Product Information
Registration Status: ActiveEKLIRA GENUAIR INHALATION POWDER 322 MICROGRAM/DOSE is approved to be sold in Singapore with effective from 2017-03-07. It is marketed by ASTRAZENECA SINGAPORE PTE LTD, with the registration number of SIN15190P.
This product contains Aclidinium 322mcg/delivered dose (343mcg/metered dose) in the form of POWDER, METERED. It is approved for RESPIRATORY (INHALATION) use.
This product is manufactured by INDUSTRIAS FARMAC?UTICAS ALMIRALL in SPAIN.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
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.
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
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.
Active Ingredient/Synonyms
Aclidinium | 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.