Aclidinium Bromide + Formoterol Fumarate

It indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

Aclidinium bromide is a long-acting antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of acetylcholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of aclidinium bromide is predominantly a site-specific effect

Formoterol fumarate is a long-acting selective beta2-adrenergic receptor agonist (LABA) (beta2- agonist). The pharmacologic effects of beta2-adrenoceptor agonist drugs, including formoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

For oral inhalation only 400 mcg/12 mcg, twice daily (once in the morning and once in the evening). Do not take more than one inhalation twice daily.

Use of other adrenergic by any route may potentiate the effect of DUAKLIR PRESSAIR. Use with caution.

• Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution
• Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non-potassium sparing diuretics may worsen with concomitant beta2-agonists.
• Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system
• Beta-blockers: Use with caution and only when medically necessary
• Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations ofthis combinations with other anticholinergic-containing drugs.

• Use of a long-acting beta2-adrenergic agonist (LABA), including formoterol fumarate, one of the active ingredients , without an inhaled corticosteroid is contraindicated in patients with asthma.
• Hypersensitivity to aclidinium bromide or formoterol fumarate or to any component of this product

Most common adverse reactions (incidence ≥ 3% and more common than with placebo) include: upper respiratory tract infection and, headache.

There are no adequate and well controlled studies of DUAKLIR PRESSAIR or its individual components, formoterol fumarate or aclidinium bromide, in pregnant women to inform drugassociated risks.There are no available data on the effects on aclidinium bromide, or formoterol fumarate on the breastfed child or on milk production or presence in human milk.

The risks associated with overdosage for the individual components described below:

The most common symptoms are blurred vision, dry mouth, nausea, muscle spasms, tremor, headache, palpitations, and systolic hypertension.

Dry place at 20°C-25°C. Do not store the inhaler on a vibrating surface.