Brintenal

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Brintenal

Medically reviewed

Laura Arias

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 Brintenal

What Type of Medicine is Brintenal? (Classification and Identity)

Brintenal is a trade name for a prescription-only pharmacological agent containing the active ingredient Selegiline (or Selegiline hydrochloride). It is formally classified as a Selective Monoamine Oxidase B Inhibitor (MAO-B Inhibitor), placing it within the larger group of Monoamine Oxidase Inhibitors (MAOI). This designation identifies Brintenal as a specialized central nervous system (CNS) agent.

Its specific targeting of the MAO-B enzyme differentiates it from older, non-selective MAO inhibitors. The drug is a single-ingredient product, which simplifies its pharmacological profile and serves as a therapeutic strategy in managing neurological function.


Selegiline: Composition and Available Forms

The therapeutic action of Brintenal is derived from its sole active ingredient, Selegiline (the INN), chemically recognized as the L-enantiomer, L-deprenyl. Selegiline is a synthetic compound, manufactured as a hydrochloride salt, and is not naturally occurring. This compound is used to modulate specific neurotransmitter systems.

This medication is presented in various pharmaceutical preparations, including the traditional oral dosage form (tablet or capsule) and the Transdermal Patch. The Transdermal Patch offers an alternative route of administration that bypasses digestive tract metabolism compared to the oral forms.


General Purpose and Benefit of Selective MAO-B Inhibition

The fundamental purpose of Brintenal is to support neurological function by selectively inhibiting the MAO-B enzyme in the central nervous system. This selective action serves to prevent the metabolic breakdown of the neurotransmitter dopamine. By preserving the existing supply, this mechanism facilitates an increase in dopaminergic activity. This targeted process helps sustain the brain's communication pathways necessary for maintaining motor control and contributing to mood stability.

What side effects are possible with Brintenal?

Possible side effects and safety information

The safety profile of Brintenal (Selegiline) details adverse reactions organized by frequency and affected physiological systems, as documented in official government regulatory sources.

Frequency and System-Organ Classes

The most frequently documented adverse reactions fall into the Very Common (ge 1/10) and Common (ge 1/100 to < 1/10) categories. A Very Common reaction is dyskinesia (involuntary movements), often noted when the medicine is used alongside levodopa. Common reactions primarily involve the Nervous System (e.g., headache, insomnia, dizziness) and Gastrointestinal System (e.g., nausea, dry mouth, constipation). Vascular effects like orthostatic hypotension are also commonly listed. Uncommon reactions include agitation or confusion.

Serious Safety Patterns

Official labeling defines several serious adverse reactions linked to the drug's class. The risk of Serotonin Syndrome is documented, primarily when Brintenal is co-administered with other serotonergic medicines. Furthermore, the potential for a Hypertensive Crisis is a high-level safety characteristic associated with the oral formulation, particularly if the dose exceeds the selective threshold or if combined with tyramine-rich foods, as noted in regulatory sources.

Safety Considerations for Specific Populations

Safety documentation includes specific considerations for certain populations. Older adults may have an increased susceptibility to central nervous system effects, such as confusion or hallucinations. For individuals with severe hepatic impairment or severe renal impairment, some formulations of the medicine are explicitly not recommended, reflecting regulatory caution regarding drug exposure and clearance. Dyskinesia is often noted as a time-related safety pattern, typically occurring early in treatment or during dose adjustments.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents outline the specific signs and symptoms observed in human experience following exposure to high doses of Brintenal (vortioxetine). Documented overdose presentations may include nausea, vomiting, dizziness, somnolence (drowsiness), and generalized pruritus (itching).

Overdose cases involving total exposures up to 75 mg have been reported in clinical studies, primarily showing an increase in these common effects. The limited available data indicates that severe clinical sequelae beyond these symptoms are not routinely associated with such exposures.

Emergency Response and Management

If an overdose is suspected, immediate medical attention is required, and a poison control center should be contacted right away. Management of Brintenal overdose is primarily based on general supportive care and monitoring. Clinicians are instructed to ensure an adequate airway, oxygenation, and ventilation for the patient. Continuous monitoring of cardiac rhythm and vital signs is recommended.

There is no specific antidote designated for Brintenal overdose. The clinical course is managed symptomatically, with interventions instituted to support the patient's vital functions until the effects of the substance subside. The decision to use decontamination procedures, such as activated charcoal, is determined by medical personnel based on the amount ingested and the time elapsed since exposure. It is not known if dialysis would be beneficial.

Therapeutic Uses of Brintenal

What Brintenal Treats: Main Uses and Benefits

Brintenal (Selegiline) is commonly used to help with two key therapeutic domains: movement disorders, specifically the symptoms of Parkinson’s Disease (PD), and Major Depressive Disorder (MDD). The medication may be part of symptomatic management across conditions involving episodic or fluctuating manifestations, primarily focusing on providing symptomatic relief for PD and addressing MDD.

In the context of movement disorders, Brintenal is commonly used to help manage symptoms that interfere with daily functioning such as bradykinesia (slowness), rigidity (stiffness), and resting tremor.

It helps address symptom clusters that may become intense or disruptive, such as motor fluctuations—the periods when primary medication benefits begin to lessen. This is relevant when supportive symptom management is appropriate as it assists with maintaining functional stability and **supports patients during episodes of heightened discomfort.

For individuals with Major Depressive Disorder, the medication provides support that helps ease the overall symptom burden associated with sustained low mood and systemic imbalance.


Quick Fact: Managing Motor Fluctuations This medication is often used when symptoms intensify and supportive relief is needed; it contributes to easing the overall symptom load by assisting with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Eligibility Profile: Who Can and Cannot Use Brintenal?

Brintenal (Selegiline) eligibility is strictly determined by regulatory labeling, classifying populations as permitted, restricted, or contraindicated.

Eligibility Classification Population Rule (Per Official Labeling)
Contraindicated Prohibited in patients with known hypersensitivity to selegiline or concurrently taking MAO inhibitors, certain opioids (e.g., meperidine), or specific antidepressants (SSRIs, SNRIs) [1.4, 1.10]. Use is also prohibited in patients with an active duodenal or gastric ulcer [1.4].
Not Recommended/Restricted Use is not recommended for certain formulations in patients with severe hepatic or renal impairment [1.7, 1.8]. A dose reduction is required for the ODT form in mild to moderate hepatic impairment [1.7].
Use Not Established Safety and efficacy have not been established in the pediatric population [1.1].
Reproductive Status Use during pregnancy is conditional due to insufficient data, while use during lactation is not recommended [1.3].

Eligibility is established for adults with Parkinson's Disease or Major Depressive Disorder, including the geriatric population where no age-specific restrictions limit use, though special care is advised [1.1, 1.8]. Use requires special caution in patients with pre-existing conditions such as specific cardiac arrhythmias or labile hypertension [1.4].

What should I know about interactions with other medicines?

Interactions with other medicines and products

Brintenal (Selegiline) interacts with several medication classes and certain foods, as documented in official regulatory sources. These interactions primarily fall into two categories: Pharmacodynamic risk and Pharmacokinetic modulation.


Contraindicated Combinations

Co-administration with the following drug categories is formally prohibited due to the risk of severe reactions, including Serotonin Syndrome or Hypertensive Crisis:

  • Opioid Drugs: Meperidine, Tramadol, Methadone, and Propoxyphene.
  • Serotonergic Agents: SSRIs, SNRIs, most TCAs, and Dextromethorphan.
  • Other MAO Inhibitors: Including Linezolid and non-selective MAOIs.
  • Sympathomimetics: Agents such as Ephedrine, Pseudoephedrine, and Amphetamines.
  • Herbal Products: St. John's wort is also contraindicated.

Timing and Exposure Rules

  • Washout Periods: A minimum of 14 days must elapse after stopping Brintenal before initiating a contraindicated drug. Conversely, at least 5 weeks should pass after discontinuing Fluoxetine before starting Brintenal.
  • Pharmacokinetic Modulation: Brintenal is metabolized via CYP450 enzymes. The concurrent use of Oral Contraceptives (e.g., those containing Gestodene/Ethinyl Estradiol) may increase Selegiline's bioavailability. Use with CYP3A4 Inducers may decrease Selegiline exposure.

Food and Population Notes

Dietary restrictions are dose-dependent. The oral form generally does not require dietary modification, but the higher-dose transdermal patch (9 mg/12 mg) requires that tyramine-rich foods be avoided. Additionally, higher drug levels may occur in patients with hepatic impairment.

Mechanism of Action

1. Inhibition of Dopamine Catabolism via MAO-B

Brintenal’s mechanism centers on the Monoamine Oxidase B (MAO-B) enzyme, the primary biological target that catalyzes the breakdown of the neurotransmitter dopamine in the brain. The drug acts as a selective, irreversible inhibitor, forming a permanent chemical bond with MAO-B, which renders the enzyme non-functional. This core action reduces the oxidative deamination of dopamine, resulting in elevated dopamine concentrations in neuronal circuits and surrounding glial cells.

2. Augmentation of Dopaminergic Signaling

Reduced metabolic degradation results in elevated concentrations of the neurotransmitter in the synaptic cleft. This increased concentration affects dopaminergic neurotransmission in the central pathways regulating motor function. The irreversible nature of the enzyme inhibition prolongs the duration of this effect, influencing the dynamics of these signaling systems. The mechanism also affects the metabolism of trace amines, such as beta-phenylethylamine, whose concentrations are also regulated by MAO-B.

3. Mechanistic Boundary and Selective Action

The selective nature of the MAO-B inhibition is concentration-dependent. At concentrations exceeding the therapeutic range, the drug's selectivity can be overcome, leading to inhibition of the MAO-A enzyme. This shift changes the pharmacological scope, affecting the catabolism of other neurotransmitters like serotonin and norepinephrine, which modulates other central nervous system pathways beyond the initial focus on dopamine.

Dosage and Administration Information

How to Use Brintenal (Vortioxetine)

This section outlines the administration instructions for Brintenal.

Administration and Dosage Structure

The medicine is administered orally as a tablet, once daily, and may be taken with or without food. The following table summarizes the dosing rules and conditions:

Condition Starting Dose Recommended Dose Range Maximum Dose
Adults (< 65 years) 10 mg once daily 5 mg to 20 mg once daily 20 mg once daily
Elderly (≥ 65 years) 5 mg once daily
CYP2D6 Poor Metabolizers 10 mg once daily 10 mg once daily

The standard starting dose is 10 mg once daily for adults under 65 years, and 5 mg once daily for elderly patients (≥ 65 years). The dose may be adjusted based on individual patient response and tolerance.

Procedural Conditions

Dose Adjustments for Interactions: If taking a strong CYP2D6 inhibitor, the dose should be reduced by one-half. Conversely, if taking a strong CYP inducer for more than 14 days, a dose increase may be considered.

Discontinuation Guidance: For patients taking 15 mg/day or 20 mg/day, it is recommended to reduce the dose to 10 mg/day for one week before completely stopping the medication. Specific guidance is also provided for switching from or to a Monoamine Oxidase Inhibitor (MAOI).

Recent Clinical Evidence

Research Evidence / Overview of Studies for Brintenal

This overview summarizes the formal research conducted on Brintenal (Selegiline), detailing the types of studies available, what the research examined, and where evidence limitations exist, according to regulatory and scientific records.


Evidence for Use in Parkinson's Disease (Movement Disorders)

The research for Parkinson's Disease (PD) is based on Randomized Controlled Trials (RCTs) and long-term observational extensions. Studies monitored individuals with early PD and those with established PD receiving levodopa. The research primarily examined changes in motor symptoms (tremor, slowness) and disability scores. Findings indicate patterns related to a delayed time to the required initiation of levodopa therapy in early PD. When evaluated in patients with motor fluctuations, research highlights changes measured during the study period that may be associated with changes in the duration of levodopa response in some patients. Data are still emerging regarding the effect on non-motor symptoms such as cognition and pain.


Evidence for Use in Major Depressive Disorder

Research for Major Depressive Disorder (MDD) was studied for the transdermal patch formulation through short-term and long-term RCTs. These studies examined outcomes related to depressive symptom scores and the prevention of relapse over a maintenance period. Research highlights changes in overall symptom severity compared to placebo in some acute trials. Long-term trials reported patterns that may be associated with observed changes in the patterns of relapse of depression symptoms. It is important to note that the oral formulation at lower dosage ranges is not established in the research for this condition.


Long-Term Data and Research Gaps

The evidence base includes long-term open-label extensions with follow-up periods extending up to 5 to 7 years for the PD indication. However, long-term effects are not fully established for outcomes related to general Quality of Life and sustained improvements in non-motor symptoms. Research provides limited information on its use in non-adult populations (children and adolescents). Additionally, comparative evidence is lacking for direct head-to-head trials against all contemporary selective MAO-B inhibitors, an area where research is ongoing.

Key Studies & References

  1. NICE Guideline: Parkinson's disease in adults (Clinical Guideline NG71)

Frequently Asked Questions (FAQ)

Common questions about Brintenal (FAQ)

Q: Does Brintenal start working immediately after the first dose?

A: According to official product information, initial biochemical changes may occur relatively quickly after starting the medicine. However, the full intended therapeutic effect often takes up to a few weeks to be observed. Clinical information suggests that some individuals may begin to notice effects within a few days to six weeks of starting treatment.


Q: How long does Brintenal stay in my system after the last dose?

A: Official instructions for discontinuing the medicine include specific washout periods, such as a minimum of 14 days before starting certain other drugs. This requirement suggests that the pharmacological effect of the medicine may persist in the body for a defined period after the last dose.


Q: Is it true that Brintenal can cause extreme tiredness?

A: Yes, regulatory safety documents indicate that tiredness or fatigue is a documented adverse reaction. This reaction is listed as a Common side effect, meaning it occurs in 1% to 10% of patients who use the medicine.


Q: Is Brintenal considered a safe option for older adults?

A: Official guidance indicates that use in the elderly population (patients 65 years and older) is established. However, special caution is advised due to potential increased susceptibility to central nervous system effects such as confusion or hallucinations.


Q: What happens if I stop taking Brintenal suddenly?

A: Official instructions for patients taking higher doses recommend a gradual dose reduction for one week before stopping the medication completely. This procedure is designed to help reduce the potential for experiencing a severe or unwanted reaction upon abrupt discontinuation.


Q: Is Brintenal a generic drug, or is it only available as a brand name?

A: Brintenal is a trade name for the active ingredient Selegiline. Selegiline is identified by its International Nonproprietary Name (INN) and is also available as a generic formulation.


Q: How is Brintenal different from other similar treatments I've heard of?

A: The medicine is formally classified as a Selective Monoamine Oxidase B (MAO-B) Inhibitor. This classification is a key differentiating factor, distinguishing its mechanism from older treatments that were non-selective MAO inhibitors.


Q: What is the risk of having a serious allergic reaction to Brintenal?

A: Regulatory documents state that use is prohibited (contraindicated) in patients with a known hypersensitivity (allergic reaction) to selegiline. Official safety information generally reports if a reaction is possible, but does not provide a statistical frequency for allergic reactions in new users.


Q: Can Brintenal affect fertility or family planning?

A: Regulatory labeling includes specific conditions for its use during pregnancy due to insufficient available data, and the drug is not recommended for use during lactation. Information regarding a direct effect on fertility is not explicitly detailed in the official documents.


Q: What is the typical duration of treatment with Brintenal?

A: Official research evidence, which includes long-term studies for Parkinson's Disease lasting up to 5 to 7 years, suggests the medicine is typically used for chronic management.


Q: Is it normal to feel a bit nauseous when first starting Brintenal?

A: Nausea is a commonly reported side effect, occurring in 1% to 10% of patients who use the medicine. Although official documents do not specify the exact time frame, common side effects may often be experienced when treatment is first initiated.


Q: Are there any known long-term side effects associated with Brintenal use?

A: While the evidence base includes long-term follow-up periods of up to 5 to 7 years, regulatory documents note that long-term effects on outcomes such as general Quality of Life are not fully established in the available research.


Q: Are there different names for Brintenal in other countries?

A: Brintenal is a trade name specific to a manufacturer. The active substance in the medicine is identified globally by its International Nonproprietary Name (INN), which is Selegiline.


Q: Can I take Brintenal if I have high blood pressure?

A: Regulatory documents advise that the medicine requires special caution in patients with pre-existing conditions such as labile hypertension (fluctuating high blood pressure). This is due to the potential for the medicine to be associated with hypertensive reactions.


Q: Is Brintenal associated with any mental health side effects like anxiety?

A: The official safety profile lists several central nervous system effects, including headache, insomnia, agitation, and confusion. While anxiety is not explicitly listed, related mental status changes are documented.


Q: Does the time of day matter when taking Brintenal?

A: While official instructions state the medicine should be taken once daily, regulatory documents for some formulations specify that the dose should not be taken late in the day because it may interfere with sleep.


Q: Can I take other drugs for the same condition while on Brintenal?

A: Clinical information indicates that this medicine has been studied and may be used in combination with some other drugs for the same condition, such as levodopa for Parkinson's Disease. However, co-administration with other treatments for depression (e.g., SSRIs) is contraindicated.


Q: What is the role of Brintenal in managing my condition?

A: The drug's role is to act as a selective MAO-B inhibitor to prevent the metabolic breakdown of the neurotransmitter dopamine. This action helps sustain the brain's communication pathways that are necessary for supporting motor control and contributing to mood stability.


Q: Is Brintenal considered a high-risk medication by regulators?

A: Regulatory documents include warnings regarding the potential for serious adverse reactions, such as Serotonin Syndrome and Hypertensive Crisis. These are high-level safety characteristics that require monitoring as defined for the drug class.


Q: How does the mechanism of Brintenal differ from older treatments?

A: The drug is defined as a Selective MAO-B Inhibitor, meaning it targets the MAO-B enzyme specifically. This selective action distinguishes its mechanism from older treatments that were non-selective MAO inhibitors, which target multiple MAO enzymes.


Q: Does the effectiveness of Brintenal change with age?

A: Official instructions for the elderly population (ge 65 years) recommend a lower starting dose (5 mg instead of 10 mg). This adjustment is based on age-related changes in the way the body handles the drug, which affects exposure.


Q: Is Brintenal a maintenance medicine or something you take as needed?

A: The drug is administered once daily and is used in clinical trials with long-term follow-up periods. This suggests the medicine is typically intended for maintenance or chronic management rather than use on an as-needed basis.


Q: How quickly should I expect to notice any effects from Brintenal?

A: The full intended effect of the medicine may take up to a few weeks to be observed. Clinical information suggests that some individuals may begin to notice effects within a few days to six weeks of starting treatment.


Q: What should I do if I miss a dose of Brintenal?

A: Regulatory information advises taking a missed dose as soon as it is remembered. If it is late afternoon or evening, however, the dose should be skipped, and the patient should return to their regular schedule. It is important that a double dose is not taken.


Q: Does Brintenal interact with common over-the-counter pain relievers?

A: The official label provides warnings for specific classes of medicines, including certain opioids and sympathomimetics (which can be found in some OTC cold medicines). Information on common over-the-counter pain relievers such as NSAIDs is not explicitly listed as a prohibited interaction.


Q: Can Brintenal be taken with multivitamins or mineral supplements?

A: Official warnings advise reporting all medications, including vitamins and herbal products, to a healthcare professional. This is due to the potential for interactions that could affect how the body absorbs or processes the medicine.


Q: Is Brintenal known to cause weight gain or weight loss?

A: Weight loss and anorexia (loss of appetite) are listed as common metabolic adverse reactions (occurring in 1% to 10% of patients). Weight gain is not listed in the common side effects.


Q: Does Brintenal affect blood sugar levels?

A: Post-marketing reports have included observations of both hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar). However, the frequency of these blood sugar effects is not formally reported in official documents.


Q: How often do I need follow-up appointments when taking Brintenal?

A: Regulatory documentation emphasizes that a healthcare professional must check progress at regular visits while a patient is taking the medicine. These visits are necessary to monitor for any unwanted effects and allow for dose changes.


Q: Is it okay to drink a small amount of alcohol while on Brintenal?

A: Alcohol should generally be avoided or limited because its use may increase side effects such as drowsiness, dizziness, confusion, and impaired judgment. These risks are documented in official safety information.


Q: Does Brintenal require any special monitoring or blood tests?

A: Official precautions note that blood tests may be needed by a healthcare professional to check for any unwanted effects or changes that may occur during the course of treatment.


Q: Does Brintenal cause problems with vision?

A: Problems with vision are documented as common or uncommon adverse reactions in official safety lists. These effects can include blurred vision and a condition known as abnormal accommodation.


Q: Does Brintenal affect the ability to drive or operate machinery?

A: The medication can cause central nervous system effects such as dizziness and drowsiness. Regulatory documents state that caution is advised regarding driving or operating machinery until an individual is aware of how the medicine affects them.


Q: Are there any non-medical ingredients in Brintenal that can cause issues?

A: Regulatory documents note that the orally disintegrating tablet form of the medicine contains phenylalanine. This ingredient can worsen conditions such as Phenylketonuria (PKU), and patients with this condition require special consideration.

How should Brintenal be stored and disposed of?

Storage and Protection Requirements

Condition Requirement (Oral Forms) Requirement (Transdermal Patch)
Temperature Store at controlled room temperature (20 C to 25 C), preventing freezing. Store at room temperature, in the original sealed pouch.
Environmental Protect from heat, moisture, and direct light. Protect from heat, moisture, and direct light.
Container Keep in the original, tightly closed container. Store in the original sealed pouch until use.

All forms of Brintenal must be stored out of the sight and reach of children for safety. Unused or expired medication must be disposed of properly according to local regulations. A used transdermal patch must be folded in half, adhesive sides together, before disposal to prevent harm.

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

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