Dosing & Uses
Dosage Forms & Strengths
capsule (Spiriva Handihaler; powder for oral inhalation)
- 18mcg
solution for inhalation (Spiriva Respimat)
- 1.25mcg/actuation
- 2.5mcg/actuation
Chronic Obstructive Pulmonary Disease
Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD); reduction of COPD exacerbations
Spiriva Handihaler: 2 PO inhalations of 1 capsule (18 mcg) qDay via HandiHaler inhalation device
Spiriva Respimat: 5 mcg (2 actuations; 2.5 mcg/actuation) inhaled PO qDay
Asthma
Indicated for long-term, once-daily, maintenance treatment of asthma in patients aged ≥12 yr
Spiriva Respimat: 2.5 mcg (2 actuations; 1.25 mcg/actuation) inhaled PO qDay
Dosage Modifications
CrCl <50 mL/min: Use only if benefit outweighs potential risk
Cystic Fibrosis (Orphan)
Improvement of pulmonary function in conjunction with standard therapy in management of patients with cystic fibrosis
Orphan indication sponsor
- Boehringer Ingelheim Pharmaceuticals, Inc, PO Box 368, 900 Ridgebury Road, Ridgefield, CT 06877
Dosage Forms & Strengths
solution for inhalation (Spiriva Respimat)
- 1.25mcg/actuation
Asthma
Indicated for long-term, once-daily, maintenance treatment of asthma in patients aged ≥6 yr
Spiriva Respimat: 2.5 mcg (2 actuations; 1.25 mcg/actuation) inhaled PO qDay
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Upper respiratory tract infection (41%)
Dry mouth (16%)
Sinusitis (11%)
1-10%
Abdominal pain
Allergic reaction
Angina pectoris (including aggravated angina pectoris)
Cataract
Chest pain (nonspecific)
Constipation
Depression
Dyspepsia
Dysphonia
Edema
Epistaxis
Gastroesophageal reflux
Herpes zoster
Hypercholesterolemia
Hyperglycemia
Infection
Laryngitis
Leg pain
Moniliasis
Myalgia
Paresthesia
Pharyngitis
Rash
Rhinitis
Skeletal pain
Stomatitis (including ulcerative stomatitis)
Urinary tract infection
Vomiting
<1%
Angioedema
Fibrillation
Supraventricular tachycardia
Urinary retention
Postmarketing Reports
Bronchospasm
Glossitis
Dehydration
Insomnia
Warnings
Contraindications
History of hypersensitivity to ipratropium or tiotropium
History of severe hypersensitivity to milk proteins (excipient in powder contained in capsule)
Lactose allergy
Cautions
Not for acute use; not a rescue medication
Immediate hypersensitivity reactions (eg, angioedema, itching, rash); stop treatment immediately
Capsule not to be swallowed; to be administered only by PO inhalation via HandiHaler device
Worsening of narrow-angle glaucoma
Worsening of urinary retention
Potential for paradoxical bronchospasm
Prostatic hyperplasia
Bladder-neck obstruction
Wash hands after handling capsules
Pregnancy & Lactation
Pregnancy
The limited human data with therapy during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes
Poorly or moderately controlled asthma in pregnancy increases maternal risk of preeclampsia and infant prematurity, low birth weight, and small for gestational age; level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control
Lactation
There are no data on presence of tiotropium in human milk, effects on breastfed infant, or effects on milk production; tiotropium is present in milk of lactating rats; however, clinical relevance of these data are not clear. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Long-acting antimuscarinic agent, often referred to as anticholinergic
Inhibits M3-receptors at smooth muscle, leading to bronchodilation
Absorption
Bioavailability: 19.5%
Onset: 30 min
Duration: >24 hr
Time to peak effect: 1-4 hr
Distribution
Protein bound: 72%
Vd: 32 L/kg
Metabolism
Metabolized in liver via CYP450-dependent oxidation and subsequent glutathione conjugation
Elimination
Half-life: 5-6 days
Total body clearance: 880 mL/min
Excretion: Urine
Administration
Oral Inhalation
Spiriva Respimat: Premeasured dose in slow-moving mist for oral inhalation; delivers medication in a way that does not depend on how fast air is breathed in from the inhaler
To receive the full dose of medication, Spiriva Respimat must be administered as 2 inhalations once-daily (ie, 2 inhalations of 2.5 mcg [5 mcg] for COPD; 2 inhalations of 1.25 mcg [2.5 mcg] for asthma)
Spiriva Handihaler: Powder for inhalation; device is dependent on the patient's ability to inhale the powder
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
