Aroneb 15 mcg/2 ml

Description

Indications
Aroneb is indicated for long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Important Limitations of Use:
Aroneb is not indicated for the treatment of acute COPD exacerbations. Patients with asthma using long-acting beta-2 adrenergic agonists (LABAs), such as Aroneb, have an increased risk of death from asthma-related complications.

Description
Aroneb contains Arformoterol, the (R,R)-enantiomer of formoterol, which is a selective beta-2 adrenergic bronchodilator. It is twice as potent as racemic formoterol, which contains both (S,S) and (R,R) enantiomers. The (S,S)-enantiomer is about 1,000 times less potent as a beta-2 agonist than the (R,R)-enantiomer. In in vitro studies, Arformoterol has been shown to inhibit the release of mast cell mediators (such as histamine and leukotrienes) from human lung tissue.

Dosage & Administration
The recommended dose of Aroneb is one 15 mcg unit-dose ampoule administered twice daily (morning and evening) via nebulization. The total daily dose should not exceed 30 mcg (15 mcg twice daily).

Pediatric Use:
COPD does not occur in children, and the safety and efficacy of Aroneb nebuliser solution in pediatric patients have not been established.

Interaction
Other adrenergic drugs may potentiate the effects of Aroneb. Xanthine derivatives, steroids, and diuretics (especially non-potassium sparing diuretics) may increase the risk of hypokalemia and ECG changes. MAO inhibitors, tricyclic antidepressants, and drugs that prolong the QTc interval may increase cardiovascular effects. Beta-blockers may reduce the effectiveness of Aroneb.

Side Effects
Common side effects include pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema, lung disorder. Serious side effects include increased risk of death from asthma problems in patients with asthma taking LABAs. Patients should seek emergency medical care if breathing problems worsen rapidly or if rescue inhaler medication does not relieve symptoms.

Pregnancy & Lactation
Pregnancy Category C: Aroneb should be used during pregnancy only if the potential benefits outweigh the potential risks to the fetus. It is unknown whether Arformoterol is excreted in human breast milk. Caution should be exercised when prescribing to breastfeeding mothers.

Precautions & Warnings
Aroneb should not be initiated in acutely deteriorating patients. It should be used with caution in patients with cardiovascular disorders, convulsive disorders, thyrotoxicosis, or sensitivity to sympathomimetic drugs. Life-threatening paradoxical bronchospasm may occur. If this happens, discontinue use immediately and seek alternative therapy.

Overdose Effects
Overdose of Aroneb may cause severe cardiac complications, including cardiac arrest and death.

Therapeutic Class
Bronchodilator

Storage Conditions
Store at 2-8°C, protected from light and excessive heat. Do not freeze. Keep out of the reach of children.