Aclidinium

Aclidinium is a prescription medication indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

• Aclidinium is available under the following different brand names: Tudorza Pressair

Common side effects of Aclidinium include:

• headache
• common cold symptoms
• runny or stuffy nose
• cough
• diarrhea
• sinus infection
• vomiting
• toothache
• urinary tract infection
• dry mouth

Serious side effects of Aclidinium include:

• diabetes mellitus
• 1st-degree AV block
• osteoarthritis
• cardiac failure
• sudden shortness of breath immediately after taking this medicine
• new or worsened pressure in the eyes (acute narrow-angle glaucoma)
• cardio-respiratory arrest

Rare side effects of Aclidinium include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Metered-dose inhaler (dry powder)

• 400 mcg/actuation

Chronic obstructive pulmonary disease

Adult dosage

• 400 mcg (1 actuation) inhaled orally two times a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Aclidinium has severe interactions with the following drug:
• umeclidinium bromide/vilanterol inhaled
• Aclidinium has serious interactions with the following drugs:
  • glucagon
  • glucagon intranasal
  • pramlintide
  • revefenacin
• Aclidinium has moderate interactions with at least 97 other drugs
• Aclidinium has minor interactions with the following drugs:
  • dimenhydrinate
  • donepezil
  • galantamine
  • rimantadine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to drug or formulation components or severe hypersensitivity to milk proteins

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Aclidinium?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Aclidinium?”

Cautions

• Not for acute episodes of bronchospasm (ie, not for rescue therapy)
• May cause paradoxical bronchospasm; if this occurs, discontinue, and consider other treatments
• Worsening of narrow-angle glaucoma may occur; use with caution in patients with narrow-angle glaucoma; prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (eg, eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema; instruct patients to consult a physician immediately if it occurs
• Worsening of urinary retention may occur (eg, prostatic hyperplasia, bladder-neck obstruction); use with caution in patients with prostatic hyperplasia or bladder-neck obstruction; instruct patients to consult a physician immediately if it occurs
• Immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis, may occur after administration; if hypersensitivity occurs, discontinue immediately and consider alternate treatment
• Coadministration with other anticholinergics may increase the risk of adverse effects

Pregnancy and Lactation

• There are no adequate and well-controlled studies of aclidinium in pregnant women to assess drug-associated risks
• Lactation
  • There are no available data on the breastfed child or milk production or presence in human milk
  • Aclidinium bromide is present in rat milk; when a drug is present in animal milk, the drug will likely be present in human milk