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Spiriva and/or Equivalent Tiotropium Bromide Prescription Information

Spiriva delivers tiotropium bromide, a long-acting Antimuscarinic class drug, by way of its HandiHaler drug delivery system. Spiriva oral inhalation powder is manufactured in capsules containing Spiriva dry powder intended only for oral inhalation with the HandiHaler inhalation device. It is usually used for the treatment of Chronic Obstructive Pulmonary Disease (COPD) and is available by prescription only.

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Indication/Usage:

Spiriva HandiHaler, typically prescribed for the treatment and maintenance of chronic obstructive pulmonary disease (COPD) and related symptoms, and is also used to control the development and/or worsening of COPD exacerbations. Technically, COPD exacerbation is diagnosed based upon the increase or new onset of more than one COPD symptom like cough, shortness of breath, mucus, or wheezing that requires additional treatment beyond rescue medicine.

Spiriva HandiHaler is also indicated as a long-term maintenance therapy for the treatment of COPD associated Bronchospasm, Chronic Bronchitis and Emphysema.

Dose, Administration and Dosage forms:

To avoid improper administration of Spiriva, patients should be advised of the following guidelines:

• The Spiriva capsule should not be swallowed; it is only for oral inhalation. Swallowing the capsule will not produce the desired effects on the lungs.
• The HandiHaler device should never be used for administering any medicine besides Spiriva.
• Spiriva contents must be administered with the HandiHaler device only via oral inhalation.
• The Spiriva HandiHaler is a once-a-day usage product which helps the lungs work better for a 24 hour period. Each Spiriva light-green, hard gelatin capsule contains 22.5mcg tiotropium bromide monohydrate. The recommended dosage is two inhalations of one capsule once per day.

To administer Spiriva, place the capsule in the center chamber of the HandiHaler device, close the mouthpiece and pierce capsule by pressing and releasing the green piercing button of the device. The released tiotropium will enter the lungs during inhalation through the mouthpiece.

Mechanism of action:

Tiotropium is an antimuscarinic class drug which works similarly to all subtypes of M1 to M5 muscarinic receptors with the same affinity. Tiotropium acts by competitive and reversible inhibition of M3-receptors at the bronchial smooth muscle and results in bronchodilation. While the patient may breathe easier from day one, the full benefit will be realized with continued use. Spiriva has proven to be very effective in a large population.

Side-effects and safety profile:

Various side-effects reported with Spiriva usage include: dry mouth, constipation, stomach pain, vomiting, indigestion, runny nose, sore throat, etc. These side effects are non-serious and can be cured easily.

Serious allergic side-effects reported with the use of Spiriva include: rash, hives, unusual hoarseness, itching, dyspnea, swallowing difficulty, chest tightness, and swelling of various body parts like lips, throat, mouth, face, or tongue, etc.

Various other serious side-effects are chest pain, burning, tingling, numbness, sinus inflammation or infection, influenza-like symptoms, persistent nose bleed, depression, painful urination, irregular heartbeat, irritation, mouth sores, worsened breathing issues, ocular pain, vision changes (blurry vision, halos, colored images etc.), arthritis, wheezing, etc.

Warnings/Contraindications:

• Spiriva is contraindicated in patients allergic to tiotropium or ipratropium.
• Patients experiencing any vision changes, ocular pain, or painful urination must immediately stop taking Spiriva and consult a physician.
• Spiriva is contraindicated in patients with a history of glaucoma, urine-passing problems, enlarged prostate, kidney problems, etc., as these may worsen while on Spiriva.
• Patients experiencing changes in vision while taking Spiriva should use caution while driving or operating heavy machinery.
• Do not use Spiriva as a rescue therapy.
• Spiriva is a pregnancy category C drug and should only be used in pregnant women if the potential benefit justifies the potential risk to the fetus. Spiriva has not been studied in pregnant women, and therefore should be avoided, if possible.
• Based on animal studies, tiotropium is reported to excrete via breast milk. Studies have not been performed on nursing women; therefore, Spiriva should be avoided by nursing women.

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