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brand spiriva 18 mcg cp-handihaler

In stock Manufacturer BOEHRINGER ING. 00597007541
$15.29 / Blist Pack

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Uses

Bronchospasm

Chronic Obstructive Pulmonary Disease

Tiotropium bromide is used for the long-term symptomatic treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. In patients with moderate to severe COPD (e.g., forced expiratory volume in 1 second [FEV1] 30 to less than 80% of predicted or, alternatively, less than 60% of predicted) who have persistent symptoms not relieved by as-needed therapy with ipratropium and/or a selective, short-acting inhaled β2-agonist, maintenance monotherapy with a long-acting bronchodilator (e.g., orally inhaled salmeterol, formoterol, or tiotropium) or an inhaled corticosteroid may be used, and a short-acting, selective inhaled β2-agonist is used as needed for immediate symptom relief. Maintenance therapy with long-acting bronchodilators in patients with moderate to severe COPD is more effective and more convenient than regular therapy with short-acting bronchodilators. Data are insufficient to favor one maintenance monotherapy over another for use in such patients. Some clinicians recommend therapy with a combination of several long-acting bronchodilators such as tiotropium and a long-acting β-adrenergic agonist in selected patients with inadequate response. In patients with severe to very severe COPD (e.g., FEV1 less than 30 to less than 50% of predicted), some clinicians recommend addition of an inhaled corticosteroid to maintenance therapy with one or more long-acting bronchodilators given separately or in fixed combination; however, the benefits of combination therapy over monotherapy have not been consistently demonstrated. If symptoms are not adequately controlled with inhaled corticosteroids and a long-acting bronchodilator or if limiting adverse effects occur, addition or substitution of extended-release oral theophylline may be considered. Orally inhaled tiotropium is not indicated for the initial treatment of acute episodes of bronchospasm or acute exacerbations of COPD; a drug with a more rapid onset of action (e.g., a short-acting β-adrenergic agonist) may be preferred in such cases.

Currently available data indicate that tiotropium improves lung function (e.g., as determined by FEV1) in patients with COPD compared with ipratropium or placebo. Such improvement in lung function has been maintained throughout the 24-hour dosing interval and for treatment periods of up to 1 year with no evidence of tolerance. In some studies, treatment with tiotropium also has been associated with a reduction in the need for supplemental short-acting β2 agonists compared with placebo.

In several long-term (e.g., 1-year) comparative studies in patients with COPD, orally inhaled tiotropium (18 mcg once daily) improved lung function (e.g., as determined by mean change in trough FEV1, morning and evening peak expiratory flow rate [PEFR]) to a greater degree than ipratropium bromide (36 mcg 4 times daily) oral inhalation aerosol. In addition, treatment with tiotropium reduced dyspnea and the number of COPD exacerbations and increased the time to a first exacerbation compared with ipratropium bromide aerosol.

In two 6-month comparative trials in patients with COPD receiving either orally inhaled tiotropium (18 mcg once daily) or salmeterol (50 mcg twice daily), tiotropium was more effective in improving bronchodilation (e.g., FEV1, evening PEFR) than salmeterol therapy or placebo. In addition, while tiotropium or salmeterol each reduced dyspnea and improved FEV1 compared with placebo, tiotropium also was more effective than placebo in reducing COPD exacerbations and all-cause hospital admissions and improving quality-of-life scores in these trials.

For additional information on the treatment of COPD, see Uses: Chronic Obstructive Pulmonary Disease, in Ipratropium Bromide 12:08.08.

Dosage and Administration

General

Dosage of tiotropium bromide, which is commercially available as the monohydrate, is expressed in terms of anhydrous tiotropium. Although each capsule under the foil lid of the blister strip contains 18 mcg of tiotropium as an inhalation powder, the precise amount of drug delivered to the lungs with each activation of the HandiHaler device depends on factors such as the patient's inspiratory flow. Peak inspiratory flow through the HandiHaler device also varies according to the exposure time of the capsule outside of the blister pack. Using standardized in vitro testing at a flow rate of 39 L/minute for 3.1 seconds, the HandiHaler inhaler delivered a mean of 10.4 mcg of tiotropium per activation from the mouthpiece.

Administration

Tiotropium bromide is administered by oral inhalation only using a special oral inhalation device (HandiHaler) that delivers powdered drug from capsules. Tiotropium bromide capsules for oral inhalation must not be taken orally, as the intended effects on the lungs will not be obtained.

To obtain optimal benefit, the patient should be given a copy of the patient instructions provided by the manufacturer. To use the inhaler, the dust cap of the inhaler should be opened by pressing the green piercing button. The dust cap on the side opposite the hinge on the gray base should be pulled upward to expose the mouthpiece. The mouthpiece of the inhaler should be opened by pulling the mouthpiece ridge upward on the side opposite the hinge on the gray base to expose the center chamber. The capsule should then be placed into the center chamber of the inhaler. After the capsule is loaded, the inhaler mouthpiece should be closed firmly until it snaps (clicks) into position; the dust cap is left open (up). Patients should push down on the mouthpiece ridge to make sure that the mouthpiece is seated in the gray base of the inhaler. While holding the inhaler with the seated mouthpiece upward, the green piercing button on the side of the inhaler should be completely depressed (green button is flush with the gray base of the inhaler) and then released. The button pierces the capsule and disperses the powdered drug upon inspiration; the piercing button should not be pressed more than one time.

Before inhaling the dose, the patient should exhale as completely as possible, being careful not to exhale into the HandiHaler device. The inhaler device should be held along the sides of the gray base taking care not to block the air intake vents near the mouthpiece ridge. With the head kept level, the patient should place the mouthpiece of the inhaler between the lips (inhaler is in horizontal position) and inhale deeply and slowly through the inhaler at a rate sufficient to hear or feel the loaded capsule vibrate. Pressure from the inhalation will disperse drug from the center chamber into the air stream created by the patient's inhalation. After a complete inhalation, the patient should remove the inhaler from the mouth and hold their breath for as long as comfortable, then resume normal breathing. The patient should breathe out completely and inhale once again to ensure full delivery of the powder from the loaded, pierced capsule.The green piercing button should not be pressed again. Upon completion of the second inhalation, the patient should open the mouthpiece and tip the inhaler device to dispose of the used capsule. The mouthpiece and dust cap of the inhaler device should then be closed.

If the patient does not feel or hear the capsule vibrate upon inhalation, the inhaler device should be tapped gently on a table while holding the device in an upright position. The patient then should check to see that the mouthpiece is properly seated in the gray base. The patient should attempt to inhale through the device again. (See Advice to Patients.)

Dry-powder capsules for oral inhalation should be left in foil-sealed blisters until immediately before use. Used or unused dry-powder capsules should not be stored in the inhaler device. The foil of the blister pack should not be cut nor should sharp objects be used to remove the capsule selected for dosing. If additional capsules are inadvertently opened and exposed to air (i.e., not intended for immediate use), they should be discarded since the effectiveness of the drug in those capsules may be reduced.

If patients taking tiotropium do not experience an improvement in control of COPD, a clinician should make sure that the patient is inhaling the drug using the oral inhaler rather than swallowing the dry-powder capsules. (See Accidental Oral Ingestion under Warnings/Precautions: General Precautions, in Cautions.)

The HandiHaler device should be cleaned once a month. The dust cap and mouthpiece should be opened, and then the base should be opened by lifting the green piercing button. The inhaler should be rinsed with warm water (cleaning agents or detergents should not be used) to remove any remaining powder. The inhaler should be dried thoroughly and the dust cap, mouthpiece, and gray base left open to air dry for 24 hours. The inhaler should not be used when wet. If needed, the outside of the mouthpiece may be cleaned with a moist, but not wet, tissue.

Dosage

For the long-term management of reversible bronchospasm associated with COPD, the usual dosage of tiotropium in adults is 18 mcg (contents of one capsule) once daily via the HandiHaler device. Orally inhaled tiotropium should not be used for the treatment of acute episodes of bronchospasm.

Special Populations

The manufacturer states that adjustment of tiotropium dosage is not necessary in geriatric patients or patients with hepatic or renal impairment. (See Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Cautions

Contraindications

Known hypersensitivity to the drug or any ingredient in the formulation.

Known hypersensitivity to atropine or its derivatives (e.g., ipratropium).

Warnings/Precautions

Warnings

Acute Bronchospasm

Tiotropium bromide oral inhalation therapy is intended for the maintenance treatment of bronchospasm associated with COPD; the drug is not indicated for treatment of acute bronchospasm (i.e., as rescue therapy).

Possible Increased Risk of Stroke, Mortality, and/or Cardiovascular Events

While data are conflicting, a possible increased risk of stroke has been identified by the manufacturer from ongoing safety monitoring and pooled analysis of placebo-controlled trials in patients receiving tiotropium therapy. Other observational data suggest an increased risk of mortality and/or cardiovascular events in patients receiving the drug.

Analysis of data on approximately 13,500 patients with COPD in 29 studies indicated a stroke case rate of 8 or 6 per 1000 patient-years of exposure in patients receiving tiotropium or placebo, respectively, representing an absolute excess risk of 2 additional strokes per 1000 patient-years. In addition, data from an observational study involving over 32,000 patients and another pooled analysis of 17 studies enrolling almost 15,000 patients have shown an increased risk of mortality and/or cardiovascular events in patients receiving inhaled anticholinergic agents, including tiotropium bromide. However, preliminary analysis of a placebo-controlled trial (UPLIFT) in approximately 6000 patients with COPD did not reveal an increased risk of stroke with tiotropium bromide. FDA has not yet confirmed the results of these analyses and is currently reviewing postmarketing adverse event reports and results of the UPLIFT trial to assess additional long-term safety data and further evaluate the risk of stroke. At the time the 2009 edition of AHFS Drug Information went to press, FDA expected to have full results of the UPLIFT study for review; several months may be required for a complete review of these results and subsequent communication of findings regarding this trial and other data on cardiovascular events.

Sensitivity Reactions

Immediate hypersensitivity reactions, including angioedema, may occur after administration of tiotropium. If such a reaction occurs, the drug should be discontinued immediately and alternative therapy considered.

As with other inhaled agents, a patient may develop acute paradoxical bronchospasm upon inhalation of tiotropium. If paradoxical bronchospasm occurs, the drug should be discontinued immediately and other therapy considered.

General Precautions

Ocular Effects

Temporary blurring of vision or pupillary dilation may occur following inadvertent contact of tiotropium with the eyes. The drug also may worsen acute narrow-angle glaucoma, which may be manifested by ocular pain or discomfort, blurred vision, visual halos, or colored images in association with conjunctival congestion and corneal edema. Patients with such manifestations should consult a clinician immediately; miotic eye drops alone are not considered effective treatment for this condition. Care should be taken to avoid contact of the drug with the eyes during oral inhalation. (See Advice to Patients.)

Genitourinary Effects

Urinary retention/difficulty or urinary tract infection has been reported with tiotropium therapy. Tiotropium may worsen symptoms and signs associated with prostatic hyperplasia or bladder neck obstruction. Use with caution in such patients.

Accidental Oral Ingestion

Acute intoxication by inadvertent oral ingestion of the dry-powder capsules for oral inhalation is unlikely since tiotropium is not well absorbed systemically. Few patients have reported adverse effects following ingestion of the dry-powder capsules.

Specific Populations

Pregnancy

Category C.

Lactation

Tiotropium is distributed into milk in rodents; it is not known whether tiotropium is distributed into milk in humans. The manufacturer recommends that orally inhaled tiotropium be used with caution in nursing women.

Pediatric Use

Safety and efficacy of oral inhalation of tiotropium have not been established in children younger than 18 years of age. However, COPD does not normally occur in children.

Geriatric Use

The frequency of dry mouth, constipation, and urinary tract infection increased with age in clinical trials of tiotropium. However, no overall differences in efficacy were observed in geriatric patients relative to younger adults. The manufacturer states that adjustment of tiotropium dosage in geriatric patients is not necessary.

Renal Impairment

Since tiotropium is excreted predominantly by the kidneys, the manufacturer recommends that patients with moderate to severe renal impairment (creatinine clearance of 50 mL/minute or less) be monitored closely while receiving tiotropium therapy.

Common Adverse Effects

Adverse events occurring in at least 3% of patients with COPD receiving tiotropium in long-term clinical trials and at a frequency at least 1% and greater than with placebo included upper respiratory tract infection, dry mouth, accidents, sinusitis, pharyngitis, urinary tract infection, chest pain (nonspecific), rhinitis, dyspepsia, abdominal pain, edema (dependent), constipation, vomiting, infection, moniliasis, epistaxis, myalgia, and rash.

Drug Interactions

Histamine H2-Antagonists

Pharmacokinetic interaction (increased area under the concentration-time curve [AUC0-4h], decreased renal clearance of IV tiotropium [not currently available in the US]) with concomitant cimetidine but not ranitidine. Pharmacokinetic interactions between tiotropium bromide and histamine H2-antagonists not considered clinically important.

Other Drugs

Tiotropium has been used concomitantly with sympathomimetic bronchodilators, methylxanthines, and oral or inhaled corticosteroids without apparent increases in adverse effects. Use of tiotropium with other anticholinergic drugs (e.g., ipratropium) has not been studied and is therefore not recommended by the manufacturer.

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