Formoterol fumarate inhalation solution for maintenance treatment of COPD

Formoterol fumarate inhalation solution is a long-acting inhaled medicine used for the long-term maintenance treatment of bronchoconstriction in adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is given twice daily by nebulization and helps relax airway muscles to improve breathing.

This medicine is indicated for maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. It is intended for long-term use twice daily (morning and evening) via inhalation using a nebulizer.

Important restrictions:

• It is not approved to treat asthma and has not been shown safe or effective for asthma treatment.
• It should not be used to treat acute worsening or flare-ups of COPD symptoms.

formoterol fumarate dihydrate

Formoterol fumarate works as a long-acting beta2-adrenergic agonist (LABA). It stimulates beta2 receptors in the airway smooth muscle, causing these muscles to relax. This action helps open the airways (bronchodilation), making breathing easier in patients with COPD by reducing bronchoconstriction.

The recommended dose is one 20 mcg unit-dose vial (2 mL) inhaled twice daily, approximately every 12 hours, using a standard jet nebulizer connected to an air compressor. Do not exceed a total daily dose of 40 mcg.

The solution should be used immediately after removing from its foil pouch, and any partially used vial should be discarded.

It should be administered orally by inhalation only, using nebulizer systems similar to the PARI-LC Plus® nebulizer with the PRONEB® Ultra compressor, as safety and efficacy have been established only with these devices.

If symptoms are not controlled or acute deterioration of COPD occurs, medical advice should be sought promptly, and the treatment regimen re-evaluated. This medicine is not for relief of acute symptoms or sudden breaths; patients should use a short-acting beta2-agonist inhaler for rescue use.

• Use in patients with asthma without inhaled corticosteroids is contraindicated due to increased risk of serious asthma-related events.
• It is not indicated for treatment of asthma.

• Not for asthma treatment: Use without inhaled corticosteroids in asthma patients is contraindicated due to increased risk of serious asthma-related events including death.
• Do not use during acute COPD worsening: It is not suitable for treatment during acute COPD flare-ups or for relief of sudden symptoms.
• Avoid overdose: Do not exceed recommended dose or use with other long-acting beta2-agonists to prevent serious cardiovascular effects and potential fatalities.
• Paradoxical bronchospasm: May cause life-threatening paradoxical bronchospasm requiring immediate discontinuation.
• Caution in cardiovascular disorders: Use carefully in patients with coronary artery disease, arrhythmias, hypertension due to possible cardiovascular effects including increased pulse, blood pressure changes, and ECG abnormalities.
• Use cautiously in convulsive disorders, thyrotoxicosis, and sensitivity to sympathomimetics.
• Monitor potassium and blood glucose: Beta-agonists can cause transient hypokalemia and hyperglycemia; clinically significant changes are rare at recommended doses.
• Hypersensitivity reactions: Cases of anaphylaxis, angioedema, rash, and bronchospasm have been reported.

Common side effects (reported in more than 2% and more frequently than placebo) include:

• Diarrhea
• Nausea
• Nasopharyngitis (common cold symptoms)
• Dry mouth
• Vomiting
• Dizziness
• Insomnia

Other adverse reactions similar to other beta2-agonists may include angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, muscle cramps, palpitations, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis.

Post-marketing reports include rare cases of anaphylaxis, urticaria, angioedema, rash, and bronchospasm.

Concomitant use with other medications containing long-acting beta2-agonists is not recommended due to increased risk of overdose and serious cardiovascular events.

Excessive use or overdose can lead to clinically significant cardiovascular effects and fatalities. Signs may include increased heart rate, blood pressure changes, and symptoms of beta-agonist overdose. Immediate medical evaluation is necessary.

Store the formoterol fumarate inhalation solution in its foil pouch and only remove immediately before use. Discard any partially used vials.