UBRETID Tablet Ref.[2752] Active ingredients: Distigmine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2009  Publisher: Sanofi-aventis, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

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 days, half an hour before breakfast, on an empty stomach.

In myasthenia gravis

Dosage to be individualised for each patient, dependent upon the severity of the condition, the degree and duration of response and the side effects encountered. The tablets should always be taken on an empty stomach half an hour before breakfast. Dosage should commence at 1 tablet daily and may be adjusted at intervals of three to four days to a total not exceeding 4 tablets daily.

Children

Up to 2 tablets daily according to age.

Elderly

No dosage adjustment is necessary for elderly patients.

Ubretid tablets are for oral administration.

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 indicated by the clinical response until signs of mild atropinisation (dry mouth, mydriasis) appear. The patient should be kept fully atropinised for at least 24 hours.

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.

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