TRENTAL 400 Modified release tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
TRENTAL 400.
Qualitative and quantitative composition
Pentoxifylline 400MG.
Pharmaceutical form
Modified release tablet.
Therapeutic indications
Trental 400 is indicated in the treatment of peripheral vascular disease, including intermittent claudication and rest pain.
Posology and method of administration
The recommended initial dose is 1 tablet (400 mg) three times daily; two tablets daily may prove sufficient in some patients, particularly for maintenance therapy. Tablets should be taken with or immediately ...
Contraindications
Trental 400 is contra-indicated in cases where there is known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients. Also in patients with cerebral ...
Special warnings and precautions for use
At the first signs of an anaphylactic/anaphylactoid reaction, Trental 400 must be discontinued immediately, and a physician must be informed. Particular careful monitoring is required: In patients with ...
Interaction with other medicinal products and other forms of interaction
High doses of Trental injection have been shown, in rare cases, to intensify the hypoglycaemic action of insulin and oral hypoglycaemic agents. However, no effect on insulin release has been observed with ...
Pregnancy and lactation
There is no information on the use of Trental in pregnancy but no untoward effects have been found in animal studies. Trental 400 should not be administered during pregnancy. Pentoxifylline passes into ...
Effects on ability to drive and use machines
No effect known.
Undesirable effects
These adverse reactions have been reported in clinical trials or post-marketing. Frequencies are unknown. Investigations: Transaminases increased Cardiac disorders: Arrhythmia, Tachycardia, Angina Pectoris ...
Overdose
The treatment of overdosage should be symptomatic with particular attention to supporting the cardiovascular system.
Pharmacodynamic properties
Leukocyte properties of haemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion ...
Pharmacokinetic properties
The half life of absorption of Trental 400 is 4-6 hours. Pentoxifylline is extensively metabolised, mainly in the liver. Sixty percent of a single dose of Trental 400 is eliminated via the kidney over ...
Preclinical safety data
Nothing of clinical relevance.
List of excipients
Hydroxyethyl cellulose Povidone Talc Magnesium stearate Hypromellose Macrogol 8000 Erythrosine (E127) Titanium dioxide (E171)
Incompatibilities
None known.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C. Store in the original package.
Nature and contents of container
Amber glass bottle: 100 or 250 tablets. Plastic (PE) pots: 100 or 250 tablets. Blister Pack (Alu/PVC): 10 or 90 tablets.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0213
Date of first authorization / renewal of the authorization
15<sup>th</sup> April 2002
Date of revision of the text
14<sup>th</sup> August 2019
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