Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
MIDODRINE HYDROCHLORIDE
SHIRE PHARMA CANADA ULC
C01CA17
MIDODRINE
2.5MG
TABLET
MIDODRINE HYDROCHLORIDE 2.5MG
ORAL
100
Prescription
ALPHA-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0123066001; AHFS:
CANCELLED POST MARKET
2010-09-30
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 Přečtěte si celý dokument