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Abbreviated Prescribing Information for Fucidin® 2% Cream

FORMULATION

Each gram contains: Fusidic acid 20 mg. in neutral cream base.

INDICATIONS

Fusidic acid (Fucidin®️) cream is indicated for treatment of skin infections caused by staphylococci, streptococci, Propionibacterium acnes, Corynebacterium minutissimum, and other organisms sensitive to Fusidic acid. The most important indications being:

Impetigo

Boils

Carbuncles

Paronychia

Infected Wounds

Sycosis barbae

Hidradenitis

Erythrasma

Folliculitis

Acne vulgaris

 

 

Fusidic acid (Fucidin®️) cream is an invisible, non-staining preparation, which is cosmetically acceptable for treatment of face and scalp infections.

APPLICATION

Fusidic acid (Fucidin®️) cream is applied to the affected area 2-3 times daily, generally for a period of 7 days, except of acne where therapy should be extended for a longer period according to the nature of this disease.

SIDE-EFFECTS

Fusidic acid (Fucidin®️) cream is remarkably well tolerated, and there is an extremely low frequency of hypersensitivity reactions.

Keep out of reach of children.

STORAGE

Storage at temperatures not exceeding 30℃.

Fucidin®️ 2% Cream API version January 2019


Abbreviated Prescribing Information for Fucidin® 2% Ointment

FORMULATION

Each gram contains: Sodium fusidate 20 mg. in neutral ointment base.

INDICATIONS

Fusidic sodium (Fucidin®️) ointment is indicated for treatment of skin infections caused by staphylococci, streptococci, Corynebacterium minutissimum, and other organisms sensitive to Sodium fusidate. The most important indications being:

Impetigo

Boils

Hidradenitis

Infected Wounds

Sycosis barbae

Paronychia

Folliculitis

Carbuncles

Erythrasma

DOSAGE AND ROUTE ADMINISTRATION

Fusidic sodium (Fucidin®️) ointment is applied to the affected area 2-3 times daily. It can be used with or without a covering dress. Caution should be observed when applying Fusidic sodium (Fucidin®️) ointment in the eye region as this preparation may cause irritation if it gets into the eye.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any excipients.

UNDESIRABLE EFFECTS

The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients. Hypersensitivity effect of topically administered Fucidin®️ Ointment.

STORAGE

Storage at temperatures not exceeding 30℃.

Fucidin®️ 2% Ointment API version January 2019


Abbreviated Prescribing Information for Fucicort®️ 20 mg/1 mg per gram Topical Cream

FORMULATION

Each gram contains: Fusidic acid 20 mg, betamethasone as valerate 1 mg, preserved with chlorocresol.

INDICATIONS

Fusidic acid and Betamethasone valerate (Fucicort®️) cream is indicated in inflammatory dermatoses where bacterial infection is present or likely to occur. Inflammatory dermatoses include:

Atopic eczema

Discoid eczema

Stasis eczema

Seborrhoeic dermatitis

Contact dermatitis

Lichen simplex chronicus

Psoriasis

Discoid lupus erythematosus

 

DOSAGE AND ADMINISTRATION

Uncovered lesions: 2-3 daily applications. Covered lesions: Less frequent application may be adequate.

CONTRADICTIONS

Topical corticosteroids are contraindicated in viral, tuberculous and fungal skin infections, perioral dermatitis, acne rosacea and ulcerative condition. Hypersensitivity to any component.

ADVERSE DRUG REACTIONS

Hypersensitivity has rarely been encountered. As with other topical corticosteroids, prolonged and intensive treatment may cause local atrophic changes of the skin, such as striae, thinning and dilation of the superficial blood vessels, particularly when occlusive dressing is used or when skin folds are involved. Systemic absorption, sufficient to produce hypercroticism/ adrenal suppression, can occur with prolonged or extensive use, especially when used under occlusion/napkin. Infants and children are particularly at risk. Caution should be exercised if a topical steroid is under near the eye. Glaucoma might be the result if the preparation enters the eye.

STORAGE

Store below 30℃.

Keep out of reach of children.

Fucicort®️ 20 mg/ 1mg per gram Topical Cream API version January 2019


Abbreviated Prescribing Information for Fucidin®️ H 20 mg/10 mg per gram Topical Cream

FORMULATION

Active ingredients: Fusidic acid 20mg/g, Hydrocortisone acetate 10 mg/g. Inactive ingredients: Butylated Hydroxy anisole, acetyl alcohol, glycerol 85%, liquid paraffin, polysorbate, potassium sorbate, white soft paraffin, purified water.

INDICATIONS

Fusidic acid and Hydrocortisone acetate (Fucidin®️ H) cream is indicated for the treatment of dermatitis, including atopic dermatitis and contact dermatitis, where and infection with bacteria sensitive to Fusidic acid is suspected or confirmed. Because of its hydrocortisone content, Fucidin®️ H Cream is particularly appropriate in cases where a milder corticosteroid is indicated, including milder inflammatory dermatoses - on the face and on children’s skin. Fucidin®️ H Cream is cosmetically acceptable for use on the face and hands and convenient for use in the groin area and armpits.

DOSAGE AND ADMINISTRATION

Apply the cream three times daily for up to 2 weeks.

CONTRADICTIONS

Hypersensitivity to Fusidic acid/ Sodium fusidate, Hydrocortisone acetate or to any of the excipients listed above(see FORMULATION). Due to the content of corticosteroid, Fucidin®️ H is contraindicated in the following conditions: Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate. Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate therapy. Perioral dermatitis and rosacea.

UNDESIRABLE EFFECTS

The most frequently reported adverse reactions during treatment are application site reactions including pruritu, burning and irritation. Hypersensitivity is an uncommon undesirable effect of topically administered Fucidin®️ H Cream.

SHELF LIFE AND STORAGE CONDITIONS

To be stored up to 3 years at temperature not exceeding 25℃. See the expiry date printed on the carton.

Fucidin®️ H 20 mg/ 1mg per gram Topical Cream API version January 2019