Gimoti

Product manufactured by Evoke Pharma, Inc.

Application Nr Approved Date Route Status External Links
NDA209388 None Nasal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Gimoti Is Indicated For The Relief Of Symptoms In Adults With Acute And Recurrent Diabetic Gastroparesis. Gimoti Is A Dopamine-2 (D 2 ) Antagonist Indicated For The Relief Of Symptoms In Adults With Acute And Recurrent Diabetic Gastroparesis. ( 1 ) Limitations Of Use : Gimoti Is Not Recommended For Use In: Pediatric Patients Due To The Risk Of Tardive Dyskinesia (Td) And Other Extrapyramidal Symptoms As Well As The Risk Of Methemoglobinemia In Neonates. ( 1 , 8.4 ) Moderate Or Severe Hepatic Impairment (Child-Pugh B Or C), Moderate Or Severe Renal Impairment (Creatinine Clearance Less Than 60 Ml/minute), And Patients Concurrently Using Strong Cyp2d6 Inhibitors Due To The Risk Of Increased Drug Exposure And Adverse Reactions. ( 1 , 5.9 , 7.1 ) Limitations Of Use : Gimoti Is Not Recommended For Use In: Pediatric Patients Due To The Risk Of Developing Tardive Dyskinesia (Td) And Other Extrapyramidal Symptoms As Well As The Risk Of Methemoglobinemia In Neonates [See Use In Specific Populations (8.4) ]. Moderate Or Severe Hepatic Impairment (Child-Pugh B Or C), Moderate Or Severe Renal Impairment (Creatinine Clearance Less Than 60 Ml/minute), And Patients Concurrently Using Strong Cyp2d6 Inhibitors Due To The Risk Of Increased Drug Exposure And Adverse Reactions [See Warnings And Precautions (5.9) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metoclopramide Hydrochloride METOCLOPRAMIDE HYDROCHLORIDE ZINC1530716

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