Gutron

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Midodrine hydrochloride 2.5mg

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Midodrine hydrochloride 2.5 mg

Dosage:

2.5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Midodrine hydrochloride 2.5mg Excipient: Hydrated silica Magnesium stearate Microcrystalline cellulose Purified talc Starch

Units in package:

Bottle, plastic, HDPE, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cadila Healthcare Ltd

Therapeutic indications:

Gutron is indicated to attenuate symptoms of chronic orthostatic hypotension due to automatic failure in patients with Bradbury-Eggleston or Shy-Drager syndromes and other medical disorders such as diabetes mellitus or Parkinson's Disease. Because midodrine can cause marked elevation of supine blood pressure, it should only be used in patients whose lives are considerably impaired despite standard clinical care including non-pharmacologic treatment, plasma volume expansion and lifestyle alterations. The initiation of Gutron therapy should be undertaken under close medical supervision in a controlled clinical setting.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 100 tablets - 60 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

1988-06-08

Patient Information leaflet

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INFORMATION FOR
CONSUMERS
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Consumer Medicine
Information
GUTRON™
midodrine HCl 2.5 mg and 5 mg tablets
What is in this leaflet
This leaflet answers some common questions about GUTRON tablets. It does not contain all the
available information.
It does not take the place of talking to your doctor and pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking GUTRON
tablets against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine
You may need to read it again.
What GUTRON tablets are used for
GUTRON is used to treat the symptoms of idiopathic orthostatic 
hypotension found in Bradbury-
Eggleston or Shy-Drager syndromes. Idiopathic orthostatic hypotension is a fall in blood pressure that
occurs upon rising abruptly to an upright position although it may also occur following a period of
prolonged standing.
The body's nervous system is responsible for this type of hypotension. GUTRON is administered in
those cases where the response to other therapy is not adequate.
GUTRON is also used where hypotension is a consequence of other medical disorders such as diabetes
or Parkinson's disease.
Hypotension is low blood pressure. It is a measure of the blood pressing on the artery walls. This
pressure helps move your blood around your body. You have hypotension when your blood pressure
stays lower than normal. 
GUTRON may increase your blood pressure by constricting the walls of
your blood vessels.
your blood vessels.
Your doctor may have prescribed GUTRON tablets for another reason.
Ask your doc

Summary of Product characteristics

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
GUTRON® 2.5 and 5 mg tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each GUTRON 2.5 mg tablet contains 2.5 mg midodrine hydrochloride.
Each GUTRON 5 mg tablet contains 5 mg midodrine hydrochloride.
EXCIPIENT(S) WITH KNOWN EFFECT
GUTRON 5 mg tablet contains Sunset yellow FCF. For the full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
GUTRON 2.5 mg tablets are white, circular, flat tablets of 7 mm
diameter scored on one side and
embossed GU above the score and 2.5 below the score.
GUTRON 5 mg tablets are orange, circular, flat tablets of 7 mm scored
on one side and embossed
GU above the score and 5.0 below the score.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
GUTRON (midodrine hydrochloride) is indicated to attenuate symptoms of
chronic orthostatic
hypotension
due
to
autonomic
failure
in
patients
with
Bradbury-Eggleston
or
Shy-Drager
syndromes and other medical disorders such as diabetes mellitus or
Parkinson's disease.
Because midodrine can cause marked elevation of supine blood pressure,
it should only be used
in patients whose lives are considerably impaired despite standard
clinical care including non-
pharmacologic treatment, plasma volume expansion and lifestyle
alterations.
The initiation of GUTRON therapy should be undertaken under close
medical supervision in a
controlled clinical setting.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS _
Treatment with GUTRON (midodrine hydrochloride) tablets should be
started under close medical
supervision in a controlled clinical setting such as in hospital, in
the clinic, or in the office. Hourly
2 | P a g e
measurements of blood pressure (supine and sitting or standing, if
possible) should be made for
3 hours following the first dose and also the second dose of a three
times daily dosage regimen.
It is recommended that treatment begin at the lowest level and be
titrated at intervals of three to
several days until the optimal response is obtained. Upon escalating
the dosage, the supin