Trima

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Trima

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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 Trima

Trima: Definition and Pharmacological Classification

Property Description
Active Ingredients Moclobemide, Trimebutine maleate
Form Oral solid dosage form (Tablets)
Pharmacological Class Antidepressant / Gastrointestinal Motility Regulator
Origin Synthetic organic compounds

Trima is a fixed-dose combination product administered as an oral solid dosage form, typically a tablet, which contains two distinct synthetic organic compounds: Moclobemide and Trimebutine maleate. This formulation is categorized across two major pharmacological classes. Moclobemide is defined as a Reversible Inhibitor of Monoamine Oxidase Type A (RIMA), a class of Antidepressant agents, distinguished by its selective action. This mechanism is associated with the stabilization of mood-regulating processes.

Conversely, Trimebutine maleate is classified as a Gastrointestinal Motility Regulator, functioning as a spasmolytic agent. The product integrates these two pharmacological effects, distinguishing it from single-agent formulations and defining it as an integrated therapeutic agent for comprehensive management.


The Dual Composition and General Purpose of Trima

The general purpose of Trima is to provide simultaneous regulatory support to both mood and gut function through its blend of active ingredients. The dual composition is engineered to address clinical situations where emotional distress and functional digestive disruption may coexist. The Moclobemide component contributes by modulating mood-regulating messengers, such as Serotonin and Norepinephrine, while the Trimebutine maleate component works to stabilize the nerves and muscles of the lower gastrointestinal tract. As a spasmolytic agent, the Trimebutine component functions to restore normal rhythm to the gut. This approach offers the benefit of simplified therapeutic management, aiming to restore balance to the body's central neurotransmission and peripheral intestinal motility in adult patient groups.

What side effects are possible with Trima?

Possible Side Effects and Safety Information

The safety profile of Trima is dual, incorporating adverse reactions documented for both Moclobemide (antidepressant component) and Trimebutine maleate (gastrointestinal regulator component), as classified in official regulatory documents.

Documented Adverse Reactions

Side effects are categorized by frequency and by the affected System-Organ Class (SOC). Very Common and Common reactions reported include sleep disorders (insomnia or somnolence), headache, nausea, dry mouth, dizziness, agitation, and anxiety. Reactions affecting the Gastrointestinal SOC, such as diarrhea or constipation, are also frequently documented.

Uncommon and Rare reactions listed in official labeling include suicidal ideation or behavior, confusional state, and visual impairment.

Serious Safety Considerations

Regulatory sources explicitly highlight rare but clinically significant adverse reactions. For the Moclobemide component, this includes the potential for Serotonin Syndrome, especially when co-administered with other serotonergic agents, and the risk of QT interval prolongation. For the Trimebutine component, reports of severe skin reactions, such as Erythema Multiforme, are documented.

Regulatory Safety Notes

Specific safety constraints are included in the labeling. The medicine is contraindicated in patients with acute confusional states and Phaeochromocytoma. Caution is advised in patients with severe hepatic impairment. Furthermore, the label notes that the risk of certain psychiatric effects requires close monitoring, particularly at the beginning of treatment.

Overdose and Emergency Response

Overdose and when to seek help

This section describes the officially documented manifestations and required emergency actions for Trima overdose, as stated in government regulatory sources.


Documented Overdose Manifestations

Overdose presentations documented in official labeling primarily involve the central nervous system and cardiovascular effects. Manifestations may include CNS depression/excitation, such as Somnolence, Drowsiness, Confusion, and Agitation. Cardiovascular signs like Tachycardia and mild hypotension have been reported. Gastrointestinal symptoms like Vomiting, Nausea, and Diarrhea may also occur.


Severe Outcomes and Emergency Actions

The regulatory profile highlights the potential for Severe or Life-Threatening Outcomes. These include Serotonin Syndrome, Convulsions/Seizures, Coma, and serious Cardiac Arrhythmia, particularly following poly-drug ingestion. Due to these risks, official guidelines mandate that individuals Seek immediate medical attention for any suspected overdose. Urgent hospitalization is required for serious presentations, and patients must Contact emergency services immediately upon the manifestation of severe symptoms.


Official Management Protocol

Official labeling states that No specific antidote is known for the active components of Trima. Management is defined as Symptomatic and supportive treatment, requiring continuous Intensive monitoring and ECG monitoring until the patient’s condition stabilizes. Increased severity is noted in the elderly population and those with pre-existing hepatic impairment.

Therapeutic Uses of Trima

What Trima Treats: Main Uses and Benefits

Addressing Acute Symptom Flare-Ups

Trima is applicable across general clinical scenarios where symptoms related to heightened physiological activity may become intense or disruptive, often used when short-term symptomatic assistance is needed. Trima is used in situations involving certain distressing symptoms, such as those associated with severe allergies, skin disorders, and specific joint conditions. The use of this formulation may contribute to easing the overall symptom load, which may help with day-to-day comfort during symptomatic periods.

Support for Episodic & Fluctuating Conditions

Commonly used across condition categories characterized by periods of heightened symptoms or conditions involving episodic or fluctuating manifestations, Trima is relevant when symptoms that become more disruptive during flare-ups cluster into patterns requiring supportive management. It may help patients cope more steadily with symptom fluctuations and may assist with maintaining functional stability. It is also applied in contexts involving heightened systemic burden.

“This medicine is relevant in contexts marked by increased discomfort or tension, supporting the patient during difficult episodes by easing distress.”

Easing Temporary Functional Strain

Used in situations involving symptomatic discomfort, Trima is applied in addressing symptoms that may lead to temporary functional strain or symptoms that interfere with daily functioning. This is often relevant when symptoms become momentarily overwhelming, and is used in settings where short-term symptom stabilization is important when they interfere with routine activities. It contributes to easing the overall symptom load.


Quick Fact: Relief for Temporary Functional Strain

This medicine is relevant for easing symptoms that create noticeable functional strain and interfere with routine activities, and may support general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Trima — official regulatory information

Eligibility Scope

  • Populations for whom use is contraindicated: Contraindications strictly prohibit the use of Trima in several patient groups. These include individuals with hypersensitivity to any of the active substances or excipients, a history of angioedema related to ACE inhibitor use, and those with severe liver or kidney impairment, including patients undergoing hemodialysis. It is also prohibited for patients with certain active bleeding disorders (e.g., active peptic ulcer, haemophilia) and those with severe heart failure.

  • Age-related eligibility rules: Use is contraindicated in children and adolescents below 18 years of age. Caution is also advised when treating very old or frail patients due to a potentially greater chance of undesirable effects.

  • Condition-specific eligibility rules: Trima is contraindicated in patients with conditions like significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, and those with hypotensive or haemodynamically unstable states. For patients with moderate hepatic impairment, use may be restricted, requiring close medical supervision and dose limitation of one component.

  • Pregnancy and lactation eligibility status: Trima is contraindicated during pregnancy and lactation, and in women of child-bearing potential not using appropriate contraceptive measures.

Eligibility-Related Restrictions

  • Use is prohibited with concomitant treatment using methotrexate at a dosage of 15 mg or more per week, with sacubitril/valsartan, and with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m^2).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of Trima (Moclobemide/Trimebutine maleate) around mandatory restrictions and necessary caution with several classes of medicinal products.


Contraindicated and High-Risk Combinations

Specific medicines are formally documented as posing a high risk for adverse outcomes due to the Moclobemide component, leading to restrictions on co-administration. These include Pethidine, Tramadol, Linezolid, Selegiline, and Irreversible Monoamine Oxidase Inhibitors (MAOIs).

Pharmacokinetic and Pharmacodynamic Interactions

Interaction documentation highlights substances that affect drug levels or enhance central nervous system activity. The official profile notes Cimetidine may increase Moclobemide's plasma concentration due to its effect on drug clearance. Conversely, Moclobemide is documented to increase the exposure of certain agents, such as Rizatriptan. Furthermore, Trimebutine maleate is documented to prolong the effects of the neuromuscular blocker d-tubocurarine.

Population and Lifestyle Considerations

Regulatory authorities note that the effects of Moclobemide may be increased in individuals with Liver Disease due to slower removal from the body, which could heighten the potential for interactions. Caution is advised regarding the co-administration of Alcohol and certain Herbal products (like St. John's Wort). Dietary restrictions related to tyramine-containing foods are not typically required at standard doses of Moclobemide.

Mechanism of Action

Trima, chemically Trimebutine, is selectively accumulated within the smooth muscle layers of the gastrointestinal tract. Its pharmacological actions are multi-modal. At the level of neuronal signaling, Trimebutine acts as a weak agonist at peripheral mu (mu)-opioid receptors, kappa (kappa)-opioid receptors, and delta (delta)-opioid receptors on myenteric neurons, modulating neurotransmitter release.

At the cellular level, the compound demonstrates concentration-dependent modulation of ion channel conductance. Trimebutine functions as an inhibitor of voltage-dependent L-type calcium (Ca^2+) channels and calcium-activated potassium (K^+) channels in the smooth muscle cell membrane. This results in an attenuation of inward Ca^2+ currents and outward K^+ currents, influencing the resting membrane potential and the frequency of action potentials. Downstream, the altered ion flux modulates the contractile activity of the smooth muscle cells. At the system level, this leads to the modulation of gastric, small intestinal, and colonic motility, and may influence afferent nerve signaling, thereby modulating visceral afferent input and associated reflexes.

Dosage and Administration Information

How to Use Trima: Administration Guidelines

This section outlines the usage parameters for the Trima fixed-dose combination and the administration principles for its components, Moclobemide and Trimebutine maleate.


Administration Scope

Feature Guideline
Route of administration Oral (via swallowing of the tablet with fluid).
Dosing schedule Typically administered in divided doses daily. The initial dose for the Moclobemide component is often 300 mg daily, which may be adjusted up to a maximum daily limit of 600 mg.
Timing in relation to meals Must be taken with or immediately following a meal (after meals).
Preparation requirements Tablets should be swallowed whole with fluid. No crushing or dilution is typically specified.
Age-group administration rules Older Adults: No general dose adjustment is required. Hepatic Impairment: The daily dose of the Moclobemide component is substantially reduced to one-half or one-third in cases of severe liver impairment.
Missed-dose rules If a dose is missed, the next scheduled dose should be taken at the regular time; doses must not be doubled.
Special procedural conditions Treatment typically continues for a minimum of four to six weeks before efficacy is fully assessed. Following long-term use, the medicine requires gradual withdrawal (tapering) rather than abrupt cessation.

Usage Protocol Structure

The administration of Trima involves defined parameters for both the required intake timing and the dose adjustment necessary for specific patient groups. These guidelines include taking the divided daily dose with food to align with the requirements of the RIMA component and necessitate a dose reduction in patients with severe hepatic impairment. The protocol also establishes a timeline for assessing treatment efficacy and describes the gradual tapering procedure for discontinuing the medicine.

Recent Clinical Evidence

Research evidence / Overview of studies for Trima

The research base for Trima, a fixed-dose combination, draws primarily from clinical studies conducted on its two active components: Moclobemide (the mood regulator) and Trimebutine maleate (the gut motility regulator).


Evidence for Use in Depressive Disorders

Research exploring how symptoms change over time was studied for the Moclobemide component, specifically in conditions characterized by fluctuating or episodic manifestations, such as various forms of depression. These investigations used short-term randomized controlled trials (RCTs) and subsequent meta-analyses to examine outcomes over periods typically lasting four to eight weeks. The primary focus of these studies was evaluated in outcomes related to systemic or functional imbalance, using standardized rating scales to describe changes in perceived stress and mood as reported by clinicians.

Evidence for Use in Functional Gastrointestinal Disorders (FGID)

The Trimebutine component was evaluated in controlled trials compared against an inert placebo or other standard comparator treatments. These studies explored the compound's use in conditions involving periods of heightened symptoms, such as Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD). Research examined outcomes related to physical discomfort and measured specific physiological parameters, such as colonic transit time.


What Remains Uncertain in the Research Landscape

Evidence highlights what is known—and what is still uncertain—about Trima. A significant research gap exists because comparative evidence is lacking for the fixed-dose combination product in a single trial setting. Most clinical trials have focused on one component at a time. The integrated effect on outcomes related to systemic or functional imbalance has not been widely examined in dedicated research, meaning that certainty remains low regarding the full scope of the combination’s influence on coexisting mood and gut symptoms.

Frequently Asked Questions (FAQ)

Common questions about Trima (FAQ)


Q: What should I do if I feel like the drug isn't working after a few days?

A: Regulatory documents state that assessing how well Trima is working takes time. Official administration guidelines indicate that treatment should continue for a minimum of four to six weeks before the full effectiveness is assessed. Feeling little change after only a few days is consistent with the drug’s protocol for assessment.


Q: How long does it usually take to notice the effects of Trima?

A: Clinical protocols indicate that a specific period is necessary before the full benefit can be determined. A timeframe of four to six weeks is typically required before the efficacy of the treatment is fully assessed by healthcare providers. This period is consistent with the timeline established in clinical studies for the potential assessment of effects.


Q: What happens if I stop taking Trima suddenly?

A: Official regulatory guidelines emphasize that following long-term use, the medicine requires gradual withdrawal, often called tapering, rather than an abrupt cessation. The label notes that stopping the medicine suddenly can be associated with the occurrence of certain symptoms related to the cessation.


Q: Will Trima interfere with lab test results?

A: The official product information notes that the Trimebutine component is documented to prolong the effects of the neuromuscular blocker d-tubocurarine. This agent, d-tubocurarine, is relevant in certain clinical and procedural settings.


Q: What are the restrictions on using Trima before surgery?

A: The official interaction profile states that the Trimebutine component may prolong the effects of the neuromuscular blocking agent d-tubocurarine. Regulatory information highlights this as a consideration in preparation for certain surgical procedures.


Q: Is Trima used for conditions other than what is listed in the official documents?

A: The officially documented purpose of the fixed-dose combination Trima is strictly limited to the therapeutic indications approved and listed in the government regulatory labeling for its two active components. Information regarding the use of Trima is strictly governed by the conditions approved and defined in regulatory labeling.


Q: How does Trima differ from [Name of common alternative drug]?

A: Trima is structurally a fixed-dose combination product containing two active substances. It includes a Reversible Inhibitor of Monoamine Oxidase Type A (RIMA), which is a type of antidepressant, and a Gastrointestinal Motility Regulator. This combination of two different pharmacological classes distinguishes it from single-agent medicines.


Q: Are there any long-term research studies on the use of Trima?

A: Clinical evidence summarized in regulatory documents primarily stems from short-term randomized controlled trials, typically lasting around four to eight weeks, that were conducted on the individual components. Official regulatory summaries do not generally detail long-term follow-up beyond those initial assessment periods.


Q: What foods or supplements should I be careful about when using Trima?

A: Regulatory documents advise caution regarding the co-administration of Alcohol and certain Herbal products, such as St. John’s Wort. However, dietary restrictions related to tyramine-containing foods are not typically required at standard doses of the Moclobemide component.


Q: How long does Trima stay in your system after you stop taking it?

A: Pharmacokinetic data available for the Trimebutine component indicates an elimination half-life of approximately 2.77 hours following a single oral dose. This half-life is the time it takes for the amount of medicine in the body to be reduced by half.


Q: Is Trima considered a controlled substance?

A: Official drug classification lists, such as the US DEA or international controlled substance schedules, do not list either Moclobemide or Trimebutine as scheduled controlled substances.


Q: What is the difference between Trima and its generic equivalent?

A: A generic equivalent is a medicine that contains the identical active ingredients—Moclobemide and Trimebutine maleate—as the brand-name product Trima. Regulatory bodies require that generics demonstrate they are bioequivalent, meaning they have the same rate and extent of absorption into the body.


Q: What are the signs of an allergic reaction to Trima?

A: Official patient information describes allergic reaction symptoms as potentially including cough, shortness of breath, wheezing, swelling of the face, lips, tongue, or other body parts, rash, itching, hives, fainting, or hayfever-like symptoms.


Q: What is the risk of overdose with Trima?

A: The regulatory documents for the components describe potential symptoms of overdose. These can include nausea, vomiting, drowsiness, disorientation, memory loss, agitation, high blood pressure, and/or convulsions (fits).

How should Trima be stored and disposed of?

How to Store and Dispose of Trima

Storage of Trima tablets must adhere to official regulatory conditions to ensure stability. The product should be stored at ambient temperature, generally required to be below 30 C. It must be kept in a cool, dry place and protected from direct sunlight and moisture.

Handling and Disposal Rules

Requirement Official Instruction
Container Rule Keep tablets in the original blister pack until use.
Safety Store out of the sight and reach of children (mandatory).
Disposal Return expired or unused product to a pharmacist for disposal in accordance with local regulations.
Environmental Do not dispose of via household wastewater or garbage; avoid environmental release.

Do not use the medicine past the expiry date indicated on the packaging.

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

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