Theo 24 CR: 24-Hour Bronchodilation for Uninterrupted Breathing Control

Theo-24 Cr

Product dosage: 400mg
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Theo 24 CR (Theophylline Extended-Release Tablets 24 Hour) is a prescription methylxanthine bronchodilator formulated for sustained, around-the-clock management of asthma and chronic obstructive pulmonary disease (COPD) symptoms, including bronchospasm. Its advanced extended-release delivery system is engineered to maintain consistent serum theophylline concentrations, providing continuous airway smooth muscle relaxation and respiratory improvement. This pharmacokinetic profile supports enhanced therapeutic outcomes by minimizing peak-trough fluctuations, thereby optimizing efficacy while supporting a manageable dosing regimen for long-term pulmonary maintenance therapy.

Features

• Pharmacological Class: Methylxanthine Bronchodilator
• Active Ingredient: Theophylline, Anhydrous
• Dosage Form: Extended-Release Capsule or Tablet for 24-hour delivery
• Available Strengths: Commonly available in 100 mg, 200 mg, 300 mg, and 400 mg dosage strengths
• Mechanism of Action: Non-selective phosphodiesterase inhibition, leading to increased intracellular cyclic AMP; adenosine receptor antagonism; and potential modulation of intracellular calcium
• Release Technology: Designed for once-daily administration, utilizing a controlled-release matrix to provide zero-order drug delivery
• Bioavailability: Demonstrates complete absorption; however, the rate and extent can be influenced by factors such as food and concomitant medications

Benefits

• Provides continuous, 24-hour bronchodilation and symptom control, reducing the frequency and severity of asthma attacks and COPD exacerbations.
• Improves overall lung function metrics, including forced expiratory volume in one second (FEV1) and peak expiratory flow rate (PEFR), facilitating easier breathing and enhanced exercise tolerance.
• Supports a simplified, once-daily dosing schedule that promotes patient adherence to long-term maintenance therapy, a critical factor in chronic disease management.
• Offers a therapeutic option for patients who may not achieve sufficient control with inhaled corticosteroids or short-acting beta-agonists alone.
• Contributes to a reduction in nighttime symptoms and sleep disturbances associated with respiratory conditions, improving overall quality of life.
• Serves as a cornerstone maintenance medication within a comprehensive, multi-modal treatment plan for chronic reversible airway obstruction.

Common use

Theo 24 CR is indicated for the treatment and chronic management of symptoms associated with reversible bronchospasm. Its primary applications include the maintenance therapy of asthma, characterized by widespread, variable airflow limitation and bronchial hyperresponsiveness. It is also extensively used in the management of chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis. Clinicians may prescribe it as a monotherapy or, more commonly, as part of a combination regimen alongside inhaled corticosteroids, long-acting muscarinic antagonists (LAMAs), or long-acting beta2-agonists (LABAs) to achieve synergistic effects and superior symptom control. Its role is pivotal in preventing the recurrence of symptoms and reducing the need for rescue inhalers.

Dosage and direction

Dosage is highly individualized and MUST be titrated based on ideal body weight, age, smoking status, and concurrent factors affecting theophylline metabolism (e.g., liver function, cardiac status, concomitant drugs). The goal of therapy is to achieve and maintain a steady-state serum theophylline concentration within the therapeutic range of 10-20 mcg/mL.

• Initial Dosing: For adults and children over 45 kg, the typical initial dose is 300 to 400 mg once daily, administered in the evening. Dosing in children is calculated by body weight (12-14 mg/kg/day up to a maximum of 300 mg daily) and requires extreme caution.
• Titration: Increases should be made no more frequently than every 3 days, in increments of no more than 25-50% of the previous dose, to allow serum concentrations to reach steady state.
• Administration: Tablets or capsules must be swallowed WHOLE. They must not be chewed, crushed, or divided, as this will disrupt the extended-release mechanism and could lead to a rapid and potentially toxic dose dump.
• Timing: For once-daily formulations, administer at a consistent time each evening, approximately 12 hours apart if a different schedule is advised.
• With Food: To ensure consistent absorption and minimize potential gastrointestinal irritation, administer with a full glass of water on an empty stomach, at least 1 hour before or 2 hours after a meal. High-fat meals can significantly alter absorption.

Precautions

Theophylline has a narrow therapeutic index, meaning the difference between an effective dose and a toxic dose is small. Extreme vigilance is required.

• Therapeutic Drug Monitoring (TDM): Serum theophylline concentration monitoring is mandatory to guide dosing and prevent toxicity, especially after initiation, after dosage changes, upon addition or discontinuation of interacting drugs, and if signs of toxicity appear.
• Hepatic/Cardiac Impairment: Patients with cirrhosis, acute hepatitis, congestive heart failure, cor pulmonale, or elderly patients have markedly reduced theophylline clearance. Dosages must be significantly reduced, and monitoring must be more frequent.
• Febrile Illness: Viral infections or vaccinations can reduce clearance. Consider dose reduction during significant illness.
• Smoking: Tobacco and marijuana smoking induce metabolizing enzymes, increasing clearance and often requiring higher doses. Cessation of smoking will reverse this effect, necessitating an immediate dose reduction to avoid toxicity.
• Seizure Risk: Theophylline can lower the seizure threshold. Use with extreme caution in patients with a history of seizure disorders.
• GERD/GI Disorders: May exacerbate gastroesophageal reflux or peptic ulcer disease due to relaxation of the lower esophageal sphincter.

Contraindications

Theo 24 CR is contraindicated in individuals with a known hypersensitivity to theophylline, any component of the formulation, or other methylxanthines like caffeine or theobromine. Its use is also absolutely contraindicated in patients with active peptic ulcer disease and in those with a history of hypersensitivity to the drug. Concurrent use with other xanthine-containing medications is not recommended.

Possible side effect

Side effects are often correlated with serum concentrations and may be early signs of toxicity.

• Common (>10%): Nausea, vomiting, headache, insomnia, gastritis, restlessness, irritability.
• Less Common (1-10%): Diarrhea, increased urination, tachycardia (fast heart rate), palpitations.
• Serious (Require immediate medical attention):
  • Cardiac: Atrial and ventricular arrhythmias, hypotension.
  • Neurological: Intractable seizures (often the first sign of significant toxicity in adults), severe vertigo.
  • Metabolic: Hypokalemia (low potassium).
  • Gastrointestinal: Hematemesis (vomiting blood).

Drug interaction

Theophylline is subject to extensive and critically significant pharmacokinetic drug interactions, primarily through inhibition or induction of the cytochrome P450 1A2 enzyme system.

• Drugs that INCREASE Theophylline Levels (Inhibitors): Cimetidine, Allopurinol, Ciprofloxacin/Levofloxacin, Erythromycin/Clarithromycin, Zileuton, Fluvoxamine, Oral Contraceptives, Propranolol, Ticlopidine. Concomitant use requires a significant reduction in theophylline dose.
• Drugs that DECREASE Theophylline Levels (Inducers): Phenytoin, Phenobarbital, Carbamazepine, Rifampin, Smoking (tobacco/marijuana), Charcoal-broiled foods. Concomitant use may require an increased theophylline dose.
• Pharmacodynamic Interactions: Concurrent use with other sympathomimetic agents (e.g., albuterol) may potentiate cardiotoxic effects like tachycardia. Use with halothane may increase the risk of cardiac arrhythmias.

Missed dose

If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. The regular dosing schedule should be resumed. The patient should NEVER take a double dose to make up for a missed one, as this drastically increases the risk of acute toxicity and life-threatening side effects due to the drug’s narrow therapeutic window.

Overdose

Theophylline overdose is a MEDICAL EMERGENCY that can be fatal. Toxicity can occur with acute overdose or chronic over-medication. Serum levels above 20 mcg/mL are associated with toxicity, and levels above 30 mcg/mL can be life-threatening.

• Signs/Symptoms: Severe nausea and vomiting, intractable seizures (often without warning), cardiac arrhythmias (e.g., ventricular tachycardia, fibrillation), hypokalemia, hyperglycemia, metabolic acidosis, hypotension, and death.
• Management: Requires immediate hospitalization, often in an intensive care unit. Treatment is supportive and includes securing the airway, managing seizures with benzodiazepines, correcting electrolyte abnormalities, and controlling arrhythmias. Gastrointestinal decontamination with activated charcoal is crucial, including repeated doses, as charcoal interrupts enterohepatic recirculation. Hemodialysis or hemoperfusion may be indicated for severe overdoses (e.g., serum levels >100 mcg/mL in acute overdose or >60 mcg/mL in chronic overdose) due to theophylline’s relatively low volume of distribution and lack of extensive protein binding.

Storage

Store at controlled room temperature, 20°-25°C (68°-77°F), in a tight, light-resistant container. Keep the bottle tightly closed to protect from moisture. Always store all medications out of reach and sight of children and pets. Do not use after the expiration date printed on the packaging. Do not flush medications down the toilet or pour them down a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed through a medicine take-back program.

Disclaimer

This information is for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting, stopping, or changing any prescribed part of your care plan. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content provided has not been evaluated by all regulatory agencies and is not intended to diagnose, treat, cure, or prevent any disease.

Reviews

“After struggling with nighttime asthma symptoms that disrupted my sleep, my pulmonologist switched me to Theo 24 CR. The once-daily dosing is simple, and the 24-hour coverage has been transformative. My peak flow readings are consistently better, and I rarely need my rescue inhaler anymore. It required careful dose adjustments at the start, but the results have been worth it.” – M.B., 58

“As a clinician, theophylline remains a valuable tool in our arsenal for severe COPD. While it demands respect due to its narrow therapeutic index and need for monitoring, its cost-effectiveness and efficacy as an add-on therapy are undeniable. In patients where adherence to multiple inhalers is a challenge, a once-daily oral option like Theo 24 CR can significantly improve outcomes. It is not a first-line drug for most, but in the right patient with careful management, it is exceptionally effective.” – Dr. A. Rivera, Pulmonologist