Aclidinium bromide/formoterol

What Is aclidinium bromide and formoterol fumarte ?

• Aclidinium bromide and formoterol fumarte powder (Duaklir Pressair) is a combination of aclidinium bromide an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA).

What are the uses of this medicine?

• This combination combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

How does this medicine work?

• Duaklir Pressair contains two bronchodilators: aclidinium a long-acting muscarinic antagonist (also known as an anticholinergic) and formoterol a long-acting beta2-adrenergic agonist.

Who Should Not Use this medicine ?

This medicine cannot be used in:

• In patients with Severe hypersensitivity to milk proteins
• In patients with hypersensitivity to aclidinium bromide, formoterol fumarate, or to any component of the product

Is this medicine FDA approved?

• This combination has initial U.S. Approval in 2019.

How should this medicine be used?

• The recommended dose of this medicine is one oral inhalation of 400 mcg/12 mcg, twice daily (once in the morning and once in the evening).
• Do not take more than one inhalation twice daily.

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

This medicine is available in fallowing doasage form:

• This combination is available as inhalation Powder
• It is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide and 12 mcg of formoterol fumarate per actuation.

What side effects can this medication cause?

Common possible side effects of this medicine include:

• upper respiratory tract infection
• headache
• back pain

Possible serious side effects, may include:

• Paradoxical bronchospasm
• hypersensitivity reactions
• Cardiovascular effects
• Worsening of narrow-angle glaucoma
• Worsening of urinary retention

What special precautions should I follow?

• Do not initiate to treat acute symptoms of COPD
• Do not use in combination with an additional medicine containing a LABA because of risk of overdose.
• If paradoxical bronchospasm occurs, discontinue the medication and institute alternative therapy.
• Use with caution in patients with cardiovascular disorders.
• Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus and ketoacidosis.
• Always be alert with hypokalemia and hyperglycemia.
• Use with caution in patients with narrow-angle glaucoma.
• Worsening urinary retention may occur with this medication.

What to do in case of emergency/overdose?

• The most common symptoms of overdosage include blurred vision, dry mouth, nausea, muscle spasms, tremor, headache, palpitations, and systolic hypertension.
• Treatment of overdosage consists of discontinuation of Duaklir Pressair together with institution of appropriate symptomatic and/or supportive therapy.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of Duaklir Pressair or its individual components, formoterol fumarate or aclidinium bromide, in pregnant women.

Can this medicine be used in children?

• This medication is not indicated for use in children.
• The safety and effectiveness of Duaklir Pressair in the pediatric population have not been established.

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

• Store Duaklir Pressair in a dry place at 20°C-25°C (68°F-77°F); excursions permitted to 15-30°C (59-86°F) .
• Do not store the inhaler on a vibrating surface.
• The Pressair inhaler should be stored inside the sealed bag and only be opened immediately before use.
• Throw away the bag and the desiccant sachet.
• Throw away (dispose of) the Pressair inhaler after the marking “0” with a red background shows in the middle of the dose indicator, when the device is empty and locks out, or 2 months after the date you opened the sealed bag that the inhaler comes in, whichever comes first.
• Keep out of reach of children.

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• Dailymed label info on Aclidinium bromide/formoterol
• FDA Aclidinium bromide/formoterol

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