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tiotropium bromide monohydrate
Overview
What is Spiriva?
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[3.3.1.0]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
CHNOSBr • HO.
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 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 FEV 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.
What does Spiriva look like?
What are the available doses of Spiriva?
SPIRIVA capsules for oral inhalation: 18 mcg tiotropium
powder, for use with HandiHaler device
What should I talk to my health care provider before I take Spiriva?
Patients with moderate to severe renal impairment should
be monitored closely for potential anticholinergic side effects ,
How should I use Spiriva?
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.
DO NOT SWALLOW SPIRIVA CAPSULES
FOR USE WITH HANDIHALER DEVICE ONLY
FOR ORAL INHALATION ONLY
The
recommended dose of SPIRIVA HandiHaler is two inhalations of the powder contents
of one SPIRIVA capsule, once-daily, with the HandiHaler device [
].
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 [
].
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 [].
What interacts with Spiriva?
Sorry No Records found
What are the warnings of Spiriva?
Sorry No Records found
What are the precautions of Spiriva?
Sorry No Records found
What are the side effects of Spiriva?
Sorry No records found
What should I look out for while using Spiriva?
SPIRIVA HandiHaler
is contraindicated in patients with a hypersensitivity
to ipratropium or tiotropium. In clinical trials and postmarketing experience
with SPIRIVA HandiHaler, immediate hypersensitivity reactions, including
angioedema (including swelling of the lips, tongue, or throat), itching, or
rash have been reported.
What might happen if I take too much Spiriva?
High
doses of tiotropium may lead to anticholinergic signs and symptoms. However,
there were no systemic anticholinergic adverse effects following a single
inhaled dose of up to 282 mcg tiotropium in 6 healthy volunteers. In a study of
12 healthy volunteers, bilateral conjunctivitis and dry mouth were seen
following repeated once-daily inhalation of 141 mcg of tiotropium.
A
case of overdose has been reported from postmarketing experience. A female
patient was reported to have inhaled 30 capsules over a 2.5 day period, and
developed altered mental status, tremors, abdominal pain, and severe
constipation. The patient was hospitalized, SPIRIVA HandiHaler was
discontinued, and the constipation was treated with an enema. The patient
recovered and was discharged on the same day.
No
mortality was observed at inhalation tiotropium doses up to 32.4 mg/kg in mice,
267.7 mg/kg in rats, and 0.6 mg/kg in dogs. These doses correspond to 7300,
120,000, and 850 times the recommended human daily inhalation dose on a mg/m
basis, respectively. These dose multiples may be over-estimated due to
difficulties in measuring deposited doses in animal inhalation studies.
How should I store and handle Spiriva?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].SPIRIVA HandiHaler consists of SPIRIVA capsules and the HandiHaler device. SPIRIVA capsules contain 18 mcg of tiotropium and are light green, with the Boehringer Ingelheim company logo on the SPIRIVA capsule cap and TI 01 on the SPIRIVA capsule body, or vice versa.The HandiHaler device is gray colored with a green piercing button. It is imprinted with SPIRIVA HandiHaler (tiotropium bromide inhalation powder), the Boehringer Ingelheim company logo, and the Pfizer company logo. It is also imprinted to indicate that SPIRIVA capsules should not be stored in the HandiHaler device and that the HandiHaler device is only to be used with SPIRIVA capsules.SPIRIVA capsules are packaged in an aluminum/aluminum blister card and joined along a perforated-cut line. SPIRIVA capsules should always be stored in the blister and only removed immediately before use. The drug should be used immediately after the packaging over an individual SPIRIVA capsule is opened.The following packages are available:The SPIRIVA capsules should not be exposed to extreme temperature or moisture. Do not store SPIRIVA capsules in the HandiHaler device.SPIRIVA HandiHaler consists of SPIRIVA capsules and the HandiHaler device. SPIRIVA capsules contain 18 mcg of tiotropium and are light green, with the Boehringer Ingelheim company logo on the SPIRIVA capsule cap and TI 01 on the SPIRIVA capsule body, or vice versa.The HandiHaler device is gray colored with a green piercing button. It is imprinted with SPIRIVA HandiHaler (tiotropium bromide inhalation powder), the Boehringer Ingelheim company logo, and the Pfizer company logo. It is also imprinted to indicate that SPIRIVA capsules should not be stored in the HandiHaler device and that the HandiHaler device is only to be used with SPIRIVA capsules.SPIRIVA capsules are packaged in an aluminum/aluminum blister card and joined along a perforated-cut line. SPIRIVA capsules should always be stored in the blister and only removed immediately before use. The drug should be used immediately after the packaging over an individual SPIRIVA capsule is opened.The following packages are available:The SPIRIVA capsules should not be exposed to extreme temperature or moisture. Do not store SPIRIVA capsules in the HandiHaler device.SPIRIVA HandiHaler consists of SPIRIVA capsules and the HandiHaler device. SPIRIVA capsules contain 18 mcg of tiotropium and are light green, with the Boehringer Ingelheim company logo on the SPIRIVA capsule cap and TI 01 on the SPIRIVA capsule body, or vice versa.The HandiHaler device is gray colored with a green piercing button. It is imprinted with SPIRIVA HandiHaler (tiotropium bromide inhalation powder), the Boehringer Ingelheim company logo, and the Pfizer company logo. It is also imprinted to indicate that SPIRIVA capsules should not be stored in the HandiHaler device and that the HandiHaler device is only to be used with SPIRIVA capsules.SPIRIVA capsules are packaged in an aluminum/aluminum blister card and joined along a perforated-cut line. SPIRIVA capsules should always be stored in the blister and only removed immediately before use. The drug should be used immediately after the packaging over an individual SPIRIVA capsule is opened.The following packages are available:The SPIRIVA capsules should not be exposed to extreme temperature or moisture. Do not store SPIRIVA capsules in the HandiHaler device.SPIRIVA HandiHaler consists of SPIRIVA capsules and the HandiHaler device. SPIRIVA capsules contain 18 mcg of tiotropium and are light green, with the Boehringer Ingelheim company logo on the SPIRIVA capsule cap and TI 01 on the SPIRIVA capsule body, or vice versa.The HandiHaler device is gray colored with a green piercing button. It is imprinted with SPIRIVA HandiHaler (tiotropium bromide inhalation powder), the Boehringer Ingelheim company logo, and the Pfizer company logo. It is also imprinted to indicate that SPIRIVA capsules should not be stored in the HandiHaler device and that the HandiHaler device is only to be used with SPIRIVA capsules.SPIRIVA capsules are packaged in an aluminum/aluminum blister card and joined along a perforated-cut line. SPIRIVA capsules should always be stored in the blister and only removed immediately before use. The drug should be used immediately after the packaging over an individual SPIRIVA capsule is opened.The following packages are available:The SPIRIVA capsules should not be exposed to extreme temperature or moisture. Do not store SPIRIVA capsules in the HandiHaler device.SPIRIVA HandiHaler consists of SPIRIVA capsules and the HandiHaler device. SPIRIVA capsules contain 18 mcg of tiotropium and are light green, with the Boehringer Ingelheim company logo on the SPIRIVA capsule cap and TI 01 on the SPIRIVA capsule body, or vice versa.The HandiHaler device is gray colored with a green piercing button. It is imprinted with SPIRIVA HandiHaler (tiotropium bromide inhalation powder), the Boehringer Ingelheim company logo, and the Pfizer company logo. It is also imprinted to indicate that SPIRIVA capsules should not be stored in the HandiHaler device and that the HandiHaler device is only to be used with SPIRIVA capsules.SPIRIVA capsules are packaged in an aluminum/aluminum blister card and joined along a perforated-cut line. SPIRIVA capsules should always be stored in the blister and only removed immediately before use. The drug should be used immediately after the packaging over an individual SPIRIVA capsule is opened.The following packages are available:The SPIRIVA capsules should not be exposed to extreme temperature or moisture. Do not store SPIRIVA capsules in the HandiHaler device.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Tiotropium
is a long-acting, antimuscarinic agent, which is often referred to as an
anticholinergic. It has similar affinity to the subtypes of muscarinic
receptors, M to M. In the airways, it exhibits
pharmacological effects through inhibition of M-receptors at the
smooth muscle leading to bronchodilation. The competitive and reversible nature
of antagonism was shown with human and animal origin receptors and isolated
organ preparations. In preclinical as well as
studies, prevention of methacholine-induced bronchoconstriction effects was
dose-dependent and lasted longer than 24 hours. The bronchodilation following
inhalation of tiotropium is predominantly a site-specific effect.
Non-Clinical Toxicology
SPIRIVA HandiHaler is contraindicated in patients with a hypersensitivity to ipratropium or tiotropium. In clinical trials and postmarketing experience with SPIRIVA HandiHaler, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.See concerning solutions containing a vasoconstrictor.
If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect.
Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) should be used cautiously in persons with known drug allergies or sensitivities, particularly to the amide-type local anesthetics.
Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine are employed in patients during or following the administration of chloroform, halothane, cyclopropane, trichloroethylene, or other related agents. In deciding whether to use these products concurrently in the same patient, the combined action of both agents upon the myocardium, the concentration and volume of vasoconstrictor used, and the time since injection, when applicable, should be taken into account.
SPIRIVA HandiHaler is intended as a once-daily maintenance treatment for COPD and is not indicated for the initial treatment of acute episodes of bronchospasm (i.e., rescue therapy).
The following adverse reactions are described, or described in greater detail, in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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