Aclidinium bromide

What is Aclidinium bromide?

• Aclidinium bromide (Tudorza pressair) is an anticholinergic used as a maintenance treatment for chronic obstructive pulmonary disease (COPD).

Aclidinium bromide

What are the uses of this medicine?

• Tudorza pressair is a prescription medicine to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
• Tudorza pressair is an anticholinergic medicine. Anticholinergic medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.

How does this medicine work?

• Aclidinium bromide is a long-acting antimuscarinic agent, which is often referred to as an anticholinergic.
• It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.
• The bronchodilation following inhalation of aclidinium bromide is predominantly a site-specific effect.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a severe allergy to milk proteins.
• are allergic to aclidinium bromide or any of the ingredients in Tudorza pressair.

What drug interactions can this medicine cause?

• Avoid administrations of Tudorza pressair with other anticholinergic-containing drugs.

Is this medicine FDA approved?

• Tudorza pressair was approved in the United States on July 24, 2012.

How should this medicine be used?

Recommended dosage:

• ​The recommended dose of Tudorza pressair is one oral inhalation of 400 mcg, twice daily (morning and evening approximately 12 hours apart).

Administration:

• Use Tudorza pressair exactly as prescribed. Do not use Tudorza pressair more often than prescribed or take more medicine than prescribed for you.
• The usual dose of Tudorza pressair is 1 oral inhalation 2 times a day. Each dose should be about 12 hours apart.
• If you miss a dose of Tudorza pressair, skip the missed dose. Take your next dose at your usual time. Do not take 2 doses at one time.
• Do not use other medicines that contain an anticholinergic for any reason. Ask your doctor or pharmacist if any of your other medicines are anticholinergic medicines.
• Tudorza pressair does not relieve sudden symptoms of COPD and you should not use extra doses of Tudorza pressair to relieve these sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your doctor to have one prescribed for you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation powder; The multi-dose device is a dry powder inhaler metering 400 mcg of aclidinium bromide per actuation.

This medicine is available in fallowing brand namesː

• Tudorza pressair

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• common cold symptoms
• cough

Tudorza pressair can cause serious side effects including:

• sudden breathing problems immediately after use of Tudorza pressair
• new or worsened increased pressure in your eyes (acute narrow-angle glaucoma)
• new or worsened urinary retention
• serious allergic reactions

What special precautions should I follow?

• Tudorza pressair is intended as a twice-daily maintenance treatment for COPD and is not indicated for the initial treatment of acute episodes of bronchospasm (i.e., rescue therapy).
• Inhaled medicines, including Tudorza pressair, may cause paradoxical bronchospasm. If this occurs, treatment with Tudorza pressair should be stopped and other treatments considered.
• Tudorza pressair should be used with caution in patients with narrow-angle glaucoma. Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs.
• Tudorza pressair should be used with caution in patients with urinary retention. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if this occurs.
• Immediate hypersensitivity reactions, including anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, or itching, have occurred after administration of Tudorza pressair. Discontinue Tudorza pressair at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis occur.
• Aclidinium has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

• No case of overdose has been reported in clinical studies with Tudorza pressair.

Can this medicine be used in pregnancy?

• There are no adequate and well controlled studies of Tudorza pressair in pregnant women to inform drug associated risks.

Can this medicine be used in children?

• Tudorza pressair is approved for use in the maintenance treatment of bronchospasm associated with COPD.
• COPD does not normally occur in children.
• The safety and effectiveness of Tudorza pressair in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: aclidinium bromide
• Inactive ingredient: lactose monohydrate

Who manufactures and distributes this medicine?

• Distributed by:

AstraZeneca Pharmaceuticals LP, Wilmington, DE Under license of ALMIRALL, S.A.

What should I know about storage and disposal of this medication?

• Store Tudorza pressair at room temperature between 68°F to 77°F (20°C to 25°C) in the sealed bag that it comes in until you are ready to use Tudorza pressair. Do not open the sealed bag until you are ready to use a dose of Tudorza pressair.
• Keep Tudorza pressair in a dry place.
• Do not store the inhaler on a vibrating surface.

• Dailymed label info on Aclidinium bromide
• FDA Aclidinium bromide

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