Sonaderm-Gm cream

SONADERM®- GM Cream

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SONADERM®- GM Cream

SONADERM®-GM cream is combination of clobetasol propionate (corticosteroid), miconazole nitrate (antifungal agent) and gentamicin sulphate (antibacterial agent) for topical administration. SONADERM®- GM Cream is indicated for the treatment of steroid-responsive dermatoses (refractory eczema/psoriasis) associated with mixed (fungal and bacterial) infections of the skin. Generally, treatment is not advised to continue for more than two weeks without medical supervision.

Sonaderm-Gm cream

Pharmacodynamics

Clobetasol propionate: clobetasol is a potent corticosteroid with topical anti-inflammatory activity. The major effect of clobetasol propionate on skin is a non-specific anti-inflammatory responses, partially due to vasoconstriction and decrease in collagen synthesis

Miconazole nitrate: miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity. Miconazole inhibit growth of the common dermatophytes such as Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum, and yeast like fungi such as Candida albicans. Also many Gram-positive bacteria including most strains of Staphylococcus are susceptible to miconazole.

Gentamicin sulphate: Gentamicin sulphate is a bactericidal antibiotic which acts by inhibiting protein synthesis. Gentamicin is active in vitro against many strains of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumonia, gonorrhoae, Pseudomonas aeruginosa and Serratia marcescens.

Pharmacokinetics

Clobetasol propionate: Parcutaneous penetration of Clobetasol propionate varies among individuals and can be increased by the use of occlusive dressings, or when the skin is inflamed or diseased. Following percutaneous absorption of clobetasol propionate, the drug probably follows the metabolic pathway of systemically administered corticosteroids, i.e., metabolized primarily by the liver and then excreted by the kidneys. However, systemic metabolism of clobetasol has never been fully characterized or quantified.

Miconazole nitrate: there is little absorption through skin or mucous membranes when miconazole nitrate is applied topically. Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%). The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.

Gentamicin sulphate: topical application of gentamicin can result in some systemic absorption. Treatment of large areas can result in plasma concentration of up to 1µg/ml. less than 10% of gentamicin is bound to plasma proteins. Elimination half-life is 2-3 hours in individuals with normal kidney function, but can be increased in cases of renal insufficiency. Greater than 90% of gentamicin is excreted in the urine by glomerular filtration.

Indications

SONADERM®- GM Cream is indicated in the treatment of resistant dermatoses such as refractory eczemas and psoriasis where secondary bacterial or fungal infection is present, suspected or likely to occur.

Dosage and administration

Adults and children over 2 years: for topical administration.

Apply a thin layer of cream to the affected skin areas twice daily and rub in gently and completely. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Repeated short courses may be used to control exacerbations.

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Or as prescribed by the physician.

Contraindications
  • Hypersensitivity to any of the ingredients
  • Rosacea
  • Acne vulgaris
  • Perioral dermatitis
  • Perianal and genital pruritus
  • Primary cutaneous viral infection (e.g herpes simplex, chickenpox)
  • Otitis externa with a perforated eardrum

Warnings and precautions

SONADERM®- GM Cream must not come in contact with the eyes. Also, it should not be used with occlusive dressing

Pregnancy

Safety for use of SONADERM®- GM Cream in pregnancy has not been established. It should be used during pregnancy when considered mandatory by the physician, after careful assessment of the potential risks to the fetus

Nursing mothers

It is not known whether the components of SONADERM®- GM Cream are excreted in the breast milk after topical administration. Nevertheless, caution should be executed when this medication is administered to nursing women

Pediatric use

Safety and effectiveness of SONADERM®- GM Cream in pediatric patients below 2 years of age have not been established

Geriatric use

Generally, no adjustment of dosage is required in the geriatric population. However, greater sensitivity of some older individuals cannot be ruled out

Undesirable effects

Generally SONADERM®- GM Cream is well tolerated. The following adverse reactions have been reported with use of this preparation. The frequency of these events is unknown

Immune system disorders – hypersensitivity: local hypersensitivity reactions such as erythema, rash, pruritus, urticarial and allergic contact dermatitis may occur at the site of application and may resemble symptoms of the condition under treatment. If signs of hypersensitivity appear, application should be stopped immediately

Endocrine disorders – features of Cushing’s syndrome: as with other topical corticosteroids, prolonged use, especially of large amounts or treatment of extensive areas can lead to sufficient systemic absorption to produce the features of Cushing’s syndrome. This effect is more likely to occur in infants and children and if occlusive dressing are used. In infants nappy may act as an occlusive dressing. Provided the weekly dosage is less than 50g in adults, any suppression of HPA axis is likely to be transient with a rapid return to normal values once the short course of steroid therapy has ceased. The same applies to children given proportionate dosage.

Vascular disorders – dilation of the superficial blood vessels: prolonged and intensive treatment with potent corticosteroid preparations may cause dilation of the superficial blood vessels, particularly when occlusive dressing are used, or when skin folds are involved.

Skin and sub-cutaneous tissue disorders:  local skin burning, local atrophy, striae, thinning, pigmentation changes, hypertrichosis, exacerbation of underlying symptoms, pustular psoriasis.

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