Arformoterol

Arformoterol is a selective beta2-adrenergic bronchodilator used for long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Arformoterol is the (R,R)-enantiomer of formoterol, which has two-fold greater potency than racemic formoterol. It selectively acts on beta2-receptors to relax bronchial smooth muscle and widen airways, making breathing easier.

In vitro tests show that arformoterol inhibits the release of mast cell mediators such as histamine and leukotrienes from the human lung.

• Long-term maintenance treatment of bronchoconstriction in COPD
• Chronic bronchitis
• Emphysema

Arformoterol tartrate is a salt of Arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. It has two-fold greater potency than racemic formoterol which contains both the (S,S) and (R,R)-enantiomers. The (S,S)-enantiomer is about 1,000-fold less potent as a beta2-agonist than the (R,R)-enantiomer.

In vitro tests show that arformoterol is an inhibitor of the release of mast cell mediators, such as histamine and leukotrienes, from the human lung.

Arformoterol selectively acts on beta2-adrenergic receptors in the lungs. Stimulation of these receptors relaxes bronchial smooth muscle (bronchodilation), which widens the airways and improves airflow. This helps relieve wheezing, shortness of breath, coughing, and chest tightness.

Recommended Dose: 15 mcg (1 ampoule) inhaled via nebulization twice daily (morning and evening).

Maximum Daily Dose: Total daily dose greater than 30 mcg (15 mcg twice daily) is not recommended.

Special Populations: No dose adjustment needed in renal impairment. COPD does not occur in children; safety and efficacy in pediatric patients have not been established.

Important Limitation: Not indicated to treat acute deteriorations of COPD.

For inhalation use only. Use this medicine in the dose and duration as advised by your doctor. Check the label for directions before use. Twist off the top of the respule/transpule and squeeze all the liquid into the nebulizer. It should be used right away after opening.

If you miss a dose, skip it and continue with your normal schedule. Do not double the dose.

• Headache
• Insomnia (difficulty in sleeping)
• Muscle cramp
• Palpitations
• Restlessness
• Tremor
• Pain
• Chest pain
• Back pain
• Diarrhea
• Sinusitis
• Dyspnea
• Rash
• Flu syndrome
• Peripheral edema
• Lung disorder

Serious Precautions:

• Patients with asthma have an increased risk of death from asthma problems - do not use for asthma treatment
• Does not work right away and should not be used to relieve sudden breathing problems - use rescue inhaler
• Should not be initiated in acutely deteriorating patients
• Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or sensitivity to sympathomimetic drugs
• Life-threatening paradoxical bronchospasm can occur
• Do not stop taking suddenly even if you do not currently have any symptoms
• Do not use for asthma without a concomitant long-term asthma control medication such as an inhaled corticosteroid
• Do not use concurrently with other long-acting beta2-agonists

• Hypersensitivity to arformoterol, formoterol, or any ingredients
• Treatment of asthma without a concomitant long-term asthma control medication (e.g., inhaled corticosteroid) - may be fatal
• Concurrency with other long-acting beta2-agonists

• Other adrenergic drugs: May potentiate effect
• Xanthine derivatives, steroids, diuretics: May potentiate hypokalemia or ECG changes
• MAO inhibitors, tricyclic antidepressants, drugs that prolong QTc interval: May potentiate effect on cardiovascular system
• Beta-blockers: May decrease effectiveness

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Arformoterol. Please consult your doctor.

[CONSULT YOUR DOCTOR] Arformoterol may be unsafe to use during pregnancy (Pregnancy Category C). Animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and potential risks before prescribing. Use only if potential benefit justifies the potential risk to the fetus.

[SAFE IF PRESCRIBED] Arformoterol is safe to use during breastfeeding. Human studies suggest that the drug does not pass into breastmilk in a significant amount and is not harmful to the baby. However, it is not fully known whether arformoterol is excreted in human milk.

COPD does not occur in children. The safety and efficacy in pediatric patients have not been established.

No dose adjustment needed for elderly patients.

No dose adjustment needed for renal impairment.

No dose adjustment needed for hepatic impairment.

As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of Arformoterol nebuliser solution.

Store at 2-8°C in a refrigerator, protected from light and excessive heat. Do not freeze. Keep out of reach of children.