Midodrine 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Midodrine hydrochloride

Available from:

Morningside Healthcare Ltd

ATC code:

C01CA17

INN (International Name):

Midodrine hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02070200; GTIN: 5055132716140

Patient Information leaflet

BLACK
ZINC Ref:
EAS3827A LEA MIDODRINE 5MG TABS TUK

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Midodrine Hydrochloride 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of midodrine hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Spotted orange, round, flat, 7.0 mm diameter tablet with a score line
on one
side. The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Midodrine Hydrochloride is indicated in adults for the treatment of
severe
orthostatic hypotension due to autonomic dysfunction when corrective
factors
have been ruled out and other forms of treatment are inadequate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Initial dose: 2.5 mg three times a day (Midodrine Hydrochloride 2.5 mg
tablets are
also available). Depending on the results of supine and standing blood
pressure
recordings, this dose may be increased weekly up to a dose of 10 mg
three times a
day. This is the usual maintenance dosage.
A careful evaluation of the response to treatment and of the overall
balance of the
expected benefits and risks needs to be undertaken before any dose
increase and
advice to continue therapy for long periods.
The last daily dose should be taken at least 4 hours before bedtime in
order to prevent
supine hypertension (see also section 4.4).
Midodrine Hydrochloride 5 mg tablets may be taken with food (see
section 5.2).
_Paediatric population_
The safety and efficacy of midodrine in children have not been
established. No data
are available.
_Elderly population_
There is limited data on dosing in the elderly and there are no
specific studies which
have focused on a possible dose reduction in the elderly population.
Cautious dose
titration is recommended.
_Patients with renal impairment_
There are no specific studies that have focused on a possible dose
reduction in
patients with renal impairment. Typically, midodrine is
contraindicated in patients
with acute renal impairment and severe renal impairment (see section
4.3).
_P