Important Disclaimer: This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product's internal leaflet or consult a healthcare professional before use.
Drug Name: Aceczema Cream 15 g (0.1 % methylprednisolone aceponate)
Manufacturer:
Aceczema Cream is manufactured by Global Napi Pharmaceuticals (GNP), Egypt. GNP is a GMP-certified Egyptian manufacturer known for producing branded and licensed medicines. [3]
Introduction:
Aceczema Cream is a mid-potency topical corticosteroid containing methylprednisolone aceponate 0.1 %. It is designed to provide rapid anti-inflammatory, antipruritic (anti-itch), and immunosuppressive effects directly at the skin surface. It is widely used for various steroid-responsive dermatoses, primarily eczema, to alleviate symptoms such as itching, redness, and inflammation. [1, 2]
Indications and Usage:
Aceczema Cream is indicated for the topical treatment of:
* Atopic dermatitis (eczema): To reduce inflammation, itching, and redness. [1, 2]
* Allergic or irritant contact dermatitis: Skin inflammation due to contact with allergens or irritants. [1]
* Seborrhoeic dermatitis: A common skin condition that causes red, flaky, itchy skin. [1]
* Localised plaque psoriasis: For non-facial, non-intertriginous (skin fold) areas. [1]
* Lichen simplex chronicus: A chronic itchy skin condition. [1]
* Other steroid-responsive inflammatory dermatoses: As determined by a healthcare professional. [1]
Characteristics:
* Active Ingredient: Methylprednisolone aceponate 0.1% (1 mg/g). [1, 2]
* Dosage Form: Topical cream (oil-in-water base), provided in a 15 g tube. [1, 2]
* Drug Class: Group III/IV (mid-potency) topical corticosteroid. [1, 2]
* Mechanism of Action: Methylprednisolone aceponate works by inhibiting phospholipase-A₂ and downstream cytokines. This action leads to a reduction in leukocyte infiltration and capillary permeability, thereby effectively reducing erythema (redness), oedema (swelling), and pruritus (itching) associated with inflammatory skin conditions. [1]
Dosage and Administration:
Aceczema Cream is for external use only.
* Adults & Children ≥ 4 months: Apply a thin film once daily to the affected skin area. [1, 2]
* Maximum Duration:
* Up to 2 weeks when applied to the face. [1]
* Up to 4 weeks when applied to the trunk and limbs. [1]
* Duration may vary if otherwise directed by a healthcare professional.
* Technique:
* Clean and dry the skin before application. [1]
* Gently massage the cream into the skin until it is absorbed. [1]
* Do not cover the treated area with occlusive dressings (e.g., bandages, plastic wraps, tight clothing, or nappies in infants) unless specifically prescribed by a physician, as this can increase systemic absorption and side effects. [1, 2]
* Paediatrics: Use the smallest amount for the shortest possible time. Avoid using under nappies or other occlusive conditions in children. [1]
Contraindications:
Aceczema Cream should not be used in individuals with the following conditions:
* Known hypersensitivity or allergy to methylprednisolone aceponate or any of the cream's excipients. [1]
* Untreated bacterial, fungal, viral (e.g., herpes simplex, varicella), or parasitic skin infections in the area to be treated. [1]
* Rosacea. [1]
* Perioral dermatitis (a rash around the mouth). [1]
* Acne vulgaris. [1]
* Application on vaccination sites, ulcerated lesions, or areas with existing skin atrophy (thinning). [1]
* Infants younger than 4 months of age. [1]
Warnings and Precautions:
* Skin Atrophy: Prolonged or excessive use, especially on sensitive areas (face, skin folds), can lead to local side effects such as skin thinning (atrophy), striae (stretch marks), telangiectasia (spider veins), or purpura (skin discoloration from bleeding). [1, 2]
* Systemic Absorption: Although systemic absorption is minimal, it can occur, especially with application to large surface areas, under occlusive dressings, or in children. This can lead to systemic corticosteroid effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression. [1, 2]
* Infections: Corticosteroids can mask or worsen existing skin infections. Discontinue use if irritation, secondary infection, or lack of response occurs, and consult a doctor. [1]
* Sensitive Areas: Use with caution on the face, flexures (skin folds), or genital skin due to increased risk of local side effects. [1]
* Pregnancy & Lactation: Use only if the physician deems the potential benefit outweighs the potential risk to the fetus or infant. [1]
* Ophthalmic Use: Avoid contact with eyes. If accidental contact occurs, rinse thoroughly with water. [1]
Pharmacokinetics:
* Absorption: When applied to intact skin, less than 1% of methylprednisolone aceponate is absorbed systemically. Absorption can increase significantly with inflammation, broken skin, or the use of occlusive dressings. [1, 2]
* Distribution / Metabolism: Once absorbed, methylprednisolone aceponate is rapidly hydrolyzed (broken down) in the epidermis and dermis to its main active metabolite, 6α-methylprednisolone-17-propionate, which then binds to the corticoid receptor. It is further metabolized to inactive metabolites in the liver. [1, 2]
* Elimination: The inactive metabolites are primarily excreted via urine and bile. The steroid half-life is approximately 16 hours. [1, 2]
Side Effects:
| Frequency | Reactions |
|---|---|
| Common | Mild, transient burning sensation, pruritus (itching), dryness, erythema (redness) at the application site. [1] |
| Less Common | Skin atrophy (thinning), striae (stretch marks), telangiectasia (spider veins), folliculitis (inflammation of hair follicles), hyper-/hypopigmentation (changes in skin color). [1] |
| Rare / Serious | Perioral dermatitis, allergic contact dermatitis, rebound flare of eczema upon discontinuation, systemic adrenal suppression (with extensive misuse or prolonged use on large areas). [1] |
Drug Interactions:
Clinically relevant systemic drug interactions are unlikely due to the minimal systemic absorption of methylprednisolone aceponate when used topically as directed. Nevertheless:
* Topical Antimicrobials / Antifungals: If other topical medications are used, apply them at separate times to avoid dilution or altered absorption. [1]
* Barrier-Disrupting Agents (e.g., salicylic acid, urea): These agents may enhance the penetration of corticosteroids into the skin. Monitor for increased side effects if used concurrently. [1]
Patient Counseling:
* Use Aceczema Cream exactly as directed by your doctor. Do not use more than prescribed or for longer than recommended. [1]
* Apply a thin layer only to the affected skin areas. Do not apply to healthy skin. [1]
* Wash your hands before and after applying the cream. [1]
* Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water. [1]
* Do not cover the treated area with occlusive dressings (e.g., bandages, plastic wraps) unless specifically instructed by your doctor, especially if it contains a corticosteroid. [1]
* If your condition worsens or does not improve after the prescribed treatment period, consult your doctor. [1]
* Be aware of potential side effects, especially skin thinning. Report any unusual skin changes to your doctor. [1]
* Protect treated areas from sunlight if advised by your doctor. [1]
* Keep out of reach of children. [1]
* Store the cream below 25 °C, away from direct heat and light, as indicated on the packaging. [1]
Sources:
* Advantan (Methylprednisolone aceponate) Cream - MIMS Philippines: https://www.mims.com/philippines/drug/info/advantan%20cream?type=full [1]
* Methylprednisolone aceponate 0.1% ointment/cream [Advantan®] - Research Review: https://www.researchreview.co.nz/articles/2018/09/methylprednisolone-aceponate-0-1-ointment-cream-advantan [2]
* Global Napi Pharmaceuticals - PharmaCompass.com: https://www.pharmacompass.com/manufacturers/global-napi-pharmaceuticals [3]
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