Midodrine Hydrochloride (Medicianz)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Midodrine hydrochloride 5mg

Available from:

Medsurge Pharma Limited

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Midodrine hydrochloride 5mg Excipient: Colloidal silicon dioxide Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Sunset yellow aluminium lake

Prescription type:

Prescription

Therapeutic indications:

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 nonpharmacologic treatment, plasma volume expansion and lifestyle alterations. The initiation of Midodrine hydrochloride therapy should be undertaken under close medical supervision in a controlled clinical setting.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/ PVDC-Alu - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 84 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ PVDC-Alu - 112 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2020-06-11

Patient Information leaflet

MIDODRINE HYDROCHLORIDE 2.5 MG AND 5 MG TABLETS
NEW ZEALAND CONSUMER MEDICINE INFORMATION
MIDODRINE HYDROCHLORIDE 2.5 MG AND 5 MG TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Midodrine
hydrochloride 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
Midodrine hydrochloride
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 MIDODRINE HYDROCHLORIDE TABLETS IS USED FOR
Midodrine hydrochloride
tablet
is used to treat the symptoms of idiopathic orthostatic
HYPOTENSION
found
in
Bradbury­
Eggleston
or
Shy­Drager
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.
Midodrine
hydrochloride
is administered in
those cases where the response to other therapy is not
adequate.
Midodrine hydrochloride
tablet 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.
MIDODRINE HYDROCHLORIDE TABLET MAY INCREASE
YOUR BLOOD PRESSURE BY CONSTRICTING THE WALLS OF YOUR BLOOD VESSELS.
Your doctor may have prescribed Midodrine hydrochloride tablets for
another reason.
Ask your doctor if you have any questions about why
Midodrine hydrochloride
tablets have
been prescribed for
you.
Midodrine hydrochloride tablets are a prescription only medicine.
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HEALTHCARE
AUSTRA

Summary of Product characteristics

Page 1 of 11
MIDODRINE HYDROCHLORIDE 2.5 AND 5 MG TABLETS
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Midodrine Hydrochloride 2.5 and 5 mg tablets MEDICIANZ
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Midodrine hydrochloride 2.5 mg tablet contains 2.5 mg midodrine
hydrochloride.
Each Midodrine hydrochloride 5 mg tablet contains 5 mg midodrine
hydrochloride.
Midodrine hydrochloride 5 mg tablet contains Sunset yellow lake.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Midodrine hydrochloride 2.5 mg tablets are white coloured round
shaped, flat tablets debossed
with ‘M2’ on one side and score line on another side.
Midodrine hydrochloride 5 mg tablets are orange coloured round shaped,
flat tablets
debossed with "M5" on one side and score line on another side.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
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 Midodrine hydrochloride therapy should be undertaken
under close medical
supervision in a controlled clinical setting.
4.2
Dose and method of administration
Dose
_ _
Adults
Treatment with 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 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.
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MEDICIANZ
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HEALTHCARE
AUSTRALIA
Page 2 of 11
It is recommended that treatment begin at the lowest