UBRETID Tablet (2009)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | SANOFI |
---|---|
Διεύθυνση | 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK |
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Name of the medicinal product
Ubretid<sup>TM</sup>.
Qualitative and quantitative composition
Active ingredient Distigmine bromide 5mg.
Pharmaceutical form
Tablets.
Therapeutic indications
Anticholinesterase. Post-operative urinary retention. Post operative ileus and intestinal atony. To assist emptying of the neurogenic bladder. As an adjunct in the treatment of myasthenia gravis.
Posology and method of administration
Adults In prevention of urinary retention, ileus or intestinal atony following surgery One Ubretid tablet daily, half an hour before breakfast. In neurogenic bladder One Ubretid tablet daily or on alternate ...
Contraindications
Ubretid is contraindicated in cases of severe post operative shock, serious circulatory insufficiency, severe constipation, serious spastic and mechanical ileus, asthma and mechanical urinary obstruction. ...
Special warnings and precautions for use
Caution should be taken in conditions where the potentiation of the effects of acetylcholine is undesirable, eg cardiac dysfunction, bronchospasm, peptic ulcer, oesophagitis, epilepsy and Parkinsonism. ...
Interaction with other medicinal products and other forms of interaction
Use with caution in patients receiving concomitantly drugs acting on the cardiovascular system, e.g. beta blockers, drugs with local anaesthetic properties and muscle relaxants. In myasthenia gravis, where ...
Pregnancy and lactation
Ubretid should be avoided during pregnancy. No information is available on lactation.
Effects on ability to drive and use machines
None stated.
Undesirable effects
The following side effects may occur infrequently: bradycardia, AV block, hypotension, bronchospasm, dyspnoea, increased bronchial secretions, sweating, salivation and lacrimation, muscle twitching, abdominal ...
Overdose
Overdosage of Ubretid may also produce skeletal muscle fatigue, weakness and eventually paralysis. The muscarinic effects of overdosage may be controlled with atropine 2mg intramuscularly repeated at intervals ...
Pharmacodynamic properties
Distigmine is an inhibitor of cholinesterase by the formation of complexes with the enzyme. This process is reversible. Specific cholinesterase or acetylcholinesterase is inhibited more strongly than pseudo ...
Pharmacokinetic properties
Maximum inhibition of plasma cholinesterase occurs 9 hours after a single intramuscular dose and persists for about 24 hours. Tritium labelled Ubretid was used to determine the urinary and biliary excretion ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Lactose Maize starch Purified talc Magnesium stearate
Incompatibilities
None stated.
Shelf life
36 months.
Special precautions for storage
Store in a dry place below 25oC.
Nature and contents of container
Blisters of 20μm aluminium foil and 250μm UPVC/PVdC opaque white film containing 30 tablets.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Sanofi-aventis, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Marketing authorization number(s)
PL 04425/0617
Date of first authorization / renewal of the authorization
7 February 2009
Date of revision of the text
February 2009