metoclopramide hydrochloride 5 mg/5mL Solution, 473 mL — NDC 62135-0526-47 package photo

metoclopramide hydrochloride 5 mg/5mL Solution, 473 mL

by Chartwell RX, LLC · 473 mL in 1 BOTTLE (62135-526-47)
NDC 62135-0526-47
🏷️ FDA NDC (as labeled) 62135-526-47 billing pads the product segment with a zero
This package
Contains473 mL Cost per mL$0.1288 NADAC Per package$60.92 / 473 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0505/unit · Part D plans $0.1035/unit — full pricing hub ↓
Also comes in: 10 cups 62135-0526-24
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 62135-526-47
Product NDC 62135-526
11-digit billing NDC 62135052647
NCPDP billing unit ML — per mL (volume)
RxCUI 104884
UNII W1792A2RVD
UPC 0362135526474
Application # ANDA073680
SPL Set ID dc364325-dd39-4259-a348-3760eccdca4b
Established class (EPC) Dopamine-2 Receptor Antagonist
Mechanism of action Dopamine D2 Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1992-10-27
Route ORAL
Dosage form SOLUTION
Substance METOCLOPRAMIDE HYDROCHLORIDE
GPI-14 52300020102013
GCN Seq No 005230
GCN 03610
HICL code 002148
Ingredient (HICL) Metoclopramide Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J9
Therapeutic class — intermediate (HIC2) Drugs Affecting Intestinal Motility
HIC3 code J9A
Therapeutic class — specific (HIC3) Intestinal Motility Stimulants
AHFS code 56:32.00.00
AHFS class Prokinetic Agents
FDB label name METOCLOPRAMIDE 5 MG/5 ML SOLN
FDB brand name Metoclopramide Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 62135-526-47 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62135-0526-47. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Dopamine-2 Receptor Antagonist class.

Pharmacologic class Dopamine-2 Receptor Antagonist
Drug family (ATC) Propulsives
How it works Dopamine D2 Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderCHARTWELL MOLECULAR HOLDINGS LLC
FDA applicationANDA073680 (ANDA)
Labeler code62135
First marketedOct 1992
Product typeHuman Prescription Drug
Portfolio521 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name METOCLOPRAMIDE 5 MG/5 ML SOLN Ingredient Metoclopramide Hcl
📖 What it is MedlinePlus · NLM

Metoclopramide is used to treat gastroesophageal reflux disease (GERD; condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus) and gastroparesis (slow stomach emptying) . Metoclopramide is in a class of medications called prokinetic agents. It works by speeding the movement of food through the stomach and intestines.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps your digestive system move food along faster. If you have acid reflux, it tightens the valve between your esophagus and stomach so acid is less likely to back up. If you h...
  • What exactly is metoclopramide supposed to do for me?
  • This medication is meant to be short-term. For acid reflux, treatment is generally 4 to 12 weeks. For diabetic gastroparesis, it's usually 2 to 8 weeks. Using it longer than recomm...
  • The most common ones — restlessness, drowsiness, and fatigue — affect roughly 1 in 10 people and are usually manageable. The ones that need urgent attention are any unusual or repe...
📖 Read our full Metoclopramide guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color orange
FlavorButterscotch
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.129 $60.92 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0505 $23.89 / 473 ml
Medicare drug plans payPart D · Q2 2026 $0.1035 $48.96 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.132 $0.037
▲ Up 232% over the last 12 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metoclopramide 5 mg/5mL 00121-0576-16 PAI 473 ml $0.127 AA FDA listed save 1%
metoclopramide hydrochloride 5 mg/5mLthis 62135-0526-47 Chartwell 473 ml $0.129 Availability likely
Metoclopramide 5 mg/5mL 62559-0190-16 ANI 473 ml $0.129 AA Availability likely
Metoclopramide 5 mg/5mL 64950-0344-16 Genus 473 ml $0.129 AA Availability likely
Metoclopramide 5 mg/5mL 00121-1576-10 PAI 10 cups AA FDA listed
Metoclopramide 5 mg/5mL 17856-1190-01 ATLANTIC 72 cups AA FDA listed
Metoclopramide 5 mg/5mL 60687-0837-56 American 10 cups AA FDA listed
Metoclopramide 5 mg/5mL 63629-1961-01 Bryant 473 ml AA FDA listed
Metoclopramide 5 mg/5mL 63629-2144-01 Bryant 473 ml AA FDA listed
metoclopramide hydrochloride 5 mg/5mL 68999-0526-24 Chartwell 10 cups FDA listed
Metoclopramide 5 mg/5mL 71335-2732-01 Bryant 473 ml AA FDA listed
Metoclopramide 5 mg/5mL 71335-2997-01 Bryant 473 ml AA FDA listed
Metoclopramide 5 mg/5mL 72162-1750-02 Bryant 473 ml AA FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1992
On the market since
Oct 1992
📍
2026
Currently FDA-listed
34 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 62135-0526-47, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11
Units reimbursed last 4 qtrs
7.1K
Gross reimbursed last 4 qtrs
$359.88
Avg / prescription
$32.72
Avg / unit
$0.0505
Latest quarter Q4 2025
0Rx
Medicaid pays / mL
$0.0505
gross reimbursed
vs
NADAC / mL
$0.1288
acquisition cost
=
Spread
−$0.0783
-61% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
100% FFS
Fee-for-service · 11 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 7,122 units · 18.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
18.318.3
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 18.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 cups62135-0526-24 No Medicaid data
Drug total (last 4 qtrs): 11 Rx · 7,122 units · $360 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Metoclopramide Hydrochloride — the ingredient across all brands.

Top reported reactions

Tardive Dyskinesia16,218
Extrapyramidal Disorder12,921
Nervous System Disorder7,526
Dystonia7,115
Nausea6,495
Pain5,969
Vomiting4,940

Age at onset

Neonate240
Infant83
Child168
Adolescent169
Adult5,074
Elderly3,544

Reporter sex

76,710 reports
Male · 36%
Female · 62%
Unknown · 2%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,386 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
62135-0526-47 You're viewing this 473 mL in 1 BOTTLE (62135-526-47) $0.1288 / mL $60.93 2023-03-21 Active
62135-0526-24 2 TRAY in 1 BOX (62135-526-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10) 2024-10-14 Active

Pack size FAQ

What quantity is in NDC 62135-0526-47?
NDC 62135-0526-47 contains 473 mL — 473 ml in 1 bottle.
What NDC number is used to bill for this package of metoclopramide hydrochloride 5 mg/5mL Solution?
Bill NDC 62135-0526-47 — the 11-digit billing format is 62135052647. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 100 words

WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia.

There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

See WARNINGS

🎯 Indications and Usage ~1 min read

INDICATIONS AND USAGE The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.

The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of 12-week trial using doses of 15 mg q.i.d.

As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (diabetic gastric stasis) Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals and anorexia) appear to respond to metoclopramide within different time intervals.

Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION Therapy with metoclopramide oral solution should not exceed 12 weeks in duration. For the Relief of Symptomatic Gastroesophageal Reflux Administer from 10 mg to 15 mg metoclopramide orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE ).

If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose. Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS ).

Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation. Therapy longer than 12 weeks has not been evaluated and cannot be recommended. For the Relief of Symptoms Associated with Diabetic Gastroparesis (diabetic gastric stasis) Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

Administration of metoclopramide injection up to 10 days may be required before symptoms subside at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation. USE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one half the recommended dosage.

Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate. See OVERDOSAGE section for information regarding dialysis. Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation.

Its safe use has been described in patients with advanced liver disease whose renal function was normal.

Contraindications 102 words

CONTRAINDICATIONS Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phentolamine.

Metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug. Metoclopramide should not be used in epileptics or patients receiving other drugs, which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.

⚠️ Warnings ~3 min read

WARNINGS Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.

Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at the higher doses. These symptoms may include 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 may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly, and they usually will subside. Benzatropine mesylate, 1 to 2 mg intramuscularly, may also be used to reverse these reactions.

Parkinsonian-like symptoms have occurred, more commonly within the first 6 months after beginning treatment with metoclopramide, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following discontinuance of metoclopramide. Patients with preexisting Parkinson’s disease should be given metoclopramide cautiously, if at all, since such patients may experience exacerbation of parkinsonian symptoms when taking metoclopramide.

Tardive Dyskinesia ( see Boxed Warnings ) Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization patterns showed that about 20% of patients who used metoclopramide took it for longer than 12 weeks.

Treatment with metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD. Although the risk of developing TD in the general population may be increased among the elderly, women, and diabetics, it is not possible to predict which patients will develop metoclopramideinduced TD. Both the risk of developing TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose.

Metoclopramide should be discontinued in patients who develop signs or symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients, TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn. Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process.

The effect of this symptomatic suppression upon the long-term course of TD is unknown. Therefore, metoclopramide should not be used for the symptomatic control of TD. Neuroleptic Malignant Syndrome There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide.

Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.…

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency: CNS Effects Restlessness, drowsiness, fatigue, and lassitude occur in approximately 10% of patients receiving the most commonly prescribed dosage of 10 mg q.i.d. (see PRECAUTIONS ).

Insomnia, headache, confusion, dizziness, or mental depression with suicidal ideation (see WARNINGS ) occur less frequently. The incidence of drowsiness is greater at higher doses. There are isolated reports of convulsive seizures without clearcut relationship to metoclopramide.

Rarely, hallucinations have been reported. Extrapyramidal Reactions (EPS) Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus like reactions) and rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine (see WARNINGS ).

Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies (see WARNINGS ). Tardive dyskinesia most frequently is characterized by involuntary movements of the tongue, face, mouth or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance (see WARNINGS ). Motor restlessness (akathisia) may consist of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, foot tapping.

These symptoms may disappear spontaneously or respond to a reduction in dosage. Neuroleptic Malignant Syndrome Rare occurrences of neuroleptic malignant syndrome (NMS) have been reported. This potentially fatal syndrome is comprised of the symptom complex of hyperthermia, altered consciousness, muscular rigidity, and autonomic dysfunction (see WARNINGS ).

Endocrine Disturbances Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia (see PRECAUTIONS ). Fluid retention secondary to transient elevation of aldosterone (see CLINICAL PHARMACOLOGY ). Cardiovascular Hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention, acute congestive heart failure, and possible AV block (see CONTRAINDICATIONS and PRECAUTIONS ).

Gastrointestinal Nausea and bowel disturbances, primarily diarrhea. Hepatic Rarely, cases of hepatotoxicity, characterized by such findings as jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential. Renal Urinary frequency and incontinence.

Hematologic A few cases of neutropenia, leukopenia, or agranulocytosis, generally without clearcut relationship to metoclopramide. Methemoglobinemia, in adults and especially with overdosage in neonates (see OVERDOSAGE ). Sulfhemoglobinemia in adults Allergic Reactions A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma.

Rarely, angioneurotic edema, including glossal or laryngeal edema. Miscellaneous Visual disturbances. Porphyria.

🆘 Overdosage 201 words

OVERDOSAGE Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions. Anticholinergic or antiparkinson drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. Symptoms are self-limiting and usually disappear within 24 hours.

Hemodialysis removes relatively little metoclopramide, probably because of the small amount of the drug in blood relative to tissues. Similarly, continuous ambulatory peritoneal dialysis does not remove significant amounts of drug. It is unlikely that dosage would need to be adjusted to compensate for losses through dialysis.

Dialysis is not likely to be an effective method of drug removal in overdose situations. Unintentional overdose due to misadministration has been reported in infants and children with the use of metoclopramide oral solution. While there was no consistent pattern to the reports associated with these overdoses, events included seizures, extrapyramidal reactions, and lethargy.

Methemoglobinemia has occurred in premature and full-term neonates who were given overdoses of metoclopramide (1 to 4 mg/kg/day orally, intramuscularly or intravenously for 1 to 3 or more days). 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 (see PRECAUTIONS – Other Special Populations ).

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. Its mode of action is unclear. It seems to sensitize tissues to the action of acetylcholine.

The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and duodenal bulb, and increases peristalsis of the duodenum, and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter.

It has little, if any, effect on the motility of the colon or gallbladder. In patients with gastroesophageal reflux and low LESP (lower esophageal sphincter pressure), single oral doses of metoclopramide produce dose-related increases in LESP. Effects begin at about 5 mg and increase through 20 mg (the largest dose tested).

The increase in LESP from a 5 mg dose lasts about 45 minutes and that of 20 mg lasts between 2 and 3 hours. Increased rate of stomach emptying has been observed with single oral doses of 10 mg. The antiemetic properties of metoclopramide appear to be a result of its antagonism of central and peripheral dopamine receptors.

Dopamine produces nausea and vomiting by stimulation of the medullary chemoreceptor trigger zone (CTZ), and metoclopramide blocks stimulation of the CTZ by agents like L-dopa or apomorphine, which are known to increase dopamine levels or to possess dopamine-like effects. Metoclopramide also abolishes the slowing of gastric emptying caused by apomorphine. Like the phenothiazines and related drugs, which are also dopamine antagonists, metoclopramide produces sedation and may produce extrapyramidal reactions, although these are comparatively rare ( See WARNINGS ).

Metoclopramide inhibits the central and peripheral effects of apomorphine, induces release of prolactin and causes a transient increase in circulating aldosterone levels, which may be associated with transient fluid retention. The onset of pharmacological action of metoclopramide is 1 to 3 minutes following an intravenous dose, 10 to 15 minutes following intramuscular administration, and 30 to 60 minutes following an oral dose; pharmacological effects persist for 1 to 2 hours. Pharmacokinetics Metoclopramide is rapidly and well absorbed.

Relative to intravenous dose of 20 mg, the absolute oral bioavailability of metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occur at about 1 to 2 hours after a single oral dose. Similar time to peak is observed after individual doses at steady state.

In a single dose study of 12 subjects, the area under the drug concentration-time curve increases linearly with doses from 20 to 100 mg. Peak concentrations increase linearly with dose, time to peak concentrations remains the same; whole body clearance is unchanged; and the elimination rate remains the same. The average elimination half-life in individuals with normal renal function is 5 to 6 hours.

Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Approximately 85% of the radioactivity of an orally administered dose appears in the urine within 72 hours. Of the 85% eliminated in the urine, about half is present as free or conjugated metoclopramide.

The drug is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about

3.5L/kg) which suggests extensive distribution of drug to the tissues. Renal impairment affects the clearance of metoclopramide. In a study with patients with varying degrees of renal impairment, a reduction in creatinine clearance was correlated with a reduction in plasma clearance, renal clearance, non-renal clearance, and increase in elimination half-life. The kinetics of metoclopra…

📦 How Supplied / Storage and Handling 111 words

HOW SUPPLIED Metoclopramide Oral Solution, USP 5 mg metoclopramide base (as the monohydrochloride monohydrate) per 5 mL (teaspoonful) is available as an orange color clear liquid with a characteristic butterscotch flavor in the following size: 473 mL (16 fl oz) NDC 62135-526-47 Unit Dose Cup 10 mL NDC 62135-526-10 20 Unit Dose Cups of 10 mL each NDC 62135-526-24 Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Store at controlled room temperature, between 20°C and 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71341 Rev. 01/2026

📋 Description 107 words

DESCRIPTION Metoclopramide Oral Solution, USP is an orange color clear, palatable, aromatic, sugar-free liquid, with characteristic butterscotch flavor, for oral administration. Each 5 mL (teaspoonful) contains: Metoclopramide base (as the monohydrochloride monohydrate) 5 mg. Inactive Ingredients: Citric acid, sodium saccharin dihydrate, propylene glycol, methylparaben, propylparaben, FD&C Yellow #6, butterscotch flavor, and water.

(pH of the product is between 2.0 and 5.5). Metoclopramide hydrochloride is a white, crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate.

Its molecular formula is C 14 H 22 ClN 3 O 2 •HCl•H 2 O, with a molecular weight of 354.3. Its structure formula is: image description

💬 Patient Medication Information ~3 min read

MEDICATION GUIDE METOCLOPRAMIDE (met-o-KLO-pra-mide) ORAL SOLUTION Read the Medication Guide that comes with Metoclopramide before you start taking it and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as REGLAN tablets, REGLAN ODT, or REGLAN injection), you should read the Medication Guide that comes with that product.

Some of the information may be different. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about Metoclopramide?

Metoclopramide can cause serious side effects, including: Tardive Dyskinesia (abnormal muscle movements). These movements happen mostly in the face muscles. You can not control these movements.

They may not go away even after stopping Metoclopramide. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking Metoclopramide. Your chances for getting tardive dyskinesia go up: the longer you take Metoclopramide and the more Metoclopramide you take.

You should not take Metoclopramide for more than 12 weeks. if you are older, especially if you are a woman if you have diabetes It is not possible for your doctor to know if you will get tardive dyskinesia if you take Metoclopramide. Call your doctor right away if you get movements you can not stop or control, such as: lip smacking, chewing, or puckering up your mouth frowning or scowling sticking out your tongue blinking and moving your eyes shaking of your arms and legs See the section “What are the possible side effects of Metoclopramide?” for more information about side effects.

What is Metoclopramide? Metoclopramide is a prescription medicine used: in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux disease (GERD) when certain other treatments do not work. Metoclopramide relieves daytime heartburn and heartburn after meals.

It also helps ulcers in the esophagus to heal. to relieve symptoms of slow stomach emptying in people with diabetes. Metoclopramide helps treat symptoms such as nausea, vomiting, heartburn, feeling full long after a meal, and loss of appetite. All these symptoms do not get better at the same time.

It is not known if Metoclopramide is safe and works in children. Who should not take Metoclopramide? Do not take Metoclopramide if you: have stomach or intestine problems that could get worse with Metoclopramide, such as bleeding, blockage or a tear in the stomach or bowel wall have an adrenal gland tumor called a pheochromocytoma are allergic to Metoclopramide or anything in it.

See the end of this Medication Guide for a list of the ingredients in Metoclopramide. take medicines that can cause uncontrolled movements, such as medicines for mental illness have seizures What should I tell my doctor before taking Metoclopramide? Tell your doctor about all your health problems, including: depression Parkinson’s disease high blood pressure kidney problems. Your doctor may start with a lower dose. liver problems or heart failure.

Metoclopramide may cause your body to hold fluids. diabetes. Your dose of insulin may need to be changed. breast cancer you are pregnant or plan to become pregnant. It is not known if Metoclopramide will harm your unborn baby. you are breast-feeding.

Metoclopramide can pass into breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you take Metoclopramide. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Metoclopramide and some other medicines may interact with each other and may not work as well, or cause possible side effects. Do not start any new medicines while taking Metoclopramide until you talk with your doctor. Especially tell your doctor if you take: another medicine that contains metoclopramide, s…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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