Tiotropium Bromide

Trade Names:
Spiriva
- Powder for inhalation 18 mcg (as base)

Pharmacology

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Inhibits smooth muscle receptors, leading to bronchodilation.

Pharmacokinetics

Absorption

Bioavailability is about 19.5%.

Distribution

Vd is 32 L/kg. Protein binding is 72%. At steady-state, peak and trough plasma levels are 17 to 19 picograms/mL and 3 to 4 picograms/mL, respectively.

Elimination

Approximately 14% is eliminated unchanged in the urine; the remainder is not absorbed in the gut and is eliminated in the feces. Terminal elimination t _½ is 5 to 6 days.

Special Populations

Advanced age is associated with a decrease in tiotropium renal Cl, which is explained by decreased renal function.

Reduced Cl and increased plasma concentrations may occur.

Indications and Usage

Long-term, maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.

Contraindications

Hypersensitivity to atropine or its derivatives, including ipratropium, or any component of this product.

Dosage and Administration

Inhalation Contents of 1 capsule daily, using the HandiHaler inhalation device.

Storage/Stability

Store capsules for oral inhalation in sealed blisters at ambient room temperature (59° to 86°F). Protect from extreme temperature and moisture. Do not remove capsule from sealed blister until immediately before use. Discard any capsule that is inadvertently removed from the sealed blister and not used immediately. Do not store capsules in inhalation device.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Angina pectoris (including aggravated angina pectoris, [1% to 3%]).

CNS

Dysphonia, paresthesia, depression (1% to 3%).

Dermatologic

Rash (4%).

EENT

Pharyngitis (9%); cataract (1% to 3%).

GI

Dry mouth (16%); dyspepsia (6%); abdominal pain (5%); constipation, vomiting (4%); stomatitis (including ulcerative stomatitis), gastroesophageal reflux (1% to 3%).

Genitourinary

UTI (7%).

Metabolic-Nutritional

Hypercholesterolemia, hyperglycemia (1% to 3%).

Musculoskeletal

Myalgia (4%); skeletal pain (1% to 3%).

Respiratory

Upper respiratory tract infection (41%); sinusitis (11%); rhinitis (6%); epistaxis (4%); coughing (at least 3%); laryngitis (1% to 3%).

Miscellaneous

Accidents (13%); non-specific chest pain (7%); dependent edema (5%); infection, moniliasis (4%); arthritis, flu-like symptoms (at least 3%); allergic reaction, leg pain, herpes zoster infection (1% to 3%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hypersensitivity

Immediate hypersensitivity reactions, including angioedema, may occur.

Renal Function

Monitor therapy closely in patients with moderate to severe renal impairment.

Special Risk Patients

Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.

Acute bronchospasm

Not indicated for initial treatment of acute episodes of bronchospasm.

Bronchospasm

Paradoxical bronchospasm may occur.

Overdosage

Symptoms

Anticholinergic signs and symptoms.

Patient Information

• Advise patient to continue taking other medications for same condition as prescribed by health care provider.
• Instruct patient on the proper storage, handling, and use of the capsules and inhalation device, referring to the Patient's Instructions for Use instruction sheet included with the medication. Ensure that patient understands how to clean the inhalation device.
• Advise patient that medication should never be administered with a spacer device or with any other inhalation device than that provided. Caution patient not to administer other inhaled medications with the inhalation device.
• Caution patient not to exceed prescribed dose. Inform patient that medication is being inhaled even if the dose being delivered is not tasted or felt.
• Instruct patient not to stop the medication once symptoms have improved. Continued daily use is necessary to control symptoms.
• Advise patient not to change the dose or stop using unless advised by health care provider.
• Warn patient that tiotropium is a maintenance medication and is not to be used for immediate relief of breathing problems. Advise patient to use rescue medication (short-acting bronchodilator) to obtain rapid relief of breathing problems.
• Advise patient that medication does not replace inhaled or oral corticosteroids and to continue to use those drugs as prescribed by health care provider.
• Advise patient to inform health care provider if symptoms do not improve or worsen, if more short-acting bronchodilator than usual is needed, or if the short-acting bronchodilator appears to become less effective.
• Instruct patient to discontinue use and immediately notify health care provider if eye pain or discomfort, blurred vision, vision halos, or colored images develop in association with red eyes. Advise patient that these symptoms may be associated with a serious problem that will require immediate medical care.
• Advise patient to carry medical identification (eg, card, bracelet) indicating that they have COPD.

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Chronic Obstructive Pulmonary Disease -- Maintenance

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