TSR

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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 TSR

Property Description
Active Ingredient Choline Theophyllinate (Oxtriphylline)
Form Oral tablets (often sustained-release), syrups, nebulization solutions
Pharmacological Class Bronchodilator (Xanthine derivative)
General Purpose To widen and maintain open airways for easier breathing
Origin Synthetic, salt form of Theophylline

What Type of Medicine is TSR (Choline Theophyllinate)?

TSR is the trade name for a medicine containing the active ingredient Choline Theophyllinate, which is primarily classified as a bronchodilator belonging to the pharmacological class of Xanthine derivatives. The drug's fundamental function is to act systemically to relieve the constriction of the airways. Choline Theophyllinate is a synthetic small molecule, chemically derived as a stable salt from the compound Theophylline.

This compound is clinically recognized for its use in providing sustained management of obstructive respiratory conditions. This Xanthine derivative is intended for regular use, which is a key differentiator from short-acting rescue inhalers, often used by patients experiencing typical conditions such as chronic wheezing.


Composition and Available Forms of TSR

The medicine TSR is a single-entity drug where the active ingredient is a chemical salt formed by combining the therapeutic agent Theophylline with the stabilizing molecule Choline. This unique salt composition is a distinguishing factor, facilitating its absorption into the bloodstream and historically offering advantages in gastrointestinal tolerance compared to pure Theophylline. TSR is prepared in several systemic dosage forms to allow flexible administration, including oral tablets (which often feature sustained-release designs) and syrups, making it suitable for both adult and pediatric patient groups. The drug may also be available as solutions for nebulization for administration via inhalation directly to the airways.


What is the General Purpose of This Bronchodilator?

The general purpose of TSR is to address the underlying physiological issue of narrowed air passages by facilitating the relaxation of bronchial smooth muscle. This action, known as bronchodilation, serves to widen the airways. The therapeutic goal is fundamentally to support easier and more effective breathing by decreasing the resistance to airflow in the lungs, which is the core challenge in obstructive respiratory diseases.

Regulatory References

  1. WHO Essential Medicines List
  2. NIH DrugBank Entry for Oxtriphylline

What side effects are possible with TSR?

Possible Side Effects and Safety Information

The safety profile for TSR (Choline Theophyllinate), based on its active component Theophylline, is characterized by systemic effects, particularly affecting the central nervous system and the cardiovascular system. Adverse reactions are classified and documented by regulatory authorities, and their severity is often linked to the concentration of the drug in the bloodstream.

Less serious signs, such as nausea, headache, tremor, and restlessness, are commonly reported and may be more frequently observed when treatment is first initiated. These effects are classified under Gastrointestinal and Nervous System disorders in official labeling.


Serious Adverse Reactions and Safety Constraints

Official documents emphasize that the risk of toxicity increases substantially when the serum concentration exceeds 20 mu g/ mL. Serious adverse reactions, which are typically associated with concentrations above this threshold, include Convulsions (Seizures) and Ventricular Arrhythmias (irregular heartbeats). These events constitute the most significant safety concerns documented by regulatory agencies.

Specific safety considerations exist for certain populations due to altered drug clearance, including older adults (geriatric patients), infants under one year of age, and individuals with impaired liver or heart function. These groups are officially recognized as having an increased potential for adverse effects. Additionally, caution is advised for patients with pre-existing conditions such as a history of seizures or peptic ulcer disease. Co-administration with other xanthine-containing preparations is discouraged by regulatory bodies.

Overdose and Emergency Response

Overdose and When to Seek Help

This information on Choline Theophyllinate (TSR) overdose is based strictly on descriptions found in official government regulatory documents.


Documented Overdose Manifestations

An overdose may present with initial signs such as nausea, persistent vomiting, headache, insomnia, tremor, and restlessness. The documented physiological systems affected are the Gastrointestinal, Central Nervous System (CNS), and Cardiovascular system. Overdose can result from either acute overexposure or chronic over-dosing, and the manifestations are typically dose-dependent.


Severe Outcomes and Emergency Action

Severe toxicity carries the potential for life-threatening outcomes, including seizures and serious cardiac arrhythmias (such as ventricular tachycardia), which can lead to cardiac arrest. Due to the risk of severe toxicity and potential for fatal outcomes, regulatory labeling mandates that users seek immediate medical attention or call emergency services/Poison Control immediately if an overdose is suspected.

No specific antidote is known for TSR/Theophylline overdose. Management involves symptomatic and supportive treatment, often requiring hospitalization with continuous ECG monitoring and assessment of serum drug levels. Specific measures, such as the administration of activated charcoal, are described to reduce systemic absorption. The risk of severe toxicity is noted to be increased in the elderly and patients with hepatic impairment.

Therapeutic Uses of TSR

TSR (Choline Theophyllinate) may be part of symptomatic management for patients with chronic lung conditions and is relevant for easing symptoms related to heightened physiological activity. This medication is applied across therapeutic domains involving reversible airflow obstruction. It is primarily used as a maintenance treatment for chronic respiratory conditions, commonly including Bronchial Asthma and Chronic Obstructive Pulmonary Disease (COPD), which encompasses Chronic Bronchitis. It is applied in addressing symptom clusters that create noticeable physiological strain, such as wheezing, shortness of breath (dyspnea), and chest tightness. The application of TSR as maintenance therapy helps maintain a sense of stability when symptoms are more noticeable, contributing to easing the overall symptom load. “It is commonly used when symptoms intensify and supportive relief is needed.” It may assist with widening the air passages, providing supportive relief when symptoms interfere with routine activities, and contributes to improved comfort during symptomatic periods. Furthermore, TSR is considered relevant as an add-on treatment when primary therapies fail to adequately control persistent or recurrent manifestations.

Quick Fact: Relief for Breathing Difficulties

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Eligibility and Restrictions for TSR (Choline Theophyllinate)

Eligibility for using TSR is strictly defined by regulatory authorities and centers on absolute contraindications and specific population restrictions relating to age and co-existing health conditions.

Contraindicated Populations (Must Not Use):

  • Patients with known hypersensitivity to Theophylline or other xanthine derivatives.
  • Individuals with active peptic ulcer disease.
  • Patients with underlying seizure disorders or certain forms of coronary artery disease.

Age and Condition Restrictions:

The use of TSR is not recommended for children under 10 years of age for certain formulations. Older adults require caution due to officially documented decreased drug clearance. Use is restricted in individuals with impaired liver function (hepatic impairment) or cardiac failure because reduced clearance formally increases the risk of toxicity. Regarding pregnancy, TSR is classified as Category C; its use, particularly in the Third Trimester, is restricted and requires close consideration due to decreased drug clearance.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Choline Theophyllinate (TSR) is primarily defined by its clearance through hepatic metabolism, mainly involving the Cytochrome P450 isoenzyme CYP1A2.

Classification Details (Official Regulatory Information)
Contraindicated Combinations Co-administration with Riociguat and other xanthine derivatives is prohibited due to documented risks. Fluvoxamine is advised to be avoided due to the documented significant reduction in clearance.
Pharmacokinetic Modifiers Substances that inhibit CYP1A2 (e.g., Ciprofloxacin, Cimetidine, Macrolides) cause increased plasma exposure due to reduced clearance. Conversely, enzyme inducers (e.g., Rifampicin, Phenobarbital) cause decreased plasma exposure.
Pharmacodynamic Effects The combination with general anesthetics like Halothane is documented to increase the risk of ventricular arrhythmias. Co-administration with Beta-adrenergic agonists may increase the documented risk of hypokalaemia.
Special Constraints Administration with other xanthine preparations must be separated by a mandatory 12-hour interval. Clearance is officially documented to be reduced in specific patient populations, including those with hepatic impairment, congestive heart failure, and during acute viral respiratory infections, which alters the product's official exposure profile.

Mechanism of Action

DNA Topoisomerase Inhibition: The Core Mechanism

This domain covers how the drug TSR acts as a Topoisomerase Poison, primarily targeting and trapping the DNA Topoisomerase I enzyme. This molecular interaction creates stable DNA-enzyme complexes that ultimately lead to lethal DNA lesions when the cell attempts to replicate.


Activation of the DNA Damage Response (DDR)

The stable DNA lesions trigger the DNA Damage Response (DDR) cascade, a fundamental cell signaling cascade that forces the cell into cycle arrest (G2/M checkpoint). By sustaining this genotoxic stress, the mechanism overcomes the cell's inherent repair capabilities.


Resulting Cytotoxicity and Apoptosis

The consequence of the unrepaired DNA damage and persistent DDR signaling is the initiation of Programmed Cell Death (Apoptosis). This mechanism produces the key physiological effect of inhibiting proliferation and reducing the viability of susceptible cell populations through targeted cytotoxicity.

Dosage and Administration Information

The administration of TSR (Choline Theophyllinate) is established for long-term maintenance in chronic respiratory conditions. The primary route for ongoing therapy is oral, using formulations such as tablets or syrups, while an intravenous (IV) solution is generally reserved for acute use in supervised hospital settings.

Dosing for healthy, non-smoking adults typically involves a maintenance range of 400 to 600 mg per day (Theophylline equivalent). Extended-release forms are commonly administered once or twice daily to maintain stable systemic levels, whereas immediate-release forms may be divided into doses taken every six to eight hours. It is a high-level principle to take the medicine at the same scheduled time each day.

Specific instructions detail the proper intake of the medicine. Extended-release tablets must be swallowed whole and should not be chewed, cut, or crushed to ensure correct drug delivery over time. While the timing with meals can vary by formulation, it may be suggested to take certain extended-release capsules one hour before a high-fat meal or without food.

Dosing requires careful attention for specific populations. For older adults (age 60 and over), the maximum total daily dose is usually not more than 400 mg. Patients with impaired liver function or certain co-existing conditions also typically require lower doses and close procedural monitoring. If a dose is missed, patients should take only the next scheduled dose and not double up. Dose adjustments are made in small increments and guided by Therapeutic Drug Monitoring (TDM) due to the drug’s narrow therapeutic window.

Recent Clinical Evidence

Research evidence / Overview of Studies for TSR

Evidence for Use in Chronic Obstructive Pulmonary Disease (COPD)

Research exploring Choline Theophyllinate (TSR) in Chronic Obstructive Pulmonary Disease has utilized various approaches, primarily Randomized Controlled Trials (RCTs) to assess change in measured physiological parameters and Systematic Reviews to pool existing findings. These studies were applied in research contexts involving fluctuating or unstable symptoms in Adults with COPD. The research examined outcomes reflecting daily functioning or activity level (such as spirometry values that measure airflow) and patient-reported outcomes describing perceived discomfort.

Studies monitored how symptoms evolved in the observed populations, and research highlights changes measured during the study period for measures of physiological strain or stress. When used as an add-on, trials reported mixed findings regarding the compound’s association with outcomes describing episodic or acute changes, such as the rate of severe COPD flare-ups.

Evidence for Use in Bronchial Asthma

For persistent Bronchial Asthma, the evidence primarily comes from a history of Comparative Clinical Trials and Randomized Controlled Trials that studied the compound's role in maintenance therapy. Research examined outcomes related to physical discomfort and outcomes reflecting daily functioning or activity level in both Adults and Pediatric groups. Research explored how symptoms evolved in the observed populations, specifically monitoring lung function parameters like FEV1 and parameters reflecting daily functioning or activity level during the study period. Studies focusing on episodes where symptoms become more noticeable reported patterns of change in lung function metrics.

What is Still Uncertain About TSR Research

The research on TSR still contains areas of uncertainty. Findings were mixed in some trials that studied the compound’s association with outcomes describing episodic or acute changes when used alongside newer standard therapies. Furthermore, evidence is limited regarding the clinical significance of certain non-bronchodilator actions. Research describing the relationship between the compound's long-term use and all-cause mortality demonstrated high variability in findings in observational studies; this area remains one where research is ongoing.

Key Studies & References Chronic Use of Theophylline and Mortality in Chronic Obstructive Pulmonary Disease: A Meta-analysis (Observational data review)

Frequently Asked Questions (FAQ)

Common questions about TSR (FAQ)


Q: Is TSR used for the same things as other similar treatments?

A: Official information describes TSR as a xanthine bronchodilator, which functions to relax the muscles in the airways. While its general purpose is to improve breathing, regulatory documents clarify that it is intended for long-term maintenance therapy for chronic respiratory conditions. This contrasts with other treatments, such as short-acting inhalers, which are used for the rapid relief of acute symptoms.


Q: How quickly does TSR typically start to have an effect?

A: TSR is not a fast-acting medicine intended for immediate relief; rather, it is used for sustained, long-term management. According to clinical reports, the drug's extended-release formulation is designed to release slowly, with the time to reach its highest concentration in the blood typically documented to be in the range of 4 to 14 hours after a dose in some clinical reports.


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

A: Official regulatory instructions address this situation specifically. Official instructions state that a patient should not double the dose to make up for the missed one. The guidance is to take only the next scheduled dose.


Q: Do regulatory agencies classify TSR as a controlled substance?

A: No. The active component of TSR, Theophylline, is not categorized as a controlled substance under official regulatory classifications. It is not listed in the schedules of drugs monitored for risk of abuse or dependence.


Q: What kind of monitoring is recommended when taking TSR?

A: Due to the drug having a narrow therapeutic range, regulatory documents recommend that healthcare providers monitor the serum theophylline concentration (the amount of medicine in the blood). This monitoring is performed to maintain the level within the appropriate therapeutic range.


Q: Is it normal to not feel any changes right away when starting TSR?

A: Yes, official prescribing information indicates that TSR is primarily used for the sustained management of chronic conditions. Because its purpose is long-term stability rather than rapid relief, the patient may not experience an immediate change in symptoms when starting treatment.


Q: How long does the body take to clear TSR from the system?

A: The time it takes for the body to clear the drug, known as the half-life, can vary widely. In otherwise healthy, non-smoking adults, the average half-life is documented to be approximately 7 to 9 hours. This time is significantly affected by a person's age, smoking habits, liver function, and other health conditions.


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

A: The official interaction profile of TSR indicates that its active component, theophylline, can interact with a large number of medications. Specific interaction checkers mention potential interactions with certain common non-prescription pain relievers such as acetaminophen and aspirin, so it is important to review the official product documents for known interactions.


Q: Are there any specific foods or drinks to avoid while taking TSR?

A: Official regulatory documents advise limiting excessive consumption of caffeine, which is found in coffee, tea, cola, and chocolate, because caffeine is chemically similar to TSR and may increase the risk of side effects. Additionally, a high intake of certain foods, such as charbroiled meat, may be documented to affect the drug's absorption.


Q: Is TSR safe to use during pregnancy, according to official sources?

A: Regulatory agencies have classified TSR as a Pregnancy Category C medication (pre-2015 system). This classification means that animal studies showed a potential risk to the fetus, but there were no controlled studies on humans. Its use involves balancing potential benefits against potential risks, as is standard practice for Category C drugs.


Q: Can I take other prescription medicines while using TSR?

A: Regulatory documents describe that TSR interacts with a very large number of other medications. Therefore, prescribing guidance emphasizes informing a healthcare professional about all other prescription and non-prescription products to check for known drug interactions.


Q: Why do some people say TSR makes them feel jittery?

A: Official safety documents list restlessness and tremor as potential adverse effects. Regulatory sources describe the appearance of these effects as being related to the drug's action as an adenosine receptor antagonist and its ability to inhibit certain enzymes, which can result in central nervous system stimulation.


Q: Is TSR a common treatment, or is it reserved for special cases?

A: Regulatory information indicates TSR is a bronchodilator used to treat chronic obstructive respiratory conditions. However, due to its narrow therapeutic window and the necessity of monitoring blood levels, it may be used as an alternative treatment or reserved for patients who have not achieved adequate control with other standard therapies.


Q: Are headaches a frequent side effect of TSR?

A: Yes. Official safety information for TSR lists headache as one of the documented less serious signs or commonly reported adverse reactions, alongside symptoms like nausea, tremor, and restlessness. This indicates it is an officially recognized possibility when taking the medicine.


Q: Can TSR be taken with common cold and flu medications?

A: Regulatory sources advise caution when combining TSR with certain ingredients often present in cold and flu medicines, such as pseudoephedrine or other CNS stimulants. The combination of these products can lead to an increased risk of synergistic side effects that affect the nervous system.


Q: What's the difference between the brand name and the generic version of TSR?

A: The brand name (TSR) is the proprietary name given to the medicine by a manufacturer. The generic version contains the exact same active ingredient, Choline Theophyllinate, which is required by regulatory agencies to work in the same way as the brand-name product.


Q: Does TSR affect blood pressure?

A: Yes, official safety documents indicate that TSR can affect the cardiovascular system. Potential serious effects listed in regulatory information include ventricular arrhythmias (irregular heartbeats) and hypotension (low blood pressure), which is why caution is advised for patients with certain heart conditions.


Q: Is TSR available over the counter in any country?

A: Official patient safety guides and regulatory information state that TSR (Theophylline) is available only with a doctor's prescription in its oral and injectable forms. It is generally not available for purchase without a prescription.


Q: What official warnings are attached to TSR?

A: Official warnings attached to TSR emphasize that serious adverse reactions may occur, particularly if the concentration in the bloodstream exceeds the therapeutic range. The most significant safety concerns documented by regulatory agencies include convulsions (seizures) and severe ventricular arrhythmias (irregular heartbeats).


Q: Do official sources discuss TSR use in the elderly?

A: Yes. Official dosing and precaution documents note that older adults (age 60 and over) often require special consideration. This is because official documents indicate that the drug's clearance from the body is decreased in this population, which means they often require a lower maximum daily dose and should be monitored carefully.


Q: What are the known interactions between TSR and herbal products?

A: Official sources note potential interactions between TSR and certain herbal products. For instance, St. John's wort may decrease the drug's effectiveness, while certain stimulants like ephedra or cayenne may increase the risk of toxicity or synergistic stimulant side effects.


Q: What happens if TSR is taken with too much caffeine?

A: Official warnings state that caffeine is chemically similar to the active ingredient in TSR. Taking too much caffeine can potentially increase the risk of side effects of TSR, which may contribute to or increase the risk of symptoms such as restlessness, tremor, or, in rare cases, seizures.


Q: Are there different strengths of TSR available?

A: Yes. The official labeling indicates that TSR is prepared and available in different strengths to accommodate the officially recommended dosage range and to meet the needs of various adult and pediatric patient populations.


Q: Why is TSR sometimes given under different names?

A: Official regulatory names include both the active ingredient (Choline Theophyllinate or Oxtriphylline), which is the generic name recognized worldwide, and several different brand names assigned by various manufacturers for marketing purposes.


Q: Can TSR be taken with antacids or heartburn medicines?

A: Official information for immediate-release formulations indicates that taking TSR with routine antacids does not typically cause clinically significant changes in the absorption of the drug. However, regulatory guidance contraindicates the use of this drug in individuals with active peptic ulcer disease.

How should TSR be stored and disposed of?

The official regulatory guidelines for TSR (Choline Theophyllinate) strictly define its storage and disposal. The medicine must be stored at controlled room temperature, typically 20 C to 25 C, and should be protected from light and excessive moisture. It is mandatory to keep the product in its tightly closed, original container and to not freeze liquid formulations.

Required Storage and Disposal

Requirement Regulatory Mandate
Temperature Store at 20 C to 25 C
Protection Protect from light and moisture; Do not freeze
Child Safety Keep out of the sight and reach of children and pets
Disposal Use a drug take-back program or mix with an undesirable substance (e.g., dirt) before discarding in household trash, as per federal guidelines. Do not flush down the toilet.

All unused or expired TSR must be discarded in accordance with these official instructions and local regulations.

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

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Equivalent of TSR found in:

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