STIEVA-A Cream (2021)
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Περιεχόμενα
Name of the medicinal product
STIEVA-A.
Indications and clinical use
STIEVA-A (tretinoin 0.01%, 0.025%, or 0.05% w/w) is indicated in the treatment of acne vulgaris, primarily where comedones, papules and pustules predominate. STIEVA-A is not effective in most cases of ...
Contraindications
STIEVA-A is contraindicated in patients with known hypersensitivity to retinoids or to any ingredient contained in the preparation or component of the container. For a complete listing, see Composition ...
Warnings and precautions
Warnings STIEVA-A IS INTENDED FOR EXTERNAL USE ONLY AND SHOULD BE KEPT AWAY FROM AREAS OF BROKEN SKIN, LIPS, EYES, NOSE, MOUTH, AND OTHER MUCOUS MEMBRANES BECAUSE OF ITS IRRITANT EFFECT. IN CASE OF ACCIDENTAL ...
Adverse reactions
Clinical Trial Adverse Drug Reactions The following very common adverse drug reactions (≥10%) have been reported in clinical trials involving topical tretinoin-containing products: <u>Skin and subcutaneous ...
Drug interactions
Concomitant application of oxidising agents, such as benzoyl peroxide, should be avoided since they may reduce the efficacy of topical tretinoin. If combination therapy is required, the products should ...
Dosage and administration
Dosing Considerations STIEVA-A cream is for topical use only. Because of increased sensitivity of ultraviolet radiation associated with the use of tretinoin, patients should be instructed to use a broad ...
Overdosage
For management of a suspected drug overdose, contact your regional Poison Control Centre. If topical medication is applied excessively, marked redness, peeling or discomfort may occur. If severe irritation ...
Action and clinical pharmacology
Therapeutic classification: Topical acne therapy The precise mechanism of action of tretinoin on the skin is not fully understood. It is known that tretinoin is both pharmacologically and structurally ...
Storage and stability
<u>Recommendations:</u> Store between 15ºC and 30ºC. Do not freeze. Keep the tube tightly closed when not in use. Keep out of the sight and reach of children.
Dosage forms, composition and packaging
STIEVA-A cream: is supplied in aluminum tubes with polypropylene caps. Each tube contains tretinoin, in a cream base, in strengths of 0.01%, 0.025%, or 0.05% (available in 25 g tubes).
Pharmaceutical information
Drug Substance <u>Proper Names:</u> Tretinoin, retinoic acid, vitamin A acid. <u>Chemical Name:</u> 3,7-dimethyl-9-(2,6,6,-trimethyl-1-cyclohexen-1-yl)- 2,4,6,8-nonatetraenoic acid <u>Structural Formula: ...
Detailed pharmacology
Tretinoin is a known metabolite of vitamin A. It appears to form oxidation products which are excreted in the urine and glucuronides excreted in the feces. In human cutaneous absorption of retinoic acid ...
Toxicology
Acute Toxicity In the animals receiving the 0.05% solution decreased motor activity, hypnosis, salivation and vasodilation occurred. Tretinoin pure substance suspended in 5% gum acacia produced sedation, ...
Marketing authorization holder
GlaxoSmithKline Inc., 7333 Mississauga Road, Mississauga, Ontario, L5N 6L4 www.stiefel.ca
Submission control number
244142
Date of revision
February 9, 2021
References
Vitamin A deficiency and xenophthalmia. World Health Organization Technical Report 1976; Series No. 590: 11-16 Frost P, Weinstein GD, Topical administration of vitamin A for ichthyosiform dermatosed and ...
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