DIPROSALIC Ointment (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Diprosalic 0.05% w/w / 3% w/w Ointment.
2. Qualitative and quantitative composition
Betamethasone Dipropionate 0.064% w/w* (* equivalent to 0.05% Betamethasone) Salicylic Acid 3.00% w/w
3. Pharmaceutical form
Ointment.
4.1. Therapeutic indications
Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid and sustained response in those inflammatory dermatoses that are normally responsive to ...
4.2. Posology and method of administration
Adults Once to twice daily. In most cases a thin film should be applied to cover the affected area twice daily. For some patients adequate maintenance therapy may be achieved with less frequent application. ...
4.3. Contraindications
Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the Diprosalic presentations contra-indicates their use as does tuberculous and most viral ...
4.4. Special warnings and precautions for use
Occlusion must not be used, since under these circumstances the keratolytic action of salicylic acid may lead to enhanced absorption of the steroid. Local and systemic toxicity is common, especially following ...
4.5. Interaction with other medicinal products and other forms of interaction
None stated.
4.6. Pregnancy and lactation
Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to ...
4.7. Effects on ability to drive and use machines
None stated.
4.8. Undesirable effects
Diprosalic skin preparations are generally well tolerated and side effects are rare. Continuous application without interruption may result in local atrophy of the skin, striae and superficial vascular ...
4.9. Overdose
Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing ...
5.1. Pharmacodynamic properties
Diprosalic preparations contain the dipropionate ester of betamethasone which is a glucocorticoid exhibiting the general properties of corticosteroids, and salicylic acid which has keratolytic properties. ...
5.2. Pharmacokinetic properties
Salicylic acid exerts only local action after topical application. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, integrity of the epidermal ...
5.3. Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6.1. List of excipients
Liquid paraffin White soft paraffin
6.2. Incompatibilities
None stated.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
15, 30 or 100 gm expoxy-lined aluminium tubes with plastic caps. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
8. Marketing authorization number(s)
PL 00025/0570
9. Date of first authorization / renewal of the authorization
10 June 1986 / 29 July 2004
10. Date of revision of the text
03 March 2021
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