AMATINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

MIDODRINE HYDROCHLORIDE

Saatavilla:

SHIRE PHARMA CANADA ULC

ATC-koodi:

C01CA17

INN (Kansainvälinen yleisnimi):

MIDODRINE

Annos:

5MG

Lääkemuoto:

TABLET

Koostumus:

MIDODRINE HYDROCHLORIDE 5MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ALPHA-ADRENERGIC AGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0123066002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2010-10-04

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
AMATINE
®*
_(Midodrine hydrochloride)_
2.5, 5 & 10 mg Tablets
VASOPRESSOR
Shire Canada Inc.
2250 Alfred-Nobel Blvd., Suite 500
Date of Revision
Ville Saint-Laurent, Quebec
2009.03.19
H4S 2C9
Control# 126680
*Amatine is a registered trade-mark
used under a licence from Shire U.S. Inc.
©
2008 Shire Canada Inc. All rights reserved.
1
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
AMATINE
®
(midodrine hydrochloride)
2.5, 5 & 10 mg Tablets
THERAPEUTIC CLASSIFICATION
Vasopressor
ACTION AND CLINICAL PHARMACOLOGY
AMATINE (midodrine hydrochloride) is a prodrug, that is, the
therapeutic effect of orally
administered midodrine is due to and directly related to its
conversion after absorption to
desglymidodrine which differs chemically from methoxamine only by
lacking in a methyl group
on the α carbon of the side chain.
Desglymidodrine is an α
1
-adrenoceptor stimulant with little effect on cardiac
β-adrenoceptors.
The actions of desglymidodrine on the cardiovascular and other organ
systems are essentially
identical
with
those
of
other
alpha
1
-adrenoceptor
stimulants,
such
as
phenylephrine
or
methoxamine.
The most prominent effects of midodrine are on the cardiovascular
system, consisting of a rise in
standing, sitting and supine systolic and diastolic blood pressures in
patients with orthostatic
hypotension. Standing systolic pressure is increased by 15 to 30 mm Hg
at 1 hour after a 10 mg
dose of AMATINE, with some effects persisting for another 2 to 3
hours. The increase in blood
pressure is due almost entirely to an increase in peripheral
resistance. AMATINE has no
clinically significant effect on standing or supine pulse rate in
patients with autonomic failure. It
slightly decreases cardiac output and renal blood flow and increases
the tone of the internal
bladder sphincter and delays the emptying of the bladder.
2
PHARMACOKINETICS:
After oral administration, midodrine is rapidly and almost completely
absorbed, with a mean absolute bioavailability (as desglymidodrine) of
93%.
After the oral administration