Skimazol^® (Cream) Instructions for Use

Marketing Authorization Holder

SK Meditech, Private Limited (India)

Manufactured By

Lok-Beta Pharmaceuticals (India), Private Limited (India)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Clotrimazole (Rec.INN registered WHO)

Betamethasone (Rec.INN registered WHO)

Gentamicin (Rec.INN registered WHO)

Dosage Form

Skimazol®

Cream for external use 0.5 mg+1 mg+10 mg/1 g: tubes 15 g or 30 g

Dosage Form, Packaging, and Composition

Cream for external use white or almost white, homogeneous, soft consistency, not containing foreign impurities.

Auxiliary substances : vaseline – 150 mg, propylene glycol – 100 mg, cetearyl alcohol – 72 mg, liquid paraffin – 60 mg, macrogol cetostearyl ether 1000 – 22.5 mg, benzyl alcohol – 10 mg, sodium dihydrogen phosphate dihydrate – 2.995 mg, phosphoric acid – 0.03 mg, phosphoric acid or sodium hydroxide – to establish pH, purified water – to 1 g.

15 g – aluminum laminated tubes (1) – cardboard packs.
30 g – aluminum laminated tubes (1) – cardboard packs.

Indications

• Dermatological conditions complicated by bacterial and/or fungal infections, or when there is a high risk of such complications.
• Atopic dermatitis (eczema) with confirmed or suspected secondary infection caused by organisms susceptible to clotrimazole and gentamicin.
• Allergic and contact dermatitis with signs of superinfection.
• Neurodermatitis (lichen simplex chronicus) with associated bacterial or fungal involvement.
• Seborrheic dermatitis, especially in intertriginous areas prone to infection.
• Diaper dermatitis in infants and young children, but only under strict medical supervision and for the shortest possible duration due to the increased risk of systemic absorption and adrenal suppression.
• Intertrigo in skin folds where candidal and bacterial overgrowth is common.

This is a combination product and its use should be reserved for cases where the inflammatory dermatosis is complicated, or likely to become complicated, by microbial infection. It is not intended for prophylactic use or for treating uninfected inflammatory skin conditions.

Contraindications

• Hypersensitivity to betamethasone, clotrimazole, gentamicin, any other aminoglycoside antibiotic, or to any of the excipients listed in the composition.
• Viral skin infections such as herpes simplex, chickenpox (varicella), herpes zoster, vaccinia, and other viral dermatoses.
• Fungal skin infections not caused by fungi susceptible to clotrimazole.
• Tuberculous and syphilitic lesions of the skin.
• Skin manifestations secondary to untreated systemic infections.
• Perioral dermatitis and acne rosacea.
• Application to the eyelids or direct use in the eye due to the risk of severe eye irritation, glaucoma, or cataract formation.
• Use in children under 2 years of age, unless specifically directed by a physician, due to the heightened risk of systemic absorption and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. The use in diaper dermatitis in infants requires extreme caution.
• Pregnancy and Lactation unless the potential benefit to the mother outweighs the potential risk to the fetus or infant. Topical corticosteroids, especially under occlusion, can be absorbed in amounts sufficient to produce systemic effects. Gentamicin is known to be ototoxic and nephrotoxic following systemic administration.

Dosage Regimen

The cream should be applied in a thin layer to the affected skin areas and gently rubbed in. The frequency and duration of application are determined by the treating physician based on the severity and location of the condition.

For adults and children over 2 years of age: The standard regimen is application twice daily, in the morning and evening. In less severe cases, application once daily may be sufficient. Treatment should generally be continued for a sufficient period to achieve clinical resolution, but the duration of continuous treatment should not exceed 4 weeks without medical re-evaluation.

For the management of diaper dermatitis in infants: Application should be limited to the shortest possible duration, typically no more than 7 days. The cream should be applied with each diaper change. Diapers or plastic pants should not be used as an occlusive dressing, as this significantly increases systemic absorption of the corticosteroid and can lead to adverse effects.

If no clinical improvement is observed within 2-4 weeks of starting treatment, the diagnosis should be re-evaluated. Patients should be instructed to avoid covering the treated area with tight, non-breathable bandages or clothing unless specifically directed by a physician.

Adverse Reactions

Adverse reactions are generally associated with prolonged and/or intensive use, application under occlusion, or use on large body surface areas, thin skin areas (face, flexures), or in children.

Local skin reactions at the application site are the most commonly reported. These may include: burning sensation, itching, irritation, dryness, folliculitis, hypertrichosis, skin atrophy (thinning), striae, acneiform eruptions, hypopigmentation, and contact dermatitis.

With prolonged use or use on large areas, systemic absorption of the corticosteroid (betamethasone) may occur, leading to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. This risk is significantly higher in infants and children.

Use of topical antibiotics like gentamicin can lead to the development of resistant organisms, including bacteria and fungi. If superinfection with non-susceptible organisms occurs during therapy, appropriate alternative antimicrobial therapy should be instituted.

Allergic contact dermatitis to any of the active ingredients or excipients (notably benzyl alcohol) is possible. If irritation or sensitization develops, treatment should be discontinued, and appropriate therapy instituted.

Drug Interactions

Concomitant use of other topical corticosteroids, preparations containing alcohol, or other drying agents may increase the risk of local adverse effects such as skin atrophy and irritation.

While systemic interactions from topical application are unlikely, caution is advised in patients receiving systemic aminoglycoside antibiotics (e.g., for another infection), as this could theoretically increase the risk of ototoxicity and nephrotoxicity, although the risk from topical gentamicin is considered very low.

The anti-inflammatory action of corticosteroids may mask the signs of an underlying infection. If a concomitant skin infection is present or develops, an appropriate antifungal or antibacterial agent should be used. If the response is not prompt, corticosteroid use should be discontinued until the infection is adequately controlled.

No specific drug interactions have been reported with clotrimazole when used topically. However, systemic clotrimazole is known to inhibit cytochrome P450 enzymes; this is not a concern with topical administration due to minimal systemic absorption.

Overdose

Acute overdose from topical application is unlikely. However, chronic or excessive application, application under occlusion, or use on large body surface areas can lead to significant systemic absorption of the corticosteroid and the antibiotic.

Symptoms of topical corticosteroid overdose are synonymous with those of systemic hypercorticism and include: Cushingoid features (moon face, central obesity), hyperglycemia, glucosuria, HPA axis suppression with symptoms of adrenal insufficiency (weakness, nausea, hypotension, hypoglycemia), and growth retardation in children.

Symptoms of topical gentamicin overdose are theoretically possible with massive application to large, denuded areas and could include ototoxicity (hearing loss, tinnitus, vertigo) and nephrotoxicity.

There is no specific antidote. In case of suspected overdose, treatment should be discontinued immediately. Management is supportive and symptomatic. If HPA axis suppression is diagnosed, systemic corticosteroid replacement therapy may be required until adrenal function recovers. Recovery of HPA axis function is usually prompt and complete upon discontinuation of the topical corticosteroid.

Clinical-Pharmacological Group

A drug with antibacterial, antifungal, and anti-inflammatory action for external use

Pharmacotherapeutic Group

Anti-inflammatory, antibacterial, antifungal agent

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.