BREVOXYL Cream (2016)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Brevoxyl 4% Cream.

Qualitative and quantitative composition

Benzoyl peroxide 4% w/w as hydrous benzoyl peroxide Ph. Eur. 100 g cream contains 4 g benzoyl peroxide. Also contains cetyl alcohol, stearyl alcohol and propylene glycol alginate. For a full list of excipients, ...

Pharmaceutical form

Cream. A white to off white cream.

Therapeutic indications

Brevoxyl is indicated for the treatment of moderate acne vulgaris.

Posology and method of administration

Adolescents and Adults Apply a thin film to the whole of the affected area once or twice daily, preferably after washing and drying the skin. The patient should start with one application daily, preferably ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

Contact with the eyes, eyelids, mouth, lips, other mucous membranes and broken skin should be avoided. In case of accidental contact, rinse well with water. Care should be taken when applying the product ...

Interaction with other medicinal products and other forms of interaction

Concomitant application of Brevoxyl with tretinoin, isotretinoin, and tazarotene should be avoided since it may reduce their efficacy and increase irritation. If combination treatment is required, the ...

Fertility, pregnancy and lactation

Fertility There are no data on the effect of topical benzoyl peroxide on fertility. Pregnancy There are limited data on the use of topical benzoyl peroxide in pregnant women. Animal studies do not indicate ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Adverse reactions are classified by System Organ Class. Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented below. Frequencies were defined ...

Overdose

Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects. Excessive application may result in severe irritation. In this event, discontinue use and ...

Pharmacodynamic properties

Pharmacotherapeutic group: Benzoyl peroxide ATC Code: D10AE01 Mechanism of action Benzoyl peroxide is a highly lipophilic, oxidising agent with keratolytic and bacteriocidal effects. Pharmacodynamic effects ...

Pharmacokinetic properties

Radio-labelled studies have shown that absorption of benzoyl peroxide through the skin can only occur following its conversion to benzoic acid. Following topical application, less than 5% of the dose enters ...

Preclinical safety data

In animal toxicity studies, benzoyl peroxide was well tolerated when applied topically. Although high doses of benzoyl peroxide have been shown to induce DNA strand breaks, the available data from other ...

List of excipients

Cetyl alcohol Stearyl alcohol and Macrogol cetostearyl ether Simethicone emulsion Propylene glycol alginate Dimethyl isosorbide Fragrance X-23304 Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 18 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Lacquered aluminium or laminated tubes with white polypropylene or polyethylene screw caps. Pack sizes: 5g, 6g, 15g, 30g, 40g and 50g. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Beecham Group PLC trading as Stiefel, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization number(s)

PL 00079/0693

Date of first authorization / renewal of the authorization

29 May 1996

Date of revision of the text

09/03/2016

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