Spiriva

DRUG DESCRIPTION

SPIRIVA HandiHaler consists of a capsule dosage form containing a dry powder formulation of tiotropium intended for oral inhalation only with the HandiHaler device.

Each light green, hard gelatin SPIRIVA capsule contains 18 mcg tiotropium (equivalent to 22.5 mcg tiotropium bromide monohydrate) blended with lactose monohydrate (which may contain milk proteins) as the carrier.

The dry powder formulation within the SPIRIVA capsule is intended for oral inhalation only.

The active component of SPIRIVA HandiHaler is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described as (1?, 2?, 4 ?, 5?, 7?)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol.

The structural formula is:

SPIRIVA® HandiHaler® (tiotropium bromide) Structural Formula Illustration

Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br •H2O.

The HandiHaler device is an inhalation device used to inhale the dry powder contained in the SPIRIVA capsule. The dry powder is delivered from the HandiHaler device at flow rates as low as 20 L/min. Under standardized in vitro testing, the HandiHaler device delivers a mean of 10.4 mcg tiotropium when tested at a flow rate of 39 L/min for 3.1 seconds (2 L total). In a study of 26 adult patients with COPD and severely compromised lung function [mean FEV1 1.02 L (range 0.45 to 2.24 L); 37.6% of predicted (range 16% to 65%)], the median peak inspiratory flow (PIF) through the HandiHaler device was 30.0 L/min (range 20.4 to 45.6 L/min). The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow and peak inspiratory flow through the HandiHaler device, which may vary from patient to patient, and may vary with the exposure time of the SPIRIVA capsule outside the blister pack.

What are the possible side effects of tiotropium inhalation (Spiriva)?

Stop using tiotropium inhalation and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • tongue swelling or redness;
  • sores or white patches of your mouth, lips, or tongue; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dry mouth, cough,...

Read All Potential Side Effects and See Pictures of Spiriva »

What are the precautions when taking tiotropium bromide (Spiriva)?

Before using tiotropium, tell your doctor or pharmacist if you are allergic to it or to ipratropium; or to atropine or other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), 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: kidney disease, glaucoma (narrow-angle), difficulty urinating (for example, due to enlarged prostate).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this...

Read All Potential Precautions of Spiriva »


Spiriva Consumer (continued)

SIDE EFFECTS: Dry mouth or constipation may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Infrequently, 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.

Tell your doctor right away if you have any serious side effects, including: vision changes (such as blurred vision, seeing halos), eye pain, difficult/painful urination, fast heartbeat.

A very serious allergic reaction to this product 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.

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 other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), 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: kidney disease, glaucoma (narrow-angle), difficulty urinating (for example, due to enlarged prostate).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dry mouth and constipation.

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.


Spiriva Patient Information Including Side Effects

Brand Names: Spiriva

Generic Name: tiotropium inhalation (Pronunciation: tye oh TROE pee um)

  • What is tiotropium inhalation (Spiriva)?
  • What are the possible side effects of tiotropium inhalation (Spiriva)?
  • What is the most important information I should know about tiotropium inhalation (Spiriva)?
  • What should I discuss with my healthcare provider before using tiotropium inhalation (Spiriva)?
  • How should I use tiotropium inhalation (Spiriva)?
  • What happens if I miss a dose (Spiriva)?
  • What happens if I overdose (Spiriva)?
  • What should I avoid while using tiotropium inhalation (Spiriva)?
  • What other drugs will affect tiotropium inhalation (Spiriva)?
  • Where can I get more information?

What is tiotropium inhalation (Spiriva)?

Tiotropium inhalation is used to prevent bronchospasm (narrowing of the airways in the lungs) in people with bronchitis, emphysema, or COPD (chronic obstructive pulmonary disease).

Tiotropium inhalation may also be used for other purposes not listed in this medication guide.

What are the possible side effects of tiotropium inhalation (Spiriva)?

Stop using tiotropium inhalation and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • tongue swelling or redness;
  • sores or white patches of your mouth, lips, or tongue; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dry mouth, cough, hoarseness;
  • blurred vision;
  • trouble swallowing;
  • nausea, constipation, upset stomach;
  • stuffy nose, nosebleed;
  • fast heart rate;
  • drowsiness; or
  • white patches in your mouth or throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tiotropium inhalation (Spiriva)?

Tiotropium capsules are for use only in the HandiHaler device. Use only one capsule at a time. Do not take the capsules by mouth.

Before using this medication, tell your doctor if you have narrow-angle glaucoma, or an enlarged prostate or bladder obstruction. If you have any of these conditions, you may not be able to use tiotropium inhalation or you may need a dosage adjustment or special tests during treatment.

Tiotropium inhalation is used to prevent bronchospasm attacks. Do not use this medication to treat a bronchospasm attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medication to treat an attack. Talk with your doctor if any of your medications do not seem to work as well in treating or preventing bronchospasm attacks.

Use this medication exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

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