Nyclobate Cream 0.05%/10gm

PRESENTATION

Nyclobate Cream: Each gram cream contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Nyclobate Ointment: Each gram ointment contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Nyclobate- S Ointment: Each gram ointment contains Clobetasol Propionate BP 0.5 mg & Salicylic Acid BP 30 mg.

Nyclobate NN Cream: Each gram cream contains Clobetasol Propionate BP 0.5 mg (0.05% w/w), Neomycin Sulphate BP 5 mg (0.5% w/w) and

Nystatin BP 1,00,000 IU equivalent to 20 mg.

Nyclobate NN Ointment: Each gram ointment contains Clobetasol Propionate BP 0.5 mg (0.05% w/w), Neomycin Sulphate BP 5 mg (0.5%

w/w) and Nystatin BP 1,00,000 IU equivalent to 20 mg.

Nyclobate Scalp Application: Each gram lotion contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Nyclobate Shampoo: Each gram shampoo contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Nyclobate Lotion: Each gram lotion contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Nyclobate Spray: Each gram spray contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

DESCRIPTION

Clobetasol Propionate is a highly active corticosteroid with topical anti-inflammatory activity. The major effect of Clobetasol

Propionate on skin is a non-specific anti-inflammatory response, partially due to vasoconstriction and decrease in collagen

synthesis.

INDICATIONS

• Eczema unresponsive to weak steroid cream or ointment

• Other inflammatory skin disorders resistant to treatment with weaker steroid creams or ointment

• Psoriasis.

DOSAGE & ADMINISTRATION

Nyclobate Cream & Ointment

Adults and children over 1 year:

• Apply sparingly to cover the affected area, and gently rub into the skin. Frequency of application is 2 to 3 times daily

according to the severity of the condition. The total dose applied should not exceed 50 g weekly.

• Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, it is

recommended that treatment should not be continued for more than 4 weeks without the patient\\\'s condition being reviewed.

• Repeated short courses of Clobetasol may be used to control exacerbations

Children below 1 year: Under 1 year this preparation is not recommended

Nyclobate Scalp Application

• It should be applied to the affected scalp areas twice daily, once in morning and once at night.

• Total dosage should not exceed 50 ml per week.

• As with other highly active topical steroid preparations, therapy should be discontinued when control is achieved

Children: Under 1 year this preparation is not recommended.

Nyclobate Shampoo

• It should be applied to the dry (not wet) scalp once a day to the affected areas only.

• It should be massaged gently into the lesions and left in place for 15 minutes before lathering and rinsing.

• Treatment should be limited to 4 consecutive weeks.

• Total dosage of shampoo should not exceed 50 g per week.

• Under 18 years this preparation is not recommended.

SIDE EFFECTS

Generally this preparation is well tolerated. However, few side effects after prolonged and intensive treatment may cause local

atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when

occlusive dressings are used, or when skin folds are involved.

PRECAUTIONS

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as 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.

If used in psoriasis careful patient supervision is important.

Scalp Application: Keep away from eye. Flammable. Do not use or dry the hair near a fire or flame.

Scalp Shampoo: Do not use on areas other than the scalp. Keep away from eye.

USE IN PREGNANCY & LACTATION

Pregnancy category C: The safe use of this preparation during pregnancy & lactation has not been established.

DRUG INTERACTION

No hazardous interactions have been reported with use of Clobetasol Propionate.

OVER DOSE

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism

may appear and in this situation topical steroids should be discontinued gradually.

COMMERCIAL PACK

Nyclobate Cream: Each tube contains 10 gm or 20 gm cream.

Nyclobate Ointment: Each tube contains 10 gm or 20 gm ointment.

Nyclobate- S Ointment: Each tube contains 10 gm ointment.

Nyclobate NN Cream: Each tube contains 10 gm or 20 gm cream.

Nyclobate NN Ointment: Each tube contains 10 gm ointment.

Nyclobate Scalp Application: Each bottle contains 30 ml of lotion.

Nyclobate Shampoo: Each bottle contains 60 ml of shampoo.

Nyclobate Lotion: Each bottle contains 60 ml of lotion.

Nyclobate spray: Each bottle contains 60 ml of spray.