Nausea:

Indications for GIMOTI:

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.

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.

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.

Boxed Warning:

Tardive dyskinesia.

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.

Pharmacologic Class:

Dopamine-2 receptor antagonist.

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. 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.

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.

Generic Availability:

NO

How Supplied:

Nasal spray (9.8mL)—1

Pricing for GIMOTI

112 metered sprays of 15mg/spray nasal spray (Qty: 1)
Appx. price $1795
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