Spiriva (Tiotropium Bromide) Drug Information: Overdosage and Contraindications

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May 27, 2012

Spiriva

Acute Bronchitis »

What is acute bronchitis?

Air is pulled into the lungs when we breathe, initially passing through the mouth, nose, and larynx (voicebox) into the trachea and continues en route to each lung via either the right or left bronchi (the bronchial tree - bronchi, bronchioles, and alveoli). Bronchi are formed as the lower part of the trachea divides into two tubes that lead to the lungs. As the bronchi get farther away from the trachea, each bronchial tube divides and gets smaller (resembling an inverted tree) to provide the air to lung tissue so that it can transfer oxygen to the blood stream and remove carbon dioxide (the waste product of metabolism).

Bronchitis describes inflammation of the bronchial tubes (inflammation = itis). The inflammation causes swelling of the lining of these breathing tubes, narrowing the tubes and promoting secretion of inflammatory fluid.

Acute bronchitis describes the inflammation of the bronchi u...

Read the Acute Bronchitis article »

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OVERDOSE

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.

Accidental Ingestion

Acute intoxication by inadvertent oral ingestion of SPIRIVA capsules is unlikely since it is not well-absorbed systemically.

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/m² basis, respectively. These dose multiples may be over-estimated due to difficulties in measuring deposited doses in animal inhalation studies.

CONTRAINDICATIONS

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.

Last reviewed on RxList: 9/7/2011
This monograph has been modified to include the generic and brand name in many instances.