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.

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.

You should not use aclidinium if you are allergic to it.

To make sure aclidinium is safe for you, tell your doctor if you have:

  • narrow-angle glaucoma;
  • bladder obstruction or other urination problems;
  • enlarged prostate; or
  • an allergy to milk proteins.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether aclidinium passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Aclidinium is not approved for use by anyone younger than 18 years old.

How should I take aclidinium?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Aclidinium is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

Aclidinium is a powder that comes with a special inhaler device preloaded with measured doses of this medicine. The device delivers a single dose each time you press a button on the inhaler.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Aclidinium should be used at evenly spaced intervals, usually every 12 hours.

Use aclidinium regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Call your doctor or seek medical attention if you think your fast-acting inhaler medications are not working as well.

Store at room temperature away from moisture and heat. Keep this medicine in the sealed pouch until ready to use. Do not store the inhaler device on top of any surface that vibrates.

Throw the inhaler device away 45 days after you have taken it out of the sealed pouch, or if the dose indicator shows a zero or the device locks, whichever comes first. Each inhaler device contains 60 doses.

What should I avoid while taking aclidinium?

If this medication gets in your eyes, rinse with water.

What other drugs will affect aclidinium?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;

  • bronchodilators such as aclidinium, ipratropium, or tiotropium;

  • cold or allergy medicine that contains an antihistamine;

  • medication for Parkinson's disease; or

  • medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome.

This list is not complete. Other drugs may interact with aclidinium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What are some things I need to know or do while I take Aclidinium?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Unsafe allergic effects may rarely happen.
  • Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
  • Do not get aclidinium powder in your eyes. Side effects like eye pain or redness, blurred eyesight, or other eyesight problems may happen. Call your doctor right away if you have any of these signs.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Aclidinium) best taken?

Use aclidinium as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Follow how to use as you have been told by the doctor or read the package insert.
  • To gain the most benefit, do not miss doses.
  • Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • For breathing in only.
  • Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.
  • If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
  • Do not use a spacer with the puffer (inhaler).
  • Put the cap back on after you are done using your dose.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Index Terms

  • 14115700
  • Aclidinium Bromide
  • LAS-34273
  • LAS-34273 Micronized
  • LAS-W-330

Pharmacology

Competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation

Distribution

Vd: ~300 L (following IV administration)

Metabolism

Rapid and extensive hydrolysis via plasma esterases to inactive alcohol and acid metabolites

Excretion

Urine (<1% each of an inhaled dose)

Time to Peak

Plasma: Within 10 minutes (steady state, following inhalation)

Half-Life Elimination

5-8 hours (following inhalation)

Dosing Adult

COPD, maintenance treatment: Inhalation, oral: 400 mcg (one inhalation) twice daily

Storage

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Product should be stored inside sealed pouch and only removed immediately before use. Discard product 45 days after opening pouch, when device locks out, or when dose indicator displays “0”, whichever comes first.

Drug Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Monitor therapy

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Amifampridine: May diminish the anticholinergic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Amifampridine. Monitor therapy

Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Anticholinergic Agents: Aclidinium may enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Monitor therapy

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Aclidinium Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and eye drops, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • anticholinergics (including tiotropium, ipratropium)
  • atropine

This is not a complete list of aclidinium drug interactions. Ask your doctor or pharmacist for more information.

 

Aclidinium and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Aclidinium falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Aclidinium Usage

Aclidinium comes as a dry powder in an inhaler, to be inhaled, by mouth, into the lungs.

The usual dose of aclidinium is one inhalation, by mouth, two times a day, about 12 hours apart. To take a dose from the inhaler, press, release and inhale the medicine. See the step-by-step instructions that come with aclidinium packaging.

If you miss a dose, skip it and take the next dose at the usual time. Do not take two doses at one time.

Do not use aclidinium more often than prescribed or take more medicine than prescribed for you.

Call your doctor or get emergency medical care right away if:

  • your breathing problems worsen with aclidinium
  • you need to use your rescue inhaler medicine more often than usual
  • your rescue inhaler medicine does not work as well for you at relieving symptoms

 

Dialysis

Data not available

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