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HYDROCORTISONE 1% BITE AND STING RELIEF CREAM

Active substance(s): HYDROCORTISONE / HYDROCORTISONE / HYDROCORTISONE

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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
4.1

CLINICAL PARTICULARS
Therapeutic indications For the treatment of insect bite and sting reactions only 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.

4.2

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, athletes foot, acne or chickenpox). Not to be used for other bites or stings or for other skin conditions. Chlorocresol may cause allergic reactions.

4.4

Special warnings and precautions for use 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. 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.

4.6

4.7

Effects on ability to drive and use machines None known. 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.

4.8

4.9

Overdose No special procedures or antidote are likely to be needed.

5
5.1

PHARMACOLOGICAL PROPERTIES
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
6.1

PHARMACEUTICAL PARTICULARS
List of excipients White Soft Paraffin Cetomacrogol Emulsifying Wax Liquid Paraffin Chlorocresol Purified Water

6.2

Incompatibilities None known. Shelf life Three years Special precautions for storage Do not store above 25oC. Nature and contents of container Internally lacquered aluminium tube fitted with a polythene cap. Pack size: 10g. Special precautions for disposal None

6.3

6.4

6.5

6.6

7

MARKETING AUTHORISATION HOLDER
TEVA UK Limited Eastbourne BN22 9AG England

8 9

MARKETING AUTHORISATION NUMBER(S)
PL 00289/0599

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/11/2007

10

DATE OF REVISION OF THE TEXT
14/07/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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