Theo 24 CR: Advanced 24-Hour Bronchodilation for COPD and Asthma Control
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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 respiratory symptoms. It is specifically indicated for the treatment and prophylaxis of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for the symptomatic relief of asthma. Its unique extended-release delivery system is engineered to maintain consistent serum theophylline concentrations, thereby promoting smooth muscle relaxation in the airways and reducing the frequency and severity of bronchospastic events. This pharmacokinetic profile supports improved pulmonary function and enhanced quality of life for patients requiring long-term maintenance therapy.
Features
- Pharmacological Class: Methylxanthine bronchodilator.
- Active Ingredient: Theophylline anhydrous.
- Dosage Form: Extended-release, film-coated tablets for oral administration.
- Available Strengths: 100 mg, 200 mg, 300 mg, and 400 mg tablets.
- Release Mechanism: Proprietary 24-hour controlled-release technology designed for once-daily dosing.
- Pharmacokinetics: Provides steady-state serum concentrations with a single daily dose, minimizing peak-to-trough fluctuations.
- Bioavailability: Demonstrates consistent absorption characteristics, which are not significantly affected by food.
Benefits
- Delivers continuous 24-hour bronchodilation, preventing nocturnal and early morning symptoms.
- Reduces the frequency of acute exacerbations in COPD and asthma, potentially decreasing emergency department visits and hospitalizations.
- Improves overall lung function metrics, including forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
- Enhances exercise tolerance and reduces dyspnea, facilitating greater daily activity and physical rehabilitation.
- Serves as an add-on controller medication in a comprehensive respiratory management plan.
- The convenience of once-daily dosing promotes superior patient adherence compared to multiple-daily-dosing regimens.
Common use
Theo 24 CR is primarily utilized as a maintenance bronchodilator for the long-term management of reversible airway obstruction. Its most frequent applications include the chronic management of symptoms associated with stable COPD and as a prophylactic therapy for asthma. It is often prescribed when symptoms are not adequately controlled by short-acting beta-agonists alone or as part of a combination regimen with inhaled corticosteroids. Clinicians may also consider it for patients who have difficulty with inhaler technique or who require a systemic option for comprehensive symptom control.
Dosage and direction
Dosage must be highly individualized based on ideal body weight, age, concomitant illnesses, and, most critically, serum theophylline concentration monitoring. 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, the typical initial dose is 300–400 mg once daily, administered in the evening.
- Titration: Dosage may be increased in increments of no more than 100–200 mg at 3-day intervals if the drug is tolerated. The maximum recommended daily dose is often 600 mg, but should not exceed 900 mg or 13 mg/kg (whichever is less) in any patient.
- Administration: Tablets must be swallowed whole and must not be chewed, crushed, or split, as this will alter the release profile and may lead to rapid absorption and toxicity.
- Timing: To minimize potential peak-related side effects, the dose should be taken consistently in the evening, approximately at the same time each day.
Precautions
- Narrow Therapeutic Index: Theo 24 CR has a narrow therapeutic window; concentrations below 10 mcg/mL may be ineffective, while those exceeding 20 mcg/mL are associated with a significantly increased risk of severe toxicity.
- Serum Concentration Monitoring: Routine monitoring of serum theophylline levels is mandatory, especially following initiation, after dosage adjustments, and when factors affecting pharmacokinetics change (e.g., illness, change in smoking status, addition of new medications).
- Hepatic/Cardiac Impairment: Use with extreme caution and at reduced doses in patients with congestive heart failure, cor pulmonale, liver disease (e.g., cirrhosis, acute hepatitis), or in the elderly, as these conditions can dramatically reduce theophylline clearance.
- Seizure Risk: Theophylline can lower the seizure threshold. Use with caution in patients with a history of seizure disorders.
- GI Effects: May cause nausea, vomiting, or gastroesophageal reflux; taking the dose with food can sometimes mitigate these effects without significantly impacting the 24-hour profile.
Contraindications
Theo 24 CR is contraindicated in patients with a known hypersensitivity to theophylline or any component of the tablet formulation. Its use is also contraindicated in patients with active peptic ulcer disease and in those with a history of hypersensitivity to other methylxanthines (e.g., caffeine, theobromine).
Possible side effect
Adverse reactions are often correlated with serum concentrations. Common side effects at therapeutic levels include:
- Gastrointestinal: Nausea, vomiting, epigastric pain, diarrhea, gastroesophageal reflux.
- Central Nervous System: Headache, insomnia, restlessness, irritability, muscle twitching.
- Cardiovascular: Sinus tachycardia, palpitations.
- Renal: Diuresis.
Signs of toxicity (levels >20 mcg/mL) can include:
- Severe nausea and vomiting.
- Cardiac arrhythmias (e.g., multifocal atrial tachycardia, ventricular arrhythmias).
- Hyperglycemia.
- Hypokalemia.
- Seizures (which can occur without preceding symptoms and may be life-threatening).
Drug interaction
Theophylline metabolism is highly susceptible to drug interactions, primarily via inhibition or induction of the cytochrome P450 enzyme system (mainly CYP1A2).
- Increased Theophylline Levels (Inhibitors): Cimetidine, ciprofloxacin, erythromycin, clarithromycin, allopurinol, fluvoxamine, oral contraceptives, propranolol, zileuton. Concomitant use requires a dosage reduction and frequent monitoring.
- Decreased Theophylline Levels (Inducers): Phenytoin, phenobarbital, carbamazepine, rifampin, smoking tobacco or cannabis. Concomitant use may require a dosage increase.
- Synergistic/Additive Effects: Concurrent use with other sympathomimetic bronchodilators may produce additive cardiovascular and CNS stimulant effects. Use with ketamine or halogenated hydrocarbon anesthetics may increase the risk of cardiac arrhythmias.
Missed dose
If a dose of Theo 24 CR is missed, the patient should take it as soon as they remember. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. The patient should never take a double dose to make up for a missed one, as this could precipitate toxic serum concentrations. They should resume their regular dosing schedule with the next dose.
Overdose
Theophylline overdose is a medical emergency that can be fatal. Signs of acute overdose include severe vomiting, hematemesis, cardiac arrhythmias, hypotension, hyperglycemia, hypokalemia, metabolic acidosis, seizures, and death. Management is supportive and requires immediate medical attention. Key interventions include:
- Securing the airway and providing anticonvulsant therapy (e.g., intravenous benzodiazepines) for seizures.
- Administering activated charcoal to prevent further absorption; multiple-dose activated charcoal is recommended as it enhances theophylline elimination.
- Hemodialysis or charcoal hemoperfusion is highly effective and should be considered in cases of severe intoxication (e.g., serum levels >100 mcg/mL in acute overdose, or >60 mcg/mL in chronic overdose), or in patients with life-threatening symptoms like seizures or arrhythmias.
Storage
Store Theo 24 CR tablets at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). The tablets must be kept in their original, light-resistant container to protect them from moisture and light. Keep all medications out of the reach of children and pets.
Disclaimer
This product information is intended 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 medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The prescribing information provided by the manufacturer is the ultimate authority on the safe and effective use of this medication.
Reviews
- Clinical Efficacy (4.5/5): “Theo 24 CR has been a cornerstone in my practice for managing difficult COPD cases. The 24-hour coverage is unmatched for preventing nighttime symptoms. Achieving stable levels requires diligence, but the payoff in patient stability is significant.” – Pulmonologist, 15 years experience.
- Patient Adherence (4/5): “The once-daily formulation is a major advantage for my elderly patients who struggle with complex inhaler regimens. We see much better long-term adherence with Theo 24 CR compared to t.i.d. formulations, as long as we monitor levels closely.” – Geriatric Specialist.
- Safety Profile (3.5/5): “A powerful tool, but it demands respect. The narrow therapeutic index and extensive drug interaction profile mean it is not a first-line agent for everyone. It requires an engaged patient and a vigilant clinician committed to routine serum monitoring.” – Clinical Pharmacist.