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Outline
What is the generic name?
METOCLOPRAMIDE HYDROCHLORIDE
What is the Trade Name for METOCLOPRAMIDE HYDROCHLORIDE?
GIMOTI
What are the Indications for METOCLOPRAMIDE HYDROCHLORIDE?
- 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) ].
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References: https://open.fda.gov/
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