Adult Dosing

Maintenance therapy for COPD

• 2 INH of one capsule contents (18 mcg) daily, using HandiHaler inhalation device
• Do not swallow capsules

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Long-term maintenance treatment of bronchospasm due to COPD, including chronic bronchitis and emphysema
• To reduce exacerbations of COPD

• Hypersensitivity to ipratropium or tiotropium
• Acute bronchospasm

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments
• 50 mL/min: Dose adjustment not defined; closely monitor for anticholinergic side effects

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

See Supplemental Patient Information

• Tiotropium capsules should not be used more frequently than once daily
• Not intended for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy
• Tiotropium capsules must not be swallowed as the intended effects on the lungs will not be obtained as these capsules are for oral inhalation only
• Discontinue if immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or paradoxical bronchospasm occurs; consider alternative therapy
• Monitor for signs and symptoms of worsening narrow-angle glaucoma; or worsening GI or GU obstruction

Cautions: Use cautiously in

• Moderate-severe renal impairment (monitor closely if CrCl< 50 mL/min)
• Narrow angle glaucoma
• Bladder neck obstruction
• Prostatic hypertrophy
• Urinary retention
• Hypersensitivity to milk protein

Supplemental Patient Information

• Instruct patients to consult a physician immediately if signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) develop
• Instruct patients to consult a physician if signs and symptoms of prostatic hyperplasia or bladder-neck obstruction develop
• Avoid getting powder into eyes

Pregnancy Category:C

Breastfeeding: Safety unknown. Poorly excreted into breastmilk. Unlikely to adversely affect the breastfed infant based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 27 January 2011). Manufacturer advises caution if tiotropium is administered to a nursing woman.

• GI: Constipation, xerostomia, bowel obstruction
• HYPERSENSITIVITY: Angioedema (including swelling of the lips, tongue, or throat), itching, rash
• RESP: Paradoxical bronchospasm, pharyngitis, sinusitis. URI
• EENT: Narrow-angle glaucoma
• GU: Urinary retention, prostatic hyperplasia/bladder-neck obstruction

• Anticholinergic bronchodilator; inhibits smooth-muscle muscarinic M₃-receptors which leads to bronchodilation
• Bioavailability is 19.5% following administration by inhalation
• Metabolism: 25% of the drug is metabolized in liver by CYP450 (3A4 and 2D6 isoenzymes)
• Excretion: Primarily excreted in feces, urine (14%)
• Half-Life: 5-6 days

US Trade Name(s)

• Spiriva HandiHaler

US Availability

Spiriva HandiHaler

• DPI: 18 mcg/cap

Canadian Trade Name(s)

• Spiriva HandiHaler

Canadian Availability

Spiriva HandiHaler

• DPI: 18 mcg/cap

UK Trade Name(s)

• Spiriva HandiHaler
• Spiriva Respimat

UK Availability

Spiriva HandiHaler

• DPI: 18 mcg/cap

Spiriva Respimat

• SOLN for INH: 2.5 mcg/metered inhalation

Australian Trade Name(s)

• Spiriva HandiHaler

Australian Availability

Spiriva HandiHaler

• DPI: 18 mcg/cap

[Outline]

Pulmonary

Bronchodilators

Anticholinergic Bronchodilators

Allergy & Immunology

Bronchodilators

Anticholinergic Bronchodilators

Pricing data from www.DrugStore.com in U.S.A.

• Spiriva HandiHaler 18 MCG CAPS [Box] (BOEHRINGER INGELHEIM)
  30 mcg = $261.99
  90 mcg = $765.93

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Spiriva 0.018 MG/ACTUAT Inhalant Powder

Ingredient(s): Tiotropium

Imprint: TI;01

Color(s): Green

Shape: Capsule

Size (mm): 16.00

Score: 1

Inactive Ingredient(s): lactose monohydrate

Drug Label Author:
Boehringer Ingelheim Pharmaceuticals Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Spiriva 0.018 MG/ACTUAT Inhalant Powder

Ingredient(s): Tiotropium

Imprint: TI;01

Color(s): Green

Shape: Capsule

Size (mm): 16.00

Score: 1

Inactive Ingredient(s): lactose monohydrate

Drug Label Author:
Physicians Total Care, Inc.

DEA Schedule:
Non-Scheduled