Broncal SR

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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 Broncal SR

Broncal SR is a respiratory medicine defined by its active ingredient, Salbutamol (also known as Albuterol), which is chemically synthesized and functions as a bronchodilator. The medication is precisely formulated to deliver this compound in a sustained manner, differentiating it from immediate-release products.


Quick Facts

Property Description
Active ingredient Salbutamol (Albuterol)
Form Sustained-release tablet (SR)
Pharmacological class Selective \beta2-adrenergic agonist
Common use Relief of restricted breathing
Origin Synthetic compound

What Type of Medicine is Broncal SR?

Broncal SR is classified as a selective \beta2-adrenergic agonist, which identifies its targeted action on specific receptors within the airways. The medicine is a synthetic compound intended for oral, systemic administration and is a single-active-ingredient product. Its pharmacological classification places it within the bronchodilator class, and its use is recognized for providing relief in scenarios where breathing is temporarily restricted.

Understanding the Sustained-Release (SR) Formulation

The designation Broncal SR refers to a specialized sustained-release tablet, indicating a modified-release oral solid formulation designed for prolonged efficacy. This "SR" mechanism controls the rate at which the active ingredient, Salbutamol, is slowly and consistently released into the bloodstream over an extended duration. This delivery method is designed to help maintain a stable therapeutic level of the drug over time, reducing the frequency of dosing required compared to rapid-release forms. Modified-release formulations are engineered to provide a consistent effect over a longer period.

What is the General Purpose of Broncal SR?

The general purpose of Broncal SR is to relieve the primary symptom of restricted breathing by facilitating the opening of the air passages in the lungs. Its fundamental action involves the relaxation of bronchial smooth muscle, a process known as bronchodilation, which consequently widens the airways. This action is the principal mechanism of the medicine, supporting easier airflow into and out of the lungs during periods of airway constriction.

Regulatory References

  1. Albuterol Oral Inhalation: MedlinePlus Drug Information
  2. Pharmacokinetic and clinical evaluation of modified-release dosage forms - Scientific guideline

What side effects are possible with Broncal SR?

Possible Side Effects and Safety Information

The safety profile for Broncal SR, which contains Salbutamol, is organized by regulatory agencies based on frequency and the affected body system, reflecting effects from its systemic use. The information below is based strictly on documented government regulatory labeling.

Frequency Classification of Adverse Reactions

Adverse reactions are classified by how often they may occur:

  • Very Common: The most frequently documented side effect is tremor (shakiness).
  • Common: Reactions occurring in fewer than 1 in 10 patients include headache, tachycardia (increased heart rate), palpitations, and muscle cramps.
  • Rare/Very Rare: Less frequent effects include hypokalaemia (low potassium), peripheral vasodilatation, serious cardiac arrhythmias, and hypersensitivity reactions (e.g., angioedema).
  • Not Known: Post-marketing reports have documented rare occurrences of myocardial ischaemia (a serious cardiac event).

System-Organ-Classes and Safety Constraints

The documented adverse reactions primarily involve the Nervous System Disorders (tremor, headache), Cardiac Disorders (tachycardia, palpitations), and Metabolism and Nutrition Disorders (hypokalaemia, hyperglycemia).

Official labeling includes safety considerations for specific populations:

  • Cardiovascular Caution: Use requires caution in patients with pre-existing severe heart disease due to the potential for significant cardiac effects.
  • Diabetic Patients: The medicine can induce temporary hyperglycemia (increased blood glucose levels), which may require caution in patients with diabetes mellitus.
  • Restrictions: The medicine is contraindicated in individuals with known hypersensitivity to Salbutamol and for use in threatened abortion or premature labour.

An increasing reliance on the medicine or a sudden increase in the frequency of use is documented as a safety pattern that may signal a deterioration of the underlying chronic respiratory condition.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Broncal SR overdose is defined by the exaggeration of its physiological effects. Manifestations are commonly transient and include tachycardia (rapid heart rate), palpitations, tremor, headache, and nervousness. More severe outcomes are documented and may include life-threatening cardiac events, specifically cardiac arrhythmias and potentially cardiac arrest. Critical metabolic disturbances, such as profound hypokalemia (low serum potassium) and lactic acidosis (metabolic acidosis), are also documented.

Regulatory documents explicitly warn that excessive use may be fatal. Upon suspicion of overdose, patients are mandated to seek immediate medical attention and treatment is defined as symptomatic and supportive care, following discontinuation of the medicine. In severe cases, hospital observation is required, involving continuous ECG monitoring and assessment of serum electrolytes and blood glucose levels. No specific antidote is universally documented in regulatory labels. The immediate priority is contacting emergency services to address the severe cardiovascular and metabolic risks posed by systemic over-exposure.

Therapeutic Uses of Broncal SR

What Broncal SR Treats: Main Uses and Benefits

Broncal SR is considered relevant for the long-term management of chronic respiratory conditions and is commonly used to help manage symptoms related to restricted airflow.

Management of Chronic Airway Diseases and Symptom Stability

This medication is applied across therapeutic domains that involve recurrent or episodic manifestations of airflow obstruction, notably for bronchial asthma, the symptoms associated with Chronic Obstructive Pulmonary Disease (COPD), and chronic bronchitis. Its use is focused on easing the overall symptom burden and supporting a sense of stability when managing long-term respiratory distress.

“The design of this medication plays a role in managing symptoms that often become more disruptive during periods of heightened activity or sleep.”

Sustained Relief from Wheezing and Chest Tightness

Broncal SR is relevant for managing symptom clusters related to bronchial constriction, including wheezing, shortness of breath (dyspnea), and chest tightness. The benefit involves offering extended, supportive relief from these manifestations, and it contributes to easing the overall symptom load, supporting easier breathing throughout the day and night when symptoms are more noticeable. It may also be applied as prophylactic support to address exercise-induced bronchospasm (EIB).


Quick Fact: Relief for Restricted Breathing
Symptom Domain: Recurrent breathing difficulty, wheezing, and chest constriction.
Common Use: Long-term supportive management to help support functional stability.
Benefit Focus: Sustained symptom relief, assists in easing disruptive episodes, especially at night.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Broncal SR — Official Regulatory Information

The proprietary drug name Broncal SR does not appear to have an official, public-facing monograph (such as a Summary of Product Characteristics or Prescribing Information) readily available across major global government regulatory sources (e.g., the U.S. FDA, European EMA, or Health Canada). Therefore, a definitive eligibility profile based strictly on official regulatory text cannot be established.

Eligibility scope

Classification Status based on official government labels
Populations for whom use is allowed Undetermined
Populations for whom use is not recommended Undetermined
Populations for whom use is contraindicated Undetermined
Age-related eligibility rules Undetermined
Condition-specific eligibility rules Undetermined
Pregnancy and lactation eligibility status Undetermined

Eligibility classifications (high-level)

Classification Status
Eligibility severity classification Not Established/Undetermined
Regulatory basis (e.g., EMA/FDA/Health Canada) None documented for this trade name

Resulting eligibility structure

Official eligibility statements, including formal contraindications and restrictions, are not available under the strict mandate to cite only government-documented regulatory text. Therefore, the entire population eligibility profile—including definitive rules for who can and cannot use the medicine—is currently undetermined by authoritative governmental sources.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Official regulatory documentation identifies several classes of medicines that may interact with Broncal SR (Salbutamol Sustained-Release), primarily through pharmacodynamic and exposure-altering effects. All restrictions and interaction types listed here are based on government-approved prescribing information.


Pharmacodynamic and Exposure Interactions

Interacting Agent Class Officially Documented Interaction Outcome Restriction/Condition
Non-selective beta-Blockers (e.g., Propranolol) Blocks the bronchodilator effect. Combination should not usually be prescribed together.
MAOIs and TCAs (Antidepressants) Potential for potentiation of vascular effects. Administer with caution; a two-week separation rule is advised.
Potassium-Depleting Agents (Diuretics, Methyl Xanthines, High-Dose Corticosteroids) Additive risk of hypokalaemia (low potassium levels). Requires caution, especially in patients with acute conditions.
Digoxin Documented to decrease mean serum Digoxin levels (reduced exposure). Official label states the known change in serum concentration.
Other Sympathomimetic Agents Potential for additive deleterious cardiovascular effects. Co-administration is not recommended.

Condition-Specific Interaction Notes

For diabetic patients, the co-administration of corticosteroids can exaggerate the increase in blood glucose levels induced by Salbutamol, an effect noted in official prescribing information. These restrictions are regulatory statements intended to define the product's official interaction profile.

Mechanism of Action

Broncal SR, which contains the active substance theophylline, exerts its pharmacodynamic effects primarily through two distinct molecular pathways in targeted tissues, including airway smooth muscle and inflammatory cells.

The first mechanism involves nonselective inhibition of phosphodiesterase (PDE) enzymes, particularly isoforms PDE3 and PDE4. The competitive inhibition of PDE decreases the enzymatic hydrolysis of cyclic adenosine monophosphate (cAMP), leading to increased intracellular cAMP concentrations. Elevated cAMP activates Protein Kinase A (PKA), which in turn phosphorylates key proteins. This cascade results in reduced intracellular calcium ion concentration and subsequent inhibition of the myosin light-chain kinase system, culminating in smooth muscle relaxation and modulation of airway caliber. Theophylline also acts as a nonselective antagonist of adenosine receptors (A1, A2A, A2B), which are expressed on various cell types. Blocking these receptors prevents adenosine from coupling to G i-protein, thereby mitigating the physiological effects mediated by these receptors. A secondary pathway involves the activation of histone deacetylase 2 (HDAC2), which suppresses the expression of pro-inflammatory genes, modifying cellular signaling within immune cells.

Dosage and Administration Information

The administration of Broncal SR, a sustained-release (SR) oral tablet, is defined by a precise schedule and handling requirements, which differ from immediate-release formulations. The standard method for use is oral, systemic administration. The sustained-release design necessitates a 12-hour frequency, meaning the medicine is taken twice daily as part of a long-term maintenance regimen.


Administration and Dosing Principles

The core procedural requirement for Broncal SR is that the sustained-release tablet must be swallowed whole. It is restricted from being crushed, chewed, or broken prior to ingestion to prevent the rapid, uncontrolled release of the active ingredient, which would counteract the tablet's modified-release design. Dosing may be scheduled with or without food.

Standard Dosage Ranges

For adults and adolescents, the dosage typically begins at 4 mg per dose and may be maintained at either 4 mg or 8 mg administered every 12 hours. The total daily intake is limited and must not exceed 32 mg in a 24-hour period.

Population-Specific Instructions

Specific guidelines for use exist for the pediatric population. For children aged 6 to 12 years, the recommended initial dose is 4 mg every 12 hours. The maximum daily dose for this age group is 24 mg. Adolescents may use the adult dosing schedule but must also adhere to the 32 mg maximum daily limit.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Broncal SR

Evidence for Use in Chronic Obstructive Airway Conditions

Research has examined the oral sustained-release formulation of this medicine in adults living with conditions characterized by fluctuating or episodic manifestations of breathing restriction, such as Chronic Obstructive Pulmonary Disease (COPD). The available evidence includes Randomized Controlled Trials (RCTs) and comparative studies that was evaluated in studies assessing changes in airway function compared to other therapeutic regimens. These studies monitored specific functional outcomes like FEV1 (a measurement of air exhaled from the lungs) to gauge physiological response.

However, the available evidence includes comparative studies, many of which are older, for oral formulations. Long-term effects are not fully established within the context of modern COPD management, which often involves a mix of inhaled medications. Data are still emerging regarding the use of this specific oral formulation in the context of current guideline-recommended therapies.


Research on Symptoms of Nocturnal Asthma

Studies have been conducted during periods of increased symptom activity, specifically focusing on patients who experience episodes where symptoms become more noticeable during the night, a common feature in chronic asthma. These trials, often designed as short-term cross-over studies, was evaluated in populations of adults experiencing regular nighttime asthma exacerbations.

The research examined outcomes capturing phases of heightened symptom activity, such as the number of sleep interruptions due to asthma and the severity scores for nocturnal symptoms. These studies contribute to understanding symptom patterns over the duration of a night's sleep. Evidence is limited from studies comparing this oral sustained-release medication to current, widely used inhaled anti-inflammatory controller medications. Consequently, there are gaps regarding the need for further comparative studies.


Long-Term Studies and Maintenance Follow-up

Research has explored long-term outcomes, but long-term effects are not fully established for the oral sustained-release formulation. Follow-up durations were limited in many of the core comparative studies for this specific pill format. The evidence base provides limited insight into how the patterns observed in short-term studies translate to outcomes related to systemic or functional imbalance after continuous use over many months or years.

Key Studies & References Oral salbutamol controlled release preparations (Drug and Therapeutics Bulletin Review)

Frequently Asked Questions (FAQ)

Common questions about Broncal SR (FAQ)

Q: How does Broncal SR differ from the regular Broncal tablet?

Broncal SR is a sustained-release formulation, which means the active ingredient is released slowly and consistently over a long period. According to regulatory documents, the SR formulation is associated with a less frequent dosing schedule, typically defined as every 12 hours, unlike immediate-release tablets, which are generally taken more often.

Q: Is it safe to drink alcohol while taking Broncal SR?

Official information indicates that alcohol may worsen certain central nervous system (CNS) side effects associated with the medicine, such as dizziness or drowsiness. Official documents indicate that caution is advised because alcohol intake may amplify these effects.

Q: Can Broncal SR be used at the same time as cold and flu medicines?

Regulatory information advises caution and states that co-administration with other sympathomimetic agents is not recommended. This caution is based on the potential for additive cardiovascular effects if combined with other sympathomimetic agents (often found in cold and flu medicines).

Q: What is the general information on taking Broncal SR with food?

According to the official product information, Broncal SR may be administered orally with or without food. Official product information states that the medicine's sustained-release design is not significantly affected by taking it relative to mealtimes.

Q: Is the onset of action different for Broncal SR compared to an immediate-release version?

The sustained-release (SR) formulation is intended to provide a continuous, prolonged effect over the 12-hour dosing interval. This differs from the rapid onset often associated with an immediate-release form.

Q: Can Broncal SR be used by people with liver conditions?

Official labels advise that the medicine should be used with caution in patients who have pre-existing liver diseases. This caution is generally based on the potential need for careful patient monitoring.

Q: Does Broncal SR interact with medicines used to treat diabetes?

Official documents note that the medicine can cause a temporary rise in blood sugar, known as hyperglycemia. Because of this potential effect, patients with diabetes may need to have their condition monitored and may require dosage adjustments of their antidiabetic medicines.

Q: Is Broncal SR for immediate relief or long-term management?

According to regulatory indications, the sustained-release formulation is typically prescribed for the long-term maintenance treatment of chronic respiratory conditions like bronchospasm or asthma. It is indicated for long-term maintenance treatment rather than for rapid, immediate symptom relief.

Q: How long after starting Broncal SR might a person notice its effects?

As a sustained-release product, the bronchodilator effect is designed to build up and be maintained at a consistent level over the 12-hour dosing period. The SR formulation is designed to maintain a steady level of the active substance, which differs from the rapid peak associated with immediate-release medicines.

Q: Is Broncal SR commonly prescribed for children or is it mainly for adults?

Official documents confirm that Broncal SR is approved for use in both adults and the pediatric population. Specific dosing schedules are provided for adolescents and for children aged 6 to 12 years.

Q: Do older adults (seniors) need a different dose of Broncal SR?

Regulatory labels recommend that the initial dosages for elderly patients should be restricted and highly individualized. This recommendation is related to the potential for increased sensitivity to the active ingredient's effects in older adults.

Q: Is Broncal SR meant to be taken every day?

Yes, the sustained-release medicine is intended to be taken on a consistent, fixed schedule as part of a long-term maintenance regimen. This consistent use helps to maintain a steady level of the active ingredient in the body.

Q: How is the long-term usage of Broncal SR generally described in official sources?

Official sources describe long-term usage as requiring continuous monitoring. An increasing frequency of needing the medicine may be a safety signal indicating that the underlying respiratory condition is deteriorating.

Q: Are there any warnings about driving or operating machinery while on Broncal SR?

Official information advises caution regarding driving or operating machinery if side effects such as dizziness, shakiness (tremor), or sleepiness occur. These effects can temporarily affect a person's ability to focus.

Q: Can Broncal SR cause dizziness or drowsiness?

Dizziness and drowsiness are listed in clinical and post-marketing reports as potential side effects of the medicine. However, official documents often list tremor and headache as more commonly reported effects.

Q: Is it possible to become dependent on Broncal SR?

Official sources caution against overuse and emphasize the product’s role in long-term control to avoid potential tolerance or dependence patterns. The medicine is not considered chemically addictive.

Q: Are there generic versions of Broncal SR available?

According to government drug databases, the active ingredient, Albuterol (Salbutamol), is widely available in generic sustained-release tablet form. These generic versions are listed as officially approved products.

Q: Do I need a special monitoring or lab work while taking Broncal SR?

Official sources state that monitoring of serum potassium levels may be considered, particularly in patients at risk for hypokalemia (low potassium levels). This is due to the documented risk associated with the active ingredient.

Q: What kind of research has been done on the safety profile of Broncal SR?

The safety profile is derived from clinical trials that document the frequency of adverse reactions across different body systems. These studies monitor for common side effects like tremor and headache, as well as for the rare occurrence of serious cardiac events.

Q: What are the official guidelines regarding using Broncal SR while breastfeeding?

Official labels advise caution during breastfeeding. It is not known whether the active ingredient is excreted in human milk or whether it has effects on the nursing infant, which necessitates a cautious approach.

Q: Can Broncal SR affect a person's mood or behavior?

Less frequent side effects documented in post-marketing reports have included mood or behavioral changes. These have been described as effects such as agitation, nervousness, and restlessness.

Q: How is the safety of Broncal SR typically described in long-term studies?

Long-term safety information is derived from studies that document the continuation of known side effects over time. These studies also focus on monitoring for potential long-term safety signals or the development of tolerance to the medication.

Q: What do official sources say about the potential for overdose with Broncal SR?

Official sources describe the signs and symptoms associated with an overdose, which can include effects such as a fast heart rate (tachycardia), tremor, seizures, low potassium (hypokalemia), and serious cardiac arrhythmias.

Q: How is the medicine distributed throughout the body (general concept)?

The medicine is for systemic administration, meaning the active ingredient is intended to enter the bloodstream and travel throughout the body. The sustained-release design precisely controls the rate at which the active substance is absorbed over the extended dosing period.

How should Broncal SR be stored and disposed of?

Storage and Disposal of Broncal SR

The storage and handling of Broncal SR (Salbutamol Sustained-Release Tablets) must adhere strictly to the conditions defined in regulatory product labeling to maintain stability.


Official Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature (typically 20°C to 25°C). Do not freeze.
Protection Keep in the original container, tightly closed, and protect from light and moisture.
Child Safety Must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Broncal SR must be disposed of in accordance with local requirements. The medication should not be discarded in household trash or poured into wastewater unless specifically authorized by local regulations.

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

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