Tedral-SA

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Tedral-SA

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Tedral-SA

Quick Facts

Property Description
Active Ingredients Choline Theophyllinate, Ephedrine
Form Extended Release Tablet (Sustained Action, SA)
Pharmacological Class Bronchodilator, Antiasthmatic Combination
General Purpose Managing reversible airflow obstruction
Origin Synthetic/Derived (Methylxanthine derivative and Sympathomimetic agent)

What Type of Medicine is Tedral-SA?

Tedral-SA is a prescription-only, sustained-action oral formulation classified primarily as a bronchodilator and antiasthmatic combination agent. Its core purpose is to relieve symptoms of bronchospastic disorders through the dilation of the airways, which targets reversible airflow obstruction. The medication is a combination product, uniting active substances from two distinct pharmacological classes. The efficacy of methylxanthines like Theophylline in managing respiratory function is recognized. The Anatomical Therapeutic Chemical (ATC) classification system places Theophylline within the group of drugs used for obstructive airway diseases. The Extended Release Tablet form is a unique differentiator, ensuring prolonged therapeutic levels compared to older immediate-release preparations.

Composition and Sustained-Release Form

The composition of Tedral-SA features two key active ingredients: Choline Theophyllinate (a synthetic methylxanthine derivative) and Ephedrine (a sympathomimetic agent). The drug is manufactured as an Extended Release Tablet, where the suffix "SA" denotes its Sustained Action design. This formulation ensures that the active components are released gradually over time into the systemic circulation, thereby reducing the need for very frequent administration. The combination of Ephedrine with a xanthine derivative is a recognized formulation intended to enhance the therapeutic effect in airway management. For patients requiring consistent management of their respiratory symptoms, the sustained-action delivery provides a reliable release profile.

The Dual Approach to Airway Management

The practical benefit of Tedral-SA arises from the coordinated, synergistic activity of its two components, leading to a robust improvement in respiratory function. The Choline Theophyllinate component acts to directly relax the constricted smooth muscle surrounding the bronchial airways. Simultaneously, the Ephedrine component, through its adrenergic agonist properties, enhances this effect by stimulating receptors that physically widen the air passages. This dual mechanism is designed to achieve potent bronchodilation, offering patients a more complete means of addressing the physiological basis of their breathing difficulties.

Regulatory References

  1. NIH/NLM: MedlinePlus - Theophylline

What side effects are possible with Tedral-SA?

The safety characteristics of Tedral-SA, which combines Choline Theophyllinate and Ephedrine, reflect the stimulant actions of both components on the body's systems, as documented in regulatory sources.

Adverse Reaction Scope

Category Officially Documented Listing
Key adverse reaction categories Central Nervous System stimulation, Cardiovascular effects, Gastrointestinal irritation, and Psychiatric disturbances.
Frequency classification Effects like nausea, vomiting, headache, insomnia, nervousness, tachycardia, and palpitations are generally classified as Common or among the most frequent adverse reactions [1.1, 5.3].
System-organ classes involved Gastrointestinal Disorders, Nervous System Disorders, Psychiatric Disorders, Cardiac Disorders, and Vascular Disorders.
Serious adverse reactions Officially documented serious reactions include Cardiac Arrhythmias and Seizures, often associated with elevated serum concentrations of the theophylline component. Increased risk of heart attack or stroke is associated with the Ephedrine component, particularly in those with pre-existing heart conditions [1.4, 3.1].
Population-specific safety considerations Older adults may exhibit increased sensitivity to effects. Pediatric patients, especially newborns, may also be more sensitive to theophylline’s effects [4.2]. Theophylline passes into breast milk, which is a consideration during lactation [4.4].
Safety-related restrictions Contraindicated in individuals with hypersensitivity to the active components or other xanthine derivatives. Other conditions cited as contraindications include acute hypertension, severe tachycardia, coronary artery disease, and peptic ulcer [1.4, 4.2].

Connection to the Overall Safety Profile

The regulatory safety profile establishes that the major risks are concentrated in the central nervous and cardiovascular systems, consistent with the pharmacological classes. The official documentation defines clear safety restrictions for patients with conditions such as severe hypertension or pre-existing heart disease, as well as specific considerations for older and pediatric populations, to outline the boundaries of use.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Tedral-SA, containing theophylline and ephedrine, defines overdose severity based on critical central nervous system (CNS), cardiovascular, and metabolic manifestations.

Property Documented Regulatory Statement
Documented Manifestations Severe or continued vomiting, nausea, tachycardia, rapid heartbeats, tremors, agitation, severe headache, confusion, hyperglycemia, and hypokalemia.
Physiological Systems Central Nervous System (CNS), Cardiovascular system, Gastrointestinal system, and Metabolic system.
Dose-Related Factors Serum Theophylline levels greater than 20 mcg/mL are associated with increased frequency and severity of adverse reactions.
Population-Specific Notes Toxicity may occur at lower serum concentrations in the elderly and in patients with co-morbidities such as hepatic cirrhosis.

Emergency Action

  • Life-threatening outcomes documented include seizures, cardiac arrest, life-threatening arrhythmias, and rhabdomyolysis.
  • Immediate assistance is mandated if specific severe symptoms such as seizure activity or severe and continued vomiting occur.
  • Seek emergency medical attention immediately, as no specific antidote is known, and management is defined as symptomatic and supportive treatment, potentially requiring procedures such as hemodialysis for severe cases.

The documented severity of these neurological and cardiovascular outcomes dictates the urgent need to seek immediate medical attention. This regulatory-defined response structure guides intervention toward managing these severe manifestations and includes mandatory procedures like continuous ECG monitoring and serum theophylline level checks.

Therapeutic Uses of Tedral-SA

What Tedral-SA Treats: Main Uses and Benefits

The combination drug Tedral-SA is considered relevant in the management of symptoms associated with respiratory conditions, particularly those involving episodic or fluctuating manifestations. The medicine provides support that helps ease the overall burden of symptoms.

Theophylline, a key component, is used to help prevent and treat symptoms such as wheezing, shortness of breath, and chest tightness.


Easing Episodic Symptom Discomfort

Tedral-SA is relevant for symptoms that interfere with daily functioning, such as breathlessness and wheezing. It is commonly used to help with situations involving certain distressing symptoms, and is applicable across domains where additional symptomatic support is needed. This includes use across conditions presenting with acute episodes.


Supportive Management for Symptom Clusters

This medicine is relevant in conditions characterized by periods of heightened symptoms. It supports the patient during difficult episodes by easing distress and contributes to easing the overall symptom load.

“This medicine may assist with symptom clusters that create noticeable physiological strain.”

Quick Fact: Supports relief of symptoms related to physical discomfort


Temporary Assistance for Functional Strain

Used during phases when symptoms become more noticeable and temporarily overwhelm the patient, the drug is relevant in settings where short-term symptom stabilization is important. It is useful in scenarios where symptoms escalate temporarily and assists with maintaining functional stability when the condition involves episodic or fluctuating manifestations.

Regulatory References

  1. Theophylline: MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who can and cannot use Tedral-SA?

The official eligibility profile for Tedral-SA, a combination product of Theophylline, Ephedrine, and Phenobarbital, is strictly defined by the cumulative restrictions of its active components. Use is permitted for adults and adolescents 12 years and older who do not have any absolute contraindications.


Absolute Contraindications

Tedral-SA must not be used by individuals with a known hypersensitivity to any of its components or by patients diagnosed with:

  • Porphyria
  • Peptic Ulcer Disease
  • Coronary Artery Disease
  • Acute Hypertension or Tachycardia

Age and Comorbidity Restrictions

The product is not recommended for children under 12 years of age, as usage and safety have not been established. Newborn infants and older adults (ge 60 years) may be especially sensitive to the drug's effects. Furthermore, use requires caution and is restricted in patients with severe Hypertension, Hyperthyroidism, Glaucoma, Prostatic Hypertrophy, and certain Seizure Disorders.

Organ Function and Reproductive Status

Patients with Liver Disease or Kidney Disease require caution due to potential impairment of drug clearance. The medicine was historically classified as Pregnancy Category D (indicating risk to the fetus) and is not recommended for use during lactation.

What should I know about interactions with other medicines?

Tedral-SA Interactions with other medicines and products

The officially documented interaction profile for Tedral-SA (Choline Theophyllinate/Ephedrine) is based on the distinct risks associated with each active component, as mandated by government regulatory bodies.

Interaction-Related Restrictions

Classification Interacting Agent Official Restriction/Effect
Contraindicated Monoamine Oxidase Inhibitors (MAOIs) Prohibited due to the risk of hypertensive crisis and augmented pressor effect from the Ephedrine component.
Significant Risk Oxytocic Drugs (e.g., Methylergonovine) Augment the Ephedrine pressor effect, associated with serious postpartum hypertension.
Caution Required Halogenated Anesthetics (e.g., Halothane) May increase the risk of ventricular arrhythmias.

Exposure-Modifying and Pharmacodynamic Interactions

Interactions involving the Theophylline component primarily affect its clearance, altering its concentration in the body.

  • Clearance-Decreasing Agents (Increased Levels): Medications such as the antibiotics Ciprofloxacin and Erythromycin, as well as Cimetidine (an H2-receptor antagonist) and Oral Contraceptives, officially decrease Theophylline clearance via hepatic enzyme inhibition (e.g., CYP1A2), leading to elevated serum levels.
  • Clearance-Increasing Agents (Decreased Levels): Substances like Rifampicin, Phenytoin, and Carbamazepine officially increase Theophylline clearance through enzyme induction, potentially reducing its overall exposure.

Pharmacodynamic interactions are also documented. Co-administration of the Ephedrine component with Cardiac Glycosides (e.g., Digitalis) may increase the possibility of arrhythmias. Additionally, official labeling notes that Caffeine from food, beverages, or other drugs presents a risk of additive CNS stimulant effects with Theophylline.

Mechanism of Action

The mechanism of action involves the coordinated activity of two components, which modulate cellular signaling to achieve simultaneous smooth muscle relaxation and mucosal tissue modification in the airways.

Dual Mechanism for Airway Smooth Muscle Relaxation

The core mechanism targets the intracellular messenger cyclic AMP ( cAMP), which is crucial for regulating muscle tone. Theophylline inhibits the Phosphodiesterase (PDE) enzyme that breaks cAMP down, while Ephedrine stimulates boldsymbolbeta2 -Adrenergic Receptors to enhance its production. This dual action maximizes cAMP levels, leading to a physiological cascade that induces bronchial smooth muscle relaxation.

Adrenergic Activation and Mucosal Modification

The Ephedrine component also acts on boldsymbolalpha1 -Adrenergic Receptors in the bronchial lining. This agonism, facilitated by the release of norepinephrine, triggers vasoconstriction of the small vessels in the bronchial mucosa. The resulting physiological consequence is a reduction in mucosal tissue edema through vasoconstriction, which modifies the physical dimensions of the airway lumen. This physiological action is distinct from the smooth muscle mechanism.

️ Modulation of Adenosine and Inflammatory Pathways

Theophylline exerts secondary effects by acting as an antagonist of Adenosine Receptors, which prevents the adenosine-mediated release of pro-constrictive mediators. It also activates HDAC2 (Histone deacetylase 2), engaging a pathway that suppresses the expression of genes responsible for certain inflammatory responses within the tissue.

Dosage and Administration Information

The usage of Tedral-SA, an Extended Release Tablet (SA) formulation combining theophylline, ephedrine, and phenobarbital, is standardized to ensure appropriate delivery of the active ingredients. The approved administration route is oral.


Administration Protocol

Instruction Official Rule
Route of Administration Oral route only.
Standard Dosing Schedule Average adult dose is one tablet per dose.
Dosing Frequency The schedule requires twice daily (b.i.d.) dosing.
Timing The regimen involves taking one tablet upon arising and the second tablet 12 hours later.
Tablet Integrity The extended-release tablet must not be chewed.
Pediatric Restriction Not recommended for children under 12 years of age.

High-Level Use Context

The instructions define Tedral-SA as an adjunct intended for use within the total management protocol of the patient's condition. This classification indicates that the medicine is typically incorporated into a long-term plan to provide sustained therapeutic levels. Due to its formulation and role, the preparation is not indicated for immediate intervention during sudden or severe acute episodes, which may necessitate different treatment methods. The specific 12-hour interval is required by the sustained-action design to regulate the continuous release of the components.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Tedral-SA


Evidence for use in Reversible Airflow Obstruction

Research has explored this combination therapy in the context of conditions characterized by fluctuating or episodic manifestations, such as chronic asthmatic symptoms and related bronchospastic disorders. The research structure involved Randomized Controlled Trials (RCTs) and comparative studies, often designed for comparison against a placebo or single active ingredients. Research examined changes in objective pulmonary function measures, such as forced expiratory volume ( FEV1), alongside patient-reported symptom scores for outcomes related to physical discomfort, like wheezing and shortness of breath. Findings describe patterns observed in the studies under defined research conditions.


Comparison of Dual-Ingredient Research

Studies specifically explored the need for the dual-ingredient approach by comparing measured effects to the use of the theophylline component alone. These comparative trials sought to evaluate the measured effects of each active substance within the combination. Studies report patterns related to physiological changes, but for some cohorts, the findings were mixed. Certain historical research described patterns related to measured effects where the combination did not demonstrate a significantly different outcome in key pulmonary function measures compared to the theophylline component administered by itself. This research provides context for evaluating the rationale of the dual-ingredient fixed-dose approach.


Evidence in Pediatric and Adult Populations

Specific patient cohorts were observed in research conducted across different age groups, including pediatric patients and adults with long-standing respiratory conditions. These studies monitored functional parameters and symptom intensity over defined time intervals. Research provides contextual information on short-term changes observed in these specific groups, but the results apply only to the populations studied and research does not determine whether an individual will respond similarly.


Long-Term Studies and Follow-up Duration

The majority of controlled clinical studies for this fixed-dose combination were conducted over short assessment periods, focusing on research exploring short-term symptom changes related to episodic symptoms. Follow-up durations were limited, reflecting the need to observe immediate responses. Consequently, long-term effects are not fully established for the specific combination product, and there is limited information available for outcomes reflecting durability of response over many years.


Evidence Gaps and Research Uncertainty

A key limitation noted in scientific literature is that the available evidence base is largely historical, with much of the data generated before the widespread use of large-scale trial designs. Furthermore, regulatory reviews have raised questions concerning the certainty that each ingredient in the fixed-dose combination contributes to the claimed effect in all patient groups. The dosing of the theophylline component generally requires individual adjustment based on blood levels, and the fixed-dose nature of the combination presented a research challenge to providing sufficient data for all regulatory endpoints. The existing evidence landscape suggests that subgroup findings are uncertain.

Key Studies & References Bronchodilator Drug Products for Over-the-Counter (OTC) Human Use; Final Rule (Addressing fixed combinations)

Frequently Asked Questions (FAQ)

Common questions about Tedral-SA (FAQ)


Q: Is Tedral-SA used for long-term or short-term treatment?

Official documents describe medicines containing theophylline as typically used in the management of chronic lung conditions, consistent with a role in long-term management protocols. However, studies conducted on this specific sustained-action combination often focused on short assessment periods to observe immediate changes.


Q: How quickly should I expect Tedral-SA to start working?

The tablet is designed as a Sustained Action (SA) formulation, meaning the ingredients are released slowly over a long period. For this reason, official information states that it is officially not indicated for use as a therapy for sudden, acute symptoms.


Q: How long does the effect of one Tedral-SA tablet usually last?

Tedral-SA is officially designed as a sustained-action product. The dosing schedule is set for twice daily (b.i.d.) administration, with a 12-hour interval between doses, which reflects the intended duration for continuous component release.


Q: Are there any known severe side effects associated with Tedral-SA that I should be aware of?

Official safety documents list serious adverse reactions that have been associated with the active ingredients. These include the risk of Cardiac Arrhythmias (irregular heart rhythms) and Seizures, particularly if the level of theophylline in the body becomes too high.


Q: What should I do if I think I've taken too much Tedral-SA?

Official documentation for theophylline products states that signs of toxicity, such as repetitive vomiting, may occur if too much medicine is taken. If signs consistent with toxicity occur, official information states that further doses should be withheld, and a measurement of the serum drug concentration may be required.


Q: Can Tedral-SA interact with common over-the-counter pain relievers?

Official labeling for the components warns about potential additive Central Nervous System (CNS) stimulant effects when Theophylline is used with certain agents, such as caffeine. Since some over-the-counter pain relievers or cold remedies may contain stimulants, their concurrent use may be associated with risk, as described in official documentation.


Q: Is it safe to take Tedral-SA with certain cold or flu medications?

Regulatory documents indicate that many different agents can interact with the components of Tedral-SA, either increasing or decreasing the concentration of Theophylline. Because common cold and flu medicines may contain stimulating ingredients or affect drug clearance, official documents describe that concurrent use may be associated with potential interactions.


Q: Does Tedral-SA interact with caffeine?

Yes, official regulatory labeling specifies that caffeine, which is found in foods, beverages, and some other medicines, can present a risk of additive Central Nervous System (CNS) stimulant effects when combined with the Theophylline component of Tedral-SA.


Q: What considerations exist for people with thyroid issues using Tedral-SA?

Official prescribing information states that the use of Tedral-SA requires caution in patients diagnosed with Hyperthyroidism (an overactive thyroid). Conversely, conditions like Hypothyroidism (an underactive thyroid) are noted in official documents as potentially leading to reduced clearance of the Theophylline component from the body.


Q: Can Tedral-SA affect sleep patterns?

Yes, official documentation lists effects like insomnia (difficulty sleeping) and nervousness among the most frequent (Common) adverse reactions. These effects are consistent with the stimulant actions of the active ingredients.


Q: Does official research show that Tedral-SA improves lung function?

Studies have investigated the combination product in conditions related to reversible airflow obstruction. Research has specifically examined changes in objective pulmonary function measures, such as forced expiratory volume ( FEV1), alongside patient-reported symptom scores under defined research conditions.


Q: What is the evidence regarding Tedral-SA and pregnancy?

Official regulatory classification for the product was historically Pregnancy Category D by the FDA. This classification is used when there is positive evidence of potential risk to the fetus, as documented in official safety information.


Q: Can Tedral-SA be taken at the same time as cold and allergy medicines?

The Ephedrine and Theophylline components can interact with many different types of medicines, including some cold and allergy products. Official documents describe that concurrent use of other medications may be associated with risk due to potential drug interactions and changes in drug levels.


Q: Is it common to feel jittery or anxious after taking Tedral-SA?

The official adverse reaction listings include frequent Central Nervous System (CNS) effects such as nervousness and restlessness. These effects are aligned with the stimulant properties of Ephedrine and Theophylline, which may be interpreted by users as feeling jittery or anxious.


Q: What is the evidence regarding Tedral-SA's use in children?

Official prescribing information states that Tedral-SA is not recommended for children under 12 years of age. This is because the usage and safety of the combination product have not been established for this specific age group, and infants and newborns may be especially sensitive.


Q: Does official information describe any mood changes linked to Tedral-SA?

Official adverse reaction lists include Psychiatric Disorders among the system-organ classes involved. Furthermore, frequent side effects like restlessness and nervousness are documented, which are related to an individual's mental state.


Q: Is there a warning about driving or operating machinery while taking Tedral-SA?

Official documents describe common Central Nervous System (CNS) effects such as headache, nervousness, and insomnia as frequent adverse reactions. These effects are described in official documents as potentially interfering with complex tasks.


Q: Is Tedral-SA considered a 'rescue' medication?

No, official prescribing instructions state that the preparation is not indicated for immediate intervention during sudden or severe acute breathing episodes. This classification means it is intended for ongoing management, not for immediate 'rescue' use.


Q: How is the dose of Tedral-SA typically adjusted?

Tedral-SA is manufactured as a fixed-dose combination product, meaning the amount of each ingredient in the tablet is fixed. Official reviews have noted that Theophylline, one of the active ingredients, typically requires individual dose adjustment based on blood levels, posing a specific challenge for this fixed-dose drug.


Q: Does Tedral-SA help with wheezing?

The product is intended to relieve symptoms related to bronchospastic disorders. Research studies have specifically examined the effects of the combination by looking at changes in patient-reported symptom scores for physical discomforts, including wheezing and shortness of breath.


Q: Can Tedral-SA cause stomach upset or nausea?

Yes, official documentation classifies adverse reactions involving the gastrointestinal system, and lists nausea and vomiting among the most frequent adverse reactions associated with the use of the medicine.


Q: Why is Tedral-SA less common now than it was in the past?

Scientific literature and regulatory reviews note that the existing evidence base for this fixed-dose combination is largely historical. Much of the data was generated before the widespread adoption of large-scale, modern trial designs, which provides context for its current place in clinical practice.


Q: What happens if I drink alcohol while using Tedral-SA?

Official drug interaction data indicates that consuming a single large dose of alcohol has been shown to decrease the clearance of the Theophylline component. This effect could potentially lead to increased concentrations of the drug in the body, as noted in official documents.

How should Tedral-SA be stored and disposed of?

How to Store and Dispose of Tedral-SA

The storage and disposal of Tedral-SA must strictly adhere to regulatory requirements, particularly due to the presence of Phenobarbital, a Schedule IV controlled substance.


Storage Conditions

  • Temperature: Store the tablets at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F).
  • Protection: The medicine must be stored in its original container, kept tightly closed, and protected from excessive light and moisture to ensure stability.
  • Safety: Storage must always be out of the reach of children and pets.

Disposal Instructions

Official guidelines state that the preferred disposal method for controlled substances is a drug take-back program or mail-back envelope. If those are unavailable, the medicine may be mixed with an unappealing substance, sealed in a container, and discarded in the household trash.

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

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