MUSE SUPPOSITORY

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ALPROSTADIL

Disponibbli minn:

PALADIN LABS INC.

Kodiċi ATC:

G04BE01

INN (Isem Internazzjonali):

ALPROSTADIL

Dożaġġ:

125MCG

Għamla farmaċewtika:

SUPPOSITORY

Kompożizzjoni:

ALPROSTADIL 125MCG

Rotta amministrattiva:

URETHRAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS VASODILATATING AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0115288009; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2023-07-12

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
PR
MUSE*
(ALPROSTADIL)
125 MCG, 250MCG, 500MCG, 1000MCG MICRO-SUPPOSITORIES
PROSTAGLANDIN
Paladin Labs Inc.
6111 Royalmount Avenue, Suite 102
Montreal, Quebec
H4P 2T4
Control No.: 130077
Date of Preparation:
June 5, 2009
* Trademark of Vivus, Inc.
2
PRODUCT MONOGRAPH
PR
MUSE*
ALPROSTADIL MICRO-SUPPOSITORY
PROSTAGLANDIN
CLINICAL PHARMACOLOGY
ACTIONS
Alprostadil
is
a
synthetic
prostaglandin
with
various
pharmacological
actions
that
includevasodilation, inhibition of platelet aggregation, inhibition of
gastric secretion, stimulation
of intestinal smooth muscle and stimulation of uterine smooth muscle.
Prostaglandin
E
1
is
a
naturally
occurring
acidic
lipid
that
is
synthesized
from
fatty
acid
precursors by most mammalian tissues and has a variety of
pharmacologic effects. Human
seminal fluid is a rich source of prostaglandins, including PGE
1
and PGE
2
, and the total
concentration of prostaglandins in ejaculate has been estimated to be
approximately 100-200
F
g/mL.
The vasodilatory effects of alprostadil on the cavernosal arteries and
the trabecular smooth
muscle of the corpora cavernosa result in rapid arterial inflow and
expansion of the lacunar
spaces within the corpora. As the expanded corporal sinusoids are
compressed against the tunica
albuginea, venous outflow through subtunical vessels is impeded and
penile rigidity develops.
This process is referred to as the corporal veno-occlusive mechanism.
3
PHARMACOKINETICS
About 80% of alprostadil administered by the MUSE system is absorbed
within 10 minutes and
is rapidly cleared from the systemic circulation by the lungs, leaving
barely detectable systemic
blood levels.
Absorption
MUSE alprostadil is designed to deliver alprostadil directly to the
urethral lining for transfer via
the
corpus
spongiosum
to
the
corpora
cavernosa.
Intraurethral
administration
of
MUSE
alprostadil is preceded by urination, and the residual urine disperses
the medicated pellet,
permitting alprostadil to be absorbed by the urethral mucosa. The
transurethral absorption of
a