gimoti
Gimoti (Metoclopramide Hydrochloride) is a dopamine-2 receptor antagonist used to treat Gastroesophageal Reflux, Gastroparesis, Postoperative Nausea and Vomiting.
Metoclopramide Hydrochloride · by Qol Medcl
Available as a generic: Clopra-"Yellow"
Key facts
- Active ingredient
- Metoclopramide Hydrochloride
- Drug class
- Dopamine-2 Receptor Antagonist
- Form
- Spray/Inhaler
- Strength
- Metoclopramide Hydrochloride EQ 15MG BASE/SPRAY
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Qol Medcl
- Half-life
- about 5 to 6 hours (how long it stays in your system)
- What the pharmacy pays
- ~$1.34 for 30 — not your price
- FDA application
- NDA209388
- FDA boxed warning
- Yes — see the boxed warning
What is Gimoti?
From the FDA label:Metoclopramide hydrochloride, the active ingredient in GIMOTI, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride is a white, crystalline, odorless substance, freely soluble in water. Its chemical name is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. The molecular formula is C 14 H 22 ClN 3 O 2 ∙HCl∙H 2 O. Its molecular weight is 354.3. The structural formula is: GIMOTI (metoclopramide) nasal spray is for nasal administration. The product is supplied as an aqueous solution with a pH of 5.5 ± 0.5 in a 10 mL amber glass vial fitted with a metered spray pump attachment. Each unit contains 9.8 mL. Each 70 microliter spray contains 15 mg metoclopramide, equivalent to 17.73 mg of metoclopramide hydrochloride. Inactive ingredients consist of benzalkonium chloride, citric acid monohydrate, edetate disodium dihydrate, purified water, sodium citrate dihydrate, and sorbitol. Chemical Structure
How to use
Administration See the full prescribing information for complete information on administration. ( 2.1 ) Recommended Dosage Adults less than 65 years of age: The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily). ( 2.2 ) Adults 65 years of age and older: GIMOTI is not recommended in geriatric patients as initial therapy. Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to GIMOTI 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily). ( 2.2 , 8.5 ) 2.1 Important Administration and Storage Instructions One spray in one nostril administers the appropriate dose. Before administering the first dose from a bottle, prime the pump by pressing down on the finger flange and releasing 10 sprays in the air. Place the spray nozzle tip under one nostril and lean the head slightly forward so the tip of spray nozzle is aimed away from the septum and toward the back of the nose. Close the other nostril with the other index finger. Move spray pump upwards so the tip of the nozzle is in the nostril. To ensure a full dose, hold the bottle upright while pressing down firmly and completely on finger flange and release while inhaling slowly through the open nostril. Remove spray pump nozzle tip from…
Side effects
The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions ( 5.1 )] Other extrapyramidal symptoms [see Warnings and Precautions ( 5.2 )] Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3 )] Depression [see Warnings and Precautions ( 5.4 )] Hypertension [see Warnings and Precautions ( 5.5 )] Fluid retention [see Warnings and Precautions ( 5.6 )] Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] Effects on the ability to drive and operate machinery [see Warnings and Precautions ( 5.8 )] The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The safety of GIMOTI was evaluated in clinical trials of patients with gastroparesis and established in clinical trials of oral metoclopramide. Most common adverse reactions (≥5%) are: dysgeusia, headache, and fatigue. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Evoke Pharma, Inc. at 1-833-4-GIMOTI (1-833-444-6684), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Safety of GIMOTI In a randomized, placebo-controlled clinical…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions ( 5.1 )] . GIMOTI is contraindicated in patients with a history of TD. Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. Immediately discontinue GIMOTI in patients who develop signs or symptoms of TD [see Warnings and Precautions ( 5.1 )] . Avoid a total duration of treatment with metoclopramide products, including GIMOTI, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )] . WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning . Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD increases with duration of treatment and total cumulative dosage. ( 5.1 ) GIMOTI is contraindicated in patients with a history of TD. ( 4 ) Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. ( 2.2 , 5.1 ) Immediately discontinue GIMOTI in patients who develop signs or symptoms of TD. ( 5.1 ) Avoid a total duration of treatment with metoclopramide products, including GIMOTI, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD. ( 5.1 )
Warnings
Important safety information
Tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS) : Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson's disease. If symptoms occur, discontinue GIMOTI and seek immediate medical attention. ( 5.1 , 5.2 , 5.3 , 7.1 , 7.2 ) Depression and suicidal ideation/suicide : Avoid use. ( 5.4 ) 5.1 Tardive Dyskinesia Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Metoclopramide, including GIMOTI, may also suppress, or partially suppress, the signs of TD, and may delay the diagnosis of TD because it may mask the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. TD may remit, partially or completely, if GIMOTI treatment is discontinued. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased in elderly patients, especially in elderly women [see Use in Specific Populations ( 8.5 )] , and in patients with diabetes mellitus. Prevention, Mitigation, and Monitoring for TD GIMOTI is contraindicated in patients with a history of TD. Avoid use of GIMOTI in patients receiving concomitant antipsychotics due to the potential additive effects of TD [see Drug Interactions ( 7.1 )] . GIMOTI is not recommended in geriatric patients as initial therapy [see Dosage and Administration ( 2.2 )] . Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. Immediately discontinue GIMOTI immediately in patients who develop signs and symptoms of TD. Avoid a total duration of treatment with metoclopramide products, including GIMOTI, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD. If patients have continued TD symptoms, consider TD treatment. 5.2 Other Extrapyramidal Symptoms In addition to TD, metoclopramide may cause other extrapyramidal symptoms (EPS), parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue GIMOTI. Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with oral metoclopramide dosages of 30 mg to 40 mg daily. Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages. EPS occurred more frequently in pediatric patients compared to adults (GIMOTI is not approved for use in pediatric patients). Symptoms can occur in the first 24 to 48 hours after starting metoclopramide. Symptoms included involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions were present as stridor and dyspnea, possibly due to laryngospasm. Diphenhydramine hydrochloride or benztropine mesylate may be used to treat these adverse reactions. Avoid GIMOTI in patients receiving other drugs that can cause EPS (e.g., antipsychotics). Parkinsonian symptoms (bradykinesia, tremor, cogwheel rigidity, mask-like facies) have occurred after starting metoclopramide, more commonly within the first 6 months, but also after longer periods. Symptoms generally have subsided within 2 to 3 months after discontinuation of metoclopramide. Avoid GIMOTI in patients with Parkinson’s disease and other patients being treated with antiparkinsonian drugs due to potential exacerbation of symptoms. If treatment is unavoidable, use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. Routinely monitor for signs and symptoms of Parkinson’s disease [see Dosage and Administration ( 2.2 )] . Motor restlessness (akathisia) has developed and consisted of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, and foot tapping. Discontinue GIMOTI if these symptoms develop. 5.3 Neuroleptic Malignant Syndrome Metoclopramide may cause a potentially fatal symptom complex called neuroleptic malignant syndrome (NMS). NMS has been reported in association with metoclopramide overdosage and concomitant treatment with another drug associated with NMS. Avoid GIMOTI in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately. In the diagnostic evaluation, consider the presence of other serious medical conditions (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, serotonin syndrome, and primary central nervous system pathology. Management of NMS includes: Immediate discontinuation of GIMOTI and other drugs not essential to concurrent therapy [see Drug Interactions ( 7.1 )] . Intensive symptomatic treatment and medical monitoring. Treatment of any concomitant serious medical problems for which specific treatments are available. 5.4 Depression Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal ideation and suicide. Avoid GIMOTI use in patients with a history of depression. 5.5 Hypertension Metoclopramide may elevate blood pressure. In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, avoid GIMOTI use in patients with hypertension or in patients taking monoamine oxidase inhibitors [see Drug Interactions ( 7.1 )] . There are also clinical reports of hypertensive crises in patients with undiagnosed pheochromocytoma. GIMOTI is contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas [see Contraindications ( 4 )]. Discontinue GIMOTI in any patient with a rapid rise in blood pressure. 5.6 Fluid Retention Because metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. Discontinue GIMOTI if any of these adverse reactions occur. 5.7 Hyperprolactinemia As with other dopamine D 2 receptor antagonists, metoclopramide elevates prolactin levels. Hyperprolactinemia may suppress hypothalamic gonadotropin-releasing hormone, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, including metoclopramide. Hyperprolactinemia may potentially stimulate prolactin-dependent breast cancer. However, some clinical studies and epidemiology studies have not shown an association between administration of dopamine D 2 receptor antagonists and tumorigenesis in humans [see Nonclinical Toxicology ( 13.1 )]. 5.8 Effects on the Ability to Drive and Operate Machinery Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle.…
Who should not take Gimoti
GIMOTI is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions ( 5.1 , 5.2) ] . When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation). In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor [see Warnings and Precautions ( 5.5 )] . In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures [see Adverse Reactions ( 6 )] . In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm [see Adverse Reactions ( 6 )] . History of TD or dystonic reaction to metoclopramide ( 4 ) When stimulation of gastrointestinal motility might be dangerous ( 4 ) Pheochromocytoma, catecholamine-releasing paragangliomas ( 4 ) Epilepsy ( 4 ) Hypersensitivity to metoclopramide ( 4 )
Overdose — what happens if you take too much
Manifestations of metoclopramide overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with metoclopramide overdose and concomitant treatment with another drug associated with NMS [see Warnings and Precautions ( 5.1 , 5.2 , 5.3) ]. There are no specific antidotes for metoclopramide overdosage. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage . Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal. Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of metoclopramide.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Antipsychotics : Potential for additive effects, including TD, EPS, and NMS; avoid concomitant use. ( 7.1 ) Central nervous system (CNS) depressants : Increased risk of CNS depression. Avoid concomitant use and monitor for adverse reactions. ( 7.1 ) Monoamine oxidase (MAO) inhibitors : Increased risk of hypertension; avoid concomitant use. ( 5.5 , 7.1 ) Additional drug interactions : See Full Prescribing Information. ( 7.1 , 7.2 ) 7.1 Effects of Other Drugs on Metoclopramide Table 1 displays the effects of other drugs on metoclopramide. Table 1. Effects of Other Drugs on Metoclopramide Antipsychotics Clinical Impact Potential for additive effects, including increased frequency and severity of tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS). Intervention Avoid concomitant use [see Warnings and Precautions ( 5.1 , 5.2 , 5.3) ]. Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above Clinical Impact Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms [see Clinical Pharmacology ( 12.3 )]. Intervention Use of GIMOTI is not recommended [see Warnings and Precautions ( 5.9 )] . Examples quinidine, bupropion, fluoxetine, and paroxetine Monoamine Oxidase Inhibitors Clinical Impact Increased risk of hypertension [see Warnings and Precautions ( 5.5 )]. Intervention Avoid concomitant use. Central Nervous System (CNS) Depressants Clinical Impact Increased risk of CNS depression [see Warnings and Precautions ( 5.8 )]. Intervention Avoid GIMOTI or the interacting drug, depending on the importance of the drug to the patient. Examples alcohol, sedatives, hypnotics, opiates, and anxiolytics Drugs that Impair Gastrointestinal Motility Clinical Impact Potential for decreased effect of metoclopramide due to opposing effects on gastrointestinal motility. Intervention Monitor for reduced effect on gastrointestinal motility. Examples antiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations Clinical Impact Decreased therapeutic effect of metoclopramide due to opposing effects on dopamine. Intervention Monitor for reduced therapeutic effect. Examples apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine 7.2 Effects of Metoclopramide on Other Drugs Table 2 displays the effects of metoclopramide on other drugs. Table 2. Effects of Metoclopramide on Other Drugs Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations Clinical Impact Opposing effects of metoclopramide and the interacting drug on dopamine. Potential exacerbation of symptoms (e.g., parkinsonian symptoms). Intervention Avoid concomitant use [see Warnings and Precautions ( 5.2 )] . Examples Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine Succinylcholine, Mivacurium Clinical Impact Metoclopramide inhibits plasma cholinesterase leading to enhanced neuromuscular blockade. Intervention Monitor for signs and symptoms of prolonged neuromuscular blockade Drugs with Absorption Altered due to Increased Gastrointestinal Motility Clinical Impact The effect of metoclopramide on other drugs is variable. Increased gastrointestinal (GI) motility by metoclopramide may impact absorption of other drugs leading to decreased or increased drug exposure. Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension Interaction does not apply to posaconazole delayed-release tablet. , fosfomycin) : Monitor for reduced therapeutic effect of the interacting drug. For digoxin, monitor therapeutic drug concentrations and increase the digoxin dose as needed (see prescribing information for digoxin). Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine) : Monitor therapeutic drug concentrations and adjust the dose as needed. See prescribing information for the interacting drug. Insulin Clinical Impact Increased GI motility by metoclopramide may increase delivery of food to the intestines and increase blood glucose. Intervention Monitor blood glucose and adjust insulin dosage regimen as needed.
How long does Metoclopramide Hydrochloride stay in your body?
The elimination half-life of metoclopramide hydrochloride is about 5 to 6 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the average elimination (terminal) half-life in adults with normal renal function; the label gives it as a 5-to-6-hour range and reports no separate distribution-phase figure. Metoclopramide is not a prodrug, and the FDA label does not describe an active metabolite that outlasts the parent — about half of the drug recovered in urine is excreted as free or conjugated (inactive) metoclopramide. Kidney impairment is the population the label singles out: as creatinine clearance falls, plasma, renal and non-renal clearance all fall and the elimination half-life lengthens, so the drug accumulates unless the maintenance dose is reduced. The label does not state a separate adult half-life for older adults or for liver impairment. It does note that in newborns the half-life is much longer (23.1 hours after a first dose in a 3.5-week-old infant) because of immature liver and kidney function, while in older children it is roughly 4 to 4.5 hours. Half-life describes how fast the drug leaves the blood — it is not a drug-test detection window (metabolites are detectable far longer) and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Metoclopramide Oral Solution — FDA label, Clinical Pharmacology / Pharmacokinetics (DailyMed SPL).
Drug class
May treat (source: NIH RxClass)
Dosage forms
Spray/Inhaler
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Gimoti treat?
- Gimoti (Metoclopramide Hydrochloride) may be used to treat gastroesophageal reflux, gastroparesis, postoperative nausea and vomiting, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Gimoti cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.34 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Gimoti?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Gimoti. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Gimoti?
- Gimoti is marketed by Qol Medcl. You can see Qol Medcl's full profile, rating, and other products on pharmaranks.
- Is Gimoti a brand-name or generic drug?
- Gimoti is a brand-name product with the active ingredient Metoclopramide Hydrochloride. Lower-cost generic equivalents containing Metoclopramide Hydrochloride are available — ask your pharmacist.
- Is Gimoti available over the counter?
- No. Gimoti is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Gimoti come in?
- Gimoti is currently marketed as spray/inhaler, per the FDA's National Drug Code Directory.
- What class of drug is Gimoti?
- Gimoti is classified as dopamine-2 receptor antagonist, per the FDA's Established Pharmacologic Class.
- Is Gimoti FDA-registered?
- Gimoti is on record with the U.S. FDA under application number NDA209388. You can verify this on its official FDA label.
- Is Gimoti safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Gimoti. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Gimoti?
- Gimoti's side effects are taken directly from its FDA label. From the label: The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions ( 5.1 )] Other extrapyramidal symptoms [see Warnings and Precautions ( 5.2 )] Neuroleptic malignant syndrome [see Warni… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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