HYDROCORTISONE Cream (2018)
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Περιεχόμενα
Name of the medicinal product
Hydrocortisone Cream BP 0.5%.
Qualitative and quantitative composition
Contains 0.50% w/w Hydrocortisone Ph. Eur. Excipients with known effect: cetostearyl alcohol and chlorocresol. For the full list of excipients, see section 6.1.
Pharmaceutical form
A white cream.
Therapeutic indications
Hydrocortisone has topical anti-inflammatory activities of value in the treatment of various dermatological conditions including: Eczema- atopic, infantile, discoid or stasis Dermatitis- primary irritant, ...
Posology and method of administration
Posology Adults (including elderly) Gently apply a thin layer of cream to the affected area two or three times daily. Children and infants Gently apply a thin layer of cream to the affected area two or ...
Contraindications
Hypersensitivity to hydrocortisone or any of the other ingredients in the product. Untreated bacterial (e.g. impetigo), viral (e.g. herpes simplex), or fungal (e.g. candida or dermatophyte) infections. ...
Special warnings and precautions for use
The use of an occlusive dressing can considerably increase the degree of systemic absorption. If the treatment continues longer than two weeks, the risk of systemic side effects will increase especially ...
Interaction with other medicinal products and other forms of interaction
No interactions have been reported for topical hydrocortisone.
Pregnancy and lactation
Pregnancy There is inadequate evidence of safety in human pregnancy. Topical administration of topical corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft ...
Effects on ability to drive and use machines
Hydrocortisone does not affect the ability to drive and use machines.
Undesirable effects
Hydrocortisone preparations are usually well tolerated but if signs of hypersensitivity appear, application should be stopped immediately. Epidermal thinning, telangectasia and striae may occur in areas ...
Overdose
Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically. Acute overdosage is very unlikely to occur. In the ...
Pharmacodynamic properties
ATC Code: D07AA02 Pharmacotherapeutic group: Weak dermatological corticosteroid (group 1). Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory ...
Pharmacokinetic properties
Absorption Hydrocortisone is absorbed through skin, particularly in denuded areas. Distribution Corticosteroids are rapidly distributed to all body tissues. They cross the placenta to varying degrees and ...
Preclinical safety data
Not Applicable.
List of excipients
Also contains: Cetomacrogol Cetostearyl alcohol Chlorocresol Paraffin
Incompatibilities
None known.
Shelf life
Shelf life: a 24 month shelf life. After dilution or reconstitution: Not applicable. After first opening: Not applicable.
Special precautions for storage
Store below 25°C; do not freeze.
Nature and contents of container
The product containers are aluminium tubes with screw caps contained in cartons: Carton: White backed folding box board printed two colours on white. Tube: Manufactured from 99.5% pure aluminium; lacquered ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Actavis UK Limited (Trading style: Actavis), Whiddon Valley, Barnstaple, North Devon, EX32 8NS
Marketing authorization number(s)
PL 0142/0128
Date of first authorization / renewal of the authorization
12 July 1979 / 21 August 1997
Date of revision of the text
05/08/2019
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