Aclidinium

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using aclidinium and call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medication;
• blurred vision, nausea, vomiting, eye pain or redness, or seeing halos or bright colors around lights;
• increased urination, painful or difficult urination;
• little or no urinating; or
• worsening or no improvement in your symptoms.

Common side effects may include:

• stuffy nose, sore throat, sinus pain;
• cough; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble passing urine.
• Pain when passing urine.
• Passing urine more often.
• Passing urine in a weak stream or drips.
• Change in eyesight, eye pain, red eyes, or seeing halos or bright colors around lights. These may be signs of a type of glaucoma. If left untreated, this can lead to lasting eyesight loss.
• This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using aclidinium, use a rescue inhaler and get medical help right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Nose and throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store the inhaler in the sealed pouch until you are ready to use it.
• Throw away inhaler after 45 days of opening the pouch, when it says 0, or locks you from using it.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

1% to 10%:

Central nervous system: Headache (7%), falling (1%)

Gastrointestinal: Diarrhea (3%), toothache (1%), vomiting (1%)

Respiratory: Nasopharyngitis (6%), cough (3%), rhinitis (2%), sinusitis (2%)

<1% (Limited to important or life-threatening): Cardiac failure, cardiopulmonary arrest, dizziness, dysuria, first degree atrioventricular block, hypersensitivity reaction, nausea, palpitations, skin rash, tachycardia, urinary retention

Concerns related to adverse effects:

• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; discontinue use and consider other therapy if bronchospasm occurs.

• Hypersensitivity reactions: Immediate hypersensitivity reactions (eg, anaphylaxis, urticaria, angioedema, rash, bronchospasm, itching) may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur. Use with caution in patients with a history of hypersensitivity to atropine; aclidinium has a similar structure to atropine.

Disease-related concerns:

• Cardiovascular disease: Use with caution; patients with unstable cardiac disease were excluded from clinical trials. Cardiac effects (eg, cardiac failure, 1st degree AV block, cardiopulmonary arrest) were observed at an incidence of <1% in clinical trials.

• Glaucoma: Use with caution in patients with narrow angle glaucoma; may worsen symptoms. Monitor for signs/symptoms (eg, eye pain/discomfort, blurred vision, visual halos or colored images associated with red eyes from conjunctival congestion and corneal edema).

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; may worsen symptoms.

• Prostatic hyperplasia/bladder neck obstruction: Use with caution in patients with prostatic hyperplasia and/or bladder neck obstruction (eg, dysuria, difficulty in passing urine); may worsen symptoms.

Dosage form specific issues:

• Lactose: Powder for oral inhalation contains lactose; use is contraindicated in patients with severe milk protein allergy.

Other warnings/precautions:

• Appropriate use: Not indicated for the initial (rescue) treatment of acute episodes of bronchospasm.

Adverse events have been observed in animal reproduction studies.

Aclidinium is a prescription medicine used long-term for the treatment of chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Aclidinium may be found in some form under the following brand names:

• Tudorza Pressair

Common side effects include:

• headache
• common cold symptoms
• cough

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

Aclidinium can cause serious side effects. See "Drug Precautions."

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dosage Forms & Strengths

metered-dose inhaler (dry powder)

• 400mcg/actuation

COPD

Breath-activated dry powder inhaler indicated for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema

400 mcg (1 actuation) inhaled PO BID

Renal & Hepatic Impairment

Renal impairment: No dosage adjustment required

Hepatic impairment: Not studied

Safety and efficacy not established

1-10%

Headache (6.6%)

Nasopharyngitis (5.5%)

Cough (3%)

Diarrhea (2.7%)

Sinusitis (1.7%)

Rhinitis (1.6%)

Toothache (1.1%)

Fall (1.1%)

Vomiting (1.1%)

<1%

Diabetes mellitus

Dry mouth

1st degree AV block

Osteoarthritis

Cardiac failure

Cardiorespiratory arrest

Postmarketing reports

Anaphylaxis

Angioedema (including swelling of lips and tongue or throat)

Urticaria

Rash

Bronchospasm

Itching

Nausea

Dysphonia

Blurred vision

Urinary retention

Tachycardia

Stomatitis

Applies to aclidinium: inhalation powder

Gastrointestinal

Common (1% to 10%): Diarrhea (2.7%), toothache (1.1%), vomiting (1.1%)
Uncommon (0.1% to 1%): Dry mouth, abdominal discomfort, tooth abscess
Postmarketing reports: Nausea, stomatitis[Ref]

Nervous system

Common (1% to 10%): Headache (6.6%)
Uncommon (0.1% to 1%): Dizziness[Ref]

Other

Common (1% to 10%): Fall (1.1%)
Uncommon (0.1% to 1%): Candidiasis[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis (5.5%), cough (3%), sinusitis (1.7%), rhinitis (1.6%)
Uncommon (0.1% to 1%): Dysphonia[Ref]

Cardiovascular

Uncommon (0.1% to 1%): First degree AV block, cardiac failure, cardiorespiratory arrest, palpitations
Postmarketing reports: Tachycardia[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary retention[Ref]

Metabolic

Uncommon (0.1% to 1%): Diabetes mellitus (less than 1%)[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Osteoarthritis (less than 1%)[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision[Ref]

Hypersensitivity

Postmarketing reports: Immediate hypersensitivity reactions, including anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, itching[Ref]

Some side effects of aclidinium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Administration advice:
-The manufacturer product information should be consulted to understand the correct use of this drug.

General: This drug is to be used as a daily maintenance bronchodilator and should not be used for immediate relief of breathing problems (i.e., as a rescue medication).

Patient advice:
-Discontinue this drug if paradoxical bronchospasm occurs.
-Report occurrence of eye pain or discomfort, blurred vision, visual halos or colored images.
-Immediately discontinue treatment and consult a physician if signs or symptoms of hypersensitivity reactions develop.