Tiotropium (Lexi-Drugs)

Pronunciation

(ty oh TRO pee um)

Brand Names: US

Spiriva HandiHaler; Spiriva Respimat

Brand Names: Canada

Spiriva; Spiriva Respimat

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. In clinical trials, doses >2.5 mcg/day were not associated with greater efficacy in FEV1 response.

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).

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

Asthma: Children ≥6 years of age and Adolescents: Inhalation: Spiriva Respimat (1.25 mcg/actuation): Soft-mist inhaler: Refer to adult dosing.

Asthma, severe symptomatic (off-label use): Children ≥6 to 11 years of age: Inhalation: Spiriva Respimat (2.5 mcg/actuation): Soft-mist inhaler: Two inhalations (5 mcg) once daily as add-on therapy to inhaled corticosteroids and other maintenance therapies (Szefler 2017).

Dosing: Renal Impairment: Pediatric

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.

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.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Asthma:

Global Strategy for Asthma Management and Prevention (GINA), 2018 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 three 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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry mouth, nausea, abdominal pain, dizziness, rhinitis, rhinorrhea, or pharyngitis. Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, red eyes, visual halos or bright colors around lights, difficult urination, painful urination, polyuria, angina, difficulty breathing, wheezing, or cough (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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.

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

Adverse events have been observed in animal reproduction studies.

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 benefits of treatment to the mother.

Briggs’ Drugs in Pregnancy & Lactation
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

Allergy and Idiosyncratic Reactions
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 

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

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 D: Consider therapy modification

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 (1ea) [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): $128.84

2.5 mcg/ACT (per gram): $55.67

Capsules (Spiriva HandiHaler Inhalation)

18 mcg (per each): $17.18

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

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]

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]

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; February 2019.

Spiriva Respimat (tiotropium bromide) [product monograph]. Burlington, Ontario, Canada: Boehringer Ingelheim (Canada) Ltd.; June 2016.

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, ID, 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, 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)

Tiotropium (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(ty oh TRO pee um)

Brand Names: US

Spiriva HandiHaler; Spiriva Respimat

Brand Names: Canada

Spiriva; Spiriva Respimat

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.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to this drug or any part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you take other drugs called anticholinergics, like ipratropium or oxybutynin. Ask your doctor if you are not sure if any of your drugs are anticholinergic.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • For all uses of this drug:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this drug affects you.
  • Unsafe allergic effects may rarely happen.
  • Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
  • Do not get this drug in your eyes. If you get it in your eyes, it may cause large pupils and blurred eyesight.
  • Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • For asthma:
  • It may take several weeks to see the full effects.
What are some side effects that I need to call my doctor about right away?
  • 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Eye redness.
  • Seeing halos or bright colors around lights.
  • Trouble passing urine.
  • Pain when passing urine.
  • Passing urine more often.
  • Passing urine in a weak stream or drips.
  • Chest pain or pressure.
  • This drug 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 this drug, use a rescue inhaler and get medical help right away.
What are some other side effects of this drug?
  • 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:
  • Dry mouth.
  • Upset stomach.
  • Nose and throat irritation.
  • Runny nose.
  • Stuffy nose.
  • Belly pain.
  • Dizziness.
  • Cough.
  • 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 your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Follow how to use as you have been told by the doctor or read the package insert.
  • To gain the most benefit, do not miss doses.
  • Keep using this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Keep out of your eyes.
  • Have your inhaler use checked with your doctor at each visit. Read and follow facts on how to use the inhaler. Make sure you use the inhaler the right way.
  • If you are using more than 1 inhaled drug, ask the doctor which drug to use first.
  • Do not use a spacer with the inhaler.
  • Use new inhaler with each refill.
  • Put the cap back on after you are done using your dose.
  • Capsules for breathing in:
  • Do not swallow capsule. The contents of the capsule will be breathed into the lungs.
  • Only use the device that comes with this drug. Do not use any other devices.
  • Inhaler (aerosol):
  • Prepare the inhaler before first use. Spray towards the ground until mist is seen. Once the mist is seen, spray 3 more times. If it has been more than 3 days since it has been used, spray once at the ground. If not used in more than 21 days, you will need to prepare the inhaler again. Spray until mist is seen then spray 3 more times.
  • Follow how to clean carefully.
  • After all sprays have been used, the inhaler will lock.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time.
  • Do not take more than 1 dose of this drug in the same day.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • 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.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Capsules for breathing in:
  • Store capsules in the original container. Use right after opening.
  • Inhaler (aerosol):
  • Do not freeze.
  • After putting together, throw away the inhaler 3 months after first use or when the inhaler locks.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Tiotropium (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(ty oh TRO pee um)

Brand Names: US

Spiriva HandiHaler; Spiriva Respimat

Brand Names: Canada

Spiriva; Spiriva Respimat

What is this drug used for?
  • This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.
  • Inhaler (aerosol):
  • It is used to treat asthma.
  • It may be given to your child for other reasons. Talk with the doctor.
  • Capsules for breathing in:
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child takes other drugs called anticholinergics, like ipratropium or oxybutynin. Ask the doctor if you are not sure if any of your child’s drugs are anticholinergic.
  • This drug may interact with other drugs or health problems.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness or clear eyesight until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Unsafe allergic effects may rarely happen.
  • Call the doctor right away if your child has breathing problems that get worse, if the rescue inhaler does not work as well, or if your child needs to use the rescue inhaler more often.
  • It may take several weeks to see the full effects.
  • Be sure this drug does not get in your child’s eyes. If it gets in your child’s eyes, it may cause large pupils and blurred eyesight.
  • Do not give more than the doctor told you to give. Do not give more often or for longer than you were told. Doing any of these things may raise the chance of very bad side effects.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • 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 child’s doctor or get medical help right away if your child has 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Eye redness.
  • Seeing halos or bright colors around lights.
  • Trouble passing urine.
  • Pain when passing urine.
  • Passing urine more often.
  • Passing urine in a weak stream or drips.
  • Chest pain or pressure.
  • This drug can cause very bad breathing problems right after your child takes a dose. Sometimes, this may be life-threatening. If your child has trouble breathing, breathing that is worse, wheezing, or coughing after using this drug, have your child use a rescue inhaler and get medical help right away.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Dry mouth.
  • Upset stomach.
  • Nose and throat irritation.
  • Runny nose.
  • Stuffy nose.
  • Belly pain.
  • Dizziness.
  • Cough.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Prepare the inhaler before first use. Spray towards the ground until mist is seen. Once the mist is seen, spray 3 more times. If it has been more than 3 days since it has been used, spray once at the ground. If not used in more than 21 days, you will need to prepare the inhaler again. Spray until mist is seen then spray 3 more times.
  • Keep out of your child’s eyes.
  • Follow how to clean carefully.
  • After all sprays have been used, the inhaler will lock.
  • Check your child’s inhaler use with the doctor at each visit. Read and follow facts on how to use the inhaler. Make sure your child uses the inhaler the right way.
  • If your child is using more than 1 inhaled drug, ask your child’s doctor which inhaled drug to give first.
  • Do not use a spacer with the inhaler.
  • Use new inhaler with each refill.
  • Put the cap back on after your child is done using a dose.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is the next day, skip the missed dose and go back to your child’s normal time.
  • Do not give more than 1 dose of this drug in the same day.
How do I store and/or throw out this drug?
  • Store at room temperature. Do not freeze.
  • Store in a dry place. Do not store in a bathroom.
  • After putting together, throw away the inhaler 3 months after first use or when the inhaler locks.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.