CORTOPIN Cream (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Cortopin 1% w/w Cream.
2. Qualitative and quantitative composition
The cream contains Hydrocortisone 1% w/w. Also contains 7.2% w/w Cetostearyl alcohol and 0.1% w/w Chlorocresol. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Cream. A smooth, white, homogenous oil in water cream.
4.1. Therapeutic indications
It can be used to treat contact and allergic dermatitis irritant, insect bite reactions and mild to moderate eczema.
4.2. Posology and method of administration
For topical use. Adults and children over 12 years For use on the skin only. Hands should be washed before and after use. Apply sparingly once or twice a day to the affected area, or as directed by the ...
4.3. Contraindications
Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. Use in acne vulgaris, acne rosacea or in perioral dermatoses.
4.4. Special warnings and precautions for use
Side effects include local irritation, hypersensitivity and intercurrent infections. Continuous treatment for longer than three weeks should be avoided in patients under the age of three years because ...
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 in pregnancy unless considered essential by the physician. Topical administrations of corticosteroids to pregnant animals can cause abnormalities of foetal development including ...
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
Rarely, local sensitivity may occur, requiring discontinuation of treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product ...
4.9. Overdose
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric ...
5.1. Pharmacodynamic properties
Hydrocortisone is the major glucocorticoid secreted by the adrenal cortex. It is released in to the circulation under the influence of adrenocorticotrophic hormone (ACTH). The half-life is normally 60-90 ...
5.2. 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 ...
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 ...
6.1. List of excipients
Macrogol cetostearyl ether Cetostearyl alcohol White soft paraffin Liquid paraffin Chlorocresol Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Keep the container tightly closed.
6.5. Nature and contents of container
Aluminium tube with polypropylene cap. Pack size 30g, 100g and 400g as a prescription-only medicine. Pack size 15g for over the counter sale through pharmacies only for indications stated on the label. ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co Tipperary, Ireland
8. Marketing authorization number(s)
PA 281/71/2
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 17 July 1989 Date of last renewal: 17 July 2009
10. Date of revision of the text
July 2016
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