Source: European Medicines Agency (EU)
Gutron is indicated in for the treatment of severe orthostatic hypotension due to dysfunction of the autonomic nervous system when corrective factors have been ruled out and other forms of treatment are inadequate.
Initial dose: 2,5 mg three times a day (Gutron 5, tablets 5 mg can be divided into two equal doses of 2.5mg). Depending on results of supine and standing blood pressure recordings, this dosage can be increased weekly up to a dose of 10 mg three times a day. This is the normal maintenance dosage. Higher dosages have not been studied.
It is essential to adjust individually the dosage to achieve a correct balance between the therapeutic effects and the possible risks.
The last daily dose should be taken at least 4 hours before bedtime in order to prevent supine hypertension (See section 4.4).
No specific studies have been performed addressing a possible dose-reduction in the elderly population.
No specific studies have been performed addressing a possible dose-reduction in patients with renal insufficiency. Generally, midodrine is contraindicated in patients with acute renal disease and severe renal insufficiency (see section 4.3).
No specific studies have been performed in this patient population, so experience is missing.
The safety and efficacy of midodrine hydrochloride in children has not been established. No data are available.
Midodrine may be taken with food (see section 5.2).
Overdose symptoms are those seen as undesirable effects, in particular hypertension, piloerection (goosebumps), and sensation of coldness, bradycardia (reflex-bradycardia) and urinary retention.
Besides basic life support, recommended general treatment based on the pharmacology of the drug includes induced emesis and administration of alpha-sympatholytic agent (e.g nitroprusside, phentolamine, nitroglycerin).
Bradycardia and bradycardic conduction defects can be counteracted by atropine. The degradation product desglymidodrine is dialyzable.
Shelf-life: 3 years.
Do not store above 25°C.
Store in the original package.
Keep container in the outer carton.
Gutron 5 tablets are packed in PVC/PVDC/aluminium strips or alternatively in brown,
hydrolytic glass type III bottles with cap closure.
Pack sizes:
Glass bottle with 100 tablets.
Blister with 20, 30 or 50 tablets.
Not all pack sizes may be marketed.
No special requirements.
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