Tiotropium

Pharmacologic Category

Anticholinergic Agent; Anticholinergic Agent, Long-Acting

Dosing: Adult

Asthma: Oral inhalation: Spiriva Respimat (1.25 mcg/actuation): Soft-mist inhaler: Two inhalations (2.5 mcg) once daily (maximum: 2 inhalations per 24 hours). Note: Maximum benefits may take up to 4 to 8 weeks of dosing. 5 mcg once daily has been recommended for patients with insufficient response to inhaled corticosteroid plus long-acting beta agonist (GINA 2019).

COPD: Oral inhalation:

Spiriva HandiHaler: Dry powder inhaler: Contents of 1 capsule (18 mcg) inhaled once daily using HandiHaler device. Note: To ensure drug delivery, the contents of each capsule should be inhaled twice.

Spiriva Respimat (2.5 mcg/actuation): Soft-mist inhaler: Two inhalations (5 mcg) once daily (maximum: 2 inhalations per 24 hours).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

CrCl >60 mL/minute: No dosage adjustment necessary.

CrCl ≤60 mL/minute: No dosage adjustment necessary; use with caution and closely for anticholinergic adverse events.

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Pediatric

Note: Maximum benefits may take up to 4 to 8 weeks of dosing.

Asthma, maintenance treatment: Children ≥6 years of age and Adolescents: Spiriva Respimat (1.25 mcg/actuation): Soft-mist inhaler: Oral inhalation: Two inhalations (2.5 mcg) once daily; maximum daily dose: 2 inhalations/day.

Asthma, severely uncontrolled or acute exacerbation: Children ≥6 years and Adolescents: Inhalation: Spiriva Respimat (2.5 mcg/actuation): Soft-mist inhaler: Oral inhalation: Two inhalations (5 mcg) once daily as add-on therapy to inhaled corticosteroids and other maintenance therapies (GINA 2020; Szefler 2017).

Dosing: Renal Impairment: Pediatric

Children ≥6 years and Adolescents:

CrCl >60 mL/minute: No dosage adjustment necessary.

CrCl ≤60 mL/minute: No dosage adjustment necessary; use with caution and closely for anticholinergic adverse events.

Dosing: Hepatic Impairment: Pediatric

No dosage adjustment necessary.

Calculations

• Creatinine Clearance by Cockcroft-Gault
• Creatinine Clearance by Cockcroft-Gault (SI units)
• Creatinine Clearance by Cockcroft-Gault with IBW
• Creatinine Clearance by Cockcroft-Gault with IBW (SI units)

Use: Labeled Indications

Asthma (Spiriva Respimat only): Maintenance treatment of asthma in patients ≥6 years.

Chronic obstructive pulmonary disease: Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema; reduction of COPD exacerbations.

Limitations of use: Not indicated for the relief of acute bronchospasm.

* See Uses in AHFS Essentials for additional information.

Class and Related Monographs

Anticholinergics (Bronchodilators)

Comparative Efficacy

• TIOTROPIUM BROMIDE

Clinical Practice Guidelines

Asthma:

Global Strategy for Asthma Management and Prevention (GINA), 2019 Update

COPD:

ACCP/CTS, “Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease: American College of Chest Physicians and Canadian Thoracic Society Guideline,” 2014

Canadian Thoracic Society Recommendations for Management of Chronic Obstructive Pulmonary Disease, 2007 Update

ERS/ATS, “Prevention of COPD Exacerbations,” September 2017

Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD), 2018

Administration: Inhalation

For oral inhalation only.

Spiriva HandiHaler: Dry powder inhaler: Do not swallow capsule. Administer at the same time each day. Do not remove capsule from blister until immediately before use. Place capsule in the center chamber of the HandiHaler Inhaler. Must only use the HandiHaler Inhaler. Close mouthpiece firmly until a click is heard, leaving dustcap open. The capsule is pierced by pressing and releasing the green piercing button on the side of the HandiHaler device. Exhale fully. Close lips tightly around mouthpiece; do not exhale into inhaler. Tilt head slightly back and inhale (rapidly, steadily, and deeply); the capsule vibration (rattle) may be heard within the device. Hold breath for a few seconds then repeat procedure using the same tiotropium capsule. Throw away empty capsule by tipping into a trash can without touching it; do not leave in inhaler. Keep capsules and inhaler dry. Discard any capsules that are exposed to air and not used immediately.

Spiriva Respimat: Soft-mist inhaler: Prior to first use, insert cartridge into the inhaler and prime the unit by actuating the inhaler toward the ground until an aerosol cloud is visible; repeat three more times and then the unit is primed and ready for use. If not used for more than 3 days, actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use.

Administration: Pediatric

Inhalation: For oral inhalation only.

Spiriva Respimat: Asthma: Soft-mist inhaler: Prior to first use, insert cartridge into the inhaler and prime the unit by actuating the inhaler toward the ground until an aerosol cloud is visible; repeat 3 more times and then the unit is primed and ready for use. If not used for more than 3 days, actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, actuate the inhaler until an aerosol cloud is visible and then repeat the process 3 more times to prepare the inhaler for use.

Storage/Stability

Spiriva HandiHaler: Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Avoid extreme temperatures and moisture. Do not store capsules in HandiHaler device. Store capsules in the blister pack and only remove immediately before use. Once protective foil is peeled back and/or removed, the capsule should be used immediately; if capsule is not used immediately it should be discarded.

Spiriva Respimat: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Avoid freezing.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat COPD (chronic obstructive pulmonary disease).

• It is used to treat asthma.

• This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

Frequently reported side effects of this drug

• Dry mouth

• Nausea

• Abdominal pain

• Dizziness

• Stuffy nose

• Runny nose

• Sore throat

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Vision changes

• Eye pain

• Severe eye irritation

• Red eyes

• Seeing halos or bright colors around lights

• Difficult urination

• Painful urination

• Passing a lot of urine

• Change in amount of urine passed

• Chest pain

• Difficulty breathing

• Wheezing

• Cough

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Administration issues:

Contraindications

Hypersensitivity to ipratropium, tiotropium, or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to atropine or its derivatives

Warnings/Precautions

Concerns related to adverse effects:

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

• CNS effects: May cause dizziness and blurred vision; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm, anaphylaxis, itching) have been reported. Discontinue immediately if signs/symptoms occur. Use with caution in patients with a history of hypersensitivity to atropine.

Disease-related concerns:

• Glaucoma: May worsen symptoms of narrow-angle glaucoma; use with caution.

• Prostatic hyperplasia/bladder neck obstruction: May worsen the symptoms of prostatic hyperplasia and/or bladder neck obstruction; use with caution.

• Renal impairment: Use with caution in patients with moderate to severe renal impairment (CrCl ≤60 mL/minute); monitor closely for anticholinergic adverse events.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Lactose: Capsule for oral inhalation may contain lactose; use with caution in patients with severe milk protein allergy.

Other warnings/precautions:

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

• Appropriate use: Spiriva HandiHaler: The contents of Spiriva capsules are for inhalation only via the HandiHaler device. Capsules should not be swallowed; there have been reports of incorrect administration (swallowing of the capsules).

• Appropriate use: Spiriva Respimat: The contents of Spiriva inhalation spray are for inhalation only via the Respimat inhaler.

• Avoid ocular contact: Avoid inadvertent instillation into the eyes; may dilate pupils and/or cause blurred vision.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

In elderly patients, renal clearance of tiotropium was decreased and plasma concentrations were increased, due to decreased renal function. In clinical trials, the incidence of constipation, UTIs and xerostomia increased with age. No dosage adjustments are recommended due to age or renal function. However, the manufacturer recommends monitoring patients with moderate-to-severe renal impairment. Monitor urinary function in men with benign prostatic hyperplasia while on this medication. Counsel patient on the appropriate use of the inhaler.

Pregnancy Considerations

Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2019).

Although information related to tiotropium use in pregnancy is limited, use is likely acceptable. Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]).

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant females in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (1-877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Breast-Feeding Considerations

It is not known if tiotropium is present in breast milk.

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. However, females with asthma should be encouraged to breastfeed (GINA 2019). Tiotropium oral inhalation is considered compatible with breastfeeding (ERS/TSANZ [Middleton 2020]).

Briggs' Drugs in Pregnancy & Lactation

• Tiotropium

Adverse Reactions

Non-postmarketing incidences listed are for powder for inhalation unless otherwise specified.

>10%:

Gastrointestinal: Xerostomia (powder and solution: 4% to 16%)

Respiratory: Upper respiratory tract infection (41% to 43%), pharyngitis (powder and solution: 7% to 16%), sinusitis (powder and solution: 3% to 11%)

1% to 10%:

Cardiovascular: Chest pain (powder and solution: ≤7%), edema (dependent, 3% to 5%), angina pectoris (1% to 3%; includes exacerbation of angina pectoris), palpitations (powder and solution: ≤3%), hypertension (solution: 1% to 2%)

Central nervous system: Headache (powder and solution: 4% to 6%), depression (≤4%), insomnia (powder and solution: ≤4%), paresthesia (1% to 3%), dizziness (powder and solution: ≤3%), voice disorder (powder and solution: ≤3%)

Dermatologic: Skin rash (powder and solution: 1% to 4%), pruritus (powder and solution: ≤3%)

Endocrine & metabolic: Hypercholesterolemia (1% to 3%), hyperglycemia (1% to 3%)

Gastrointestinal: Abdominal pain (5% to 6%), dyspepsia (1% to 6%), constipation (powder and solution: 1% to 5%), vomiting (1% to 4%), gastrointestinal disease (not otherwise specified; 1% to 3%), gastroesophageal reflux disease (powder and solution: ≤3%), oropharyngeal candidiasis (powder and solution: ≤3%), stomatitis (includes ulcerative stomatitis; powder and solution: ≤3%), diarrhea (solution: 1% to 2%)

Genitourinary: Urinary tract infection (powder and solution: 1% to 7%)

Hypersensitivity: Hypersensitivity reaction (powder and solution: ≤3%)

Infection: Candidiasis (3% to 4%), infection (1% to 4%), herpes zoster (powder and solution: ≤3%)

Neuromuscular & skeletal: Arthralgia (powder and solution: ≤4%), myalgia (4%), arthritis (≥3%), leg pain (1% to 3%), skeletal pain (1% to 3%)

Ophthalmic: Cataract (1% to 3%)

Respiratory: Rhinitis (powder and solution: ≤6%), epistaxis (powder and solution: ≤4%), cough (powder: ≥3%; solution: 1% to 2% ), flu-like symptoms (≥3%), bronchitis (solution: 3%), laryngitis (powder and solution: ≤3%), allergic rhinitis (solution: 1% to 2%)

Miscellaneous: Fever (solution: 1% to 2%)

<1%, postmarketing, and/or case reports: Abnormal hepatic function tests, anaphylaxis, angioedema, application site irritation (powder; includes glossitis, oral mucosa ulcer, pharyngolaryngeal pain), atrial fibrillation, blurred vision, bronchospasm, dehydration, dermal ulcer, dysphagia, dysuria, gingivitis, glaucoma, glossitis, hepatic insufficiency, hoarseness, increased intraocular pressure, intestinal obstruction (includes paralytic ileus), joint swelling, limb pain, muscle spasm, mydriasis (if powder comes in contact with eyes), oropharyngeal pain, paradoxical bronchospasm, skin infection, supraventricular tachycardia, tachycardia, throat irritation, tonsillitis, urinary retention, urticaria, xeroderma

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Belladonna Alkaloid Allergy

Toxicology

• Anticholinergic Agents

Metabolism/Transport Effects

Substrate of CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions Open Interactions

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Methacholine: Long-acting muscarinic antagonists (LAMAs) may diminish the therapeutic effect of Methacholine. Risk D: Consider therapy modification

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Monitoring Parameters

FEV1, peak flow (or other pulmonary function studies); anticholinergic adverse reactions (patients with CrCl ≤50 mL/min); signs and symptoms of narrow angle glaucoma and urinary retention

Advanced Practitioners Physical Assessment/Monitoring

Assess results of pulmonary tests prior to and periodically during therapy. Monitor for signs and symptoms of narrow angle glaucoma and urinary retention. In patients with moderate to severe renal impairment, monitor for anticholinergic side effects.

Nursing Physical Assessment/Monitoring

Check results of pulmonary tests and report abnormalities. Monitor for signs and symptoms of narrow angle glaucoma such as eye pain, blurred vision, or visual halos. Monitor for signs of urinary retention including dysuria or difficulty passing urine especially in patients with a history of BPH. In patients with moderate to severe renal impairment, monitor for anticholinergic side effects. Educate patient on importance of proper administration.

Dosage Forms Considerations

Spiriva Respimat 4 g cartridges contain 60 metered actuations (institutional pack contains 28 metered actuations).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation:

Spiriva Respimat: 1.25 mcg/actuation (4 g); 2.5 mcg/actuation (4 g) [contains benzalkonium chloride, disodium edta]

Capsule, Inhalation:

Spiriva HandiHaler: 18 mcg [contains milk protein]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation:

Spiriva Respimat: 2.5 mcg/actuation (1 ea) [contains benzalkonium chloride, disodium edta]

Capsule, Inhalation:

Spiriva: 18 mcg [contains milk protein]

Anatomic Therapeutic Chemical (ATC) Classification

• R03BB04

Generic Available (US)

No

Pricing: US

Aerosol solution (Spiriva Respimat Inhalation)

1.25 mcg/ACT (per gram): $136.57

2.5 mcg/ACT (per gram): $55.67

Capsules (Spiriva HandiHaler Inhalation)

18 mcg (per each): $18.21

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation

Pharmacodynamics/Kinetics

Absorption: Poorly absorbed from GI tract, systemic absorption may occur from lung

Distribution: Vd: 32 L/kg

Protein binding: 72%

Metabolism: Hepatic (minimal), via CYP2D6 and CYP3A4

Bioavailability: Following inhalation, 19.5% (dry powder inhaler) or ~33% (soft-mist inhaler); Oral solution: 2% to 3%

Half-life elimination:

Dry powder inhaler: COPD: ~25 hours

Soft-mist inhaler: Asthma: 44 hours; COPD: 25 hours

Time to peak, plasma:

Dry powder inhaler: 7 minutes (following inhalation)

Soft-mist inhaler: 5 to 7 minutes (following inhalation)

Excretion: Urine (7% of an inhaled dose [dry powder inhaler]; 18.6% of an inhaled dose [COPD] or 12.8% [asthma] [soft-mist inhaler])

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Reduced clearance and increased plasma concentrations may occur.

Geriatric: Reduced clearance may occur.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation) and ulcerative stomatitis.

Effects on Bleeding

No information available to require special precautions

Related Information

• Inhalant Agents

Index Terms

Tiotropium Bromide Monohydrate

FDA Approval Date

January 30, 2004

References

Adams SG, Anzueto A, Briggs DD Jr, et al, “Tiotropium in COPD Patients Not Previously Receiving Maintenance Respiratory Medications,” Respir Med, 2006, 100(9):1495-503.[PubMed 16698259]

Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf. Updated 2019. Accessed September 23, 2019.

Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/wp-content/uploads/2020/04/GINA-2020-full-report_-final-_wms.pdf. Updated 2020. Accessed April 13, 2020.

Gross NJ, “Tiotropium Bromide,” Chest, 2004, 126(6):1946-53.[PubMed 15596697]

Hvizdos KM and Goa KL, “Tiotropium Bromide,” Drugs, 2002 62(8):1195-203.[PubMed 12010082]

Maltais F, Hamilton A, Marciniuk D, et al, “Improvements in Symptom-Limited Exercise Performance Over 8 H With Once-Daily Tiotropium in Patients With COPD,” Chest, 2005, 128(3):1168-78.[PubMed 16162703]

Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ task force statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020;55(2):1901208. doi:10.1183/13993003.01208-2019[PubMed 31699837]

Niewoehner DE, Rice K, Cote C, et al, “Prevention of Exacerbations of Chronic Obstructive Pulmonary Disease With Tiotropium, a Once-Daily Inhaled Anticholinergic Bronchodilator: A Randomized Trial,” Ann Intern Med, 2005, 143(5):317-26.[PubMed 16144890]

Rodrigo GJ and Nannini LJ, “Tiotropium for the Treatment of Stable Chronic Obstructive Pulmonary Disease: A Systematic Review With Meta-Analysis,” Pulm Pharmacol Ther, 2007, 20(5):495-502.[PubMed 16621638]

Spiriva (Tiotropium) [product monograph]. Burlington, Ontario, Canada: Boehringer Ingelheim (Canada) Ltd; November 2017.

Spiriva HandiHaler (tiotropium bromide) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim; February 2018.

Spiriva Respimat (tiotropium bromide) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; March 2019.

Spiriva Respimat (tiotropium bromide) [product monograph]. Burlington, Ontario, Canada: Boehringer Ingelheim (Canada) Ltd; May 2019.

Szefler SJ, Murphy K, Harper T 3rd, et al. A phase III randomized controlled trial of tiotropium add-on therapy in children with severe symptomatic asthma. J Allergy Clin Immunol. 2017;140(5):1277-1287. doi: 10.1016/j.jaci.2017.01.014.[PubMed 28189771]

Brand Names: International

Braltus (IE); Dilriva Unicap (BD); Favint (NZ); Inhalex (EG); Neumotropio (LB); Norvent (BD); Spiriva (AE, AR, AT, AU, BE, BG, BH, BO, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GR, GT, HK, HN, HR, IE, IL, IQ, IR, IS, IT, JO, JP, KR, KW, LT, LV, LY, MT, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PL, PR, PT, PY, QA, RO, RU, SA, SE, SG, SI, SK, SV, SY, TH, TR, TW, UA, UY, VE, VN, YE); Spiriva Handihaler (BB); Spiriva Respimat (AE, AU, BB, BH, CN, CY, EG, ID, KR, LB, MY, PH, QA, SG, TH, VN); Spivira (LU); Srivasso (BE); Teromar (CO); Tioriva Bexicap (BD); Tiova Rotacaps (IN); Triomate (LK); Triomid (BD)

Last Updated 5/5/20