ELICA 0.1% OINTMENT 30G

Indications

Approved Uses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (e.g., atopic dermatitis and psoriasis).

Off-Label Uses

Off-label uses may include localized vitiligo, alopecia areata, lichen planus (cutaneous), and prurigo nodularis; phimosis is more commonly treated off-label with other topical steroids (e.g., betamethasone) rather than being a typical mometasone-specific use.

Dosage & Administration

Dosing by Condition

Corticosteroid-responsive dermatoses (including atopic dermatitis and psoriasis): apply a thin film to affected areas once daily; occlusion is generally not recommended and should be used only if specifically directed for resistant lesions.

Initial Dose

Apply a thin film to the affected skin areas once daily.

Maintenance Dose

After initial improvement, the frequency of application should be decreased gradually as directed by a physician.

Maximum Dose

Apply a thin layer once daily; use the lowest amount for the shortest duration-no fixed gram/week maximum is universally established for this product; reassess if not improved within ~2 weeks and avoid prolonged continuous use, especially on face/intertriginous areas.

Children's Dosage

Approved for children 2 years of age and older. Apply a thin film to the affected area once daily. Use should be limited to the least amount effective and for the shortest possible duration. Safety and efficacy for use longer than 3 weeks in children have not been established.

Dose Adjustment Notes

No renal/hepatic dose adjustment is routinely required due to low systemic absorption when used appropriately; discontinue/taper when control is achieved and reassess if no improvement within ~2 weeks; avoid prolonged use, large surface areas, or occlusion to reduce risk of HPA-axis suppression.

How to Take

For topical use only: apply a thin film to affected skin once daily and rub in gently; wash hands before and after (unless treating hands); avoid eyes and mucous membranes; avoid use on face, groin, or axillae unless directed; do not use occlusive dressings/bandages unless prescribed; use the smallest amount for the shortest duration.

Side Effects

Common Side Effects

Common local effects: burning/stinging/tingling, pruritus, irritation, dryness, erythema, folliculitis/acneiform eruption; with prolonged or inappropriate use: skin atrophy, striae, telangiectasia, hypopigmentation, secondary infection.

Side Effect Frequency

Common (≥1%): burning/stinging, pruritus, irritation/dryness; Uncommon (<1%): folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin atrophy/striae/telangiectasia (risk increases with prolonged use/occlusion); Rare: HPA-axis suppression/Cushingoid features, hyperglycemia, secondary infection; ocular effects (glaucoma/cataract) are rare and mainly associated with periocular use or prolonged exposure.

Safety & Warnings

Warnings & Precautions

Avoid eyes/mucosa; avoid prolonged use on face and use on groin/axillae only if directed; do not use under occlusion unless prescribed; do not apply to infected lesions without appropriate antimicrobial therapy; use lowest effective amount/shortest duration and monitor for atrophy and HPA-axis suppression (higher risk in children and with large areas).

Age Restriction

Not recommended for children under 2 years (unless specifically directed by a specialist).

Drug Interactions

Drug Interactions

No clinically significant interactions are expected with normal topical use; additive systemic corticosteroid effects may occur with other steroids, and systemic exposure may increase with strong CYP3A4 inhibitors only if absorption is substantial; occlusive dressings increase absorption (a key practical interaction).

Interaction Severity

Clinically significant drug interactions are uncommon; caution with strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole/itraconazole) if used extensively/under occlusion due to potential increased systemic corticosteroid effects; additive effects may occur with concurrent topical/systemic corticosteroids or occlusive dressings.

Food Interaction

None (not applicable for topical administration).

Special Populations

Children

Approved for children 2 years of age and older. Apply a thin film to the affected area once daily. Use should be limited to the least amount effective and for the shortest possible duration. Safety and efficacy for use longer than 3 weeks in children have not been established.

Kidney Impairment

No adjustment needed

Storage & Patient Advice

Overdose

Acute topical overdose is unlikely, but excessive/prolonged use or use under occlusion/large areas can cause local atrophy and systemic effects (HPA-axis suppression/Cushingoid features); management is to stop or taper as appropriate and treat symptomatically; accidental ingestion is usually low risk but warrants medical assessment if significant.

Patient Counseling

Apply a thin layer to affected area once daily as prescribed; wash hands after use; avoid eyes/mucosa and do not use on face, groin, or axillae unless directed; do not use occlusive dressings unless instructed; use for the shortest duration-stop and seek review if no improvement in ~2 weeks or if infection/irritation occurs; do not share and keep out of reach of children.

Monitoring Requirements

Monitor clinical response and local adverse effects (atrophy, striae, telangiectasia, irritation, secondary infection); if prolonged use, large surface area, occlusion, or pediatric use: consider periodic evaluation for HPA-axis suppression; advise review if visual symptoms occur (rare risk of glaucoma/cataract with periocular exposure).

Pharmacology

Mechanism of Action

Synthetic glucocorticoid that binds intracellular glucocorticoid receptors to alter gene transcription, inducing lipocortins that inhibit phospholipase A2 and reducing prostaglandin/leukotriene production, producing anti-inflammatory, antipruritic, and vasoconstrictive effects.

Onset of Action

Within hours to 1 day for reduction in itching/redness; noticeable improvement typically within 1-3 days.

Duration of Effect

Approximately 24 hours (supports once-daily application).

Bioavailability

Systemic absorption is low; about 0.4% of the applied dose is absorbed through intact skin without occlusion (can increase with inflammation, large surface area, prolonged use, or occlusion).

Excretion

Excreted mainly in bile/feces with a minor renal component (after hepatic metabolism of absorbed drug).

Product Information

Available Dosage Forms

Ointment, Cream, Lotion, Solution (scalp), Nasal spray (separate indication)

Composition per Dose

Each gram of ointment: 1 mg mometasone furoate (0.1%)

Generic Availability

Yes

OTC Alternatives

Hydrocortisone 1% cream/ointment (OTC) for mild inflammatory dermatoses; consider hydrocortisone 0.5% as an even milder OTC option where available.

Skin Condition

Eczema, Psoriasis, Dermatitis

Steroid Potency

Potent

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.