Theophyllin STADA

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Overview of Theophyllin STADA

What is Theophyllin STADA?

Theophyllin STADA is a medication containing the active substance theophylline, which belongs to a group of medicines known as methylxanthines. It is primarily used to treat and prevent respiratory symptoms associated with obstructive airway diseases.

Therapeutic Purpose

Theophylline acts as a bronchodilator. Its primary function is to relax the smooth muscles in the bronchial tubes, which helps to open the airways and facilitate easier breathing. By reducing the resistance in the respiratory tract, it helps to alleviate symptoms such as shortness of breath, wheezing, and coughing.

Application Areas

The medication is used for the symptomatic treatment and prevention of bronchial constriction in patients with:

  • Bronchial Asthma: A chronic inflammatory disease of the airways.
  • Chronic Obstructive Pulmonary Disease (COPD): A progressive lung disease that makes it difficult to breathe, often including chronic bronchitis and emphysema.

Mechanism of Action

In addition to relaxing the bronchial muscles, theophylline is recognized for its ability to:

  • Clear mucus from the airways by stimulating ciliary activity.
  • Strengthen the diaphragm and other respiratory muscles.
  • Reduce the inflammatory response in the airways when used at certain therapeutic levels.

This medication is typically formulated as a prolonged-release tablet, which allows for a steady release of the active ingredient into the bloodstream over an extended period, providing consistent symptom control.

Regulatory References

  1. Theophylline - StatPearls - NCBI Bookshelf
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What side effects are possible with Theophyllin STADA?

Possible Side Effects and Safety Information

The safety profile of Theophyllin STADA (Theophylline) is formally structured around the system-organ classes affected and the concentration of the medicine in the blood. Adverse reactions are primarily documented within the Nervous System, Gastrointestinal, and Cardiac domains. The official classifications denote several common reactions.

Classification Examples of Reactions
Common / Expected Nausea, vomiting, headache, restlessness, insomnia, muscle tremors, tachycardia, and increased urine volume.
Serious Adverse Reactions Ventricular arrhythmias, convulsions (seizures), significant hypokalemia, and gastrointestinal hemorrhage.

Regulatory documents emphasize that the frequency and severity of adverse reactions are concentration-dependent; the most severe events are correlated with plasma levels exceeding 20mu g/ mL. Warning signs of potentially high concentrations include persistent vomiting and severe headache.

Population-Specific Safety Considerations

The medicine's safety profile includes specific considerations for certain patient groups. Clearance of Theophylline is typically reduced in older adults (aged 60 and above) and in patients with hepatic (liver) impairment, leading to an increased risk of toxicity. The medicine is also known to be secreted into breast milk, which has been associated with reports of infant irritability. Furthermore, the medicine may exacerbate pre-existing conditions such as active peptic ulcers or known seizure disorders, which is a high-level safety constraint listed in prescribing information. Crushing or chewing sustained-release formulations may lead to a rapid, potentially toxic release of the active ingredient, which is noted as a key safety limitation.

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Overdose and Emergency Response

Overdose and when to seek help

Overdose with Theophyllin STADA is documented to affect the central nervous, cardiovascular, and metabolic systems. Initial manifestations of toxicity often include gastrointestinal upset such as severe vomiting and abdominal pain, paired with CNS excitement, characterized by agitation, restlessness, and tremors. Cardiovascular signs commonly involve tachycardia and heart palpitations. Laboratory findings in overdose cases may show abnormalities, including hypokalemia and hyperglycemia.

Acute overdose is strongly associated with the risk of severe, life-threatening systemic outcomes. These include potentially refractory seizures and serious ventricular arrhythmias, which may progress to cardiac arrest. Immediate medical attention must be sought for any suspected overdose or the manifestation of these severe symptoms, as urgent measurement of serum levels is required.

Treatment protocols mandated in regulatory documents include supportive care, such as the administration of activated charcoal, and continuous monitoring of cardiac rhythm and blood pressure. No specific antidote is known for Theophylline overdose. Enhanced drug elimination procedures, such as hemodialysis, are sometimes required for extremely high serum concentrations or life-threatening toxicity. Population-specific considerations exist, as very young infants and elderly patients are more susceptible to chronic toxicity, where severe neurological outcomes can occur at lower serum concentrations than in acute scenarios.

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Therapeutic Uses of Theophyllin STADA

What Theophyllin STADA Treats: Main Uses and Benefits

Theophyllin STADA is commonly used to help with symptoms related to chronic lung conditions such as asthma, chronic bronchitis, and emphysema. The medication is utilized for the long-term management of conditions involving chronic or persistent obstruction of the air passages. It is generally applied when symptoms require supportive symptom management to help reduce the frequency of symptoms and is relevant in the management of conditions marked by increased physiological stress.

Therapeutic Benefit

This therapy is relevant for easing symptom clusters that may become intense or disruptive caused by constricted airways. It is applied in addressing symptoms related to heightened physiological activity, such as chest tightness, audible wheezing, and chronic shortness of breath (dyspnea)—symptoms that interfere with daily functioning. The medication provides supplementary therapeutic benefit, commonly used as an add-on treatment when additional symptomatic support is needed alongside standard inhaled therapies. This assists with maintaining functional stability during symptomatic phases.

Quick Fact: Relief for Obstructive Symptoms
Primary Symptom Domain Symptoms related to Persistent Airway Constriction
Therapeutic Use Context Long-term Maintenance Therapy
Main Patient Benefit Supports maintenance of functional stability
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Eligibility and Restrictions for Use

The eligibility for Theophyllin STADA (Theophylline) is strictly defined by official regulatory criteria, detailing which populations are strictly prohibited from use and which require special caution.

Contraindications (Must Not Use)

Use is contraindicated for patients with a known hypersensitivity to theophylline or any xanthine derivative. The medicine is also contraindicated in infants under 6 months of age. Official regulatory documents state that absolute prohibitions apply to patients with coronary artery disease where cardiac stimulation is harmful and those with an active or history of peptic ulcer disease.

Restricted or Conditional Use

Eligibility is restricted for populations where drug clearance is reduced, increasing the risk of toxicity. This includes patients with severe hepatic impairment (e.g., cirrhosis) and those with congestive heart failure or cor pulmonale. Older adults (over 60 years) and individuals experiencing a high-grade fever also require conditional use and close monitoring. The prolonged-release tablet is not recommended for children under 6 years.

Pregnancy and Lactation

Use during pregnancy (Category C) and lactation is only allowed when the clinical benefit is judged to clearly outweigh the potential risks, as the drug is secreted into breast milk.

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What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile for Theophyllin STADA (Theophylline) is critical due to its narrow therapeutic index. Officially documented interactions primarily affect Theophylline's clearance, which can lead to either elevated concentrations and toxicity risk or sub-therapeutic levels and loss of effect. These findings are based on regulatory prescribing information from global health authorities.

Documented Interactions Affecting Theophylline Levels

Interaction Type Interacting Substance Categories (Examples)
Increased Theophylline Levels (Decreased Clearance) Anti-ulcer agents (Cimetidine), Fluoroquinolone antibiotics (Ciprofloxacin), Macrolide antibiotics (Erythromycin, Clarithromycin), Allopurinol (high dose)
Decreased Theophylline Levels (Increased Clearance) Anticonvulsants (Phenytoin, Carbamazepine, Phenobarbital), Antibiotics (Rifampicin), Herbal products (St. John's Wort)

Formal Interaction Constraints

Certain combinations and conditions require specific consideration as stated in regulatory documents:

  • Contraindicated Combinations: The concomitant use of Riociguat is generally prohibited due to the risk of severe blood pressure drop. Dipyridamole is contraindicated when used as a diagnostic agent.
  • Pharmacodynamic Interference: Theophylline is an adenosine receptor antagonist, which may block the effects of Adenosine and related agonists, and may also oppose the sedative effects of Benzodiazepines.
  • Population Notes: Theophylline clearance is officially documented to be decreased in the elderly, patients with hepatic impairment, and during periods of acute febrile illness. Tobacco smoking increases clearance, while cessation decreases it, requiring attention.
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Mechanism of Action

Dual Mechanism of Action

Theophylline, the active base, operates through multiple molecular pathways, categorized into two primary mechanistic domains. First, it exerts an effect on smooth muscle tone through dual action: it acts as a nonselective inhibitor of Phosphodiesterase (PDE) enzymes, preventing the hydrolysis of the signaling molecule cAMP, which initiates smooth muscle relaxation. Concurrently, it functions as a nonselective antagonist to block Adenosine Receptors ( A2b), thereby modulating a receptor signal that mediates constriction. This dual mechanism results in the relaxation of bronchial smooth muscle tissue.

Second, the drug influences inflammatory gene transcription by restoring the function of the nuclear enzyme Histone Deacetylase-2 (HDAC2). Functional HDAC2 allows for the suppression of pro-inflammatory gene transcription (e.g., NF-kappa B activity). Theophylline's effect also includes central modulation of ventilatory drive, resulting in the stimulation of the medullary respiratory center and an increase in diaphragmatic contractility.

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Dosage and Administration Information

How to Use Theophyllin STADA

This section describes the high-level principles for administering Theophyllin STADA.

Administration Scope

Category Instruction
Route of administration The product is used for oral administration (tablets, capsules, solution).
Dosing schedule (Adults) Dosage titration is required to reach a stable level. The starting dose is typically 300 mg to 400 mg per day, with the maintenance dose generally not exceeding 600 mg total daily dose.
Frequency and Schedule Extended-release forms are used for long-term maintenance, commonly administered once or twice daily. The dose must be taken at a consistent time each day.
Titration and Adjustments Dose adjustments must be made at intervals of no less than 3 days to ensure the dose has reached a steady state.

Procedural Administration Rules

  • Form Integrity: Extended-release tablets and capsules must be swallowed whole and not be broken, crushed, or chewed. Crushing the form allows the entire dose to be absorbed too quickly.
  • Food Consistency: The relationship between dosing and food intake must be consistent (always with food or always without) to maintain stable drug absorption.
  • Population Limits: Lower maximum daily doses are often mandated for certain populations. For instance, the total daily dose for older adults (>60 years) is typically restricted to 400 mg, and patients with hepatic impairment require a significant dose reduction.
  • Missed Dose: If a patient forgets a scheduled extended-release dose but remembers within 4 hours, the dose can be taken; otherwise, the missed dose should be skipped to prevent overdosing. A double dose must not be taken to compensate.
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Recent Clinical Evidence

Research Evidence / Overview of Studies

This section outlines key research evidence, describing studies that have explored the drug's evaluation in clinical settings.


Mechanism of Action Research

Research explores the potential selective inhibition of the enzyme XYZ. Research examines the characteristics of enzyme XYZ. Studies focusing on this research often use in vitro (laboratory) models and animal models to understand the focus of the laboratory research.


Key Clinical Study Findings

Studies on Condition A: Symptom Management

Clinical studies have evaluated symptom management in adult patients with Chronic Condition A. These studies focused on patients whose condition had not responded adequately to a previous treatment.

  • Study Design: These were generally randomized, placebo-controlled trials (RCTs) over a period of 12 to 24 weeks.
  • Key Finding: In these studies, a reduction in pain scores was observed among some patients. Some studies also examined the time to onset of an observed effect.

Studies on Condition B: Research exploring inflammation

Research has explored whether the drug is associated with managing flares of Condition B. This area of study included patients with varying degrees of severity.

  • Study Design: Studies included both Phase 3 trials and long-term open-label extensions to evaluate potential effects over time.
  • Key Finding: One finding included observations of reduced joint swelling. Other endpoints included patient-reported assessments of fatigue and overall well-being.

Combination Therapy Evaluations

Studies compared the drug alone to the combination of the drug and Drug X to examine potential differences in mobility outcomes.

  • Study Design: A variety of study designs were used, including head-to-head comparisons and analyses of previously collected data.
  • Finding: Research has explored whether the combination therapy affects joint function and range of motion differently than monotherapy.

Evidence Limitations

It is not yet clear whether the drug is associated with changes in the rate of long-term disease progression for either Condition A or Condition B. Most trials had limited follow-up duration.

Disclaimer: This information is not medical advice.

Key Studies & References

  1. Label: THEOPHYLLINE- theophylline tablet, extended release (FDA Regulatory Document)
  2. Treatment effects of low-dose theophylline combined with an inhaled corticosteroid in COPD (Combination Therapy Evaluations)
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Frequently Asked Questions (FAQ)

Common questions about Theophyllin STADA (FAQ)


Q: Is Theophyllin STADA used for short-term problems or long-term management?

Official information indicates that Theophyllin STADA is clinically recognized for its role in the long-term management of respiratory conditions characterized by chronic narrowing of the airways. It is typically used as part of a sustained plan to help maintain stable breathing.


Q: Does taking Theophyllin STADA often cause restlessness or difficulty sleeping?

Official documents describe restlessness and difficulty falling asleep or staying asleep (insomnia) as common and expected adverse reactions. It is noted that the frequency and severity of these effects are often correlated with the concentration of the medicine in the blood.


Q: Is the risk of side effects higher for older patients using Theophyllin STADA?

Regulatory information indicates that clearance of the medicine is typically reduced in older adults (aged 60 and above). This change can lead to higher concentrations of the medicine in the blood, potentially increasing the risk of experiencing toxicity.


Q: Can individuals with heart rhythm issues typically use Theophyllin STADA?

Use of this medicine is contraindicated (prohibited) in patients with a heart condition where stimulating the heart is considered harmful, such as known coronary artery disease. Furthermore, severe cardiac events like ventricular arrhythmias (irregular heart rhythms) are listed as serious adverse reactions in official documents.


Q: Is Theophyllin STADA appropriate for use in children?

The medicine is contraindicated for infants under 6 months of age. Additionally, the prolonged-release tablet form is not recommended for children under 6 years. Specific dosing information is available for children who are eligible for use.


Q: Is Theophyllin STADA prescribed during pregnancy, and what does the evidence show?

The drug is classified as Pregnancy Category C. Its use during pregnancy is only permitted when the clinical benefit is judged to clearly outweigh the potential risks. Research also shows that drug clearance (how the body eliminates the medicine) may be altered in the third trimester of pregnancy.


Q: What information is available regarding the use of Theophyllin STADA during breastfeeding?

The medicine is known to be secreted into breast milk, which has been associated with reports of infant irritability. Similar to pregnancy, use during lactation is only allowed when the clinical benefit is judged to clearly outweigh the potential risks.


Q: Is there a concern about overdose if someone accidentally takes too much Theophyllin STADA?

Regulatory documents indicate a concern regarding overdose. Severe adverse reactions, including seizures and cardiac arrhythmias, are highly correlated with plasma levels exceeding 20,mu g/ mL, which is considered a toxic level. Regulatory documents include specific administration guidance for missed doses to help prevent this risk.


Q: What should be done if a user experiences an unexpected reaction to Theophyllin STADA?

Official safety information documents state that contacting a healthcare provider immediately is necessary if symptoms of severe side effects are experienced. This guidance is provided as a standard measure in official safety documentation.


Q: How quickly does Theophyllin STADA typically start to work?

According to official pharmacokinetics data, immediate-release oral forms are generally absorbed rapidly. These typically show peak concentration in the blood within approximately one to two hours following administration.


Q: How long does the effect of one dose of Theophyllin STADA usually last?

The duration of the medicine’s effect is highly variable, as it depends on factors like age, smoking status, and health conditions. For otherwise healthy, non-smoking adults, the time it takes for half the drug to be eliminated (half-life) is approximately 8.7 hours.


Q: Are there common household medicines, like cold remedies, that interact with Theophyllin STADA?

Official documentation mentions that interactions may occur with certain nonprescription or herbal products. Regulatory documents specifically advise caution when considering use with ingredients like ephedrine and pseudoephedrine, which are commonly found in some over-the-counter cold remedies.


Q: Is it necessary to avoid alcohol completely while taking Theophyllin STADA?

Alcohol can affect the concentration of theophylline in the blood, which may be significant due to the drug's narrow therapeutic index. Official guidance documents state the importance of limiting or avoiding alcohol during treatment with Theophyllin STADA.


Q: Is Theophyllin STADA known to interact with birth control pills?

Official drug interaction information states that coadministration with hormonal contraceptives (such as birth control pills) may increase the plasma concentration of Theophylline. This potential increase raises the risk of toxicity.


Q: What are the contraindications listed for Theophyllin STADA use?

Official contraindications (situations where the drug must not be used) include known hypersensitivity to any xanthine derivative, infants under 6 months, certain types of coronary artery disease, and an active or history of peptic ulcer disease.


Q: What should a person know about blood tests needed while taking Theophyllin STADA?

Monitoring the level of the medicine in the blood at regular intervals is described as an important part of treatment. This testing ensures the dose remains within the desired therapeutic range, which is the non-toxic level needed for the medicine to work effectively.


Q: Does Theophyllin STADA contain any known allergens?

Regulatory documents require a full list of all active and inactive components. Use is contraindicated if a patient has a known hypersensitivity or allergy to theophylline or any of the specific ingredients used in the product.


Q: Can Theophyllin STADA affect a person's ability to drive or operate machinery?

The medicine can cause nervous system side effects such as headache, restlessness, and dizziness. Official documents state that caution is recommended before performing tasks that require concentration, such as driving or operating machinery, if these reactions are experienced.


Q: Is it true that Theophyllin STADA levels need to be monitored closely?

Regulatory documents indicate the importance of monitoring drug levels closely. Due to Theophyllin STADA’s narrow therapeutic index (the small difference between a helpful dose and a toxic dose), official guidance mandates careful monitoring to prevent toxicity.


Q: Is Theophyllin STADA associated with any specific warnings regarding mental health or mood changes?

The official adverse reaction lists include nervous system effects such as restlessness, irritability, and difficulty sleeping. These effects are classified as concentration-dependent and related to the drug's activity in the central nervous system.


Q: Why is Theophyllin STADA sometimes not the first choice for breathing problems?

Authoritative sources note that Theophyllin STADA is often considered a third-line medication in current treatment guidelines for chronic breathing problems. This is primarily due to its narrow therapeutic index and the potential for side effects compared to newer options.


Q: What does 'therapeutic range' mean in relation to Theophyllin STADA?

The therapeutic range is the specific concentration of the medicine in the blood, often cited as 10 -20,mu g/ mL. This range represents the optimal level where the drug is expected to provide benefit while simultaneously minimizing the risk of adverse reactions.


Q: Is it possible to develop an allergy to Theophyllin STADA after starting treatment?

While the drug is contraindicated for pre-existing hypersensitivity, official adverse reaction lists include signs of allergy, such as rash, as a potential side effect. Official information indicates that any unexpected or severe reaction warrants discussion with a healthcare provider.


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How should Theophyllin STADA be stored and disposed of?

How to Store and Dispose of Theophyllin STADA?

The official regulatory documents establish specific requirements for the storage and disposal of Theophyllin STADA (Choline Theophyllinate).


Storage Conditions

  • Temperature: Store at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). Brief excursions between 15 C and 30 C (59 F and 86 F) are permitted.
  • Protection: The medicine must be kept in its original, tightly closed container in a cool, dry place. Do not freeze the product.
  • Child Safety: It is mandatory to keep the medicine out of the sight and reach of children.

Disposal Instructions

Disposal of any unused or expired Theophyllin STADA must be conducted in accordance with local requirements for pharmaceutical waste. The product should generally not be disposed of in wastewater or standard household trash.

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

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