Aclidinium

Name: Aclidinium

What is aclidinium?

Aclidinium is a bronchodilator.

Aclidinium is used to prevent bronchospasm in adults with chronic bronchitis, emphysema, or other forms of COPD (chronic obstructive pulmonary disease).

Aclidinium may also be used for purposes not listed in this medication guide.

What is the most important information I should know about aclidinium?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Administration

Administer via oral inhalation. Remove inhaler from sealed pouch immediately prior to first use. Prior to each use, remove protective cap from the inhaler and prepare inhaler by pressing and releasing the green button (while keeping the green button straight up and avoiding tilting the inhaler). After this step, ensure that the inhaler is ready for use by the colored control window which should have changed from red to green. The green control window indicates the inhaler is ready for use. If the control window is red, retry activating the inhaler again by pressing and releasing the green button. Prior to inhaling the dose, exhale fully (do not exhale into the inhaler), then close lips tightly around the inhaler mouthpiece and inhale (rapidly, steadily, and deeply); do not hold the green button down while inhaling. Keep breathing in until a “click” is heard to ensure that the full dose has been given. Hold breath as long as possible, then breathe out slowly through nose. Ensure the dose was delivered correctly by observing the control window which should have changed from green to red. If the control window is still green, repeat inhalation steps. When control window has been verified as red, replace the protective cap for next use.

Aclidinium Overview

Aclidinium is a prescription medication used to prevent wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD). Aclidinium belongs to a group of drugs called bronchodilators, which work by relaxing the smooth muscle of the airways, opening the air passages to the lungs which makes it easier to breathe.

This medication comes in the form of a dry powder in an inhaler, to be inhaled into the lungs, usually twice daily.

Common side effects include headaches, runny or stuffy nose, and cough.

Aclidinium Drug Class

Aclidinium is part of the drug class:

  • Anticholinergics

Aclidinium Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of aclidinium there are no specific foods that you must exclude from your diet.

Aclidinium and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. Aclidinium may be excreted in human breast milk. The effects on the nursing baby are unknown.

 

Aclidinium Dosage

Take aclidinium exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dose of aclidinium is one inhalation, by mouth, twice daily. Each dose should be about 12 hours apart.

 

Other Requirements

Store aclidinium at room temperature, in the sealed protective pouch, out of the reach of children. The sealed pouch should not be opened until you are ready to use it.

The aclidinium inhaler has a dose indicator to show you how many doses are left in your inhaler. A new aclidinium inhaler has 60 doses of medicine. Discard the inhaler 45 days after opening the pouch, after the marking “0” with a red background shows in the middle of the dose indicator, or when the device locks out, whichever comes first.

  • Keep in a dry place.
  • Do not store the inhaler on a vibrating surface.

Pregnancy & Lactation

Pregnancy Category: C

Lactation: Distributed in human breast milk is probable

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Pharmacology

Mechanism of Action

Long-acting muscarinic antagonist (LAMA), often referred to as an anticholinergic; selective muscarinic antagonist with affinity for the M3 (subscript) receptor in the airways; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle

Absorption

~55% of administered dose is swallowed, but negligible oral absorption is observed; fraction of inhaled dose that reaches systemic circulation is low (<5%)

Peak Plasma Time: 10-15 minutes (in COPD)

Peak Plasma Concentration: 80 pg/mL (in COPD)

Distribution

Whole lung deposition: 30% of the metered dose

Vd: 300 L (IV administration)

Metabolism

Aclidinium bromide is rapidly hydrolyzed in plasma into its alcohol (LAS34823) and acid (LAS34850) metabolites by both enzymatic and non-enzymatic cleavage; neither of these metabolites are active

Elimination

Half-life: 5-8 hr following repeat BID administration

Renal clearance: Low

Total clearance: 170 L/hr (IV administration)

Excretion: Urine 0.1% (as aclidinium bromide), 65% (as metabolites); feces 33% (as metabolites)

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