EKLIRA GENUAIR INHALATION POWDER 322 MICROGRAM/DOSE

Aclidinium

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

Aclidinium | Aclidinium |

Description

Aclidinium is an anticholinergic for the long-term management of chronic obstructive pulmonary disease (COPD). It has a much higher propensity to bind to muscarinic receptors than nicotinic receptors. FDA approved on July 24, 2012.

Indication

Aclidinium bromide inhalation powder is indicated for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Mechanism of Action

Aclidinium is a long-acting, competitive, and reversible anticholinergic drug that is specific for the acetylcholine muscarinic receptors. It binds to all 5 muscarinic receptor subtypes to a similar affinity. Aclidinium's effects on the airways are mediated through the M3 receptor at the smooth muscle to cause bronchodilation. Prevention of acetylcholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours.

Pharmacodynamics

Aclidinium does not prolong the QTc interval or have significant effects on cardiac rhythm.

Pharmacokinetics

Absorption:

Bioavailability, healthy subjects = 6%; T max, healthy subjects = 10 minutes; Time to steady state, healthy subjects = 2 days;

Distribution:

Following IV administration, the volume of distribution is 300 L

Metabolism:

The major route of metabolism of aclidinium bromide is hydrolysis, which occurs both chemically and enzymatically by esterases in the plasma. Aclidinium bromide is rapidly and extensively hydrolyzed to its alcohol and dithienylglycolic acid derivatives, neither of which binds to muscarinic receptors and are pharmacologically inactive.

Elimination:

Intravenously administered radiolabelled aclidinium bromide was administered to healthy volunteers and was extensively metabolized with 1% excreted as unchanged aclidinium. Approximately 54% to 65% of the radioactivity was excreted in urine and 20% to 33% of the dose was excreted in feces. The combined results indicated that almost the entire aclidinium bromide dose was eliminated by hydrolysis. After dry powder inhalation, urinary excretion of aclidinium is about 0.09% of the dose.

Half-life

Plasma half-life = 2.4 minutes (indicating that aclidinium is very rapidly hydrolyzed in plasma into its two inactive metabolites and has a low chance of causing systemic side effects). Effective half-life = 5-8 hours.

Clearance

Total clearance, IV dose, young healthy subjects = 170 L/h (inter-individual variability of 36%)

Toxicity

Most common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

EKLIRA GENUAIR INHALATION POWDER 322 MICROGRAM/DOSE was registered with Health Science Authority of Singapore by ASTRAZENECA SINGAPORE PTE LTD. It is marketed with the registration number of SIN15190P with effective from 2017-03-07.

This product contains 322mcg/delivered dose (343mcg/metered dose) of Aclidinium in the form of POWDER, METERED.

The medicine was manufactured by INDUSTRIAS FARMAC?UTICAS ALMIRALL in SPAIN

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: R03BB05

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