tiotropium

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tiotropium

Spriva (UK), Spiriva HandiHaler

Pharmacologic class: Antimuscarinic, anticholinergic

Therapeutic class: Bronchodilator

Pregnancy risk category C

Action

Inhibits smooth-muscle muscarinic M3-receptors, leading to bronchodilation

Availability

Capsules for inhalation: 18 mcg

Indications and dosages

Long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease

Adults: Contents of one capsule inhaled orally once daily using supplied HandiHaler

Contraindications

• Hypersensitivity to atropine or its derivatives (including ipratropium) or drug components

Precautions

Use cautiously in:

• angle-closure glaucoma, prostatic hyperplasia, bladder neck obstruction, moderate to severe renal impairment, severe hypersensitivity to milk proteins

• concurrent use of other anticholinergics

• pregnant or breastfeeding patients

• children (safety and efficacy not established).

Administration

• Give contents of one capsule once daily using HandiHaler.

• Don't let patient swallow capsule.

Adverse reactions

CNS: depression, paresthesia

CV: angina, increased heart rate

EENT: eye pain or discomfort, blurred vision, visual halos, cataract, colored images in association with red eyes (with inadvertent eye exposure), epistaxis, rhinitis, sinusitis, laryngitis, pharyngitis, dysphonia

GI: vomiting, constipation, dyspepsia, abdominal pain, gastroesophageal reflux, stomatitis, dry mouth

GU: urinary tract infection, urinary retention, urinary difficulty

Musculoskeletal: myalgia, skeletal pain, arthritis, leg pain

Respiratory: upper respiratory tract infection, coughing, paradoxical bronchospasm

Skin: rash

Other: nonspecific chest pain, edema, infection, candidiasis, flulike symptoms, herpes zoster, hypersensitivity reaction (including angioedema)

Interactions

Drug-diagnostic tests. Blood glucose, cholesterol: increased

Patient monitoring

Closely monitor patient for allergic reaction and paradoxical bronchospasm; if these occur, discontinue drug and consider alternative therapy.

• Closely monitor patients with moderate to severe renal impairment.

Patient teaching

• Give patient information portion of package insert on HandiHaler use.

• Inform patient that drug is once-daily maintenance medicine that opens narrowed airways and helps keep them open for 24 hours. Stress that it's not for immediate (rescue) relief of breathing problems.

• Tell patient that capsules are intended for oral inhalation only and should be used only with HandiHaler device. Emphasize that HandiHaler must not be used to take any other drug.

Caution patient not to let powder get into eyes.

• Teach patient to take prescribed dose in these steps: Immediately before use, open one sealed blister foil and HandiHaler device, insert capsule, press HandiHaler button once to pierce capsule, and exhale completely before placing mouthpiece into mouth with head upright. Then breathe in slowly and deeply at a rate fast enough to hear capsule vibrate, until lungs are full. Holding breath as long as comfortable, take HandiHaler device out of mouth. Then place device back in mouth and inhale again to get full dose.

• Tell patient not to exhale into HandiHaler mouthpiece at any time.

• Caution patient not to swallow capsules.

• Tell patient not to store capsules in HandiHaler device.

• Instruct patient to clean device as shown in patient information sheet.

• Instruct patient to discard any capsules inadvertently exposed to air while preparing dose.

Tell patient to contact prescriber immediately if eye pain or discomfort, blurred vision, visual halos, or colored images occur.

2Instruct patient to immediately stop drug and report signs and symptoms of hypersensitivity reaction (including itching, rash, swelling of the lips, tongue, or throat) or difficulty breathing.

Tell patient to immediately report signs and symptoms of prostatic hyperplasia or bladder-neck obstruction (such as difficulty passing urine or painful urination).

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

tiotropium

(tye-o-trope-ee-yum) ,

Spiriva

(trade name)

Classification

Therapeutic: bronchodilators
Pharmacologic: anticholinergics
Pregnancy Category: C

Indications

Long-term maintenance treatment of bronchospasm due to COPD.Reducing exacerbations in patients with COPD.

Action

Acts as anticholinergic by selectively and reversibly inhibiting M3 receptors in smooth muscle of airways.

Therapeutic effects

Decreased incidence and severity of bronchospasm.

Pharmacokinetics

Absorption: 19% absorbed following inhalation.
Distribution: Extensive tissue distribution; due to route of administration ↑ concentrations occur in lung.
Metabolism and Excretion: 74% excreted unchanged in urine; 25% of absorbed drug is metabolized.
Half-life: 5–6 days.

Time/action profile (bronchodilation)

ROUTEONSETPEAKDURATION
inhalnrapid5 min24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to tiotropium or ipratropium;Concurrent ipratropium.
Use Cautiously in: Hypersensitivity to atropine or milk proteins;Narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction (may worsen condition);CCr ≤50 mL/min (monitor closely); Obstetric / Lactation / Pediatric: Pregnancy, lactation, or children (safety not established).

Adverse Reactions/Side Effects

Ear, Eye, Nose, Throat

  • glaucoma

Respiratory

  • paradoxical bronchospasm

Cardiovascular

  • tachycardia

Gastrointestinal

  • dry mouth (most frequent)
  • constipation

Genitourinary

  • urinary difficulty
  • urinary retention

Dermatologic

  • rash

Miscellaneous

  • hypersensitivity reactions including angioedema (life-threatening)

Interactions

Drug-Drug interaction

Should not be used concurrently with ipratropium due to risk of additive anticholinergic effects.

Route/Dosage

Inhalation (Adults) 18 mcg once daily.

Availability

Dry powder capsules for inhalation: 18 mcg Cost: $317.33 / 30 capsules

Nursing implications

Nursing assessment

  • Inhalation: Assess respiratory status (rate, breath sounds, degree of dyspnea, pulse) before administration and at peak of medication. Consult health care professional about alternative medication if severe bronchospasm is present; onset of action is too slow for patients in acute distress. If paradoxical bronchospasm (wheezing) occurs, withhold medication and notify health care professional immediately.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Risk for activity intolerance (Indications)

Implementation

  • Do not confuse Spiriva (tiotropium) with Inspra (eplerenone).
  • Inhalation: See for administration of inhalation medications.

Patient/Family Teaching

  • Instruct patient to take medication as directed. Capsules are for inhalation only and must not be swallowed. Take missed doses as soon as remembered unless almost time for the next dose; space remaining doses evenly during day. Do not double doses.
  • Advise patient that tiotropium is not to be used for acute bronchospasm attacks, but may be continued during an acute exacerbation.
  • Instruct patient in proper use and cleaning of the Handihaler inhaler. Review the Patient's Instructions for Use guide with patient. Capsules should be stored in sealed blisters; remove immediately before use or effectiveness of capsules is reduced. Tear blister strip carefully to expose only one capsule at a time. Discard capsules that are inadvertently exposed to air. Spiriva should be administered only via the Handihaler and the Handihaler should not be used with other medications. When disposing of capsule, tiny amount of powder left in capsule is normal.
  • Advise patient to notify health care professional immediately if signs and symptoms of angioedema (swelling of the lips, tongue, or throat, itching, rash) or signs of glaucoma (eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) occur.
  • Caution patient to avoid spraying medication in eyes; may cause blurring of vision and pupil dilation.
  • Advise patient that rinsing mouth after using inhaler, good oral hygiene, and sugarless gum or candy may minimize dry mouth; usually resolves with continued treatment.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, including eye drops.
  • Advise patient to inform health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decreased dyspnea.
    • Improved breath sounds.
  • Fewer exacerbations in patients with COPD.

Spiriva

A long-acting once-daily antimuscarinic bronchodilator indicated for long-term management of bronchospasm in chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis, emphysema).

Adverse effects
Dry mouth, constipation, vomiting, dyspepsia.
References in periodicals archive ?
This phase III clinical trial compared the efficacy and safety of inhaled DUAKLIR PRESSAIR to its individual components aclidinium and formoterol, and to inhaled Spiriva Handihaler (tiotropium) in 1,583 patients with moderate-to-very-severe symptomatic.
PUR0200 is a once-daily, reformulation of tiotropium bromide for COPD patients and is being developed as a branded alternative to Spiriva HandiHaler. The data was published online in the British Journal of Clinical Pharmacology.
[39] Spiriva HandiHaler (Tiotropium Bromide) [Prescribing Information], CT: Boehringer Ingelheim, Ridgefield, Conn, USA, January 2016.
M2 EQUITYBITES-September 3, 2012-Pfizer and Boehringer Ingelheim to present Spiriva HandiHaler and COPD data at the 2012 European Respiratory Society (ERS) Congress(C)2012 M2 COMMUNICATIONS http://www.m2.com
market, following tiotropium bromide (Spiriva HandiHaler), approved for COPD in 2004, but taken once a day.
Treatment with the Spiriva HandiHaler, which contains a dry powder formulation of the anticholinergic tiotropium, does not appear to be associated with an increased risk of stroke, MI, or cardiovascular death in patients with chronic obstructive pulmonary disease, the FDA announced.
The Spiriva HandiHaler is made by German drugmaker Boehringer Ingelheim GmbH and co-marketed in the U.S.
Adapting to a new model is always a challenge, but because multiple brands, namely Spiriva HandiHaler (tiotropium bromide inhalation powder), Flomax (tamsulosin HCI) capsules 0.4 mg, Mirapex (pramipexole dihydrochloride) tablets, Aggrenox (aspirin/extended-release dipyridamole) 25 mg/200 mg capsules, Micardis (telmisartan) tablets, and Micardis HCT (telmisartan/hydrochlorothiazide) 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg tablets, and multiple channels (commercial, federal, state, trade, senior care) needed to be considered, integrating this new model was especially complicated.
In the published study, moderate-to-severe COPD patients were administered one of three PUR0200 doses (3mg, 6mg or 9mg tiotropium bromide), Spiriva HandiHaler (18mg tiotropium bromide) or placebo in a cross-over study design.
In December 2009, Boehringer Ingleheim Pharmaceuticals received expanded FDA approval for its Spiriva HandiHaler, a sleek, futuristic looking device that delivers its powdered API in the treatment of COPD.