Quibron-T/SR

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Quibron-T/SR

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Overview of Quibron-T/SR

Property Description
Active Ingredient Choline Theophyllinate (Oxtriphylline)
Form Extended-Release Tablet (Sustained-Release)
Pharmacological Class Methylxanthine (Bronchodilator)
General Purpose Relieves difficulty breathing by widening airways
Origin Synthetic derivative (Salt form)

What Type of Medicine is Quibron-T/SR?

Quibron-T/SR is a pharmaceutical preparation classified as a Methylxanthine derivative and a systemic bronchodilator used to support respiratory function. Under the Anatomical Therapeutic Chemical (ATC) classification system, Choline Theophyllinate is categorized as a Xanthine with the code R03DA02. The drug is a synthetic derivative intended for continuous therapeutic effect. This classification places it within the general pharmacological group of Xanthines, substances known for their capacity to promote the relaxation of the smooth muscles of the respiratory tract. It is designed as a single-ingredient product, which is applied in clinical practice for obstructive airway management.

Composition and Form: What is Choline Theophyllinate?

The active substance is Choline Theophyllinate, also known by the non-proprietary name Oxtriphylline, which is the highly soluble choline salt form of the core compound, Theophylline. This formulation is delivered as an Extended-Release Tablet, or Sustained-Release Formulation (SR), for oral administration. The specific choline salt and the specialized formulation are designed to provide a steady therapeutic blood level, thereby enhancing consistency of effect. The use of a salt like Choline Theophyllinate is a strategy to improve the bioavailability of the bronchodilating component. This means the body can absorb and utilize the medicine more efficiently compared to some other derivative forms.

What is the General Purpose of This Drug?

The primary general purpose of Quibron-T/SR is to relieve breathing difficulty by acting as a respiratory smooth muscle relaxant. By achieving bronchodilation, the active substance effectively widens the constricted air passages in the lungs. Xanthines like this are utilized to relax muscles in the lungs, facilitating easier breathing. This continuous action supports the free and efficient flow of air, which is the foundational therapeutic benefit provided by this class of medication in the context of chronic airway constriction, such as when supporting a patient's long-term breathing stability.

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What side effects are possible with Quibron-T/SR?

Possible Side Effects and Safety Information for Quibron-T/SR (Theophylline)

The safety profile of Quibron-T/SR, based on regulatory labeling, is primarily defined by dose-related adverse reactions affecting the central nervous system (CNS), gastrointestinal (GI), and cardiovascular systems. These reactions are more likely to occur when the concentration of theophylline in the blood exceeds the recommended therapeutic range.

Adverse Reactions by Frequency

Classification Examples of Documented Side Effects
Common Headache, nausea, vomiting, restlessness, insomnia, tremor, abdominal pain.
Uncommon / Rare Tachycardia (fast heart rate), palpitations, arrhythmias (irregular heartbeat), and hypersensitivity reactions.
Frequency Not Known Changes in blood pressure, hypokalemia (low potassium), hyperglycemia (high blood sugar), and muscle twitching.

Serious Adverse Reactions

The regulatory profile highlights the risk of clinically significant, serious adverse reactions, which, while rare, require immediate attention. These include seizures (convulsions) and potentially life-threatening cardiac arrhythmias. These events are strongly associated with excessive serum concentrations of the drug.

Safety Restrictions and Monitoring

The medicine is contraindicated in individuals with known hypersensitivity to theophylline. Caution is required in patients with pre-existing conditions such as severe coronary artery disease, acute myocardial injury, or uncontrolled seizures. Official labeling mandates Therapeutic Drug Monitoring (TDM)—regular measurement of theophylline levels in the blood—to ensure the concentration remains within the safe therapeutic window.

Population-Specific Safety Notes

Specific caution and potential dose adjustments are necessary for certain populations. This includes elderly patients and individuals with hepatic (liver) impairment, as they may experience reduced drug clearance, leading to an increased risk of toxicity. Safety considerations are also documented for use during pregnancy and lactation.

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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for an overdose of Choline Theophyllinate (Quibron-T/SR) defines manifestations that require immediate intervention. Documented overdose presentations involve severe systemic toxicity, primarily affecting the central nervous and cardiovascular systems.

Documented Overdose Manifestations

Overdose may present with significant neurological symptoms, including tremors, nervousness, and potentially life-threatening seizures. Cardiovascular toxicity is documented, presenting as sinus tachycardia and serious ventricular arrhythmias that can lead to hemodynamic instability. Gastrointestinal signs such as persistent vomiting and nausea are frequently noted as early indicators of toxicity.

Mandated Emergency Actions

The official labeling states that immediate medical attention must be sought upon the first signs of toxicity, especially if repetitive vomiting or severe neurological symptoms occur. Management procedures require the immediate cessation of the drug and measurement of serum theophylline concentrations. In severe or life-threatening cases, supportive measures, including the administration of activated charcoal or procedures like charcoal haemoperfusion, may be required to eliminate the drug.

Specific Risks and Supportive Care

Management is strictly symptomatic and supportive, as no specific antidote is known. Documented metabolic disturbances include hypokalemia (low potassium) and hyperglycemia (high blood sugar). Regulatory information notes that the elderly and very young infants carry an increased risk of severe toxicity, as do patients with reduced protein binding.

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Therapeutic Uses of Quibron-T/SR

What Quibron-T/SR Treats: Main Uses and Benefits

Quibron-T/SR is commonly used for the continuous, long-term management of chronic conditions, which may include Asthma and Chronic Obstructive Pulmonary Disease (COPD). The active substance is commonly used to help with managing breathing difficulties in conditions like asthma, chronic bronchitis, and emphysema. Its therapeutic role is to provide daily support against the persistent narrowing of airways, helping maintain functional stability.


The medication is applied in addressing the key symptoms related to physical discomfort from constricted airways, such as pronounced wheezing, bothersome shortness of breath, and feelings of chest tightness. The goal of using this medication is to provide supportive relief from symptoms linked to organ-specific functional stress, which provides support that helps ease the overall symptom burden. It is commonly used when supportive symptom management is appropriate, particularly in contexts involving heightened systemic burden. This supportive strategy assists with maintaining functional stability, which may help patients cope more steadily with symptom fluctuations.

“This medication is considered relevant in contexts involving heightened systemic burden and is used across domains where additional symptomatic support is needed.”

Quick Fact: Support for Symptoms Related to Physical Discomfort

Quibron-T/SR is commonly used to help with managing symptoms that interfere with daily comfort, supporting patients during episodes of heightened discomfort by easing the overall symptom load.

Regulatory References

  1. NIH MedlinePlus overview
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Eligibility and Restrictions for Use

Eligibility for Quibron-T/SR Use

Quibron-T/SR (theophylline sustained-release) is an oral medication that can only be used by individuals for whom its benefits outweigh the risks, based on an assessment by a healthcare provider.


Populations Who Must Not Use This Medicine

  • Contraindicated Populations: Use is strictly prohibited in patients with a known hypersensitivity or allergy to theophylline or any ingredient in the product.

  • Acute Symptoms: Due to its slow-release formulation, this medicine is not recommended for patients experiencing acute bronchospasm or status asthmaticus, as it is not intended for rapid relief of severe symptoms.

Populations Requiring Special Caution

Use requires extreme caution and intensive medical monitoring in patients with specific conditions that can decrease theophylline clearance, increasing the risk of toxicity:

  • Concurrent Illnesses: Active peptic ulcer disease, seizure disorders, or cardiac arrhythmias (excluding bradyarrhythmias), which may be exacerbated.
  • Reduced Clearance Risk: Congestive heart failure, acute pulmonary edema, cor-pulmonale, liver disease (cirrhosis, acute hepatitis), hypothyroidism, sepsis, or shock.
  • Age-Related: Neonates, children under 1 year, and the elderly (over 60 years), who have naturally reduced drug clearance or may be more sensitive to the effects. Fever also temporarily reduces clearance.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Quibron-T/SR (Choline Theophyllinate) has a regulatory interaction profile primarily defined by its effects on drug clearance and pharmacodynamic activity. Co-administration with Riociguat is formally contraindicated due to the risk of additive hypotension. The official regulatory documents state that many medicines can significantly modify theophylline plasma concentrations.

Exposure-Altering Interactions (Pharmacokinetic)

Many substances alter theophylline exposure by modulating liver enzymes, particularly the Cytochrome P450 system. Agents that decrease theophylline clearance and increase plasma levels include Cimetidine, Ciprofloxacin, and Erythromycin. Conversely, substances that increase theophylline clearance and reduce effectiveness include Rifampin and certain anticonvulsants like Phenytoin and Phenobarbital. Theophylline also increases the renal clearance of Lithium, potentially lowering its blood levels.

Other Clinically Significant Interactions

Pharmacodynamic interactions are documented, such as theophylline's antagonism of the sedative effects of Benzodiazepines. Non-selective beta-blockers like Propranolol are noted to both reduce theophylline clearance and oppose its primary pharmacological action. Non-medicinal substances such as smoking (tobacco/marijuana) and a single large dose of alcohol are officially documented to alter clearance and subsequent plasma concentrations. Administration of the extended-release formulation must remain consistent with respect to meals to maintain stable drug levels.

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Mechanism of Action

How Quibron-T/SR Works

This mechanism involves a combination of three distinct pharmacological actions. The primary action is the non-selective inhibition of Phosphodiesterase (PDE) enzymes within airway smooth muscle cells. This inhibition prevents the breakdown of the secondary messenger cyclic AMP (cAMP), causing its intracellular concentration to rise. The increase in cAMP activates a signaling cascade that reduces intracellular calcium, resulting in the relaxation of bronchial smooth muscle and a subsequent increase in airway caliber.

Simultaneously, the drug acts as a non-selective antagonist at adenosine receptors ( A1 and A2). This receptor blockade attenuates the reflex-mediated constriction of the airways by preventing the binding of the neuromodulator adenosine. The third mechanism involves the modulation of calcium ( Ca^2+) dynamics in respiratory striated muscle, notably the diaphragm, leading to improved contractile force and resistance to fatigue. These three mechanistic pathways converge to modulate smooth muscle tone, reflex sensitivity, and respiratory muscle contractility.

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Dosage and Administration Information

Official Administration Guidelines

The use of Quibron-T/SR (Choline Theophyllinate Extended-Release) is governed by specific instructions to ensure predictable systemic exposure to the active substance, theophylline. The dosing is highly individualized and relies on therapeutic drug monitoring as specified in official labeling.

Administration Scope

Feature Guideline
Route of administration: Oral administration only for the Extended-Release Tablet.
Dosing schedule (Adults > 45 kg): Initial starting dose is 300 to 400 mg total daily dose. The dose is titrated based on blood levels, with a maximum generally not exceeding 600 mg per day.
Timing in relation to meals: May be taken with or without food, but consistent daily intake relative to meals is necessary for stable concentrations.
Preparation requirements: The Extended-Release Tablet must be swallowed whole; it should not be broken, crushed, or chewed.
Age-group administration rules: Older Adults (Geriatric) are generally limited to a maximum total daily dose of 400 mg. Pediatric dosing (ages 12 to 15 years, < 45 kg) is weight-based, starting at 12 to 14 mg/kg per day.

Resulting Procedural Structure

The established protocol is centered on ensuring continuous drug delivery. The dose is typically administered once or twice daily, and doses must be taken at the same time each day to maintain steady therapeutic concentrations. Dose increases must be made incrementally over intervals of no less than three days. Serum theophylline concentrations should be measured when initiating therapy to guide the final dosage, and periodically (e.g., every 6 to 12 months) during long-term use to confirm maintenance stability.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Quibron-T/SR

The clinical evaluation of Choline Theophyllinate (the active ingredient in Quibron-T/SR) has been conducted over many decades. The research base includes Randomized Controlled Trials (RCTs) and Systematic Reviews that combine findings from multiple studies. This overview focuses strictly on what official research has explored and reported, without offering any clinical advice or summarizing safety information.

Evidence for Use in Stable Chronic Obstructive Pulmonary Disease (COPD)

Research was studied for the use of this medicine in the long-term management of stable Chronic Obstructive Pulmonary Disease (COPD). Studies exploring this use involved adults whose breathing difficulties were confirmed by lung function tests. Researchers carefully monitored outcomes related to systemic or functional measures, including changes in objective lung measurements.

The available evidence describes that when the drug was evaluated in maintenance therapy trials, studies report patterns related to changes in measured lung function parameters. Furthermore, longer-term research has evaluated outcomes related to the frequency of exacerbations and monitored how these episodes evolved in observed populations. Findings also describe patterns related to patient-reported outcomes describing perceived discomfort and difficulty breathing.

Evidence for Use in Chronic Asthma

Research was studied for its use in chronic asthma, a condition marked by functional limitations. Studies in this area have typically been shorter-term RCTs, often placebo-controlled. These trials examined outcomes related to physical discomfort by measuring changes in lung function and monitoring patient-reported outcomes describing nocturnal symptom patterns.

Studies focusing on episodes where symptoms become more noticeable monitored short-term changes in measured lung function parameters. Findings help contextualize how patients reported their experience with symptoms, particularly those occurring overnight. These findings contribute to the broader evidence landscape regarding how symptoms may vary in intensity.

Evidence Quality, Consistency, and Research Gaps

Overall, the research base for the active substance contributes to the broader evidence landscape, yet evidence quality varies across studies. Many pivotal trials are historical, meaning they predate the use of commonly prescribed modern treatments. Comparative evidence is lacking when research has not provided comparison against the newest treatments, and long-term effects are not fully established. Data for certain groups remain insufficient, and research is ongoing in key areas.

Key Studies & References

  1. Label: THEOPHYLLINE extended-release tablet (DailyMed/FDA Regulatory Information)
  2. Theophylline - StatPearls (Clinical Overview and Guideline Context for Dosing and Monitoring)
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Frequently Asked Questions (FAQ)

Common questions about Quibron-T/SR (FAQ)


Q: Are there any common foods or drinks that interact with Quibron-T/SR?

Official documentation indicates that the composition of your diet can affect how your body processes this medicine. For example, a diet that is high in carbohydrate and low in protein can lower the rate at which the drug is cleared from the body. To help maintain stable concentrations of the medicine, official documents describe the importance of taking the doses consistently each day relative to mealtimes.


Q: Is it true that caffeine should be avoided while on Quibron-T/SR?

Official regulatory sources note that consuming large amounts of food or drinks that contain caffeine, such as coffee, tea, or chocolate, may require caution. This note is issued because excessive caffeine intake can potentially alter the blood levels of the active substance in Quibron-T/SR. It may also increase the likelihood of experiencing caffeine-like side effects like nervousness or tremor.


Q: What is the main reason Quibron-T/SR is used as a sustained-release formulation?

The primary purpose of using a sustained-release (SR) formulation is to ensure that the active ingredient, theophylline, is delivered at a consistent rate over an extended period. This design helps maintain sustained therapeutic levels in the blood, which is necessary to provide stable bronchodilation and symptom relief for chronic respiratory conditions.


Q: Are there specific organs, like the liver or kidneys, that are important for processing Quibron-T/SR?

The liver is the primary organ noted in official product information for processing (metabolizing) the active substance, theophylline. Because of this, populations with pre-existing hepatic (liver) impairment may process the drug slower, which can increase the risk of toxicity. For these populations, careful monitoring and possible dosage evaluation are points of regulatory caution.


Q: What should I do if I forget a dose of Quibron-T/SR?

Official regulatory guidance regarding a missed dose is based on skipping that missed dose, with directions to return to the regular dosing schedule the next time. The official guidance strictly advises against taking two doses at once to compensate for a missed one.


Q: Can I take over-the-counter cold and flu medicine with Quibron-T/SR?

Official product information advises consulting a healthcare professional before starting or stopping any medication, including over-the-counter (OTC) products. This is important because many OTC cold and flu medicines contain ingredients that can alter theophylline blood levels or might increase the risk of stimulating side effects.


Q: How does the concentration of Quibron-T/SR in the blood relate to its effect?

Official information indicates that clinically important benefit is generally associated with serum concentrations greater than 10 mu g/ mL. Regulatory monitoring is designed to keep the drug's concentration within the range of 5 –20 mu g/ mL. When concentrations rise above 20 mu g/ mL, the risk and severity of common side effects are noted to increase.


Q: How quickly should I expect to feel the effect of Quibron-T/SR after starting it?

Because this is an extended-release formulation designed for chronic management, a steady therapeutic effect relies on building a stable concentration over several days of consistent dosing. Studies indicate that the active ingredient generally achieves its maximum concentration in the blood within 6 to 10 hours following a single tablet administration.


Q: How long does one dose of Quibron-T/SR usually last?

The extended-release formulation is typically used with a 12-hour dosing interval to ensure sustained therapeutic levels. The average half-life of the active ingredient in adults is documented to be approximately 8 hours, although this rate can vary significantly from person to person due to several factors.


Q: Can Quibron-T/SR cause stomach upset or nausea?

Official safety documents list nausea and abdominal pain as commonly reported side effects. Gastrointestinal upset is a recognized adverse reaction linked to theophylline therapy.


Q: What are the ingredients in the tablet besides the active medicine?

The tablets contain the active drug, anhydrous theophylline, along with a number of other components known as inactive ingredients. These components, which help form the tablet and control its release, may include substances such as hypromellose, lactose monohydrate, magnesium stearate, and povidone.


Q: Is there a generic version of Quibron-T/SR available?

Quibron-T/SR is a brand name. However, the active substance, theophylline, is widely available as a generic, extended-release tablet under its chemical name, anhydrous theophylline, in many regions.


Q: Are there any lab tests I need to have regularly while taking Quibron-T/SR?

Regulatory labeling includes the regular measurement of blood theophylline levels (Therapeutic Drug Monitoring) as a required part of monitoring to guide dosing and ensure concentrations remain safe. Official information also advises notifying lab personnel that you are taking this medicine, as it may potentially interfere with the results of certain other lab tests.


Q: How does being sick (like having a fever or flu) affect Quibron-T/SR?

Official guidance advises that developing a new illness, especially one accompanied by a fever, requires a doctor’s evaluation. This is because significant fever (sustained at or above 102 F for 24 hours or more) or a worsening chronic illness can potentially reduce the body's rate of clearing the medicine, which official guidance identifies that notifying a doctor is important.


Q: What is the maximum amount of time Quibron-T/SR is typically prescribed for?

The medicine is indicated for the symptomatic management or prevention of chronic respiratory conditions such as asthma and reversible bronchospasm associated with COPD. This regulatory description indicates that its use is intended for the long-term management of these chronic conditions, potentially over extended periods.


Q: Is Quibron-T/SR used only for prevention, or can it help during a flare-up?

The extended-release formulation is intended solely for the management and prevention of chronic symptoms. Official product information specifically states that it is not indicated for the treatment of acute bronchospasm or status asthmaticus and will not stop an asthma attack once one has started.


Q: Are there documented reports of Quibron-T/SR interacting with herbal supplements?

Authoritative medical sources note the importance of informing a healthcare professional about all medications, including any herbs and supplements. Regulatory-based warnings specifically mention the potential for interaction with certain supplements, such as St. John's wort and ephedra.


Q: Are there different strengths of Quibron-T/SR tablets available?

Regulatory documents describe extended-release tablets containing different strengths of the active ingredient, anhydrous theophylline. These typically include strengths of 300 mg and 450 mg to accommodate the need for highly individualized dosing.


Q: Is there any information about Quibron-T/SR use during pregnancy or breastfeeding?

Official information states that the medicine's active substance is known to be found in breast milk. Official sources note that the use during pregnancy or while breastfeeding is a topic that requires discussion with a healthcare provider, based on their clinical assessment.


Q: Can I take other respiratory inhalers while I am taking Quibron-T/SR?

Regulatory patient instructions emphasize that the medicine is for chronic control and will not stop an asthma attack. Regulatory patient instructions indicate that patients should possess appropriate rescue medicine, such as a bronchodilator inhaler, for use in case of an acute attack.


Q: Is it possible to take Quibron-T/SR with certain antacids?

Clinical studies of the immediate-release form of the active ingredient indicate that co-administration with standard antacids does not cause clinically significant changes in the body's absorption of the medicine.

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How should Quibron-T/SR be stored and disposed of?

How to Store and Dispose of Quibron-T/SR

This information details the official regulatory requirements for the storage and disposal of theophylline extended-release tablets (Quibron-T/SR).

Storage Requirements

The medication must be stored at controlled room temperature, typically between 20 C and 25 C (68 F and 77 F). Protect the tablets from both excess heat and excess moisture; do not store them in high-moisture areas like a bathroom. The tablets must be kept in their original container, which should be tightly closed and fitted with a child-resistant closure. For safety, the medicine must always be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Quibron-T/SR should be disposed of through a drug take-back program or mail-back option when available. If those options are not accessible, the product may be disposed of in household trash by first mixing it with an unappealing substance (such as dirt or cat litter) and placing the mixture in a sealed plastic bag before discarding it. Do not crush the tablets during disposal.

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

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