PIROXICAM Gel (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Piroxicam 0.5% Gel.
Qualitative and quantitative composition
Piroxicam 0.5% w/w. <u>Also contains:</u> Propylene Glycol 15g / 100g (or 15% w/w).
Pharmaceutical form
Gel.
Therapeutic indications
Piroxicam gel is a non-steroidal anti-inflammatory agent indicated for a variety of conditions characterised by pain and inflammation, or stiffness. It is effective in the treatment of osteoarthritis of ...
Posology and method of administration
Posology Adults No occlusive dressings should be employed. Apply 1g of gel, corresponding to 3cm, and rub into the affected site three to four times daily leaving no residual material on the skin. Therapy ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The potential exists for cross sensitivity to aspirin and other non-steroidal anti-inflammatory agents. Piroxicam ...
Special warnings and precautions for use
Piroxicam 0.5% Gel is not suitable for use in children under 12 years of age. The gel should not be used for any condition other than those specified. Skin reactions Life-threatening cutaneous reactions, ...
Interaction with other medicinal products and other forms of interaction
Dose-dependent percutaneous absorption of piroxicam has been demonstrated in rabbits and there is theoretical possibility of systemic interactions/effects. For example, oral piroxicam has been reported ...
Fertility, pregnancy and lactation
Fertility Based on the mechanism of action, the use of NSAIDs, including piroxicam may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Piroxicam Gel is well tolerated. Mild to moderate local irritation, erythema, pruritus, and dermatitis may occur at the application site. The systemic absorption of Piroxicam 0.5% Gel is very low. In common ...
Overdose
Overdose is unlikely to occur with this topical preparation.
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use ATC code: M02AA07 Piroxicam is a non-steroidal anti-inflammatory agent useful in the treatment of inflammatory conditions. ...
Pharmacokinetic properties
A study in man examining skin biopsies following piroxicam gel administration concluded that piroxicam rapidly permeates through the stratum corneum into the epidermis/dermis after application of the gel ...
Preclinical safety data
In reproductive toxicity studies, piroxicam increases the incidence of dystocia and delayed parturition in animals, when drug administration is continued during pregnancy. Administration of prostaglandin ...
List of excipients
Propylene glycol Isopropyl alcohol Macrogol 7 glyceryl cocoate Hypromellose Methoxyl 29.0%; Hydroxypropoxyl 8.5% Sodium hydroxide Sodium metabisulphite Potassium dihydrogen phosphate Purified water
Incompatibilities
The metabolism of Piroxicam is inhibited by cimetidine and it itself can inhibit antipyrine metabolism.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C. Keep the tube tightly closed.
Nature and contents of container
Aluminium tubes with inner protective lacquer and polypropylene screw caps. Each tube contains 60g or 112g of Piroxicam gel.
Special precautions for disposal and other handling
Pierce the tube by reversing the cap and screwing down to break the seal on the tube. Apply 3cm (1¼” approximately) of the gel on the affected area. Rub the gel into the skin until the gel disappears. ...
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0704
Date of first authorization / renewal of the authorization
16 March 2001
Date of revision of the text
17/07/2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
