DOSAGE AND ADMINISTRATION
DO NOT SWALLOW SPIRIVA CAPSULES
FOR USE WITH HANDIHALER DEVICE ONLY
FOR 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
].
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
].
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
].
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 , Use in Specific
Populations (8.5, 8.6, 8.7), and Clinical Pharmacology
].
DOSAGE FORMS AND STRENGTHS
SPIRIVA
HandiHaler consists of SPIRIVA capsules and a HandiHaler device. SPIRIVA
capsules contain 18 mcg dry powder formulation of tiotropium in a
light green, hard gelatin capsule with TI 01 printed on one side and Boehringer
Ingelheim company logo on the other side. Supplied with a HandiHaler device.
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