Aclidinium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sree Teja Yelamanchili, MBBS [2]
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Overview
Aclidinium is an antimuscarinic and bronchodilator that is FDA approved for the treatment of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.. Common adverse reactions include headache, cough, and nasopharyngitis..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg, twice daily.
Inhalation Powder. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide per actuation.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Aclidinium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Aclidinium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Aclidinium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Aclidinium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Aclidinium in pediatric patients.
Contraindications
None.
Warnings
Not for Acute Use
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).
Paradoxical Bronchospasm
Inhaled medicines, including TUDORZA PRESSAIR, may cause paradoxical bronchospasm. If this occurs, treatment with TUDORZA PRESSAIR should be stopped and other treatments considered.
Worsening of Narrow-Angle Glaucoma
TUDORZA PRESSAIR should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., 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 should any of these signs or symptoms develop.
Worsening of Urinary Retention
TUDORZA PRESSAIR should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of prostatic hyperplasia or bladder-neck obstruction (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of TUDORZA PRESSAIR. If such a reaction occurs, therapy with TUDORZA PRESSAIR should be stopped at once and alternative treatments should be considered. Given the similar structural formula of atropine to aclidinium, patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to TUDORZA PRESSAIR. In addition, TUDORZA PRESSAIR should be used with caution in patients with severe hypersensitivity to milk proteins.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Aclidinium Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Aclidinium Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Aclidinium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Aclidinium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Aclidinium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Aclidinium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Aclidinium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Aclidinium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Aclidinium in geriatric settings.
Gender
There is no FDA guidance on the use of Aclidinium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Aclidinium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Aclidinium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Aclidinium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Aclidinium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Aclidinium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Aclidinium Administration in the drug label.
Monitoring
There is limited information regarding Aclidinium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Aclidinium and IV administrations.
Overdosage
There is limited information regarding Aclidinium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Aclidinium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Aclidinium Mechanism of Action in the drug label.
Structure
There is limited information regarding Aclidinium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Aclidinium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Aclidinium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Aclidinium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Aclidinium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Aclidinium How Supplied in the drug label.
Storage
There is limited information regarding Aclidinium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Aclidinium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Aclidinium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Aclidinium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Aclidinium Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.