Maxolone

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Maxolone

Property Description
Active Ingredient Metoclopramide (Hydrochloride)
Primary Forms Tablet, Oral Solution, Injection (Parenteral)
Pharmacological Class Antiemetic and Prokinetic Agent
General Purpose Managing nausea and stimulating digestive transit
Origin Synthetic (Substituted Benzamide Derivative)

What Type of Medicine is Maxolone (Metoclopramide)?

Maxolone is a prescription-only pharmaceutical preparation primarily classified as both an antiemetic and a prokinetic agent. The medicine’s core identity is defined by its single active component, Metoclopramide, which is indicated for the management of certain gastrointestinal conditions. This medicine is often utilized in scenarios where the primary goal is to address discomfort caused by the body's sickness response.

Composition, Origin, and Available Forms

The active substance, Metoclopramide, is a synthetic derivative that chemically belongs to the substituted benzamide class of compounds and is generally supplied as the hydrochloride salt. Metoclopramide is utilized for regulating digestive motility, which characterizes its prokinetic classification. Metoclopramide acts as a dopamine receptor antagonist used in clinical practice. Maxolone is provided in versatile dosage forms, including oral tablets, an oral solution for measured ingestion, and a parenteral solution utilized for injection (intravenous or intramuscular) in acute clinical settings.

General Purpose and How it Affects the Body

Maxolone’s general purpose is to alleviate feelings of sickness and prevent the reflex of vomiting by acting on two distinct systems. The medicine targets the gastrointestinal tract, regulating movement by speeding up the emptying of the stomach contents and increasing the tone of the lower esophageal sphincter. Concurrently, it works centrally to block specific chemical signals, acting as a Dopamine D2 Receptor Antagonist in the brain’s chemoreceptor trigger zone. This combined approach offers the benefit of suppressing sickness centrally while physically normalizing the flow of digestion, making it a comprehensive tool for managing related symptoms.

Regulatory References

  1. WHO Model List of Essential Medicines

What side effects are possible with Maxolone?

Possible Side Effects and Safety Information

The safety profile of Maxolone is strictly documented by government regulatory agencies, detailing potential adverse reactions and use restrictions.

Serious Adverse Reactions and Limitations

Maxolone carries a prominent safety alert regarding the risk of tardive dyskinesia (TD), a potentially irreversible neurological disorder characterized by involuntary, repetitive body movements. This risk is officially noted to increase with the cumulative dose and duration of treatment. To mitigate this risk, regulatory agencies mandate strict limitations on the maximum duration of use, typically restricting treatment to no more than 12 weeks for non-acute indications.

Other serious documented neurological reactions include Neuroleptic Malignant Syndrome (NMS), a potentially fatal syndrome, and acute movement disorders such as dystonia and drug-induced Parkinsonism. Cardiovascular safety concerns, such as bradycardia (slow heart rate) and arrhythmia (irregular heart rhythm), are also documented, particularly with intravenous administration.

Common Adverse Reactions

Adverse reactions are formally classified by frequency. Very common side effects (occurring in 1 out of 10 people or more) typically involve the central nervous system and include drowsiness, fatigue, and restlessness (akathisia). Common side effects (occurring in up to 1 out of 10 people) may include headaches, diarrhea, and insomnia.

Population-Specific Considerations

The drug is contraindicated in specific patient groups, including infants under one year of age. Caution is required when prescribing to the elderly and individuals with pre-existing conditions such as renal or hepatic impairment and certain cardiac conditions, as these patients may be more sensitive to the drug’s effects.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosing on Maxolone (metoclopramide) requires immediate medical attention. The reported symptoms of an overdose often involve the central nervous system and muscular control.

Recognized Overdose Symptoms:

  • Severe drowsiness or confusion
  • Seizures or convulsions
  • Unusual, uncontrollable body movements (extrapyramidal reactions)
  • Lack of energy or disorientation
  • Headache and shortness of breath
  • Bluish coloring of the skin

Extrapyramidal reactions, such as uncontrolled spasms or twisting movements, are a key feature of Maxolone overdose, especially at higher-than-recommended doses. The risk of neurological adverse effects is noted to be greater in children, particularly with oral liquid formulations.

Emergency Actions

If you suspect an overdose, you must act quickly. Immediately call emergency medical services if the person has collapsed, has trouble breathing, has a seizure, or cannot be awakened. Otherwise, contact a poison control center immediately for expert advice. Do not wait for symptoms to worsen. Bringing the medication container can assist healthcare providers in their assessment and treatment. While symptoms may resolve within 24 hours, expert medical observation is critical for safety.

Therapeutic Uses of Maxolone

Maxolone (Metoclopramide) is applied across specific therapeutic domains to provide essential symptomatic assistance, supporting patient comfort during challenging episodes. The medicine is relevant for use in specific therapeutic areas, including contexts marked by increased discomfort where short-term symptomatic management is appropriate.


Controlling Acute Sickness and Vomiting Responses

This medication is relevant for easing symptom clusters that may become intense or disruptive, specifically nausea and vomiting (emesis). It is often used during phases when symptoms become more noticeable, such as for relief of sickness associated with highly emetogenic treatments like chemotherapy or radiotherapy, or managing sickness following surgical procedures. This use provides support that helps ease the overall symptom burden, which contributes to general well-being during symptomatic phases.

“It is used for managing the physical reactions of sickness and vomiting across various acute scenarios.”

Symptomatic Relief for Delayed Stomach Emptying

Maxolone is also applied in addressing symptoms related to conditions where functional stability becomes affected, primarily in the upper gastrointestinal tract. It is used in conditions like diabetic gastroparesis to help manage symptoms that interfere with daily functioning, such as persistent fullness after meals, bloating, and loss of appetite (symptoms that create noticeable physiological strain). The medicine supports the patient during episodes of heightened discomfort.

Quick Fact: Relief for Dyspeptic Symptoms The medicine is commonly used to help with discomfort and fullness associated with upper gastrointestinal discomfort.

Addressing Migraine-Associated Sickness and Refractory Heartburn

The medicine is relevant for easing pronounced symptomatic manifestations in two other key areas. It is applied in situations requiring short-term symptomatic support to manage the severe nausea and vomiting that commonly accompany acute migraine attacks. Furthermore, it is used in conditions where symptoms may intensify temporarily, such as in cases of documented, symptomatic gastroesophageal reflux disease (GERD) when patients require additional symptomatic support with symptoms like heartburn.

Commonly managed indications include diabetic gastroparesis, symptomatic GERD (when additional symptomatic support is needed), and the relief of acute sickness caused by emetogenic cancer therapy or surgery.

Eligibility and Restrictions for Use

Official Eligibility for Maxolone (Metoclopramide)

Maxolone is subject to official population eligibility rules that strictly define who can and cannot use the medicine, as detailed in regulatory labeling.

Contraindicated Populations

Maxolone is contraindicated in several patient groups due to regulatory concern over serious risk:

  • Patients with a known or suspected gastrointestinal hemorrhage, obstruction, or perforation.
  • Patients with a history of epilepsy, Parkinson’s disease, pheochromocytoma, or tardive dyskinesia from metoclopramide or neuroleptics.
  • Infants under 1 year of age are prohibited from using this medicine.

Age and Condition Restrictions

Treatment duration is generally restricted to short-term use only (e.g., maximum of five days in many regions) and is not recommended for chronic conditions. Use is contraindicated in children less than one year old, and it is not recommended for children aged 1 to 18 for most uses. Patients with severe renal or hepatic impairment are eligible only if a mandatory dose reduction is applied to prevent accumulation. During pregnancy, Maxolone can be used if clinically needed but should be avoided near delivery. It is not recommended while breastfeeding.

What should I know about interactions with other medicines?

Maxolone (Metoclopramide) interactions are defined by regulatory authorities based on its core pharmacological and metabolic activities, classifying them into prohibited combinations, additive effects, and exposure modification.

Official Interaction Statements

Interaction Type Interacting Substances/Conditions Interaction Pattern Statement
Contraindicated Combination Levodopa and Dopaminergic Agonists (e.g., Bromocriptine) Formally prohibited due to reciprocal antagonism (Maxolone counters the agonist's effect).
Other Prokinetic Agents (e.g., Domperidone) Generally prohibited due to the risk of additive pharmacodynamic effects on the digestive tract.
Pharmacodynamic Effects CNS Depressants (e.g., Opioids, Sedatives, Alcohol) Documented additive CNS depressant effects, increasing the risk of sedation.
Serotonergic Drugs (e.g., SSRIs, MAOIs) Official warning regarding the potential for Serotonin Syndrome due to additive effects.
Anticholinergic Agents Results in antagonism of the prokinetic effect, counteracting digestive motility enhancement.
Exposure Modification Strong CYP2D6 Inhibitors (e.g., Fluoxetine, Paroxetine) Co-administration is documented to increase the systemic exposure (AUC/Cmax) of Maxolone.
Digoxin and Ciclosporin Maxolone may reduce Digoxin exposure and increase Ciclosporin exposure due to altered gastrointestinal transit time.

Population and Food Interaction Notes

  • Alcohol is noted to enhance the documented CNS depressant effects of the medicine.
  • Food intake officially delays the absorption of oral Maxolone but does not change the total extent of absorption.
  • Patients with Renal or Hepatic Impairment have compromised Maxolone elimination, which heightens the risk of interaction-related accumulation.

Mechanism of Action

The action of Maxolone (Metoclopramide) is based on a dual mechanism that simultaneously affects the central nervous system's signal processing and the muscles of the digestive tract. It engages receptor systems to dampen excessive signaling centrally while increasing peripheral muscular contractility.

Central Mechanistic Domain: Modulation of Emetogenic Signals

Maxolone exerts its central effect by acting as an Antagonist of the Dopamine D2 receptors and, to a lesser degree, the 5 -HT3 receptors located in the Chemoreceptor Trigger Zone (CTZ). By occupying these targets, the drug prevents circulating emetogenic substances from binding and activating the central reflex, leading to the inhibition of emetic signal transmission. This action modulates overactive signals that initiate the emetic sequence.

Peripheral Mechanistic Domain: Modulation of Gastrointestinal Contractility

In the gastrointestinal tract, the drug has a combined effect on the Enteric Nervous System. It acts as an Agonist of the 5 -HT4 receptors, which increases the local release of Acetylcholine (ACh), a key neurotransmitter for muscle contraction. Concurrently, it blocks peripheral D2 receptors, removing an inhibitory brake on smooth muscle. This combined mechanism results in modulated muscular activity, leading to two key physiological changes: accelerated gastric emptying and increased Lower Esophageal Sphincter (LES) tone.

Dosage and Administration Information

Administration Routes and Standard Regimen

Maxolone (Metoclopramide) is administered through three officially approved routes: Oral (tablet or solution) for routine outpatient therapy, and Intravenous (IV) or Intramuscular (IM) injection for acute clinical situations. For continuous oral regimens, the medicine must be administered four times daily (q.i.d.), with specific instructions to take the dose 30 minutes before each meal and at bedtime. A strict procedural rule requires maintaining a minimum interval of 6 hours between any two administrations, even if the previous dose was rejected.


Official Dosing and Duration Limits

Dosing is standardized based on the indication, with the typical oral dose being 10 mg per administration. Injectable use typically starts with a 10 mg dose. Use is strictly time-bound: continuous oral treatment is restricted to a maximum duration of 12 weeks, and acute parenteral use is generally limited to a maximum of 5 consecutive days. The maximum total oral daily dose must not exceed 60 mg.


Population Adjustments and IV Protocol

Official labeling requires specific dose modifications for patients with reduced organ function. A starting dose reduction of approximately 50% is mandated for patients with documented severe renal or hepatic impairment. For parenteral use, the IV dose must be administered as a slow injection over a period of at least 1 to 3 minutes; doses exceeding 10 mg often require prior dilution in a compatible parenteral solution.

Recent Clinical Evidence

Maxolone: Recent Clinical Evidence

Clinical research on Maxolone (metoclopramide) has focused on its effects in various patient groups and its use as a measure to affect gastric emptying time. All statements below describe what studies examined or reported.


Clinical Trial Findings

Key clinical trials examined symptoms in study participants using this regimen over periods up to one year. The primary period of observation was 12 weeks. In specific trials, the formulation was evaluated against standard care.

Sub-Group Analysis and Investigative Focus

Studies evaluated clinical outcomes in specific populations, including people over the age of 65 and individuals with mild co-existing conditions. Study protocols included monitoring liver function in all participants, with a specific focus on those in the sub-groups.

  • Exploratory Data: Initial data from studies explored overall quality of life. Research also investigated a change in pain in participants.
  • Special Populations: The drug's use in people with liver impairment was not studied or is currently under investigation. Ongoing research is evaluating its effect on residual gastric content in patients using certain GLP-1 receptor agonists (medications known to slow gastric emptying).

Safety and Tolerability Profile

Short-term use in adults was evaluated in the studies. The research included investigation into the drug's effect on the risk of complications.

Research Focus Study Endpoint Status of Data
Gastric Emptying Change in pyloric transit time Data suggests a reduction in transit time
Lactation Change in milk production Evidence is inconclusive; no significant increase reported
Migraine/Headache Change in headache scores Studies examined reduction in headache intensity

Key Studies & References

  1. Metoclopramide Oral Tablet: Official FDA Label and Patient Information
  2. Treatment of Established Migraine Attack in Adults: NICE Guideline [NG141] (Relevant sections on antiemetics)
  3. Monitoring and Management of Liver Function Abnormalities Associated with Metoclopramide Therapy
  4. Metoclopramide and Gastric Emptying Time in Patients Using GLP-1 Receptor Agonists: A Prospective Study Abstract

Frequently Asked Questions (FAQ)

Common questions about Maxolone (FAQ)

Q: How quickly should I expect Maxolone to start working?

A: The speed at which Maxolone begins to work depends on how it is administered. Official product information states that its action can begin within 1 to 3 minutes when given intravenously, 10 to 15 minutes following an intramuscular injection, and 30 to 60 minutes after taking an oral dose. The clinical effects typically persist for one to two hours, according to pharmacokinetic data.

Q: Does Maxolone interact with common over-the-counter cold medicines?

A: Regulatory warnings mention that Maxolone can interact with certain ingredients commonly found in over-the-counter (OTC) cold and flu medicines. Specifically, it may have additive sedative effects when combined with CNS depressants. It may also counteract the effects of anticholinergic ingredients, which are sometimes present in OTC cold remedies.

Q: What foods should I avoid when taking Maxolone?

A: Official drug labels indicate that while food intake will delay the rate at which oral Maxolone is absorbed, it does not change the total amount absorbed by the body. No specific foods are prohibited, but official documents note that alcohol may increase the risk of side effects, such as excessive sedation, and concurrent use is discouraged.

Q: Is Maxolone effective for all types of stomach upset?

A: Maxolone is specifically indicated for certain gastrointestinal conditions, rather than being a general treatment for all types of stomach upset. According to official labeling, this includes the short-term relief of symptomatic gastroesophageal reflux disease (GERD) when other conventional treatments have not worked, and for managing diabetic gastroparesis.

Q: Is Maxolone a first-line treatment for its primary indication?

A: Official guidelines often suggest that Maxolone is not used as a first-line treatment. It is generally reserved for patients with conditions like diabetic gastroparesis or specific forms of GERD that have not responded adequately to other treatments, due to the potential for serious side effects associated with its use.

Q: How long does Maxolone stay in your system?

A: The medicine's presence in the body is related to its elimination half-life. For individuals with normal kidney function, the mean elimination half-life is reported to be around 5 to 6 hours. This time may be longer in patients who have impaired kidney function.

Q: What's the difference between Maxolone and Metoclopramide?

A: Maxolone is a brand name for a prescription medicine. The active ingredient that provides the therapeutic effect is Metoclopramide. Metoclopramide is the official generic name for the chemical substance.

Q: Can Maxolone affect sleep patterns?

A: Official product information indicates that side effects which may impact sleep have been reported. These commonly listed reactions include drowsiness, fatigue, and insomnia (difficulty falling or staying asleep).

Q: Is it normal to feel a little dizzy after taking Maxolone?

A: According to official regulatory sources and adverse reaction lists, dizziness is listed as a common reported side effect of metoclopramide.

Q: What is the average duration of treatment with Maxolone?

A: Maxolone is generally intended for short-term use. For continuous oral treatment, official guidelines strictly limit the duration of use to a maximum of 12 weeks. This limitation is in place to help reduce the risk of potential serious, long-term neurological side effects.

Q: Is Maxolone safe for people with kidney problems?

A: Official labeling addresses the use of Maxolone in patients with kidney problems. For those with severe kidney (renal) impairment, official labeling states that a dose reduction of approximately 50% is necessary to avoid drug accumulation and potential side effects.

Q: Does Maxolone show up on standard drug tests?

A: The active ingredient in Maxolone, metoclopramide, can be detected and identified as a specific compound in certain toxicology screening tests.

Q: Is it okay to take Maxolone before driving?

A: Official warnings state that Maxolone can potentially impair the mental and physical abilities required for hazardous tasks. Because Maxolone can impair abilities required for tasks such as driving or operating machinery, caution is recommended until an individual knows how the medicine affects them.

Q: Why is Maxolone sometimes given before surgery?

A: The Maxolone injection is officially indicated for the prevention of post-operative nausea and vomiting. Its use in this setting is related to its indications for preventing sickness after surgery.

Q: Can Maxolone cause headaches?

A: Yes, headache is listed in official adverse reaction reports as a common side effect of metoclopramide.

Q: Can Maxolone be taken on an empty stomach?

A: Official administration instructions include taking the medicine before meals. While food may affect the timing of absorption, taking it before a meal is consistent with standard usage.

Q: Are there any clinical trials currently studying Maxolone for new uses?

A: Public regulatory databases, such as the NIH's ClinicalTrials.gov, provide records of studies that have investigated or are currently exploring the use of metoclopramide for various conditions. These records are constantly updated to reflect ongoing research.

Q: Does Maxolone affect blood pressure?

A: Official safety warnings indicate that cardiovascular concerns have been associated with Maxolone. These concerns include a potential for bradycardia (slow heart rate) and arrhythmia (irregular heart rhythm). High blood pressure (hypertension) is also noted as a possible side effect.

Q: Does research show Maxolone helps with heartburn?

A: Maxolone is indicated for the short-term relief of symptomatic, documented gastroesophageal reflux disease (GERD). Heartburn is one of the symptoms commonly associated with GERD.

Q: Is Maxolone prescribed for migraine relief?

A: The injectable form of the medicine has official approvals in some regions for the symptomatic treatment of nausea and vomiting associated with an acute migraine episode.

Q: Does Maxolone interact with herbal supplements like St. John's Wort?

A: Maxolone carries a warning about the potential risk of Serotonin Syndrome when combined with serotonergic drugs. Because St. John's Wort is a supplement with serotonergic activity, regulatory warnings regarding this type of interaction would apply.

How should Maxolone be stored and disposed of?

Official Storage and Disposal Profile

Storage of Maxolone (metoclopramide) is governed by specific regulatory requirements to maintain its integrity. Maxolone Tablets must be kept in a cool, dry place where the temperature remains below 30 C. Both tablets and injection ampoules must be stored in their original packaging and protected from light, heat, and humidity.

For Maxolone Injection that has been diluted for infusion, the solution must be protected from light and is typically stable for 24 hours, provided it is stored at 2 C to 8 C. Any solution showing yellow discoloration must not be used.

All forms of Maxolone must be stored securely out of the reach and sight of children, preferably in a locked cupboard. To dispose of expired or unused Maxolone, do not use household waste or flush it down the toilet; it must be returned to a pharmacist for disposal in accordance with local environmental requirements.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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