Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Topical administration.
Recommended dosage;
Apply a thin film to the affected skin areas once daily.
(Do not use occlusive dressings on affected area. if no improvement is seen in 2 weeks, re-assessment of diagnosis may be necessary)

• Eczaderm® should be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established.
But it is not recommended to use it in pediatric patients below 2 years of age, since safety and efficacy of Eczaderm® have not been established.
• In children avoid prolonged use and use it under specialist supervision, extreme caution is required in dermatoses of infancy including nappy rash-treatment should be limited to 5-7days.
• Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of hypothalamic –pituitary-adrenal (HPA) axis suppression.
• If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be use. If a favorable response does not occur promptly, use of Eczaderm® should be discontinued until the infection is controlled.
• If irritation develops, Eczaderm® should be discontinued and appropriate therapy instituted.
• This medication should not be used on the face, underarms or groin areas unless directed by the physician.

• There are no known drug interactions with topical mometasone furoate.

• Eczaderm® should be used during pregnancy (Category C) only if the potential benefit justifies the potential risk to the fetus.
• Eczaderm® should be used with caution during lactation .

Not applicable.

Table 1: Treatment-related adverse reactions reported with Elocon by body system and frequency Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100);
rare (≥1/10,000, <1/1,000); very rare (<1/10 000,); not known (cannot be estimated from available data)
Infections and infestations
Not known Very rare: : Infection, furuncle Folliculitis

Nervous system disorders
Not known Very rare:Paraesthesia, burning sensation

Skin and subcutaneous tissue disorders
Not known:Dermatitis contact, skin hypopigmentation, hypertrichosis, skin striae, dermatitis acneiform, skin atrophy
Very rare:Pruritus
General disorders and administration site conditions
Not known:Application site pain, application site reactions

To Report Side Effects
National Pharmacovigilance Centre info:
Fax: +966-11-205-7662
Toll- free number: 8002490000 E-mail: npc.drug@sfda.gov.sa Website: www.sfda.gov.sa/npc

Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.
The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.

Pharmacotherapeutic group: Corticosteroid. ATC code: D07AC13.
Mometasone furoate is a topical corticosteroid. It has anti-inflamatory, antipruritic and vasoconstrictive properties.

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate cream 0.1% is minimal, approximately 0.4% of the applied dose in man, the majority of which is excreted within 72 hours following application. Characterization of metabolites was not feasible owing to the small amounts present in plasma and excreta.

No available data.

White Soft Paraffin Liquid Paraffin Cetostearyl Alcohol Cetomacrogol -1000
Sodium Dihydrogen phosphate anhydrous Methyl Hydroxybenzoate
Propyl Hydroxybenzoate Purified Water

Not applicable

Do not store above 30 °C.
Do not use after 12 months from opening the tube and storage condition (25°C)

ECZADERM® 0.1 % Cream is presented as carton box containing aluminum tube of 30 gram along with a leaflet.

No special requirements.