrocortisone Cream is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktacort Hydrocortisone Cream and other miconazole topical formulations (See Adverse reactions).

If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Daktacort Hydrocortisone Cream must not come into contact with the mucosa of the eyes. Visual disturbance may be reported with systemic and topical corticosteroid 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 have been reported after use of systemic and topical corticosteroids.

As with any topical corticosteroid, caution is advised when Daktacort Hydrocortisone Cream is to be applied to extensive surface areas or under occlusive dressings including baby napkins; similarly application to the face should be avoided.

Long term continuous topical corticosteroid therapy should be avoided. Adrenal suppression can occur even without occlusion. 1). Contact should be avoided between latex products such as contraceptive diaphragms or condoms and Daktacort Hydrocortisone Cream since the constituents of Daktacort Hydrocortisone Cream may damage the latex.

Daktacort Hydrocortisone Cream can damage certain synthetic materials. Therefore, it is recommended to wear cotton underwear if this clothing comes into contact with the affected area. This medicine contains 2 mg/g of Benzoic acid (E210) which may cause local irritation.

1. Tubercular or viral infections of the skin or those caused by Gram-negative bacteria. Daktacort Hydrocortisone Cream should not be used in the following conditions: • If the skin is broken • On large areas of skin • Used for longer than 7 days • To treat cold sores and acne • Use on the face, eyes and mucous membranes • Children under 10 years of age, unless prescribed by a doctor • On the ano-genital region unless prescribed by a doctor • To treat ringworm unless prescribed by a doctor • To treat secondary infected conditions unless prescribed by a doctor