Midodrine 5mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Midodrine hydrochloride

Tersedia dari:

Tillomed Laboratories Ltd

Kode ATC:

C01CA17

INN (Nama Internasional):

Midodrine hydrochloride

Dosis:

5mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02070200; GTIN: 5024655006038

Selebaran informasi

The maximum daily dosage is 30 mg and this
limit should be exceeded only in exceptional
cases.
TIMING OF THE EVENING DOSE
Please
take
Midodrine
with
a
glass
of
water.
Midodrine can be taken with meals. You should
take your last dose of Midodrine at least four
hours before bedtime. This is because Midodrine
can cause high blood pressure if you are lying
down
for
any
period
of
time
(for
example,
sleeping or sunbathing).
USE IN CHILDREN AND ADOLESCENTS
Do
not
give
this
medicine
to
children
and
adolescents under the age of 18 because the
safety and efficacy of midodrine hydrochloride
tablets in patients aged below 18 years has not
been established.
USE IN ELDERLY PATIENTS
The initial dosage is small and the increase in
dose
is
dependent
on
the
patient's
clinical
condition and should be done with caution.
PATIENTS WITH RENAL FUNCTION DISORDERS
Due
to
lack
of
data,
information
regarding
dosage
adjustment
cannot
be
provided
for
patients
with
renal
function
disorders.
In
general, Midodrine should not be administered
in patients with acute renal disorders and severe
renal function disorders (see section 2).
PATIENTS WITH HEPATIC IMPAIRMENT
No specific studies have been performed in this
patient
population
for
dosage
adjustment.
Therefore,
information
regarding
dosage
adjustment is not available for this group.
DURATION OF USE
The duration is based on the progression of the
disease.
Please talk to your doctor if you have the feeling
that the effect of Midodrine is strong or weak.
IF YOU TAKE MORE MIDODRINE THAN YOU SHOULD
If you take more Midodrine, contact your doctor
immediately
or
go
to
your
nearest
hospital
accident and emergency department. Take this
package leaflet to your doctor.
Overdose
may
result
in
very
high
blood
pressure, feeling of cold, urination difficulties as
well
as
prolongation
of
pulse
and
“goose
bumps”, especially in the neck and scalp area.
Depending
on
the
severity
of
overdose,
the
doctor may initiate measures such as induced
vomiting
and
administration
of
an
antidote
(alpha receptor blocker suc

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Midodrine 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg midodrine hydrochloride.
Excipients with known effect:
Each tablet contains 0.1 mg Sunset Yellow FCF aluminium lake (E110).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Light orange coloured, round, scored tablets debossed with 'H' above
the score
and 'P' below the score on one side and '505' on the other side. The
diameter of
the tablet is 7.10 mm ±0.2 mm.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use in the treatment of severe orthostatic hypotension due to
dysfunction
of the autonomic nervous system when corrective factors have been
ruled out.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The usual initial dosage is 2.5 mg of midodrine hydrochloride 2-3
times daily. The
dose should be increased at weekly intervals in small increments until
an optimal
response is obtained. The maintenance dosage should be determined
individually for
each patient to achieve optimal therapeutic effect while reducing the
impact of
adverse reactions.
The maximum daily dosage is 30 mg midodrine hydrochloride, divided
into 3 single
doses and this limit can be exceeded only in exceptional cases.
Midodrine 5 mg tablets should be taken during daytime when the patient
performs his
daily activities in upright position. A dosing schedule of 3-4 hour
intervals is
suggested. The last dose should be taken at least four hours before
bedtime to reduce
the risk of supine hypertension. Blood pressure in supine and sitting
position should
be regularly monitored at the beginning of the treatment (at least
twice a week).
Treatment with Midodrine 2.5 mg tablets should be stopped if supine
hypertension is
significantly excessive.
Midodrine 5 mg tablets should be taken with sufficient amount of
fluid. They can be
taken during meal time. The duration of treatment is based on the
progression of the
disease.
Spe