tiotropium (Rx)

Brand and Other Names:Spiriva HandiHaler, Spiriva Respimat
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule (Spiriva Handihaler; powder for oral inhalation)

  • 18mcg

solution for inhalation (Spiriva Respimat)

  • 1.25mcg/actuation
  • 2.5mcg/actuation

Chronic Obstructive Pulmonary Disease

Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD); reduction of COPD exacerbations

Spiriva Handihaler: 2 PO inhalations of 1 capsule (18 mcg) qDay via HandiHaler inhalation device

Spiriva Respimat: 5 mcg (2 actuations; 2.5 mcg/actuation) inhaled PO qDay

Asthma

Indicated for long-term, once-daily, maintenance treatment of asthma in patients aged ≥12 yr

Spiriva Respimat: 2.5 mcg (2 actuations; 1.25 mcg/actuation) inhaled PO qDay

Dosage Modifications

CrCl <50 mL/min: Use only if benefit outweighs potential risk

Cystic Fibrosis (Orphan)

Improvement of pulmonary function in conjunction with standard therapy in management of patients with cystic fibrosis

Orphan indication sponsor

  • Boehringer Ingelheim Pharmaceuticals, Inc, PO Box 368, 900 Ridgebury Road, Ridgefield, CT 06877

Dosage Forms & Strengths

solution for inhalation (Spiriva Respimat)

  • 1.25mcg/actuation

Asthma

Indicated for long-term, once-daily, maintenance treatment of asthma in patients aged ≥6 yr

Spiriva Respimat: 2.5 mcg (2 actuations; 1.25 mcg/actuation) inhaled PO qDay

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Interactions

Interaction Checker

and tiotropium

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • umeclidinium bromide/vilanterol inhaled

              tiotropium, umeclidinium bromide/vilanterol inhaled. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Duplicate therapy.

            Serious - Use Alternative (4)

            • glucagon

              glucagon increases toxicity of tiotropium by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .

            • glucagon intranasal

              glucagon intranasal increases toxicity of tiotropium by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .

            • pramlintide

              pramlintide, tiotropium. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Synergistic inhibition of GI motility.

            • revefenacin

              revefenacin and tiotropium both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.

            Monitor Closely (94)

            • abobotulinumtoxinA

              abobotulinumtoxinA increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .

            • amantadine

              tiotropium, amantadine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Potential for increased anticholinergic adverse effects.

            • amitriptyline

              tiotropium and amitriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • amoxapine

              tiotropium and amoxapine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • anticholinergic/sedative combos

              anticholinergic/sedative combos and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • aripiprazole

              tiotropium decreases levels of aripiprazole by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of aripiprazole by pharmacodynamic antagonism. Use Caution/Monitor.

              aripiprazole increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • atracurium

              atracurium and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • atropine

              atropine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • atropine IV/IM

              atropine IV/IM and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • belladonna alkaloids

              belladonna alkaloids and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • belladonna and opium

              belladonna and opium and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • benperidol

              tiotropium decreases levels of benperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of benperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              benperidol increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • benztropine

              benztropine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor. Additive anticholinergic adverse effects may be seen with concurrent use.

            • bethanechol

              bethanechol increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • carbachol

              carbachol increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • cevimeline

              cevimeline increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • chlorpromazine

              tiotropium decreases levels of chlorpromazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of chlorpromazine by pharmacodynamic antagonism. Use Caution/Monitor.

              chlorpromazine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • cisatracurium

              cisatracurium and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • clomipramine

              tiotropium and clomipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • clozapine

              tiotropium decreases levels of clozapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of clozapine by pharmacodynamic antagonism. Use Caution/Monitor.

              clozapine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • cyclizine

              cyclizine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • cyclobenzaprine

              cyclobenzaprine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • darifenacin

              darifenacin and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • desipramine

              tiotropium and desipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • dicyclomine

              dicyclomine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • diphenhydramine

              diphenhydramine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • donepezil

              donepezil increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dosulepin

              tiotropium and dosulepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • doxepin

              tiotropium and doxepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • droperidol

              tiotropium decreases levels of droperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of droperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              droperidol increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • echothiophate iodide

              echothiophate iodide increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • fesoterodine

              fesoterodine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • flavoxate

              flavoxate and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • fluphenazine

              tiotropium decreases levels of fluphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of fluphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

              fluphenazine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • galantamine

              galantamine increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • glycopyrrolate

              glycopyrrolate and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • glycopyrrolate inhaled

              glycopyrrolate inhaled and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • glycopyrronium tosylate topical

              glycopyrronium tosylate topical, tiotropium. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.

            • haloperidol

              tiotropium decreases levels of haloperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of haloperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              haloperidol increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • henbane

              henbane and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • homatropine

              homatropine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • huperzine A

              huperzine A increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • hyoscyamine

              hyoscyamine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • hyoscyamine spray

              hyoscyamine spray and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • iloperidone

              tiotropium decreases levels of iloperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of iloperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              iloperidone increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • imipramine

              tiotropium and imipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • ipratropium

              ipratropium and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor. Due to the poor systemic absorption of ipratropium, interaction unlikely at regularly recommended dosages.

            • levodopa

              tiotropium, levodopa. Other (see comment). Use Caution/Monitor. Comment: Anticholinergic agents may enhance the therapeutic effects of levodopa; however, anticholinergic agents can exacerbate tardive dyskinesia. In high dosage, anticholinergics may decrease the effects of levodopa by delaying its GI absorption. .

            • lofepramine

              tiotropium and lofepramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • loxapine

              tiotropium decreases levels of loxapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of loxapine by pharmacodynamic antagonism. Use Caution/Monitor.

              loxapine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • loxapine inhaled

              loxapine inhaled increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              tiotropium decreases levels of loxapine inhaled by pharmacodynamic antagonism. Use Caution/Monitor.

            • maprotiline

              tiotropium and maprotiline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • meclizine

              meclizine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • methscopolamine

              methscopolamine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • neostigmine

              neostigmine increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • nortriptyline

              tiotropium and nortriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • olanzapine

              tiotropium decreases levels of olanzapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of olanzapine by pharmacodynamic antagonism. Use Caution/Monitor.

              olanzapine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • onabotulinumtoxinA

              onabotulinumtoxinA and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • orphenadrine

              tiotropium and orphenadrine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin

              oxybutynin and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin topical

              oxybutynin topical and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin transdermal

              oxybutynin transdermal and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • paliperidone

              tiotropium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • pancuronium

              pancuronium and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • perphenazine

              tiotropium decreases levels of perphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of perphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

              perphenazine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • physostigmine

              physostigmine increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pilocarpine

              pilocarpine increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pilocarpine ophthalmic

              pilocarpine ophthalmic increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pimozide

              tiotropium decreases levels of pimozide by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of pimozide by pharmacodynamic antagonism. Use Caution/Monitor.

              pimozide increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • pralidoxime

              pralidoxime and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • prochlorperazine

              tiotropium decreases levels of prochlorperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of prochlorperazine by pharmacodynamic antagonism. Use Caution/Monitor.

              prochlorperazine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • promethazine

              tiotropium decreases levels of promethazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of promethazine by pharmacodynamic antagonism. Use Caution/Monitor.

              promethazine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • propantheline

              propantheline and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • protriptyline

              tiotropium and protriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • pyridostigmine

              pyridostigmine increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • quetiapine

              tiotropium decreases levels of quetiapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of quetiapine by pharmacodynamic antagonism. Use Caution/Monitor.

              quetiapine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • rapacuronium

              rapacuronium and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • risperidone

              tiotropium decreases levels of risperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of risperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              risperidone increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • rocuronium

              rocuronium and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • scopolamine

              scopolamine and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • solifenacin

              solifenacin and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • succinylcholine

              succinylcholine increases and tiotropium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • thioridazine

              tiotropium decreases levels of thioridazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of thioridazine by pharmacodynamic antagonism. Use Caution/Monitor.

              thioridazine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • thiothixene

              tiotropium decreases levels of thiothixene by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of thiothixene by pharmacodynamic antagonism. Use Caution/Monitor.

              thiothixene increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • tolterodine

              tiotropium and tolterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • trazodone

              tiotropium and trazodone both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • trifluoperazine

              tiotropium decreases levels of trifluoperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of trifluoperazine by pharmacodynamic antagonism. Use Caution/Monitor.

              trifluoperazine increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • trihexyphenidyl

              tiotropium and trihexyphenidyl both decrease cholinergic effects/transmission. Use Caution/Monitor. Potential for additive anticholinergic effects.

            • trimipramine

              tiotropium and trimipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • trospium chloride

              tiotropium and trospium chloride both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • umeclidinium bromide

              umeclidinium bromide and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

            • vecuronium

              tiotropium and vecuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • ziprasidone

              tiotropium decreases levels of ziprasidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of ziprasidone by pharmacodynamic antagonism. Use Caution/Monitor.

              ziprasidone increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • zotepine

              tiotropium decreases levels of zotepine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of zotepine by pharmacodynamic antagonism. Use Caution/Monitor.

            Minor (3)

            • dimenhydrinate

              dimenhydrinate increases toxicity of tiotropium by pharmacodynamic synergism. Minor/Significance Unknown. Additive anticholinergic effects.

            • donepezil

              donepezil decreases effects of tiotropium by pharmacodynamic antagonism. Minor/Significance Unknown.

            • galantamine

              galantamine decreases effects of tiotropium by pharmacodynamic antagonism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Upper respiratory tract infection (41%)

            Dry mouth (16%)

            Sinusitis (11%)

            1-10%

            Abdominal pain

            Allergic reaction

            Angina pectoris (including aggravated angina pectoris)

            Cataract

            Chest pain (nonspecific)

            Constipation

            Depression

            Dyspepsia

            Dysphonia

            Edema

            Epistaxis

            Gastroesophageal reflux

            Herpes zoster

            Hypercholesterolemia

            Hyperglycemia

            Infection

            Laryngitis

            Leg pain

            Moniliasis

            Myalgia

            Paresthesia

            Pharyngitis

            Rash

            Rhinitis

            Skeletal pain

            Stomatitis (including ulcerative stomatitis)

            Urinary tract infection

            Vomiting

            <1%

            Angioedema

            Fibrillation

            Supraventricular tachycardia

            Urinary retention

            Postmarketing Reports

            Bronchospasm

            Glossitis

            Dehydration

            Insomnia

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            Warnings

            Contraindications

            History of hypersensitivity to ipratropium or tiotropium

            History of severe hypersensitivity to milk proteins (excipient in powder contained in capsule)

            Lactose allergy

            Cautions

            Not for acute use; not a rescue medication

            Immediate hypersensitivity reactions (eg, angioedema, itching, rash); stop treatment immediately

            Capsule not to be swallowed; to be administered only by PO inhalation via HandiHaler device

            Worsening of narrow-angle glaucoma

            Worsening of urinary retention

            Potential for paradoxical bronchospasm

            Prostatic hyperplasia

            Bladder-neck obstruction

            Wash hands after handling capsules

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            Pregnancy & Lactation

            Pregnancy

            The limited human data with therapy during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes

            Poorly or moderately controlled asthma in pregnancy increases maternal risk of preeclampsia and infant prematurity, low birth weight, and small for gestational age; level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control

            Lactation

            There are no data on presence of tiotropium in human milk, effects on breastfed infant, or effects on milk production; tiotropium is present in milk of lactating rats; however, clinical relevance of these data are not clear. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Long-acting antimuscarinic agent, often referred to as anticholinergic

            Inhibits M3-receptors at smooth muscle, leading to bronchodilation

            Absorption

            Bioavailability: 19.5%

            Onset: 30 min

            Duration: >24 hr

            Time to peak effect: 1-4 hr

            Distribution

            Protein bound: 72%

            Vd: 32 L/kg

            Metabolism

            Metabolized in liver via CYP450-dependent oxidation and subsequent glutathione conjugation

            Elimination

            Half-life: 5-6 days

            Total body clearance: 880 mL/min

            Excretion: Urine

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            Administration

            Oral Inhalation

            Spiriva Respimat: Premeasured dose in slow-moving mist for oral inhalation; delivers medication in a way that does not depend on how fast air is breathed in from the inhaler

            To receive the full dose of medication, Spiriva Respimat must be administered as 2 inhalations once-daily (ie, 2 inhalations of 2.5 mcg [5 mcg] for COPD; 2 inhalations of 1.25 mcg [2.5 mcg] for asthma)

            Spiriva Handihaler: Powder for inhalation; device is dependent on the patient's ability to inhale the powder

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Spiriva Respimat inhalation
            -
            1.25 mcg/actuation inhalation
            Spiriva Respimat inhalation
            -
            2.5 mcg/actuation inhalation
            Spiriva Respimat inhalation
            -
            2.5 mcg/actuation inhalation
            Spiriva with HandiHaler inhalation
            -
            18 mcg capsule
            Spiriva with HandiHaler inhalation
            -
            18 mcg capsule
            Spiriva with HandiHaler inhalation
            -
            18 mcg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            tiotropium bromide inhalation

            TIOTROPIUM - INHALATION

            (TYE-oh-TROE-pee-um)

            COMMON BRAND NAME(S): Spiriva Respimat

            USES: Tiotropium is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). It must be used regularly to prevent wheezing and shortness of breath. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Tiotropium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

            HOW TO USE: Read the Patient Instruction Sheet for directions on the proper use of this medication. If you have any questions, consult your doctor or pharmacist.Follow the instructions for test sprays in the air if you are using the inhaler for the first time or if you have not used it for more than 3 days or for more than 21 days. Make sure to spray away from the face so that you do not get the medication into your eyes. A slow-moving mist is a sign that the inhaler is working properly.Inhale this medication by mouth as directed by your doctor, usually 2 sprays once daily. Do not inhale more than 2 sprays in 24 hours.Avoid getting this medication into your eyes. It may cause eye pain/irritation, temporary blurred vision, and other vision changes. When using the inhaler, put your lips tightly around the mouthpiece.Rinse your mouth after using the inhaler to prevent dry mouth and throat irritation.If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Clean the mouthpiece of the inhaler at least once a week as directed.When this medication is used to treat asthma, it may take 4 to 8 weeks before you get the full benefit of this drug.Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.Tell your doctor if your symptoms do not improve or if they worsen.

            SIDE EFFECTS: Dry mouth and dizziness may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: difficulty urinating, painful urination.Rarely, this medication may cause severe sudden worsening of breathing problems right after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before using tiotropium, tell your doctor or pharmacist if you are allergic to it; or to ipratropium; or to atropine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of glaucoma (angle-closure type), difficulty urinating, enlarged prostate, kidney disease.This drug may make you dizzy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older men may be at greater risk for difficulty urinating while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other anticholinergics (such as ipratropium, atropine).

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as lung function tests) should be done while you are using this medication. Keep all medical and lab appointments.Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.If you are using this medication to treat asthma, learn to use a peak flow meter, use it daily, and promptly report worsening breathing problems (such as readings in the yellow/red range, increased use of quick-relief inhalers).Because the flu virus can worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.

            MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. The inhaler should be thrown away when it becomes locked (which means that all the medication is used up) or 3 months after putting the cartridge in the inhaler, even if there is medication left in the cartridge. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.