Ország: Kanada
Nyelv: angol
Forrás: Health Canada
ERGOTAMINE TARTRATE; PHENOBARBITAL; BELLADONNA
PALADIN LABS INC.
A03ED
ANTISPASMODICS IN COMBINATION WITH OTHER DRUGS
0.6MG; 40.0MG; 0.2MG
TABLET (EXTENDED-RELEASE)
ERGOTAMINE TARTRATE 0.6MG; PHENOBARBITAL 40.0MG; BELLADONNA 0.2MG
ORAL
100
Schedule G (CDSA IV)
ANTIMUSCARINICS ANTISPASMODICS
Active ingredient group (AIG) number: 0333204001; AHFS:
CANCELLED POST MARKET
2018-06-05
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 Olvassa el a teljes dokumentumot