Catena

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Catena

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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 Catena

Property Description
Active ingredient Idebenone
Form Film-coated tablets (Oral)
Pharmacological class Psychoanaleptic, Nootropic, Bioenergetic Agent
General purpose Cellular energy support and antioxidant protection
Origin Synthetic (Analogue of Coenzyme Q10)

Defining Catena: Identity and Pharmacological Class

Catena is a specialized prescription pharmaceutical preparation that contains the single active ingredient, Idebenone, and is formulated as oral film-coated tablets. The medicine's active substance is classified by the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) system under the group of Psychoanaleptics, specifically as N06BX13. This classification broadly categorizes the drug based on its effect on the nervous system. The functional identity of the medicine, however, is best understood as a bioenergetic agent due to its targeted action within the cell, a function that has been clinically recognized through pharmacological studies.


Idebenone: Composition, Origin, and Differentiation

The core composition of Catena relies solely on the compound Idebenone, which is a synthetic short-chain benzoquinone derivative. Idebenone is not a naturally occurring substance but was specifically engineered as an analogue of Ubiquinone (also known as Coenzyme Q10 or CoQ10), a vital molecule in cellular respiration. Catena is a single-ingredient product, typically positioned for use in adolescent patients (12 years and older) and adults, targeting conditions associated with compromised mitochondrial function. The key distinction of this synthetic analogue is its molecular structure, which facilitates its function under specific pathological conditions where the natural CoQ10 pathway is compromised.


What is the Core Purpose of Catena?

The fundamental purpose of Catena is to provide specialized Cellular Energy Support and potent Antioxidant Protection at the mitochondrial level. The physiological action of Idebenone involves acting as an electron carrier to restore the critical process of energy (ATP) generation inside the cells, particularly where energy production is dysfunctional. Furthermore, the drug acts as an antioxidant, helping to neutralize free radicals and mitigate the oxidative stress that can damage cell components. This dual function is intended to support the function and viability of metabolically active tissues, such as those in the nervous system and musculature, which are highly vulnerable to energy failure.

What side effects are possible with Catena?

Possible Side Effects and Safety Information

The official safety profile for Catena (Idebenone) is defined by government regulatory documents, which classify adverse reactions based on their frequency and the body system affected. The data provided reflects observations from clinical experience and post-marketing surveillance.


Frequency-Classified Adverse Reactions

The most commonly reported adverse reactions are generally related to the respiratory and gastrointestinal systems:

  • Very Common (ge 1 in 10 patients): Nasopharyngitis and cough.
  • Common (ge 1 in 100 to <1 in 10 patients): Diarrhoea and back pain.

Reactions such as nausea, vomiting, and anorexia are also documented in regulatory labels, often with a Not Known frequency, meaning the occurrence rate cannot be estimated from the available data.


Systemic Safety Concerns and Restrictions

The regulatory label documents adverse effects across several organ classes, frequently noted as having a Not Known frequency due to reliance on post-marketing data. These include effects on:

  • Hepatobiliary System: Documented effects include elevated liver enzymes and, rarely, hepatitis.
  • Blood and Lymphatic System: Potential effects include changes in blood cell counts, such as agranulocytosis and thrombocytopenia.
  • Nervous System: Reactions such as seizure, delirium, and dyskinesia are listed.

Official Safety Constraints: Catena is contraindicated in patients with moderate or severe hepatic impairment or severe renal impairment. Due to the potential for hematological and liver effects, the label requires mandatory monitoring of complete blood cell count and liver function tests prior to and during treatment. A documented, harmless side effect is chromaturia, the reddish-brown discoloration of the urine caused by metabolites.

Overdose and Emergency Response

Catena Overdose and when to seek help

The official regulatory documentation for Catena (Idebenone) addresses the management of overexposure, primarily by defining the risks associated with high-dose scenarios and mandating immediate help-seeking actions.


Domain Official Regulatory Statement
Documented Manifestations No reports of accidental overdose were received during core clinical studies. The safety profile observed at high doses (up to 2250 mg/day) is stated to be consistent with the known adverse reactions.
Potential Severe Outcomes The high-dose reference implies the potential for serious physiological effects, including severe hematological abnormalities like agranulocytosis and hepatic findings such as hepatitis.
Antidote Information There is no specific antidote known for idebenone.
Management and Action Management is limited to the provision of supportive symptomatic treatment. If a dose higher than prescribed is taken, the official instruction is to talk to your doctor straight away.

The official overdose profile functions as a clear instruction set for immediate response, driven by the absence of confirmed accidental overdose data and the reference to high-dose safety. The need to contact a medical professional immediately is mandated due to the potential for severe, documented abnormalities related to the tested high-dose exposure. This required action ensures timely access to necessary supportive symptomatic treatment.

Therapeutic Uses of Catena

What Catena Treats: Main Uses and Benefits

The primary therapeutic role of Catena (Idebenone) is applied across domains where additional symptomatic support is needed in rare, inherited conditions presenting with systemic or localized discomfort. Its use is generally centered around managing the symptomatic burden of these progressive disorders. The medication is relevant for managing symptoms related to visual impairment in certain patient groups.

It is commonly used to help with managing the symptoms of Leber's Hereditary Optic Neuropathy (LHON), Duchenne Muscular Dystrophy (DMD), and other conditions involving episodic or fluctuating manifestations.

Support for Vision and Function

Catena is commonly used for LHON in adolescent and adult patients, where it helps address the symptoms associated with acute or episodic changes in central sight. The overall benefit may assist with managing symptoms that interfere with daily comfort, and contributes to improved comfort during symptomatic periods.

In neuromuscular disorders like DMD, Catena is applied to manage symptoms related to progressive muscle weakness. This use targets the crucial symptoms that create noticeable physiological strain associated with symptoms linked to organ-specific functional stress in the respiratory system. The key benefit supports the management of these symptoms, which assists with maintaining functional stability.


Quick Fact: Relief for Progressive Symptoms

The medication is considered relevant for managing symptoms that intensify temporarily, particularly in inherited degenerative conditions where symptomatic support for vision loss and symptoms linked to organ-specific functional stress is appropriate.

Eligibility and Restrictions for Use

Catena (Idebenone) eligibility is strictly defined by regulatory documents, primarily for use in adolescent and adult patients. The medicine is contraindicated for any patient with known hypersensitivity to the active substance or its excipients. Use is also strictly prohibited for individuals with rare hereditary problems, including galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.

Eligibility Restrictions and Special Populations

Category Regulatory Status (Use is...)
Pediatric Patients (typically under 12 years) Not Established (Safety and efficacy data are insufficient).
Hepatic or Renal Impairment Conditional/Caution (These populations have not been investigated in trials).
Pregnancy and Lactation Not Established (Use is conditional upon potential benefit decisively outweighing any potential risk).
Co-Treatment Restriction Not Recommended (Specific patient groups taking concomitant glucocorticoids are excluded in some protocols).

For elderly patients, regulatory guidance states that no specific dose adjustment is required. For all conditional populations, use requires special consideration and mandatory caution by a physician.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Catena (idebenone) is subject to pharmacokinetic interactions that may alter the exposure of co-administered medicines, and vice versa. Official regulatory information identifies that idebenone is a mild inhibitor of the CYP3A4 enzyme.

After repeated dosing, the plasma concentrations ( C max and AUC) of certain CYP3A4 substrates may be increased. Therefore, caution is advised, and co-administration should be avoided, if possible, with CYP3A4 substrates that have a narrow therapeutic index.

Idebenone may also inhibit P-glycoprotein (P-gp), a key efflux transporter. This inhibitory action can potentially lead to increased exposure of co-administered medicines that are P-gp substrates, such as digoxin, aliskiren, or dabigatran etexilate. These combinations require caution.

Interaction Type Interacting Agent Category Regulatory Constraint
Pharmacokinetic CYP3A4 Substrates (narrow therapeutic index) Use with caution; avoidance advised
Transporter-Mediated P-gp Substrates (e.g., Dabigatran, Digoxin) Use with caution

Furthermore, the maximum plasma concentration of idebenone itself is increased when the product is administered with food, a required constraint for proper absorption. There are no documented timing-separation requirements for co-administered medicines. The final interaction profile is defined by these documented pharmacokinetic and transporter-mediated effects.

Mechanism of Action

The mechanism of Idebenone (Catena) involves a dual function focused on the modulation of cellular bioenergetics and the mitigation of oxidative damage in metabolically active tissues.

Mitochondrial Bioenergetic Support

This domain describes the drug's function as an alternative electron carrier. Idebenone ensures the continuation of the Oxidative Phosphorylation process by transferring electrons directly to Mitochondrial Complex III, effectively bypassing compromised upstream components of the electron transport chain. This action facilitates the generation of Adenosine Triphosphate (ATP) and supports electron flow for processes in the nervous system and other high-demand tissues.

️ Cellular Protection and Antioxidant Action

Idebenone exerts an antioxidant function by operating as a lipid-soluble scavenger of Reactive Oxygen Species (ROS) and free radicals. By neutralizing these damaging species, the drug prevents the initiation of the lipid peroxidation cascade, thereby preserving the structural integrity of both the outer cellular membrane and the critical inner mitochondrial membrane. This combined bioenergetic and antioxidant activity results in the modulation of cellular homeostasis and the maintenance of electrochemical gradients across the mitochondrial membrane.

Dosage and Administration Information

The administration of Catena, which contains the active substance Idebenone, follows specific guidelines. The medicine is supplied as 150 mg film-coated tablets intended solely for oral use. The standard dosing regimen establishes a total daily intake of 900 mg of Idebenone. This amount is typically administered by dividing the total into three separate 300 mg portions, taken three times per day.

Administration Guideline Requirement
Route of Administration Oral use.
Dosing Frequency Three times daily (t.i.d.).
Relation to Meals Must be administered with food (meals).
Tablet Integrity Tablets must be swallowed whole with water and must not be broken or chewed.

The 900 mg dose is fixed for patients 12 years of age and older, which is the minimum age specified for use in the labeling. This continuous regimen is typically managed under specialist supervision. The mandatory instruction to take the medicine with meals is a procedural requirement defined by the label, as this timing is required to achieve the necessary drug absorption. If an administration is missed, the next dose should be taken at its usual time; the official prescribing information does not recommend doubling the subsequent dose to compensate. Continuous use is an established pattern for this medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Catena (Idebenone)

The clinical evaluation of Catena (Idebenone) relies on controlled trials and long-term observational research documented in regulatory and scientific sources. This overview describes the research landscape—the types of studies conducted, what they measured, and what remains uncertain—without offering personal medical advice or describing individual outcomes.


Evidence for use in Leber's Hereditary Optic Neuropathy (LHON)

Catena was studied for LHON in a key short-term, randomized, placebo-controlled trial (RCT), followed by open-label follow-up studies. These studies explored how visual measurements changed over time in adolescent and adult patients. The primary research focus was on measuring changes in Best Corrected Visual Acuity (VA).

For instance, the primary measurement goal of the pivotal short-term RCT, which focused on the best recovery of visual acuity in one eye, did not reach its pre-specified statistical endpoint. However, studies report how symptoms evolved in the observed populations through certain secondary analyses, where data show patterns related to changes in visual measurements in some outcomes. Long-term effects are not fully established by blinded RCTs, and much of this data is drawn from open-label settings which evidence quality varies across studies due to their methodology.


Evidence for use in Duchenne Muscular Dystrophy (DMD)

Research for Catena in DMD was evaluated in intermediate-term, randomized, placebo-controlled trials, complemented by long-term, open-label extension studies. These studies research explored the impact on outcomes related to systemic or functional imbalance in pediatric and adolescent male patients. The main endpoints was studied for respiratory function decline, specifically focusing on the percentage of predicted values for lung capacity and flow.

One key trial reported how symptoms evolved in the observed populations of patients not taking steroids. This trial data show patterns related to changes in the rate of pulmonary function decline and findings indicate differences in the rates of complications, which was observed in some studies. The most definitive findings are in the steroid-naïve subgroup. In both conditions, sample sizes were modest in some initial trials due to the rarity of the conditions studied.

Frequently Asked Questions (FAQ)

Common questions about Catena (FAQ)


Q: Is Catena a brand name or the generic name for the drug?

Catena (sometimes marketed under the brand name Raxone) is a brand name for a medicine. The single active substance contained within it is idebenone. The official product information specifies the drug by its brand and its active ingredient.


Q: How long does it typically take for Catena to start working?

The official prescribing information for Catena does not specify a typical timeframe for the drug to start working. According to the available clinical summaries, the time to onset of effect is not clinically established or defined.


Q: What is the expected timeframe to see the full benefit of Catena?

The drug’s prescribing information does not define an expected timeframe to see its full benefit. Because of its specific function (cellular energy support), the impact is generally explored over long-term periods in clinical trials.


Q: Is there an interaction between Catena and alcohol?

Official interaction studies with alcohol in humans have not been performed or the data is unknown. Information about alcohol consumption in combination with this medicine is best discussed with a healthcare professional.


Q: Do the side effects of Catena go away after a few weeks of use?

Most observed side effects for many medications, including Catena, are generally described as temporary and mild. While the time it takes for side effects to resolve is not specifically quantified in the label, patients typically discuss persistent or worsening symptoms with their healthcare professional.


Q: Is there a risk of dependence or withdrawal symptoms associated with Catena?

Catena (Idebenone) is not classified as a controlled substance by regulatory agencies. Furthermore, official drug information does not report any habit-forming tendencies or a risk of physical dependence or withdrawal symptoms associated with its use.


Q: Does Catena cause weight gain or weight loss?

Weight change (gain or loss) is not listed as a common or frequently reported adverse reaction in the regulatory safety profile. Some clinical summaries have noted a potential for changes in body fat or cholesterol in some patients, but weight fluctuations are not an established side effect.


Q: Does Catena affect a person's ability to drive or operate machinery?

Official product information states that Catena has no or negligible influence on the ability to drive or use heavy machinery. Patients are advised to note that adverse reactions, such as dizziness, have the potential to impact performance or judgment.


Q: Is Catena considered a Schedule II controlled substance?

No, Catena (Idebenone) is not classified as a controlled substance under the U.S. Drug Enforcement Administration (DEA) scheduling system or by equivalent regulatory agencies.


Q: Why does Catena have a black box warning (if applicable)?

Catena (Idebenone) does not currently carry a Black Box Warning (also known as a Boxed Warning) in the official prescribing information from the FDA or the European Medicines Agency (EMA).


Q: Is Catena known to cause any allergic reactions?

Regulatory information indicates that Catena is contraindicated in patients with a known hypersensitivity (a type of severe allergic reaction) to the active substance or its inactive ingredients. Use of the drug is forbidden for individuals with a known allergy to its components.


Q: What is the half-life of Catena?

Idebenone has a relatively short half-life and is known to be rapidly and extensively metabolized in the body. According to pharmacokinetic studies, the vast majority of the parent drug is quickly broken down by the body.


Q: Does Catena have any known long-term effects?

While long-term effects are often explored through clinical research, the most definitive long-term effects are not fully established by blinded randomized trials. However, some long-term safety data is gathered from non-blinded observational and extension studies, which contribute to the known safety profile.


Q: Is it true that Catena can affect my mood?

Changes in mood (such as depression or anxiety) are not explicitly listed as classified adverse reactions in the official safety profile. The regulatory information does document other neurological reactions, which may affect the central nervous system.


Q: Can Catena affect fertility in men or women?

The safety of Catena on fertility in men and women is generally not addressed in the official prescribing information. The regulatory guidance for this drug often focuses on established use in specific populations but is not conclusive regarding reproductive health outcomes.


Q: Is Catena used to treat chronic pain?

Catena is primarily approved for its actions as a bioenergetic agent that provides cellular energy support and antioxidant protection. Its approved indications relate to conditions associated with mitochondrial dysfunction, and it is not indicated or approved for the treatment of chronic pain.


Q: Does Catena have an enteric coating?

The tablets are described as film-coated and must be swallowed whole with water. The label specifies this administration requirement, but it does not explicitly state whether the coating is specifically an enteric coating.


Q: Is it normal to have a dry mouth or mild headache after starting Catena?

Specific symptoms like dry mouth or mild headache are not listed among the most common adverse reactions in the regulatory safety profile. Other side effects affecting the gastrointestinal and nervous systems are documented, but these two specific effects are not frequently classified.


Q: Does Catena affect sleep patterns (insomnia or increased drowsiness)?

Sleep changes, such as insomnia or drowsiness, are not explicitly listed as adverse reactions in the main safety profile. The drug’s regulatory documentation does list other central nervous system effects, but these two specific effects are not commonly documented.


Q: What are the serious side effects or warning signs I should watch for?

The official safety profile documents rare but serious systemic concerns, including effects on the liver (e.g., elevated liver enzymes, hepatitis) and the blood (e.g., changes in blood cell counts). Due to these risks, mandatory blood monitoring is required during treatment. Patients are encouraged to contact a healthcare professional if unusual symptoms are noticed.


Q: Are there any major food groups or drinks to avoid while taking Catena?

The official prescribing information does not list any major food groups or drinks that must be avoided. The key administration requirement is that the medicine must be taken with food (meals) to ensure proper drug absorption.


Q: Does Catena interact with common blood pressure medications?

The drug's prescribing information notes that Catena can affect certain drug transporters, such as P-glycoprotein (P-gp). Regulatory documents indicate that co-administration with some blood pressure medicines (which are P-gp substrates) requires clinical caution and may necessitate special monitoring.


Q: Can Catena be taken safely with vitamins or herbal supplements?

The regulatory documents focus primarily on drug-drug interactions. Because Catena can inhibit certain enzymes and transporters (like CYP3A4 and P-gp), it can affect the levels of co-administered medicines, including potential interactions with some supplements. A patient's full regimen, including supplements, is typically reviewed with a healthcare professional.


Q: Are there any known drug interactions with common over-the-counter (OTC) pain relievers?

Catena has been shown to mildly inhibit a key liver enzyme (CYP3A4) that processes many medicines. While specific OTC pain relievers are not named, co-administration with any medicine that is primarily metabolized by CYP3A4 is typically reviewed by a pharmacist or healthcare professional.


Q: What happens if I accidentally take two doses of Catena?

The official documentation provides guidance for a missed dose (do not double the next dose) but does not provide explicit instruction for managing an accidental double dose or overdose. It is essential that a healthcare professional or poison control be contacted immediately if more than the prescribed amount is taken.


Q: Is Catena considered an antidepressant or an anti-inflammatory medication?

The World Health Organization (WHO) classifies the active substance (Idebenone) as a Psychoanaleptic. Functionally, the drug is considered a bioenergetic agent that supports cellular energy and acts as an antioxidant. It is not clinically categorized as an antidepressant or a common anti-inflammatory medication.


Q: Does Catena need to be taken long-term, or is it a short course of treatment?

For its established uses, the official documentation states that continuous use is an established pattern for Catena. Treatment is typically managed under specialist supervision and is generally explored for long-term management rather than a short, curative course.


Q: Is Catena safe for women who are pregnant or breastfeeding?

The safety of Catena during pregnancy and lactation is generally not fully established. Regulatory guidance indicates that use is strictly conditional upon the potential benefit decisively outweighing any potential risk to the fetus or infant. Use is always under the special consideration of a physician.


Q: Does Catena cause sun sensitivity?

Official drug labels do not list sun sensitivity (photosensitivity) as a common or adverse reaction. Idebenone is noted for its antioxidant properties, and the regulatory label does not suggest any increased risk of sun sensitivity.

How should Catena be stored and disposed of?

The drug Catena contains the active ingredient idebenone and was previously approved for conditional use in Canada for Friedreich's Ataxia. While the product is no longer marketed in Canada, the general principles derived from regulatory guidance must be followed for the storage and disposal of all medications.

Storage & Disposal Scope Official Regulatory Requirement
Storage Temperature The drug label is the only source for specific temperature requirements (e.g., room temperature or refrigerated).
Protection Needs Keep the medication in its original container and protect it from excessive heat, moisture, and direct light, unless otherwise directed by the pharmacist or label.
Child-Proofing To prevent accidental poisoning, all medicines, including Catena, must be stored up and away, out of the sight and reach of children and pets.
Disposal Do not flush unused or expired medication down the toilet or pour it down a drain unless explicitly instructed by the drug's label or a drug take-back program. Use a community drug disposal program, mail-back program, or follow official U.S. FDA or Canadian government instructions for household disposal.

All unused or expired medications should be handled according to specific local guidelines to ensure safe environmental disposal and to prevent misuse.

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

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