Spiriva
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FDA Labeling Changes
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Uses
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA HandiHaler is indicated to reduce exacerbations in COPD patients.
History
There is currently no drug history available for this drug.
Other Information
SPIRIVA HandiHaler consists of a capsule dosage form containing a dry powder formulation of tiotropium intended for oral inhalation only with the HandiHaler device.
Each light green, hard gelatin SPIRIVA capsule contains 18 mcg tiotropium (equivalent to 22.5 mcg tiotropium bromide monohydrate) blended with lactose monohydrate (which may contain milk proteins) as the carrier.
The dry powder formulation within the SPIRIVA capsule is intended for oral inhalation only.
The active component of SPIRIVA HandiHaler is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described as (1α, 2ß, 4ß, 5α, 7ß)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol.
The structural formula is:
Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br • H2O.
The HandiHaler device is an inhalation device used to inhale the dry powder contained in the SPIRIVA capsule. The dry powder is delivered from the HandiHaler device at flow rates as low as 20 L/min. Under standardized in vitro testing, the HandiHaler device delivers a mean of 10.4 mcg tiotropium when tested at a flow rate of 39 L/min for 3.1 seconds (2 L total). In a study of 26 adult patients with COPD and severely compromised lung function [mean FEV1 1.02 L (range 0.45 to 2.24 L); 37.6% of predicted (range 16% to 65%)], the median peak inspiratory flow (PIF) through the HandiHaler device was 30.0 L/min (range 20.4 to 45.6 L/min). The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow and peak inspiratory flow through the HandiHaler device, which may vary from patient to patient, and may vary with the exposure time of the SPIRIVA capsule outside the blister pack.
Sources
Spiriva Manufacturers
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Physicians Total Care, Inc.
![Spiriva (Tiotropium Bromide Monohydrate) Capsule [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Spiriva | Physicians Total Care, Inc.
DO NOT SWALLOW SPIRIVA CAPSULES
FOR USE WITH HANDIHALER DEVICE ONLYFOR ORAL INHALATION ONLY
SPIRIVA capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of the SPIRIVA capsules are only for oral inhalation and should only be used with the HandiHaler device [see Overdosage (10)].
The recommended dose of SPIRIVA HandiHaler is two inhalations of the powder contents of one SPIRIVA capsule, once-daily, with the HandiHaler device [see Patient Counseling Information (17.6)].
For administration of SPIRIVA HandiHaler, a SPIRIVA capsule is placed into the center chamber of the HandiHaler device. The SPIRIVA capsule is pierced by pressing and releasing the green piercing button on the side of the HandiHaler device. The tiotropium formulation is dispersed into the air stream when the patient inhales through the mouthpiece [see Patient Counseling Information (17.6)].
No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients. However, patients with moderate to severe renal impairment given SPIRIVA HandiHaler should be monitored closely for anticholinergic effects [see Warnings and Precautions (5.6), Use in Specific Populations (8.5, 8.6, 8.7), and Clinical Pharmacology (12.3)].
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Spiriva | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
DO NOT SWALLOW SPIRIVA CAPSULES
FOR USE WITH HANDIHALER DEVICE ONLYFOR ORAL INHALATION ONLY
SPIRIVA capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of the SPIRIVA capsules are only for oral inhalation and should only be used with the HandiHaler device [see Overdosage (10)].
The recommended dose of SPIRIVA HandiHaler is two inhalations of the powder contents of one SPIRIVA capsule, once-daily, with the HandiHaler device [see Patient Counseling Information (17)].
For administration of SPIRIVA HandiHaler, a SPIRIVA capsule is placed into the center chamber of the HandiHaler device. The SPIRIVA capsule is pierced by pressing and releasing the green piercing button on the side of the HandiHaler device. The tiotropium formulation is dispersed into the air stream when the patient inhales through the mouthpiece [see Patient Counseling Information (17)].
No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients. However, patients with moderate to severe renal impairment given SPIRIVA HandiHaler should be monitored closely for anticholinergic effects [see Warnings and Precautions (5.6), Use in Specific Populations (8.5, 8.6, 8.7), and Clinical Pharmacology (12.3)].
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Boehringer Ingelheim Pharmaceuticals Inc.
Spiriva | Boehringer Ingelheim Pharmaceuticals Inc.
DO NOT SWALLOW SPIRIVA CAPSULES
FOR USE WITH HANDIHALER DEVICE ONLYFOR ORAL INHALATION ONLY
SPIRIVA capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of the SPIRIVA capsules are only for oral inhalation and should only be used with the HandiHaler device [see Overdosage (10)].
The recommended dose of SPIRIVA HandiHaler is two inhalations of the powder contents of one SPIRIVA capsule, once-daily, with the HandiHaler device [see Patient Counseling Information (17)].
For administration of SPIRIVA HandiHaler, a SPIRIVA capsule is placed into the center chamber of the HandiHaler device. The SPIRIVA capsule is pierced by pressing and releasing the green piercing button on the side of the HandiHaler device. The tiotropium formulation is dispersed into the air stream when the patient inhales through the mouthpiece [see Patient Counseling Information (17)].
No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients. However, patients with moderate to severe renal impairment given SPIRIVA HandiHaler should be monitored closely for anticholinergic effects [see Warnings and Precautions (5.6), Use in Specific Populations (8.5, 8.6, 8.7), and Clinical Pharmacology (12.3)].
![Spiriva (Tiotropium Bromide) Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=910fae46-5eaf-427f-b137-e4e775b065c7&name=SpirivaHandiHalerLabel.jpg)
![Spiriva (Tiotropium Bromide) Capsule [Boehringer Ingelheim Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9&name=10006541-05.jpg)
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