Clobetasol Propionate 0.05% + Neomycin Sulphate 0.5% + Nystatin BP 1,00,000 IU

Clobetasol Propionate 0.05% + Neomycin Sulphate 0.5% + Nystatin BP 1,00,000 IU is a combination cream/ointment used for the treatment of psoriasis, eczema, and severe inflammatory skin disorders. Clobetasol Propionate is a highly active corticosteroid with topical anti-inflammatory action brought about partly by vasoconstriction and reduced collagen synthesis. Neomycin Sulphate is an aminoglycoside antibiotic that binds to ribosomal 30S and 50S subunits of susceptible bacteria, thus inhibiting protein synthesis. Nystatin is an antifungal that works by binding to ergosterol in the cell membrane of fungus resulting in a change in cell wall permeability and leakage of cellular components.

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

Clobetasol Propionate is a highly active corticosteroid with topical anti-inflammatory activity. The major effect of Clobetasol Propionate on skin is a nonspecific anti-inflammatory response, partially due to vasoconstriction and decrease in collagen synthesis. Neomycin binds to the 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 (Topical): Apply a thin layer onto the affected area(s) 1-2 times daily until improvement occurs. Not to be used for >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): 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. Therapy should be discontinued when control is achieved. Treatment should not be continued for more than 7 days without medical supervision. Avoid contact with eyes during application.

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:

• Perioral dermatitis
• Striae (especially in flexures)
• Dermal and epidermal atrophy (especially on the face)
• Steroid purpura
• Pigmentation changes
• Hypertrichosis

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

• Long-term continuous topical therapy should be avoided where possible, particularly in infants and children (adrenal suppression can occur readily even without occlusion).
• If used in childhood, or on the face, courses should be limited to 5 days and occlusion should not be used.
• If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye (glaucoma might result).
• If used in psoriasis, careful patient supervision is important.
• Flammable; do not use or dry the hair near a fire or flame.
• Not recommended during pregnancy and lactation.

• Rosacea
• Acne vulgaris
• Perioral dermatitis
• Primary cutaneous viral infection (herpes simplex, chicken pox)
• Hypersensitivity
• Long-term treatment of ulcerative conditions
• Pruritus
• Presence of acute infections

If there is substantial systemic absorption, neomycin may prolong and intensify respiratory depressant effects of neuromuscular blockers. No hazardous interactions have been reported with the use of Clobetasol Propionate or Nystatin.

No food interactions have been found or established.

There is little information to demonstrate the possible 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): Same as adult dose. Not recommended for neonates and infants (younger than 2 years). Increased absorption may occur in very young children.

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