HYDROCORTISONE 1% w/w Ointment (2018)
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Περιεχόμενα
Name of the medicinal product
Hydrocortisone 1% w/w Ointment.
Qualitative and quantitative composition
Each 1 gram of the ointment contains 10 mg of Hydrocortisone (i.e. 1% w/w). Excipient with known effect: Each 1 gram of the ointment contains 100 mg (10% w/w) of wool fat. For the full list of excipients, ...
Pharmaceutical form
Ointment for cutaneous use only.
Therapeutic indications
Hydrocortisone has topical anti-inflammatory activity of value in the treatment of irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema.
Posology and method of administration
Posology Use sparingly over a small area once/twice a day for a maximum period of one week. If the condition has not improved, or worsens, consult your doctor. This product should not be recommended for ...
Contraindications
Bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin. Hypersensitivity to the active substance or to any of the excipients listed in section ...
Special warnings and precautions for use
Remarks on indications There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions from other causes. ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
Pregnancy 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 ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately. Striae may occur especially in intertriginous areas. Reporting ...
Overdose
Not applicable.
Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, weak (group 1) ATC code: D07AA02 Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of ...
Pharmacokinetic properties
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 ...
Preclinical safety data
Adverse effects of Hydrocortisone are due to its effect on electrolyte balance, metabolism and particularly adrenal suppression. Topical use of Hydrocortisone has only rarely been associated with systemic ...
List of excipients
Wool fat Liquid paraffin White soft paraffin
Incompatibilities
None known.
Shelf life
Shelf life: 60 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacquer, latex end seal band in the crimp seal and a white plastic cap for reclosure after piercing membrane. Pack Sizes: ...
Special precautions for disposal and other handling
Any unused medicinal products or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pinewood Laboratories Limited, Trading as Pinewood Healthcare, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Marketing authorization number(s)
PL 04917/0020
Date of first authorization / renewal of the authorization
11<sup>th</sup> November 1997
Date of revision of the text
21/06/2018
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