Aroneb

• 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.

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.

• 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

[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.

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

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.