Data Sheet

BK™ LOTION - HC 1%

Hydrocortisone USP 1% w/w

Presentation

White, uniform, moderately viscous emulsion containing Hydrocortisone USP 1% w/w; Lanolin anhydrous liquid fraction 0.6% w/w and Light mineral oil 15.7% w/w.

Uses

Indications

BK lotion with hydrocortisone 1% w/w is a topically effective antiinflammatory. anti-allergic, anti-pruritic and emollient treatment. It is indicated for adjunctive therapy and symptomatic relief of inflammatory manifestations of acute and chronic corticosteroid responsive dermatoses, including such conditions as: eczematous dermatitis, contact dermatitis, atopic dermatitis, neurodermatitis (lichen simplex chronicus), soap and irritant dermatitis, psoriasis and pruritus ani. In infants it is indicated in the treatment of nappy rash only to control symptoms when they are severe.

Dosage and Administration

A thin, even layer should be gently applied to the affected area 2 to 4 times daily. This dosing regimen applies to adults, children and infants.

Contraindications

Viral, fungal, bacterial and parasitic infections at the site, skin cancer and pruritus caused either by psychogenic or internal organ disease.

Warnings and Precautions

The possibility of significant systemic absorption of hydrocortisone is increased when extensive areas are treated, particularly in infants and young children. Systemic effects are more likely to result if occlusive dressings are used or if the treatment is prolonged. The safe use of topical corticosteroids during pregnancy has not been fully established.

Adverse Effects

Adverse effects associated with topical low strength hydrocortisone products are highly unlikely. Significant abuse of the product will be required to cause adverse effects. The adverse effects that potentially could occur under this circumstance are divided into topical and systemic.

Topical reactions

Cutaneous atrophy, petechiae, steroid acne.

Systemic reactions

These occur when relatively large amounts of hydrocortisone are absorbed from the skin. The amount used, the duration of use and the nature of the skin influences absorption. The most likely situation for this to occur is with the use of high potency corticosteroids in infants with nappy rash.

Interactions

Nil.

Overdosage

Nil.

Pharmaceutical Precautions

Store below 25°C.

Medicine Classification

Prescription Medicine (when supplied in a quantity > 15 ml)

Restricted Medicine (when supplied in a quantity ≤ 15 ml)

Package Quantities

Bottles of 100 ml and 250 ml lotion.

Further Information

Nil.

Name and Address

3M Pharmaceuticals
a division of 3M New Zealand Limited
P.O. Box 2201 Shortland Street
AUCKLAND

Telephone: (09) 444 5289
Facsimile: (09) 444 5770

Date of Preparation

29 June 1999

™BK and 3M are registered trademarks.

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