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Antasone cream

 

DESCRIPTION

Antasone cream is a white uniform cream.

 

COMPOSITION

Each gram contains:
Betamethasone valerate ... 1 mg (Base)
Gentamicin sulfate ... 1 mg (Potency)

PHARMACOLOGY/PHARMACOKINETICS
Following topical application, corticosteroids produce anti-inflammatory, antipruritic and vasoconstrictor actions, while Gentamicin is usually bactericidal in action.

Following topical application of a corticosteroid to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation; however, absorption is markedly increased when the skin has lost its keratin layer and can be increased by inflammation and/or diseases of the epidermal barrier (e.g. psoriasis, eczema).

Although the exact mechanism of action of Gentamicin has not been fully elucidated, the drug appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.

INDICATIONS
1. Allergic and inflamed dermatitis: acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, seborrheioc dermatitis, chronic lichen simplex, intertrigo, desquamative dermatitis, urticaria papulosa, psoriasis, prurtius itching (anus, pudenda), solar dermatitis.

2. It is used in the treatment of impetigo, erythema and other localised primary bacterial infection with a gram-negative component and also for secondary bacterial infections complicating other pre-existing dermatoses.

DOSAGE AND ADMINISTRATION
A small amount of Antasone cream should be applied to the lesion one to several times daily.

CONTRAINDICATIONS
Antasone cream is contraindicated as follows:
1. Tuberculosis of the skin, herpes simplex, varicella, herpes zoster, syphilis.
2. Patients with a history of hypersensitivity to this drug.
3. Eczematoid external auditory meratusitis with drum membrance perforation.
4. Ulcer(Behcet's syndrome), burn of second-degree or more perfrigeration.
5. Patients with a history of hypersensitivity to aminoglycosides antibiotics; streptomycin, kanamycin, gentamicin, neomycin etc. or bacitracin.

PRECAUTIONS
1. Pregnancy : Because the safety has not been established in pregnant women, pro-longed use or large amounts of this drug should be avoided in the treatment of pregnant women.

2. Do not administrate for opthalmic use.

Use of topical Gentamicin preparation in closed hospital setting is actively discouraged.

INCOMPATIBITIES

None

ADVERSE REACTIONS
1. Skin infection : Mycotic infection(candidiasis, trichophytosis), bacterial infection (infectious impetigo, folliculitis) can occur. When these symptoms occur, especially in case of occiusive dressing, use together adequate antifungal agent or antibacterial agent and then the symptoms are not developed fast, discontinue use.

2. Other skin symptoms : In case of long-term administration, steroidal vulgaris (it is similar to acne vulgaris but induce white acnes), steroidal skin (skin atrophy, teleangiectasia), steroidal rosacea namely dermatitis mouth surrounding(erythema, teleangiectasia, crust, on mouth surrounding or occasionally full face), petechia, hypertrichosis, depigmentation may occur, when these symptoms occur, reduce amount and choose other drug without adrenal corticosteroids.

3. Hypersensitivity : When irritation or rash occur, discontinue use.

4. Pituitary, adrenal cortex : A large amount or long-term administration and occlusive dressing may inhibit the function of pituitary, and adrenal cortex.

5. Eye: In case of administration to eye lid can occur intra-ocular pressure acceleration, glaucoma. By a large amount or long term administration and occlusive dressing, cataract and glaucoma may occur.

6. Superinfection : Occasionally infection of unsusceptive bacteria to this drug may occur, in this case, discontinue use.

7. Forbid long term administration because nephrotoxicity and dysacousis may occur.

STORAGE

Store in a tight container at room temperature(30C)or below.


EXPIRY

3 years.


HOW SUPPLIED

10g tube and 450g jar.

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