Hydrocortisone 1% Bite And Sting Relief Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 1% Bite and Sting Relief Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone 1% w/w For excipients see 6.1.
3 PHARMACEUTICAL FORM
Cream
A smooth white cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of insect bite and sting reactions only
4.2 Posology and method of administration
To be applied topically.
Adults and elderly: Apply sparingly to a small area once or twice daily for a maximum period of 2-3 days. If the condition does not improve consult your doctor.
Children aged 10 years and above: As for adults and the elderly. Do not use for children under 10 years old.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
Hydrocortisone cream should not be used on the eyes, face, and ano-genital region or on broken or infected skin (including scabies and infected bites or stings, cold sores, athlete’s foot, acne or chickenpox). Not to be used for other bites or stings or for other skin conditions.
Chlorocresol may cause allergic reactions.
Special warnings and precautions for use
4.4
Do not use under an occlusive dressing.
Contains hydrocortisone. Do not use on the eyes, face or ano-genital region, broken or infected skin including scabies and infected bites and stings. Do not use in pregnancy without medical advice. Do not use on children under 10. Stop treatment if symptoms of hypersensitivity occur. If the condition does not improve after 2-3 days consult a doctor. Not to be used for other bites or stings or for other skin conditions.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
This product should not be used without medical advice.
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.
There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers. In this event, the product should not be applied to the chest area.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Striae may occur especially in intertriginous areas.
Treatment with hydrocortisone is usually well tolerated but treatment should be stopped if symptoms of hypersensitivity occur.
4.9 Overdose
No special procedures or antidote are likely to be needed.
5 PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Hydrocortisone is a mild, topical corticosteroid.
Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates. The granulation reaction is also decreased due to the inhibition effect of Hydrocortisone on connective tissue. Stabilisation of most cell granules and lysomal membranes decreases the mediators involved in inflammatory response and reduces release of enzymes in prostaglandin synthesis. The vasoconstrictor action of Hydrocortisone may also contribute to its antiinflammatory activity.
5.2 Pharmacokinetic properties
a) General characteristics and b) Characteristics in patients:
Absorption: Topically applied steroids are absorbed to a significant extent only if applied to broken skin, to very large areas, or under occlusive dressings.
Distribution: Corticosteroids are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk
Metabolism: Hydrocortisone is metabolised mainly in the liver, but also the kidney, to various degraded and hydrogenated forms such as tetrahydrocortisone.
Elimination: Hydrocortisone is excreted in the urine, mostly conjugated as glucuronides. Only very small amounts of unchanged hydrocortisone are excreted.
5.3 Preclinical safety data
Adverse effects of Hydrocortisone are due to its effects on electrolyte balance, metabolism and particularly adrenal suppression. Topical use of Hydrocortisone has only rarely been associated with systemic side effects.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White Soft Paraffin Cetomacrogol Emulsifying Wax Liquid Paraffin Chlorocresol Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf life
Three years
6.4 Special precautions for storage
Do not store above 25oC.
6.5 Nature and contents of container
Internally lacquered aluminium tube fitted with a polythene cap.
Pack size: 10g.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
TEVA UK Limited Eastbourne BN22 9AG England
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/0599
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/11/2007
10 DATE OF REVISION OF THE TEXT
14/07/2011