METROHALER 12 MCG (FORMOTEROL FUMARATE) – 30 CAPSULES + INHALER

Active Ingredient: Formoterol fumarate 12 mcg per capsule
Pharmaceutical Form: Inhalation powder capsules
Pack Size: 30 capsules + inhaler device
Therapeutic Class: Long-Acting Beta-2 Adrenergic Agonist (LABA) – Bronchodilator.

Product Overview

Metrohaler 12 mcg contains formoterol fumarate, a long-acting bronchodilator used for the maintenance treatment of respiratory conditions characterized by reversible airway narrowing, particularly asthma and chronic obstructive pulmonary disease (COPD).

Formoterol works by stimulating beta-2 adrenergic receptors in the smooth muscles surrounding the airways, causing these muscles to relax and allowing the airways to widen.

Its bronchodilator effect has a relatively rapid onset, usually within 1–3 minutes, and can last for approximately 12 hours.

The capsule-based inhalation formulation delivers the medication directly into the lungs through the supplied inhaler device.

Important: Metrohaler is intended for inhalation only. The capsules must never be swallowed.

Indications and Uses

Metrohaler may be prescribed for:

• Bronchial Asthma: Long-term maintenance bronchodilator therapy to help control symptoms such as wheezing, breathlessness, chest tightness, and coughing. In asthma, formoterol must be used together with an inhaled corticosteroid (ICS), not as monotherapy.
• Chronic Obstructive Pulmonary Disease (COPD): Maintenance treatment to improve airflow and relieve persistent respiratory symptoms.
• Bronchospasm Prevention: Helps prevent airway narrowing associated with exercise or exposure to certain triggers when prescribed for an appropriate indication.
• Improvement of Respiratory Function: Helps maintain airway relaxation and reduce episodes of bronchoconstriction during its duration of action.

Important: Formoterol is a maintenance bronchodilator and should not replace an appropriate rescue inhaler during an acute asthma attack. It should not be used alone for asthma treatment.

Mechanism of Action

Formoterol selectively stimulates beta-2 adrenergic receptors in bronchial smooth muscle, activating intracellular pathways that increase cyclic AMP (cAMP).

This produces relaxation of bronchial smooth muscles and prolonged bronchodilation.

Its main effects include:

• Relaxation of airway smooth muscles.
• Widening of narrowed airways.
• Reduction of bronchospasm.
• Improvement of airflow and respiratory function.
• Relief of wheezing and breathlessness associated with reversible airway obstruction.

Formoterol has a rapid onset of action and a prolonged bronchodilator effect lasting approximately 12 hours.

Dosage and Administration

Route of Administration: Oral inhalation using the supplied capsule-based inhaler.

Recommended Adult Dosing

• Asthma maintenance treatment: Usually one 12 mcg capsule inhaled twice daily, together with an inhaled corticosteroid.
• COPD maintenance treatment: Usually one 12 mcg capsule inhaled every 12 hours.
• Exercise-induced bronchospasm prevention: When specifically prescribed, one 12 mcg capsule may be inhaled at least 15 minutes before exercise.

The dosage may vary according to the patient's condition and the manufacturer's approved instructions.

Administration Instructions:

1. Remove one capsule from its blister immediately before use.
2. Open the inhaler and place the capsule in the designated capsule chamber.
3. Close the inhaler securely.
4. Press the piercing buttons according to the device instructions.
5. Breathe out fully, away from the mouthpiece.
6. Place the mouthpiece between your lips and inhale deeply and forcefully.
7. Hold your breath for several seconds, if comfortable.
8. Check whether the capsule is empty; repeat inhalation if powder remains.
9. Remove and discard the empty capsule.

Do not exceed the prescribed dose or combine Metrohaler with another long-acting beta-2 agonist unless specifically directed by your physician.

Possible Side Effects

Common side effects may include:

• Fine hand tremors.
• Headache.
• Palpitations (awareness of heartbeat).
• Muscle cramps.
• Nervousness or restlessness.
• Dizziness.
• Increased heart rate.
• Sleep disturbances.

Less common but potentially serious adverse reactions include:

• Cardiac arrhythmias (irregular heartbeat).
• Significant changes in blood pressure.
• Low potassium levels (hypokalemia).
• Increased blood glucose levels.
• Paradoxical bronchospasm (sudden worsening of breathing immediately after inhalation).
• Severe allergic reactions.

Seek immediate medical attention if breathing suddenly worsens after inhalation or if severe chest pain or an irregular heartbeat develops.

Contraindications and Precautions

Contraindications:

• Known hypersensitivity to formoterol fumarate or any product component.
• Use as monotherapy for asthma without concomitant inhaled corticosteroid treatment.
• Use as the sole treatment for an acute severe asthma attack or status asthmaticus.

Precautions:

• Patients with cardiovascular diseases, including coronary artery disease and cardiac arrhythmias, should use formoterol cautiously.
• Use cautiously in patients with hypertension or prolonged QT interval.
• Patients with hyperthyroidism or diabetes mellitus may require additional monitoring.
• Patients with a history of seizures should inform their healthcare professional.
• Hypokalemia may occur, particularly in patients receiving high doses or concomitant medications that lower potassium levels.
• Do not discontinue prescribed inhaled corticosteroid treatment when starting formoterol.
• Pregnant or breastfeeding women should consult a healthcare professional before use.

Special Asthma Warning: Formoterol is a long-acting beta-2 agonist (LABA). In patients with asthma, it must be combined with an inhaled corticosteroid (ICS) to reduce the risk of serious asthma-related complications.

Important Drug and Lifestyle Interactions

• Beta-blockers: May reduce the bronchodilator effect of formoterol and potentially cause bronchospasm.
• Other sympathomimetic agents: May increase cardiovascular adverse effects.
• Diuretics: Non-potassium-sparing diuretics may increase the risk of hypokalemia.
• MAO inhibitors: May increase cardiovascular effects; concomitant use requires particular caution.
• Tricyclic antidepressants: May increase the risk of cardiovascular adverse reactions.
• Other QT-prolonging medications: May increase the risk of cardiac arrhythmias.
• Corticosteroids: May increase the risk of low potassium levels, particularly when used with other potassium-lowering medications.

Inform your healthcare professional about all medications and supplements you are taking.

Storage Conditions

• Store according to the manufacturer's recommended storage temperature.
• Protect capsules from excessive heat and moisture.
• Keep capsules in their original blister packaging until immediately before use.
• Do not remove capsules from the blister in advance.
• Keep the inhaler clean and dry.
• Keep out of reach of children.
• Do not use after the expiry date.

Patient Counseling Points

• Metrohaler is intended for inhalation only, not oral administration.
• Always use the capsules with the supplied inhaler device.
• Learn the correct inhalation technique from your pharmacist or healthcare professional.
• Use the medication regularly as prescribed, even when symptoms improve.
• Asthma patients must continue their prescribed inhaled corticosteroid treatment.
• Keep an appropriate rescue inhaler available for sudden breathing difficulties.
• Do not exceed the prescribed number of inhalations.
• Clean the inhaler according to the manufacturer's instructions.
• Seek medical advice if symptoms become more frequent or require additional rescue medication.

References

1. U.S. Food and Drug Administration (FDA): Foradil Aerolizer (Formoterol Fumarate 12 mcg) – Prescribing Information. View prescribing information.
2. Spanish Agency of Medicines and Medical Devices (AEMPS): Formoterol 12 mcg Hard Capsules – Summary of Product Characteristics. View clinical information.
3. Global Initiative for Asthma (GINA): Global Strategy for Asthma Management and Prevention. View asthma guidelines.
4. National Library of Medicine (Mayo Clinic): Formoterol Inhalation – Uses, Dosage, Administration, and Precautions. Read medical information.
5. Medicines.org.uk (Electronic Medicines Compendium): Formoterol 12 mcg – Summary of Product Characteristics. View product information.

Patient Disclaimer: This information is intended for educational purposes only and should not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional before using this medication. The appropriate dosage and treatment regimen depend on the patient's respiratory condition, age, clinical response, and medical history. Correct inhaler technique and adherence to prescribed treatment are essential for achieving optimal therapeutic results.