Tiotropium bromide


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : Inhalation COPD; Asthma As inhalation cap: 1 cap (18 mcg)/day via inhaler device, at the same time each day. As inhalation soln: 2 inhalations (5 mcg)/day, at the same time each day.
Dosage Details
Inhalation/Respiratory
Asthma, Chronic obstructive pulmonary disease
Adult: As inhalation cap: 1 cap (18 mcg) daily via inhaler device, at the same time each day. As inhalation soln: 2 inhalations (5 mcg) daily, at the same time each day.
Renal Impairment
CrCl (mL/min) Dosage
≤50 Use w/ caution.
Contraindications
Hypersensitivity to tiotropium bromide, atropine or its derivatives.
Special Precautions
Patient w/ narrow-angle glaucoma, prostatic hyperplasia/bladder neck obstruction, cystic fibrosis. History of MI (<6 mth), or unstable or life threatening cardiac arrhythmia w/in the past yr. Not intended for use as initial treatment for acute bronchospasm and as monotherapy for asthma. Moderate to severe renal impairment (CrCl ≤50 mL/min). Pregnancy and lactation.
Adverse Reactions
Dry mouth, upper resp tract infection, pharyngitis, sinusitis, rhinitis, epistaxis, non-specific chest pain, UTI, dyspepsia, hypersensitivity reactions (e.g. urticaria, angioedema, rash, itching), dizziness, dysphagia, hoarseness, intestinal obstruction, increased intraocular pressure, palpitations, tachycardia; application site irritation (e.g. glossitis, mouth ulceration, pharyngolaryngeal pain).
Potentially Fatal: Paradoxical bronchospasm, anaphylaxis.
Patient Counseling Information
This drug may cause dizziness and blurred vision, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor pulmonary function.
Drug Interactions
Additive effect w/ other anticholinergic drugs.
Action
Description: Tiotropium bromide antagonises the cholinergic effects of acetylcholine by reversibly and competitively binding to type 3 muscarinic (M3) receptors, resulting in bronchial smooth muscle relaxation.
Pharmacokinetics:
Absorption: Systemically absorbed from the lungs. Bioavailability: Approx 20% (dry powd inhalation); approx 33% (inhalation soln). Time to peak plasma concentration: 5 min (dry powd inhalation); 5-7 min (inhalation soln).
Distribution: Volume of distribution: 32 L/kg. Plasma protein binding: Approx 72%.
Metabolism: Undergoes minimal hepatic metabolism by non-enzymatic cleavage and by CYP2D6 and CYP3A4 isoenzymes.
Excretion: Via urine as unchanged drug. Half-life: 5-6 days (dry powd inhalation).
Chemical Structure

Chemical Structure Image
Tiotropium bromide

Source: National Center for Biotechnology Information. PubChem Database. Tiotropium bromide, CID=5487426, https://pubchem.ncbi.nlm.nih.gov/compound/Tiotropium-bromide (accessed on Jan. 23, 2020)

Storage
Inhalation cap: Store at 25°C. Protect from excessive heat and moisture. Do not store in inhaler device. Inhalation soln: Store at 25°C. Do not freeze.
ATC Classification
R03BB04 - tiotropium bromide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, anticholinergics.
References
Anon. Tiotropium. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/07/2015.

Buckingham R (ed). Tiotropium Bromide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/07/2015.

Spiriva Capsule (Boehringer Ingelheim Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/07/2015.

Disclaimer: This information is independently developed by MIMS based on Tiotropium bromide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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