Dermocort cream 15 gm

Trade Name:

Dermocort 

Topical Cream

15 gm

Composition:

Each 1 gm of cream contains:

Clioquinol 3 % 

Hydrocortisone 1 %

Inactive ingredients:

Methyl paraben, propylparaben. propylene glycol, liquid paraffin, cetomacrogol 1000, cetostearyl alcohol, white soft paraffin, purified water.

Properties:

-Antibacterial

-Antifungal

-Topical Corticosteroid

Clioquinol, the antimicrobial component of Dermocort, is active against a broad spectrum of pathogenic Microorganisms including fungi (e.g, Candida, Microsporum, Trichophyton) and gram – positive bacteria (e.g.Staphylococci) Clioquinol has only a slight inhibitory effect on gram negative bacteria. Clioquinol exerts a bacteriostatic, rather than a bactericidal action.

Hydrocortisone is a mild glucocorticoid with an anti-inflammatory, antiallergic vasoconstrictive effect in inflammatory skin diseases of widely varying type and origin. It affords prompt relief and eliminates symptoms such as Pruritus.

Dermocort combines the antifungal and antibacterial actions of clioquinol with the anti-inflammatory and antipruritic effects of hydrocortisone for broad control of acute and chronic dermatologic disorders.

Indications:

The initial treatment of corticosteroid – responsive inflammatory skin diseases complicated by bacterial and/ or fungal infections, with appropriate systemic antibiotics if necessary. For example: atopic dermatitis, seborrheic dermatitis, contact dermatitis ( dermatitis venenata), superficial forms of intertrigo, and dermatomycosis in which acute inflammation is a prominent feature.

The cream has a slightly drying effect primarily useful for moist, weeping lesions and in intertriginous areas.

Dosage and administration:

Apply Dermocort to the affected area in a thin layer 2 to 3 times daily.

Use of Dermocort under occlusive dressings is not recommended as the resulting humid conditions may promote secondary infections with nonsensitive organisms and also may increase the possibility of elevated PBI.

Side effects:

Common: signs of irritation such as burning sensation, itching or skin rash at the site of application. 

Contraindications:

-Viral infections of the skin (e.g., chicken-pox, skin eruptions following vaccination, herpes simplex, herpes zoster). Tuberculosis of the skin, syphilitic skin infections.

-Known hypersensitivity to hydrocortisone or to corticosteroids in general, hydroxyquinolines, clioquinol or other quinolone derivatives, iodine, as well as to any other components of Dermocort.

-Application to ulcerated areas

-Application to the eye 

-Use in children under 2 years of age.

Warnings and precautions:

• Pregnancy and lactation:

-The safety of Dermocort during pregnancy or lactation has not been established. Studies have shown that corticosteroids may induce fetal abnormalities in pregnant animals. The relevance of this to human use has not been elucidated. 

-It is not known whether the active substance passes into the breast milk when applied topically.Therefore, the potential benefit of Dermocort, if used during pregnancy (particularly in the first 3 months ) or lactation, should be weighed against possible hazard to the fetus or the nursing infant.

• Application to relatively large and / or eroded areas, treatment for longer than 1 week, as well as use under occlusive dressings may lead to a marked increase in protein bound iodine ( PBI ) and should be avoided.
• Long-term therapy:

If no improvement occurs within1 week, the therapy should be discontinued- it is then advisable to identify and treat the causative pathogens.

• Dermocort should not be used to treat bacterial or mycotic skin diseases in which acute inflammation is not present.
• May turn yellow when exposed to air and may cause staining of the skin, nails, hair or fabrics.
• If in exceptional cases Dermocort is applied in large amounts, the patient should be kept under regular medical supervision.
• As a general rule, advise patients to inform subsequent physicians that they have been using corticosteroids.
• Dermocort should not be allowed to come into contact with the conjunctiva.
• Dermocort should not be used in the external auditory canal if the eardrum is perforated.
• In patients suffering from hepatic and/ or renal failure caution is indicated .
• Topical use of clioquinol , as well as other iodine containing compounds, may increase the amount of protein – bound iodine (PB) in patients with normal thyroid function and therefore with some thyroid function tests (such as PBI radioactive iodine and butanol- extractable iodine). These tests should not be performed within a period shorter than 1 month following the use of dermocort.
• Other Thyroid function tests, such as the T3 resin sponge test or the T4 determination, are unaffected by clioquinol.

• The ferric chloride test for phenylketonuria may yield a false -positive result when clioquinol is present in the urine. 

Storage:

Store at a temperature not exceeding 30°C 

Package:

Carton box holds a tube of 15 g and an insert leaflet.