Trihale
Generic Name
Tiotropium Bromide + Formoterol Fumarate + Budesonide
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| trihale 25 mcg inhalation capsule | ৳ 70.00 | ৳ 700.00 |
Description
Overview of the medicine
Trihale is a triple combination inhaler containing Tiotropium Bromide, Formoterol Fumarate, and Budesonide. It is used for the long-term maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) and severe persistent asthma. The combination helps to open the airways and reduce inflammation in the lungs.
Uses & Indications
Dosage
Adults
Typically 1 inhalation once daily, or as directed by physician. Dosage may vary based on product and patient condition.
Elderly
No specific dose adjustment required for elderly patients, but caution is advised.
Renal_impairment
Use with caution in patients with severe renal impairment, monitor for anticholinergic side effects.
How to Take
For inhalation use only. Do not swallow. Administer using the provided device. Rinse mouth with water after each dose to prevent oral candidiasis and reduce systemic absorption of Budesonide. Do not use for acute relief of bronchospasm.
Mechanism of Action
Tiotropium is a long-acting muscarinic antagonist (LAMA) that causes bronchodilation by blocking M3 muscarinic receptors. Formoterol is a long-acting beta2-adrenergic agonist (LABA) that causes bronchodilation by stimulating beta2 receptors in the airways. Budesonide is an inhaled corticosteroid (ICS) that reduces inflammation in the lungs.
Pharmacokinetics
Onset
Formoterol has a rapid onset (within minutes). Tiotropium and Budesonide have a slower onset for full therapeutic effect.
Excretion
Tiotropium is primarily excreted unchanged in urine. Formoterol is primarily excreted renally. Budesonide metabolites are excreted via urine and feces.
Half life
Tiotropium: Terminal half-life approx. 25-30 hours. Formoterol: Terminal half-life approx. 10 hours. Budesonide: Systemic half-life approx. 2-3 hours.
Absorption
Systemic absorption of each component is low following inhalation, with local action being predominant in the lungs. Some absorbed drug is swallowed.
Metabolism
Budesonide and Formoterol are extensively metabolized in the liver, primarily via CYP3A4. Tiotropium is minimally metabolized, primarily by ester hydrolysis.
Side Effects
Contraindications
- Hypersensitivity to Tiotropium, Formoterol, Budesonide, or any excipients
- Acute bronchospasm or status asthmaticus
- Not for acute exacerbations of COPD or asthma
Drug Interactions
Beta-blockers
May reduce the bronchodilatory effect of Formoterol and cause severe bronchospasm.
Anticholinergics
Concomitant administration of other anticholinergic-containing drugs may lead to an increase in anticholinergic side effects.
MAOIs, TCAs, other QT-prolonging drugs
May potentiate the effect of Formoterol on the cardiovascular system.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase systemic exposure to Budesonide, potentially leading to systemic corticosteroid effects.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Do not refrigerate or freeze. Keep the inhaler in its original sealed pouch until ready for use.
Overdose
Overdose may lead to exaggeration of typical beta2-agonist (e.g., tachycardia, tremor, palpitations), anticholinergic (e.g., dry mouth, blurred vision), and corticosteroid (e.g., Cushing's syndrome symptoms with chronic overdose) side effects. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult a doctor. Caution should be exercised when Trihale is administered to a nursing mother. It is unknown whether Tiotropium and Formoterol are excreted in human milk, but Budesonide is excreted.
Side Effects
Contraindications
- Hypersensitivity to Tiotropium, Formoterol, Budesonide, or any excipients
- Acute bronchospasm or status asthmaticus
- Not for acute exacerbations of COPD or asthma
Drug Interactions
Beta-blockers
May reduce the bronchodilatory effect of Formoterol and cause severe bronchospasm.
Anticholinergics
Concomitant administration of other anticholinergic-containing drugs may lead to an increase in anticholinergic side effects.
MAOIs, TCAs, other QT-prolonging drugs
May potentiate the effect of Formoterol on the cardiovascular system.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase systemic exposure to Budesonide, potentially leading to systemic corticosteroid effects.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Do not refrigerate or freeze. Keep the inhaler in its original sealed pouch until ready for use.
Overdose
Overdose may lead to exaggeration of typical beta2-agonist (e.g., tachycardia, tremor, palpitations), anticholinergic (e.g., dry mouth, blurred vision), and corticosteroid (e.g., Cushing's syndrome symptoms with chronic overdose) side effects. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult a doctor. Caution should be exercised when Trihale is administered to a nursing mother. It is unknown whether Tiotropium and Formoterol are excreted in human milk, but Budesonide is excreted.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 months from manufacturing date, check specific product packaging.
Availability
Available in pharmacies across Bangladesh
Approval Status
Approved for COPD and Asthma
Patent Status
Generic versions available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of triple therapy combinations (LAMA/LABA/ICS) in improving lung function, reducing exacerbations, and improving quality of life in patients with moderate to severe COPD and uncontrolled asthma.
Lab Monitoring
- Routine lab monitoring is generally not required. Monitor for signs of systemic corticosteroid effects with prolonged high-dose use.
- Regular lung function tests are recommended for disease management.
Doctor Notes
- Emphasize proper inhalation technique and adherence to daily dosing.
- Educate patients on the difference between maintenance and rescue inhalers.
- Monitor for signs of oral candidiasis and advise rinsing mouth after use.
- Be aware of potential drug interactions, especially with beta-blockers and strong CYP3A4 inhibitors.
Patient Guidelines
- Use exactly as prescribed by your doctor.
- Do not use for sudden breathing problems; use your rescue inhaler for acute symptoms.
- Rinse your mouth with water and spit it out after each dose to reduce the risk of oral thrush.
- Learn the correct inhalation technique from your doctor or pharmacist.
- Do not stop using this medicine without consulting your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Trihale is unlikely to affect your ability to drive or operate machinery. However, if you experience side effects like dizziness, tremor, or blurred vision, avoid driving until you feel well.
Lifestyle Advice
- Avoid smoking and exposure to smoke/pollutants.
- Stay hydrated and maintain a healthy diet.
- Engage in regular, moderate exercise as tolerated.
- Identify and avoid triggers that worsen your breathing conditions.
- Attend regular follow-up appointments with your doctor.
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