SKDERM Cream

SKDERM CREAM®

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SKDERM CREAM

Composition

  • Betamethasone Dipropionate USP, equivalent to Betamethasone 0.05% w/w
  • Clotrimazole BP 1.0%w/w
  • Gentamicin sulfate BP, equivalent to Gentamicin base 0.1%w/w
  • Chlorocresol BP (as preservative) 0.1% w/w
  • In a cream base (q.s)

Pharmacology

Betamethasone Dipropionate

The corticosteroids are a class of compounds comprising steroid hormones, secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as betamethasone dipropionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic and vasoconstrictive actions.

However while the physiologic, pharmacologic and clinical effects of the corticosteroids are well known, the exact mechanism of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

SKDERM Cream

Clotrimazole

Clotrimazole, an azole antifungal agent, inhibits 14-α-demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-α-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi.

Gentamicin

Gentamicin sulfate is a wide spectrum antibiotic that provides highly effective topical treatment in primary and secondary bacterial infections of the skin. Gentamicin sulfate cream may clear infections that have not responded to treatment with other topical antibiotic agents. In primary skin infections such as impetigo contagiosa, treatment 3-4 times daily with Gentamicin sulfate cream usually clears the lesion promptly. In secondary skin infections, Gentamicin sulfate cream aids in the treatment of the underlying dermatoses by controlling the infection.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications

Betamethasone Dipropionate is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Clotrimazole is an antifungal agent. Gentamicin is a topical antibiotic. Clotrimazole and betamethasone dipropionate is a combination of antibacterial, antifungal and corticosteroid.

All three of them in combination is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, Trichophyton rubrum and also in skin infections caused by certain bacteria.

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 Contraindications

SKDERM CREAM® is contraindicated in individuals who have shown hypersensitivity to any of the components of this cream

Dosage and administration

Topical, to the skin as a cream once or twice a day or as directed by the physician

Special warning and precautions

Long-term continuous topical therapy should be avoided where possible, particularly in children, as adrenal suppression can occur even without occlusion. If infection persists systemic chemotherapy is required. Withdrawal topical corticosteroid if there is a spread of infection. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings and the skin should be cleansed before a fresh dressing is applied.

Avoid prolonged application on the face. The face more than other areas of the body, may exhibit atropic changes after prolonged treatment with potent topical corticosteroids, this must borne in mind when treating such conditions like psoriasis discoid lupus erythematosus and severe eczema if applied to the eyelids, care is needed to ensure that the preparation does not enter the eye as glaucoma might result.

If Betamethasone Dipropionate + Gentamicin + clotrimazole cream does enter the eye, the affected eye should be bathed, in copius amounts of water. Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalized postular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important

Extended or recurrent application may increase the risk of contact sensitization. Extension of infection may occur due to the masking effect of the steroid. Following significant systemic absorption, aminoglycosided such as gentamicin can cause irreversible ototoxicity and gentamicin is nephrotoxic potential. In renal impairment the plasma clearance of gentamicin is reduced. Products which contain antimicrobial agents should be diluted.

Drug interactions

Following significant systemic absorption, clotrimazole and gentamicin  sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.

Fertility, pregnancy and lactation

SKDERM cream is suitable to use in treatment of vaginal candidiasis during second and third trimester of pregnancy but, it should be avoided during first trimester as it may lead to fetal harm.

Lactation

There are no data on the excretion of betamethasone dipropionate, clotrimazole and gentamicin into human milk upon topical application.

Effects on ability to drive and use machines

Not available

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