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
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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

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

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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 category: No data

            Lactation: Unknown whether drug is distributed in breast milk

            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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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            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.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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