BELLERGAL SPACETABS TABLET (EXTENDED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ERGOTAMINE TARTRATE; PHENOBARBITAL; BELLADONNA

Disponibil de la:

PALADIN LABS INC.

Codul ATC:

A03ED

INN (nume internaţional):

ANTISPASMODICS IN COMBINATION WITH OTHER DRUGS

Dozare:

0.6MG; 40.0MG; 0.2MG

Forma farmaceutică:

TABLET (EXTENDED-RELEASE)

Compoziție:

ERGOTAMINE TARTRATE 0.6MG; PHENOBARBITAL 40.0MG; BELLADONNA 0.2MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Schedule G (CDSA IV)

Zonă Terapeutică:

ANTIMUSCARINICS ANTISPASMODICS

Rezumat produs:

Active ingredient group (AIG) number: 0333204001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2018-06-05

Caracteristicilor produsului

Page 1 of 11
PRESCRIBING INFORMATION
C
Bellergal
®
Spacetabs
(Ergotamine, Phenobarbital, Belladonna)
0.6mg Ergotamine tartrate, 40mg Phenobarbital, 0.2mg Belladonna
Alkalloides
ANTICHOLINERGIC - ANTISPASMODIC - SEDATIVE
Paladin Labs Inc.
Date of Revision
100 Alexis Nihon Blvd, Suite 600
February 13, 2014
St-Laurent, QC
H4M 2P2
Control Number:
166278
Page 2 of 11
PRESCRIBING INFORMATION
Bellergal
®
Spacetabs
ERGOTAMINE, PHENOBARBITAL, and BELLADONNA TABLETS
PHARMACOLOGY
_ERGOTAMINE _
Limited information is available about the tissue distribution of
ergotamine in humans. Following
oral or intravenous administration in rats, ergotamine has been
detected in high concentrations in
the liver and lung and in lower concentrations in the kidney, heart,
and brain. About 98% of the
drug is protein bound. Studies based on an in vitro model system using
porcine brain endothelial
cells have shown that ergot alkaloids such as ergotamine are able to
cross the blood-brain barrier
reaching the central nervous system (CNS) in a high concentration.
Ergotamine is extensively
metabolized in the liver and cleared from the blood by first-pass
hepatic metabolism resulting in
low or undetectable systemic drug concentrations. Parent drug and
metabolites are mainly
excreted in the feces via biliary elimination, only a small amount is
excreted in the urine.
Pharmacokinetic interactions (increased blood levels of ergotamine)
have been reported in patients
treated orally with ergotamine and macrolide antibiotics (e.g.,
troleandomycin, clarithromycin,
erythromycin), and in patients treated orally with ergotamine and
protease inhibitors (e.g.
ritonavir) presumably due to inhibition of cytochrome P450 3A (CYP3A)
metabolism of
ergotamine (see CONTRAINDICATIONS). Ergotamine has also been shown to
be an inhibitor
of CYP3A catalysed reactions. No pharmacokinetic interactions
involving other cytochrome P450
isoenzymes are known.
_PHENOBARBITAL _
Phenobarbital, like many other barbiturates, is a nonselective central
nervous system (CNS)
depressant, c