ISOTREX Gel (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Isotrex Gel.
Qualitative and quantitative composition
Isotretinoin 0.05% w/w. Excipients with known effect: Butylated Hydroxytoluene For the full list of excipients, see section 6.1.
Pharmaceutical form
Gel for topical application.
Therapeutic indications
Isotrex Gel is intended for use in the treatment of mild to moderate inflammatory and non-flammatory acne vulgaris.
Posology and method of administration
Adults and adolescents Apply Isotrex Gel sparingly over the entire affected area once or twice daily, preferably after washing and drying the skin. If undue irritation (redness, peeling, or discomfort) ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Isotrex Gel is contraindicated in pregnancy (see section 4.6), in women planning a pregnancy and lactation. ...
Special warnings and precautions for use
Contact with the mouth, eyes and mucous membranes and with abraded skin should be avoided. Care should be taken not to let the medicine accumulate in skin fold areas and in the nasolabial folds. Due to ...
Interaction with other medicinal products and other forms of interaction
Concomitant application of oxidising agents, such as benzoyl peroxide, should be avoided since they may reduce the efficacy of topical isotretinoin. If combination therapy is required, the products should ...
Fertility, pregnancy and lactation
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result ...
Effects on ability to drive and use machines
Not applicable; the product is a topical preparation which acts locally at the site of application.
Undesirable effects
The frequency of adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare ...
Overdose
Symptoms and signs Oral ingestion of a 30g tube of topical isotretinoin would result in less exposure than achieved with the recommended dosage of oral isotretinoin. Consequently, the theoretical occurrence ...
Pharmacodynamic properties
Pharmacotherapeutic group: retinoids for topical use in acne, isotretinoin ATC Code: D10AD04 Mechanism of action Isotretinoin is structurally and pharmacologically related to vitamin A which regulates ...
Pharmacokinetic properties
Absorption ollowing isotretinoin 0.05% gel application to acne patients at a daily dose of 20g (equivalent to 10 mg of isotretinoin) to the face, chest and back for 30 days, plasma concentrations of isotretinoin ...
Preclinical safety data
Carcinogenesis/Mutagenesis In a carcinogenicity study in Fischer 344 rats given oral isotretinoin up to 32 mg/kg/day, there was an increased incidence of phaeochromocytomas relative to controls in both ...
List of excipients
Butylated hydroxytoluene Hydroxypropylcellulose Ethanol
Incompatibilities
Not applicable.
Shelf life
Shelf life For the product as packaged for sale: 3 years. After first opening the container: 2 months.
Special precautions for storage
Store below 25°C. Keep the tube tightly closed when not in use. Contents are flammable. Keep away from fire, flame or heat. Do not leave Isotrex gel in direct sunlight.
Nature and contents of container
Aluminium tube of 5g, 15g, 25g, 30g, 50g, 60g fitted with a screw cap. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
There are no special instructions for use or handling of Isotrex Gel.
Marketing authorization holder
GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS Trading as Stiefel: Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Marketing authorization number(s)
PL 19494/0063
Date of first authorization / renewal of the authorization
20/12/2005
Date of revision of the text
17<sup>th</sup> September 2018
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