Tardive dyskinesia can be irreversible.
Use the shortest appropriate course and track cumulative exposure across all metoclopramide products. Stop and seek immediate assessment for new involuntary movements, severe muscle spasms, fever with rigidity/confusion or airway swelling. Dose adjustments and interaction avoidance depend on the exact product and indication.
Warnings and precautionsIndications
Adult gastrointestinal uses differ from procedural injection uses.
Oral and nasal uses
Reglan/selected ODT/solution: adult symptomatic, documented GERD failing conventional therapy, treated for 4–12 weeks; adult acute/recurrent diabetic gastroparesis. Gimoti is adult diabetic gastroparesis only, not a nasal GERD indication. Oral/ODT/nasal pediatric use is not recommended or established.
Injection indications and limits
Selected injection: adult diabetic gastroparesis, prevention of emetogenic cancer-chemotherapy nausea/vomiting, postoperative nausea/vomiting, small-bowel tube passage when conventional maneuvers fail, and assistance with delayed gastric emptying in adult barium examinations. The only established pediatric injection indication is a single dose for small-bowel intubation. A retained CINV regimen does not establish current guideline-preferred oncology treatment.
Dosage and administration
Use the exact indication, route and product adjustment table.
Reglan adult oral regimens
| Indication | Regimen / duration |
|---|---|
| Continuous GERD | 10–15 mg four times daily, 30 minutes before meals and at bedtime; maximum 60 mg/day. 4–12 weeks according to endoscopic response; maximum 12 weeks, shortest effective duration and reassess. |
| Intermittent GERD | Single dose up to 20 mg before the provoking situation; reduce for relevant special populations. |
| Diabetic gastroparesis | 10 mg four times daily, 30 minutes before meals and at bedtime; maximum 40 mg/day. Shortest duration, reassess; avoid total metoclopramide exposure beyond 12 weeks. Unavoidable longer use requires routine TD monitoring. |
| Unable to take oral treatment | Severe nausea/vomiting may require IV or IM metoclopramide for up to 10 days, then oral treatment when tolerated; use injection-specific instructions. |
Reglan organ and CYP2D6 adjustment tables
| Setting | Selected oral regimen |
|---|---|
| Older adults | Consider 5 mg four times daily initially, titrating by response/tolerance to indication-specific adult dose. |
| GERD · Child-Pugh B/C, poor CYP2D6 metabolizer or strong CYP2D6 inhibitor | 5 mg four times daily or 10 mg three times daily; maximum 30 mg/day. Child-Pugh A follows usual adult dose. |
| GERD · CrCl ≤60 mL/min or ESRD including dialysis | 5 mg four times daily or 10 mg twice daily; maximum 20 mg/day. |
| Gastroparesis · Child-Pugh B/C, poor CYP2D6 metabolizer or quinidine | 5 mg four times daily; maximum 20 mg/day. Avoid bupropion, fluoxetine and paroxetine for this regimen. |
| Gastroparesis · CrCl <60 mL/min or ESRD including dialysis | 5 mg twice daily; maximum 10 mg/day. |
| Exact CrCl 60 boundary | Table 2 says <60, whereas section 8.6 says ≤60; obtain product/indication-specific pharmacist review at exactly 60, rather than choosing an unverified dose. |
ODT and oral solution distinctions
Selected ODT follows the displayed adjusted oral doses, but its renal gastroparesis table says CrCl ≤60 and all strong CYP2D6 inhibitors use reduction, unlike current Reglan’s gastroparesis avoidance for three antidepressants. ODT and solution retain 2–8 weeks for gastroparesis; do not substitute this for the new Reglan duration wording. ODT: empty stomach ≥30 minutes before food; dry hands, remove immediately, discard a crumbled tablet, dissolve on tongue and swallow granules without water. If accidentally taken with food, do not repeat. Solution is 5 mg/5 mL (1 mg/mL): labeled usual adult doses are the same 10–15 mg four-times-daily GERD and 10 mg four-times-daily gastroparesis regimens. Its older renal instruction is CrCl <40 mL/min, start about half dose; this differs from current tablet/injection guidance. Advanced-organ-disease or interacting-drug use requires exact-product pharmacy review, not the old liquid label’s blanket liver reassurance.
Gimoti nasal dosing and pump
| Setting / instruction | Regimen |
|---|---|
| Adults <65 years | One 15 mg spray in one nostril, 30 minutes before each meal and at bedtime; maximum 4 sprays/day. Shortest course; avoid total exposure >12 weeks, routinely monitor TD if longer use unavoidable. |
| Age ≥65 years | Not recommended as initial treatment. Only patients stable on an alternative metoclopramide product at 10 mg four times daily may switch to the above nasal regimen. |
| Organ / metabolic restrictions | Not recommended with CrCl <60 mL/min, Child-Pugh B/C, poor CYP2D6 metabolism or strong CYP2D6 inhibitors; the fixed pump cannot deliver a reduced dose. |
| Administration | Prime 10 sprays into air before first use and when unused for 2 weeks. One spray in one nostril is one dose; never repeat an uncertain spray. Skip a missed dose, resume scheduled dose, never double. |
| Handling | Wipe nozzle after use; clogged nozzle: remove, soak/rinse in warm water, air-dry and replace. Never use a pin. Discard 4 weeks after opening, even with medicine remaining. |
Selected injection regimens
| Indication | Label regimen / limit |
|---|---|
| Adult severe diabetic gastroparesis | 10 mg IM or slow IV over at least 1–2 minutes; up to 10 days before oral transition. The dose paragraph supplies no universal repeat interval; obtain the prescribed schedule. |
| Adult CINV prevention | 1 mg/kg for less emetogenic drugs or 2 mg/kg for highly emetogenic drugs; IV infusion ≥15 minutes, 30 minutes before chemotherapy, then every 2 hours for 2 doses, then every 3 hours for 3 doses. Doses >10 mg diluted in 50 mL approved solution; oncology-selected regimen, not pediatric extrapolation. |
| Adult postoperative prevention | Single 10 or 20 mg IM dose near end of surgery. |
| Small-bowel intubation | After tube fails to pass pylorus with conventional maneuvers for 10 minutes: single undiluted IV dose over ≥1–2 minutes. Adults and ages >14: 10 mg; ages 6–14: 2.5–5 mg; ages <6: 0.1 mg/kg. |
| Adult radiological examination | Single 10 mg undiluted IV dose over ≥1–2 minutes when delayed emptying interferes with examination. |
| Repeated doses · organ impairment | CrCl ≤60: half usual dose; ESRD including dialysis: one-quarter usual dose. Child-Pugh B/C: half usual dose. These reductions apply when receiving more than a single dose; mild organ impairment requires no specified adjustment. |
| CYP2D6 / administration | Avoid injection with strong CYP2D6 inhibitors or poor metabolizer status; unavoidable use needs adverse-effect monitoring. Undiluted IV 10 mg requires ≥1–2 minutes; diluted IV requires ≥15 minutes. |
Safety
Neurologic, psychiatric and cardiovascular risks can be severe.
Warnings and precautions
- TD risk rises with cumulative dose and duration; older adults, especially women, and diabetes increase risk. It may be masked during treatment. Stop immediately if TD occurs; no claim that persistent TD is untreatable.
- Acute dystonia, airway spasm, akathisia and parkinsonism can occur, including within 24–48 hours; younger/pediatric patients have greater EPS risk. Stop and seek immediate care. Avoid antipsychotics and Parkinson disease/antiparkinsonian combinations; unavoidable Parkinson use in current labels requires shortest duration and monitoring.
- Fever, rigidity, altered consciousness and unstable vital signs can signal fatal neuroleptic malignant syndrome; immediately discontinue and obtain emergency care.
- Depression and suicidal thinking can occur with or without history. Current Reglan/Gimoti advise avoiding use in patients with depression history; injection wording permits only benefit outweighing risk, not casual use.
- Avoid hypertension and MAO-inhibitor combinations; discontinue for rapid BP rise. Cirrhosis or heart failure increases fluid-retention risk; stop if overload occurs.
- Prolactin elevation may affect menstrual, breast, sexual, fertility and bone function. Human breast-cancer causation is not established. Sedation impairs driving; avoid alcohol/CNS depressants.
- NADH-cytochrome b5 reductase deficiency increases methemoglobin/sulfhemoglobin risk. G6PD deficiency matters if methemoglobinemia occurs: methylene blue is not recommended because potentially fatal hemolysis can result.
- Rapid IV administration can cause intense anxiety/restlessness and subsequent drowsiness. Injection use following GI anastomosis requires assessment of pressure on the suture line.
Contraindications
Current Reglan, Gimoti, selected ODT and injection: history of TD or a metoclopramide dystonic reaction; hazardous GI stimulation such as hemorrhage, mechanical obstruction or perforation; pheochromocytoma or catecholamine-releasing paraganglioma; epilepsy; metoclopramide hypersensitivity, including severe airway reactions. The older solution lists fewer formal items; that is not permission to ignore current ingredient-level safety or a TD history.
Boxed warning · tardive dyskinesia
All reviewed products carry a TD boxed warning. Current Reglan distinguishes GERD maximum 12 weeks from gastroparesis total exposure beyond 12 weeks: avoid it; if unavoidable, routinely monitor TD. Gimoti/injection similarly track total exposure and monitoring for unavoidable longer gastroparesis treatment. Older ODT/solution retain older boxed-duration wording; no universal extended-use authorization is inferred.
Adverse reactions and overdose
Common oral effects include restlessness, drowsiness, fatigue and lassitude; GI upset/diarrhea and dizziness can occur. Nasal trials commonly reported taste change, headache and fatigue; incidence cannot be compared across products. Serious reports include movement disorders, seizures, serotonin syndrome with serotonergic agents, blood disorders, methemoglobinemia and severe allergy. Overdose may cause disorientation, severe sedation, EPS, NMS, methemoglobinemia and death. Emergency/Poison Help (1-800-222-1222); no specific overdose antidote. Hemodialysis/CAPD remove no significant amount; professional supportive treatment, with G6PD safeguards, is required.
Drug interactions
CYP2D6 restrictions and CNS risks vary by product.
Avoidance and dose review
Avoid antipsychotic combinations, MAO inhibitors and overlapping CNS depressants such as alcohol, opioids, hypnotics and anxiolytics. Strong CYP2D6 inhibitors include quinidine, bupropion, fluoxetine and paroxetine: Reglan GERD reduces dose; its gastroparesis table avoids the latter three, while quinidine uses reduction. Selected older ODT reduces doses for all four; Gimoti is not recommended and current injection advises avoidance, or monitoring if unavoidable. Poor-metabolizer restrictions are similarly product-specific.
Motility, dopamine and absorption effects
Anticholinergic drugs, opioids and other motility-slowing drugs can oppose benefit. Dopamine agonists/levodopa have opposing effects and may worsen Parkinson symptoms; avoid concomitant use. Metoclopramide may prolong succinylcholine/mivacurium neuromuscular block: monitor. It can reduce digoxin, atovaquone, fosfomycin and posaconazole oral-suspension absorption; the posaconazole interaction does not apply to delayed-release tablets. It can increase tacrolimus, cyclosporine and sirolimus exposure; use therapeutic monitoring where indicated. Faster food delivery may alter glucose/insulin needs: monitor and adjust clinically. Serotonergic combinations can contribute to serotonin syndrome.
Use in specific populations
Age, organ clearance and reproductive context matter.
Children and older adults
Oral/ODT/nasal pediatric efficacy and safety are not established, with greater EPS and neonatal methemoglobin risks. Injection pediatric approval is limited to single-dose small-bowel intubation; other pediatric uses are unestablished. Older adults generally need low initial dosing and renal assessment; Gimoti has the specific stable-oral-treatment prerequisite described above.
Renal and hepatic considerations
Current tablet and injection adjustment thresholds, exact CrCl 60 tablet discrepancy and older solution <40 threshold are separated in dosage. Severe liver disease can reduce clearance by about 50%; moderate impairment lacks direct PK data. Avoid blanket reassurance from older liquid wording. Gimoti is not recommended in the specified moderate/severe organ impairment. Dialysis does not effectively remove metoclopramide; use product-specific prescribed dosing.
Pregnancy and lactation
Oral observational studies do not report increased adverse-pregnancy risk, but cannot prove zero risk; nasal-specific evidence is limited. Placental passage during delivery can cause neonatal EPS/methemoglobinemia: monitor neonates. Metoclopramide occurs in milk; consider maternal need and feeding benefits/risks, monitor infant GI discomfort, dystonia and methemoglobinemia. Prolactin elevation does not establish efficacy as a milk-production treatment; no lactation-enhancement regimen supplied.
Clinical pharmacology
Upper-GI motility and dopamine antagonism explain clinical effects.
Mechanism
Metoclopramide increases gastric/upper-small-intestinal motility and lower-esophageal-sphincter tone, with acetylcholine sensitization contributing; mechanisms in GERD/gastroparesis are incompletely established. Dopamine-receptor antagonism contributes to antiemetic effects and also EPS/prolactin adverse effects. It does not treat mechanical obstruction.
Pharmacokinetics
Oral bioavailability is roughly 80%; peak concentrations generally at 1–2 hours, normal-renal-function half-life about 5–6 hours. CYP2D6 oxidation plus glucuronide/sulfate conjugation and renal elimination matter. Organ disease and CYP2D6 inhibition increase exposure. Nasal 15 mg produced systemic exposure broadly similar to oral 10 mg in the label study; this is not an independently chosen substitution. ODT is swallowed oral therapy, not an inferred sublingual route.
Monitoring and counseling
Track cumulative exposure, movement symptoms and exact formulation.
Monitoring priorities
Review indication, total prior/current metoclopramide duration, TD/EPS history, depression/Parkinson symptoms, renal/hepatic function and medicines. Reassess response and shortest ongoing need. Watch movements, sedation, mood/suicidality, BP and fluid status; monitor glucose or interacting-drug concentrations when relevant. No universal lab interval or invented TD screening score threshold supplied.
Counseling
Use only the prescribed route/product. Stop and promptly report new uncontrolled movements or spasms; urgent care for fever/rigidity/confusion, airway symptoms, suicidality or overdose. Avoid alcohol and driving until effects known. Follow meal timing and oral/ODT/pump directions; skip missed scheduled doses rather than double. Keep secure from children and tell all clinicians about prior metoclopramide courses. Clinical decisions near disputed renal thresholds or with older liquid labeling require pharmacist review.
Product identification
Concentration, device and label edition must be checked.
Representative Reglan product
- 5 mg tablet
- Green elliptical tablet, REGLAN 5 / ANI; bottle of 100, NDC 62559-165-01.
- 10 mg tablet
- White scored capsule-shaped tablet, REGLAN / ANI 10; bottle of 100, NDC 62559-166-01.
- Status
- Prescription oral product; generic appearance differs.
Dosage forms and strengths
- Selected oral forms
- Reglan tablets 5 and 10 mg; ANI ODT 5 and 10 mg; Chartwell oral solution 5 mg/5 mL (1 mg/mL).
- ODT identification
- White round tablets N / 581 (5 mg) or N / 580 (10 mg); 10-tablet blister boxes NDC 43386-581-31 or 43386-580-31.
- Nasal
- Gimoti 15 mg per 70 microliter metered spray; 9.8 mL bottle, NDC 72089-307-15.
- Injection
- Selected 5 mg/mL solution, 2 mL single-dose vial (10 mg total), NDC 0703-4502-93; IV or IM as prescribed.
Storage and handling
Reviewed products generally store at 20–25°C; liquid/Gimoti permit 15–30°C excursions. Tablets/solution: tight light-resistant container. ODT stays in blister until use. Gimoti discard 4 weeks after opening. Selected injection: protect light in shelf pack, do not freeze, inspect for discoloration/particles, discard unused preservative-free single-dose vial. Its CINV dilution text describes historical frozen-saline stability, while current supply instructions say do not freeze; no home freezing or universal compounded-storage protocol is supplied.
References
Original sources for the clinical and product information.
- DailyMed / official U.S. product labelingReglan oral tablets · full label
Clinical highlights revised February 2026; SPL v8 effective 20260209; API publication Feb 16, 2026. Clinical revision is distinct from publication. Checked October 1, 2026.
- DailyMed / official U.S. product labelingGimoti nasal spray · full label and IFU
Clinical highlights revised February 2026; retained IFU approved June 2020; SPL v6 effective 20260220; API publication Feb 23, 2026. Clinical revision is distinct from publication. Checked October 1, 2026.
- DailyMed / official U.S. product labelingMetoclopramide injection · full Baxter/Teva label
Full clinical label Rev B April 2026; SPL v8 effective 20260415; API publication May 29, 2026. Clinical revision is distinct from publication. Checked October 1, 2026.
- DailyMed / official U.S. product labelingMetoclopramide ODT · full ANI label
Highlights revised December 2020; Medication Guide revised October 2019; currently served older labeling; SPL v3 effective 20201202; API publication Dec 03, 2020. Clinical revision is distinct from publication. Checked October 1, 2026.
- DailyMed / official U.S. product labelingMetoclopramide oral solution · full Chartwell label
Label footer January 2026; older-format clinical content with different renal threshold; SPL v3 effective 20260202; API publication Feb 04, 2026. Clinical revision is distinct from publication. Checked October 1, 2026.