UBRETID TABLET 5 MG [SIN02915P]

Product Info

UBRETID TABLET 5 MG

[SIN02915P]

Indications
Functional insufficiency of the vesical sphincteral apparatus
Hypotonia of the urinary bladder
Chronic hypotonic constipation and megacolon
In various neurological indications (peripheral paralyses of the striated muscles, myasthenia gravis pseudoparalytica) a functional improvement can be obtained.

General instruction for dosage
Method of administration
For oral administration with some fluid in the morning on empty stomach about half an hour before breakfast.

Duration of use
Duration of treatment will depend on the course of the disease and will be determined by the physician.
Ubretid 5mg tablets are principally suitable for long-term treatment.

When using UBRETID®, its slow onset of action and its long duration of action as well as the individual response of the patient should be considered. The dosage level has to be individualized for each patient, dependent upon the patient's weight, clinical status, response to therapy, and the drug's long duration of action.

Posology

As a rule, the initial oral dose is usually one UBRETID® 5 mg tablet taken daily in the morning, half an hour before breakfast on an empty stomach. If however, due to preceding or simultaneous food intake a dose of UBRETID® does not take effect, this should by no means be compensated by repeating the medication within a few hours as this might lead to an uncontrolled accumulation. The long duration of effects of UBRETID® might allow dosage interval of 2 to 3 days.

The strong and prolonged effects of UBRETID® have to be taken into account with special caution in the treatment of vagotonic patient in particular his/her autonomic nervous system.

Indication-related instructions:

Functional Insufficiency of the vesicosphincteral system
Oral therapy will be sufficient; it is recommended that UBRETID® 5 mg (one tablet), be given daily at the commencement of treatment until an improvement is observed. Usually the effect can be maintained by administering one to two tablets every other or third day. The tablets should always be taken in the morning on an empty stomach, half an hour before breakfast.

Chronic hypotonic constipation, megacolon
UBRETID® is particularly suitable for the treatment of megacolon and of the hypokinetic form of habitual constipation especially for breaking the habit of taking laxatives.
The individual optimal dosage is usually arrived at by gradually increasing the dosage, Oral therapy is continued until normal intestinal function has been restored (10 to 14 days).
Intial dose: half a tablet daily half an hour before breakfast and increasing this dosage by half a tablet (maximum two tablets daily) every third day. Close observation is required owing to the danger of overdosage leading to cumulation.

Peripheral paralysis, particularly after poliomyelitis and diphtheria, posttraumatic paralysis; bulbar paralysis, amyotrophic lateral sclerosis
After testing the individual response to short acting anticholinesterases, UBRETID®, three tablets, should be given every day. The relief from fatigue will set in after some hours and then will last for one day and a half to two days.

Myasthenia gravis pseudoparalytica
In mild and moderately severe cases the oral treatment will be sufficient. During the first week one tablet (5 mg) should be taken daily on empty stomach taken in the morning about half an hour before breakfast is recommended. During the second week the daily doses should be increased to one and a half tablets (7.5 mg) and to two tablets (10 mg) during the third week. Dosage is individualized depending on the severity of the condition, the degree and duration of response and the side effects encountered.

Dosing instructions for special patient populations:
For patients with impaired hepatic function no dosage adjustment is required.
No dosing recommendations can be given for patients with impaired renal function as no studies are available.
For elderly patients (>65 years) dosage should be reduced.
The safety of UBRETID® has not been established in children.

Contraindications
UBRETID® must not be used in:
Hypersensitivity to the active substance or to any of the excipients as well as bromine allergy, severe vagotonia (dominance of the parasympathetic part of the autonomic-vegetative-nervous system) accompanied by low blood pressure, slow heart rate, hyperacidity, hyperperistalsis of intestine and stomach, increased salivation, peripheral circulatory disturbances, mechanical obstruction to urinary outflow, obstructive ileus, stenosis or spasms in the intestinal tract, in the biliary ducts and urinary passages, gastric ulcers, enteritis; very low blood pressure, increased muscular tone, muscular spasm (tetany), falling sickness (epilepsy), shaking palsy (Parkinson’s disease), postoperative shock and circulatory crises; non-treated cardiac insufficiency, cardiac infarction, congestive heart failure, recent myocardial infarction, cardiac arrhythmias, in particular bradycardia and AV block, bronchial asthma, Iritis, myotonia, and thyrotoxicosis.