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Gimoti Generic Name & Formulations
Legal Class
Rx
General Description
Metoclopramide 15mg; per nasal spray (70microliter); contains benzalkonium chloride.
Pharmacological Class
Dopamine-2 receptor antagonist.
How Supplied
Nasal spray (9.8mL)—1
Manufacturer
Generic Availability
NO
Gimoti Indications
Indications
Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Limitations of Use
Not for use in pediatric patients due to risk of tardive dyskinesia, other extrapyramidal symptoms, and risk of methemoglobinemia in neonates.
Gimoti Dosage and Administration
Adult
Give 30mins before each meal and at bedtime for 2–8 weeks; max 4 times daily. <65yrs: 1 spray (15mg) in one nostril. ≥65yrs: requires a lower starting dose; not recommended as initial therapy; can be switched from an alternative metoclopramide product.
Children
Not recommended.
Gimoti Contraindications
Contraindications
History of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide. When stimulation of GI motility may be dangerous (eg, hemorrhage, obstruction, or perforation). Pheochromocytoma or other catecholamine-releasing paragangliomas. Epilepsy.
Gimoti Boxed Warnings
Boxed Warning
Tardive dyskinesia.
Gimoti Warnings/Precautions
Warnings/Precautions
Increased risk of TD with long-term use; avoid treatment >12 weeks. Diabetes mellitus. Discontinue if signs/symptoms of TD, extrapyramidal symptoms (EPS), parkinsonian symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), or rapid increase in BP occurs. Avoid in Parkinson's disease, depression, hypertension. Cirrhosis. CHF. Moderate or severe renal (CrCl <60mL/min) or hepatic (Child-Pugh B or C) impairment: not recommended. NADH-cytochrome b5 reductase deficiency. G6PD deficiency. CYP2D6 poor metabolizers: not recommended. Elderly (esp. women). Neonates. Pregnancy. Nursing mothers: monitor infants.
Gimoti Pharmacokinetics
See Literature
Gimoti Interactions
Interactions
Avoid concomitant drugs that can cause or potentially affect TD, EPS, or NMS (eg, antipsychotics). Potentiated by strong CYP2D6 inhibitors (eg, quinidine, bupropion, fluoxetine, paroxetine); not recommended. Increased risk of hypertension with MAOIs; avoid. Increased risk of CNS depression with alcohol, sedatives, hypnotics, opiates, anxiolytics; avoid. May be antagonized by drugs that impair GI motility (eg, antiperistaltic antidiarrheals, anticholinergics, opiates); monitor. Avoid concomitant dopaminergic agonists and other drugs (eg, apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine). May potentiate succinylcholine, mivacurium, sirolimus, tacrolimus, cyclosporine; monitor and adjust dose. May antagonize digoxin (adjust dose), atovaquone, posaconazole (oral susp), fosfomycin; monitor. Concomitant insulin: monitor and adjust dose.
Gimoti Adverse Reactions
Adverse Reactions
Dysgeusia, headache, fatigue; TD, EPS, NMS, parkinsonism, akathisia, seizures, hallucinations, depression, hypertension (discontinue if occurs), fluid retention or volume overload (discontinue if occurs), hyperprolactinemia, hypersensitivity reactions.
Gimoti Clinical Trials
See Literature
Gimoti Note
Not Applicable
Gimoti Patient Counseling
See Literature
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