GUTRON Tablets
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Περιεχόμενα
Name of the medicinal product
GUTRON 5, tablets 5 mg.
Qualitative and quantitative composition
Each tablet contains 5 mg midodrine hydrochloride. Excipients with known effects: Each tablet of Gutron 5 contains 0.25 mg Sunset Yellow (E110). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Orange round biplanar tablets with bevelled edge scored on one side with GU above and 5 below the score. The tablet can be divided into equal doses.
Therapeutic indications
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 ...
Posology and method of administration
Posology 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 ...
Contraindications
Midodrine is contraindicated in patients with the following conditions/diseases: Severe organic heart disease (e.g. bradycardia, ischaemic heart disease, congestive heart failure, cardiac conduction disturbances ...
Special warnings and precautions for use
Serious orthostatic hypotension Regular monitoring of orthostatic blood pressure is necessary due to the risk of hypertension in the supine position, e.g. at night. If hypertension occurs in the supine ...
Interaction with other medicinal products and other forms of interaction
Midodrine is an inhibitor of Cytochrome P450 CYP2D6 and may therefore affect the metabolism of other drugs metabolised by this isoenzyme (e.g. perphenazine, amiodorone, metoclopramide). This may lead to ...
Pregnancy and lactation
Pregnancy There are no data from the use of midodrine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Gutron is not recommended during pregnancy ...
Effects on ability to drive and use machines
Negligible influence; however in case of dizziness or lightheadedness, care should be taken when driving vehicles or operating machinery.
Undesirable effects
Summary of safety profile The most frequently occurring events associated with treatment include piloerection, dysuria and pruritus. Events of supine hypertension have been reported during treatment, the ...
Overdose
Symptoms Overdose symptoms are those seen as undesirable effects, in particular hypertension, piloerection (goosebumps), and sensation of coldness, bradycardia (reflex-bradycardia) and urinary retention. ...
Pharmacodynamic properties
Pharmacotherapeutic category: cardiac stimulants (excl. cardiac glycosides) ATC-code: C01CA17 Midodrine is the rapidly absorbed pro-drug of the pharmacologically active constituent desglymidodrine. Desglymidodrine ...
Pharmacokinetic properties
Absorption After oral administration, midodrine is rapidly absorbed. The peak plasma concentrations are reached after approximately 30 minutes, and the plasma concentration of the active metabolite, desglymidodrine, ...
Preclinical safety data
Pharmacology safety studies and toxicity studies with animals did not show any indications of a safety risk for humans after repeated administration. Studies on animals are inadequate to determine the ...
List of excipients
Magnesium stearate Talc Colloidal anhydrous silica Microcrystalline cellulose Maize starch Sunset Yellow (E110)
Incompatibilities
Not applicable.
Shelf life
Shelf-life: 3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package. Keep container in the outer carton.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
No special requirements.
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