ACLIDINIUM BROMIDE (Oral Inhalation) – Drug Information

Generic Name: Aclidinium Bromide Oral Inhalation

Therapeutic Classification: Bronchodilator

Information about Aclidinium Bromide Oral Inhalation. Learn its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug.

Description:

This medication is an anticholinergic. It is used as a long term treatment to prevent wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD, a group of diseases that affect the lungs and airways) such as chronic bronchitis (swelling of the air passages that lead to the lungs) and emphysema (damage to air sacs in the lungs). It relaxes airway muscles that result in easy breathing. It comes as a dry powder in an inhalation device to inhale by mouth. It is usually inhaled twice a day, once every 12 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Mechanism of Action:

Aclidinium bromide is a long-acting anticholinergic agent. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it acts by inhibiting M3 receptor at the smooth muscle, thus resulting bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. The bronchodilation following inhalation of aclidinium bromide is predominantly a site-specific effect.

Pharmacokinetics:

Absorption
  • Peak Plasma Time: 10-15 minutes (in COPD)
  • Peak Plasma Concentration: 80 pg/mL (in COPD)
Distribution
  • About 30% of inhaled drug are deposited in the lung
Metabolism
  • It is rapidly hydrolyzed in plasma into its alcohol and acid metabolites by both enzymatic and non-enzymatic cleavage; neither of these metabolites are active
Elimination
  • Half-life: 5-8 hr following repeat BID administration
  • Renal clearance: Low
Excretion
  • Urine 0.1% (as aclidinium bromide), 65% (as metabolites); feces 33% (as metabolites)

Contraindication for Aclidinium Bromide:

  • Severe hypersensitivity to milk proteins
  • Hypersensitivity to aclidinium bromide or any of the excipients

Warnings and Precautions for Aclidinium Bromide:

  • Caution should be exercised in patients with history of narrow-angle glaucoma, urinary retention, any allergy, who are taking other medications, liver or kidney impairment, elderly, children, during pregnancy and breastfeeding.
  • Avoid contact with eyes; otherwise it may cause blurred vision.
  • Not for acute episodes of bronchospasm (ie, not for rescue therapy).
  • May cause paradoxical bronchospasm; if this occurs, discontinue and consider other treatments.
  • Immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis, may occur after administration; if hypersensitivity occurs, discontinue immediately and consider alternate treatment.
  • Co-administration with other anticholinergics may increase risk for adverse effects.
  • Avoid excess dosage.

Pregnancy Category:

Category C

Animal studies have shown adverse effects on the fetus and there are no appropriate studies in pregnant women, but potential benefits may allow the use of the drug in pregnant women despite the potential for risks.

Adverse Reactions / Side Effects of Aclidinium Bromide:

  • Most Common: Headache, common cold and cough.
  • Miscellaneous: Nose inflammation, sinus inflammation, diarrhea, toothache, rhinitis, vomiting.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Dose:

Inhalation- One oral inhalation of 400 mcg twice daily. It comes as a dry powder in an inhalation device to inhale by mouth.

Trade Names / Brand Names of Aclidinium Bromide Oral Inhalation:

International – | Tudorza Pressair |

 

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