Quinocort Cream

1. Name Of The Medicinal Product

QUINOCORT™ CREAM

2. Qualitative And Quantitative Composition

Potassium Hydroxyquinoline Sulphate BP	0.5%
Hydrocortisone BP	1.0%

3. Pharmaceutical Form

Quinocort Cream is a faintly yellow vanishing cream. It is intended for topical use only.

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of infected eczema, intertrigo and other steroid-responsive dermatoses where anti-infective cover is appropriate.

4.2 Posology And Method Of Administration

Route of administration: For topical use only.

Adults, children and the elderly

By gentle massage over all the affected area two to three times daily.

4.3 Contraindications

Patients with known sensitivity or intolerance to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Contact with eyes and other mucosal surfaces should be avoided. Caution should be exercised when using this preparation in infants. Long term continuous topical therapy should be avoided in infants - adrenal suppression can occur even without occlusion.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not applicable.

4.6 Pregnancy And Lactation

In pregnant animals administration of corticosteroids can cause abnormalities of foetal development. The relevance of this finding in human beings has not been established. However, topical steroids should not be used extensively in pregnancy i.e. in large amounts for long periods.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Not applicable.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

Hydrocortisone provides anti-inflammatory action yet is the least potent topical corticosteroid available. Potassium hydroxyquinoline sulphate provides broad spectrum antibacterial and anticandidal activity. The combination facilitates treatment of steroid-responsive dermatoses where complication by infection with bacteria or yeasts is evident suspected, or a possibility.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactic Acid BP, White Soft Paraffin BP, Edetic Acid BP, Sodium Acid Phosphate BP, Maize Starch BP, cetyl stearyl alcohol, sodium cetyl stearyl sulphate, PEG 40 castor oil, Chlorocresol BP, Purified Water BP.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Quinocort Cream should be stored in a cool, dry place avoiding extremes of temperature i.e. not less than 5°C and not more than 30°C.

6.5 Nature And Contents Of Container

Quinocort Cream is available in heat sealed low density polyethylene tubes with flush fitting cap containing 30 g of product. Each tube is cartoned and contains a patient information leaflet.

6.6 Special Precautions For Disposal And Other Handling

For topical use only.

8. Marketing Authorisation Number(S)

0291/0014.

10. Date Of Revision Of The Text

May 1995.

Legal category

POM.