Theo 24 CR: 24-Hour Bronchodilation for Uninterrupted Breathing Control
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Theo 24 CR (Theophylline Extended-Release Tablets, 24-hour) is a methylxanthine bronchodilator indicated for the treatment and prevention of symptoms from asthma, chronic bronchitis, emphysema, and other chronic obstructive pulmonary diseases (COPD). Its unique 24-hour controlled-release delivery system is engineered to maintain consistent serum theophylline concentrations, thereby providing around-the-clock smooth muscle relaxation in the bronchial airways and pulmonary vasculature. This pharmacokinetic profile minimizes peak-to-trough fluctuations, reduces the frequency of dosing to once daily, and supports long-term management of reversible airflow obstruction. It is a cornerstone maintenance therapy for patients requiring sustained bronchodilation.
Features
- Pharmacological Class: Methylxanthine bronchodilator.
- Active Ingredient: Theophylline, anhydrous.
- Dosage Form: Extended-release, film-coated tablets for oral administration.
- Delivery System: 24-hour controlled-release technology designed for once-daily dosing.
- Available Strengths: 100 mg, 200 mg, 300 mg, and 400 mg tablets.
- Mechanism of Action: Non-selective phosphodiesterase (PDE) inhibition, adenosine receptor antagonism, and possible modulation of intracellular calcium.
- Bioavailability: Nearly 100% when administered on an empty stomach.
- Half-Life: Highly variable among patients (mean 8 hours in adults, longer in others), necessitating therapeutic drug monitoring (TDM).
Benefits
- Provides sustained 24-hour bronchodilation, preventing nocturnal and early morning asthma symptoms and reducing the frequency of acute attacks.
- The once-daily dosing regimen significantly improves patient adherence compared to shorter-acting formulations, supporting consistent therapeutic outcomes.
- Offers an alternative or adjunctive treatment option for patients whose symptoms are not adequately controlled by inhaled corticosteroids and short-acting beta-agonists (SABAs) alone.
- May improve diaphragmatic contractility and reduce respiratory muscle fatigue, contributing to overall respiratory function in severe COPD.
- The predictable pharmacokinetics of the extended-release formulation, when managed with TDM, allow for precise dose titration to maximize efficacy while minimizing the risk of toxicity.
Common use
Theo 24 CR is primarily prescribed for the maintenance therapy of chronic, stable asthma and for the symptomatic relief of bronchospasm associated with chronic bronchitis and emphysema. It is not indicated for the relief of acute bronchospasm. Its use is typically reserved for patients who require continuous bronchodilator coverage and for whom the convenience of a once-daily oral medication is preferable to multiple daily inhalations. It is often used in a stepwise approach to asthma management, as outlined in guidelines from organizations like GINA (Global Initiative for Asthma), particularly in moderate to severe persistent cases.
Dosage and direction
Dosage must be highly individualized based upon specific patient factors, including age, weight, concomitant illnesses, and—most critically—serum theophylline concentration. The goal of therapy is to achieve and maintain a steady-state serum concentration within the therapeutic range of 10-20 mcg/mL.
- Initial Dosing for Adults (non-smoking): The typical initial dose is 300 to 400 mg once daily, administered in the morning.
- Titration: The dose may be increased by approximately 25% at 3-day intervals if the drug is well-tolerated, until the desired therapeutic response is achieved or the maximum recommended dose is reached.
- Administration: Tablets must be swallowed whole and must not be chewed, crushed, or split, as this will disrupt the extended-release mechanism and could lead to rapid drug release and potential toxicity. For optimal absorption and to minimize rate of absorption variability, administer at a consistent time each morning, at least one hour before or two hours after a meal.
- Therapeutic Drug Monitoring (TDM): Serum concentration levels must be monitored after the patient is on a stable dose for at least 3 days, and then periodically thereafter (e.g., every 6-12 months for stable patients, more frequently if factors affecting clearance change).
Precautions
- Narrow Therapeutic Index: Theo 24 CR has a narrow therapeutic window; concentrations below 10 mcg/mL may be ineffective, while concentrations exceeding 20 mcg/mL are associated with a significantly increased risk of severe toxicity.
- Variable Metabolism: Theophylline clearance is affected by numerous factors including age, cardiac failure, liver dysfunction, prolonged fever, viral illness, and concomitant use of certain drugs. These factors necessitate vigilant monitoring and dose adjustment.
- Seizure Risk: Theophylline can cause seizures, even in patients without a prior history, particularly at high serum concentrations.
- Cardiac Effects: May cause tachycardia, palpitations, and other arrhythmias. Use with caution in patients with pre-existing cardiovascular disease.
- GERD and GI Effects: May lower esophageal sphincter pressure and aggravate symptoms of gastroesophageal reflux (GERD) or peptic ulcer disease.
Contraindications
Theo 24 CR is contraindicated in patients with:
- A known hypersensitivity to theophylline or any component of the formulation.
- Underlying seizure disorders not adequately controlled by anticonvulsant medication.
- Active peptic ulcer disease.
- Uncontrolled cardiac arrhythmias.
Possible side effect
Side effects are often correlated with serum concentration and may include:
- Common (>10%): Nausea, vomiting, headache, insomnia.
- Less Common (1-10%): Diarrhea, irritability, restlessness, muscle twitching, tachycardia.
- Rare but Serious (<1%): Intractable vomiting, cardiac arrhythmias (e.g., atrial fibrillation, ventricular arrhythmias), seizures, hypokalemia, hyperglycemia. These are more frequently associated with serum concentrations >30 mcg/mL.
Drug interaction
Theophylline metabolism is highly susceptible to drug interactions, primarily via inhibition or induction of the cytochrome P450 1A2 enzyme system.
- Increased Theophylline Levels (Risk of Toxicity): Cimetidine, ciprofloxacin, erythromycin, clarithromycin, allopurinol, fluvoxamine, oral contraceptives, propranolol, disulfiram, zileuton.
- Decreased Theophylline Levels (Risk of Therapeutic Failure): Phenytoin, phenobarbital, carbamazepine, rifampin, smoking (tobacco or marijuana), charcoal-broiled foods, St. John’s Wort.
- Synergistic/Side Effect Potentiation: Concurrent use with other sympathomimetic agents may exacerbate cardiovascular and central nervous system effects. Use with caution with beta-blockers, which may antagonize the bronchodilating effect.
Missed dose
If a dose is missed, it should be taken as soon as possible on the same day. However, if it is nearing the time for the next scheduled dose, the missed dose should be skipped. The regular dosing schedule should be resumed. Do not double the next dose to make up for a missed dose, as this significantly increases the risk of toxicity.
Overdose
Theophylline overdose is a medical emergency that can be fatal. Manifestations of acute overdose may include severe nausea, intractable vomiting, hematemesis, tremors, hyperthermia, agitation, tachycardia, ventricular arrhythmias, hypotension, seizures, and metabolic derangements (hypokalemia, hyperglycemia, metabolic acidosis). Chronic overdose presents similarly but may occur at lower serum concentrations.
- Action: Seek immediate emergency medical attention.
- Treatment: Includes securing the airway, cardiac monitoring, treatment of seizures and arrhythmias, and multiple-dose activated charcoal to enhance elimination. In severe cases, hemodialysis or charcoal hemoperfusion may be indicated.
Storage
Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from light and moisture. Keep in the original container, tightly closed. Keep out of reach of children and pets.
Disclaimer
This information is for educational and informational purposes only and does not constitute medical advice. It 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 product information provided may not be comprehensive or include all possible uses, directions, precautions, interactions, or adverse effects.
Reviews
- “As a pulmonologist with over 20 years of experience, Theo 24 CR remains a valuable tool in my arsenal for severe COPD patients. The once-daily dosing is a game-changer for adherence. The key, without exception, is meticulous therapeutic drug monitoring. When managed correctly, the benefits significantly outweigh the risks.” – Dr. A. Reynolds, MD
- “I’ve been on this medication for my asthma for five years. It took a few weeks to get the dose right with blood tests, but the difference is night and day. I no longer wake up gasping for air. Remembering one pill in the morning is so much easier than my old inhaler routine.” – Verified Patient
- “From a clinical pharmacy perspective, this drug demands respect. Its extensive interaction profile and narrow therapeutic index require constant vigilance from the entire healthcare team. It is not a ‘set it and forget it’ medication, but for the right patient with careful management, it is profoundly effective.” – Clinical Pharmacist, Major Hospital Network