Midodrine 2.5mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Midodrine hydrochloride

Commercializzato da:

Accord-UK Ltd

Codice ATC:

C01CA17

INN (Nome Internazionale):

Midodrine hydrochloride

Dosaggio:

2.5mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 02070200

Foglio illustrativo

BLACK
ZINC Ref:
EAS3824A LEA MIDODRINE 2.5MG TABS TUK

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Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Midodrine Hydrochloride 2.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of midodrine hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, round, flat, 7.0 mm diameter tablet with a score
line on
one side.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Midodrine Hydrochloride 2.5 mg tablets are 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. 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 2.5 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 impa