Drug Name |
Alosetron hydrochloride |
Drug ID |
BADD_D00083 |
Description |
Alosetron is a 5-HT3 antagonist used only for the management of severe diarrhoea-predominant irritable bowel syndrome (IBS) in women. Alosetron has an antagonist action on the 5-HT3 receptors and thus may modulate serotonin-sensitive gastrointestinal (GI) processes. Alosetron was voluntarily withdrawn from the US market in November 2000 by the manufacturer due to numerous reports of severe adverse effects including ischemic colitis, severely obstructed or ruptured bowel, and death. In June 2002, the FDA approved a supplemental new drug application allowing the remarketing of the drug under restricted conditions of use. |
Indications and Usage |
Only for the treatment of symptoms of severe diarrhea-predominant irritable bowel syndrome (IBS) in women with chronic symptoms (generally lasting greater than 6 months) who does not present with anatomic or biochemical GI abnormalities and have not responded to conventional therapy. |
Marketing Status |
approved; withdrawn |
ATC Code |
A03AE01 |
DrugBank ID |
DB00969
|
KEGG ID |
D02829
|
MeSH ID |
C090840
|
PubChem ID |
60758
|
TTD Drug ID |
D06GKN
|
NDC Product Code |
76055-0009; 64980-453; 64980-454; 54766-894; 45963-480; 65162-248; 0054-0295; 0054-0296; 58159-032; 45963-479; 49884-819; 65162-249; 53104-7658; 49884-820; 54766-895 |
UNII |
2F5R1A46YW
|
Synonyms |
alosetron | Lotronex | alosetron hydrochloride | alosetron monohydrochloride | 2,3,4,5-tetrahydro-5-methyl-2-((5-methylimidazol-4-yl)methyl)-1H-pyrido(4,3-b)indol-1-one monohydrochloride | GR 68755 | GR68755 |