Clobetasol Propionate + Neomycin Sulphate + Nystatin

Clobetasol Propionate + Neomycin Sulphate + Nystatin is a combination cream/ointment used for short courses treatment of recalcitrant eczemas, neurodermatoses, psoriasis (excluding widespread plaque psoriasis) where secondary bacterial infection or fungal infection is present, suspected or likely to occur, and other inflammatory conditions which do not respond satisfactorily to less active steroids. Clobetasol Propionate is a very potent corticosteroid used to treat severe inflammatory skin disorders. Neomycin Sulphate is an aminoglycoside antibiotic used to treat bacterial infections. Nystatin is an antifungal that kills fungi and yeasts by interfering with their cell membranes.

• Short courses treatment of recalcitrant eczemas
• Neurodermatoses
• Psoriasis (excluding widespread plaque psoriasis) where secondary bacterial infection or fungal infection is present, suspected or likely to occur
• Other inflammatory conditions which do not respond satisfactorily to less active steroids

Clobetasol Propionate is a very potent corticosteroid prescribed to treat severe inflammatory skin disorders that have not responded to weaker corticosteroids. Neomycin Sulphate is an antibiotic of the aminoglycoside type used to treat bacterial infections. Nystatin is an antifungal that kills fungi and yeasts by interfering with their cell membranes. The mechanism of topical steroids like Clobetasol is unclear. However, Clobetasol Propionate is a highly active corticosteroid with topical anti-inflammatory activity. Neomycin binds to ribosomal 30s and 50s sub-units of susceptible bacteria and inhibits protein synthesis. Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components.

Clobetasol Propionate reduces inflammation through vasoconstriction and decreased collagen synthesis. Neomycin inhibits bacterial protein synthesis. Nystatin destroys fungal cell membranes, killing fungi.

Adult Dose: Apply sparingly to the affected area once or twice daily until improvement occurs. Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, treatment should not be continued for more than 4 weeks without the patient's condition being reviewed.

Pediatric Dose (2 years and over): Same as adult dose. Not recommended for neonates and infants (younger than 2 years).

Apply sparingly to the affected area once or twice daily until improvement occurs. Avoid contact with eyes during application. Do not use for more than 7 days without medical supervision.

If you miss a dose of this combination, apply it as soon as you remember. However, if it is almost time for your next application, skip the missed dose. Do not double the dose.

Common Side Effects:

• Thinning of skin
• Striae (stretch marks)
• Dilatation of superficial blood vessels
• Pigmentation changes
• Hypertrichosis (excessive hair growth)

Serious Side Effects (long-term/large area use): Hypercortisolism (adrenal suppression), Cushing's syndrome.

• Long-term continuous topical therapy should be avoided where possible, particularly in infants and children (adrenal suppression can occur readily even without occlusion).
• If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye (glaucoma might result). If it enters the eye, wash thoroughly with copious amount of water.
• If used in psoriasis, careful patient supervision is important.
• Not recommended during pregnancy and lactation.

• Rosacea
• Acne vulgaris
• Perioral dermatitis
• Primary cutaneous viral infection (herpes simplex, chicken pox)
• Hypersensitivity

Neomycin Sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents following significant systemic absorption. However, if used in accordance with recommendations, systemic exposure is expected to be minimal. No hazardous interactions have been reported with Clobetasol Propionate or Nystatin.

No food interactions have been found or established.

There is little information on the effect of topically applied Neomycin in pregnancy. Neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of fetal toxicity. Use is not recommended during pregnancy and lactation.

The safety of Clobetasol Propionate has not been established in lactating mothers. Use is not recommended during pregnancy and lactation.

Pediatric dose (2 years and over): Same as adult dose. Not recommended for neonates and infants (younger than 2 years). Increased absorption may occur in very young children.

This preparation is suitable for use in elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of Neomycin Sulphate may occur.

For topical use, no dose adjustment is required in renal or hepatic impairment. However, systemic absorption may occur when used over large areas, and renal function impairment may increase Neomycin systemic absorption.

Acute overdosage is very unlikely to occur. In the case of chronic overdosage or misuse, features of hypercortisolism may appear; topical steroids should be discontinued gradually.

Store below 25°C temperature. Do not freeze. Keep out of reach of children.

Clobetasol Propionate + Neomycin Sulphate + Nystatin