Spiriva 18mcg Caps 30s & Handihaler
It is used to treat COPD (chronic obstructive pulmonary disease).Do not use this drug to treat intense flare-ups of shortness of breath. Use a rescue inhaler. If you have questions, talk with the doctor.
Drug Class
Bronchodilator
Pharmacologic Class
Long-acting muscarinic antagonist (LAMA)
Pregnancy Category
Category C
FDA Approved
Jan 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tiotropium is an inhaled medicine used once a day to help people with chronic obstructive pulmonary disease (COPD) breathe easier. It works by relaxing the muscles around your airways, making them wider and helping air flow more freely. It is not for sudden breathing problems.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication properly, follow your doctor's instructions and read all the information provided. Do not swallow the capsule; instead, breathe its contents into your lungs using the device that comes with the medication. Only use the provided device, and do not attempt to use any other devices.
Before using the medication, make sure to:
Remove it from the blister pack immediately before use; do not store the removed medication for future use.
Not open the capsules.
* Keep the medication out of your eyes.
Continue using the medication as directed by your doctor or healthcare provider, even if you start feeling well. If you are using multiple inhaled medications, consult your doctor about which one to use first. Do not use a spacer with the inhaler, and use a new inhaler with each refill. After taking your dose, replace the cap on the inhaler.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing and moisture. Keep it in a dry place, away from bathrooms, and store it in the original blister pack.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if you don't remember until the next day, skip the missed dose and resume your regular dosing schedule. Do not take more than one dose of this medication within a 24-hour period.
To use this medication properly, follow your doctor's instructions and read all the information provided. Do not swallow the capsule; instead, breathe its contents into your lungs using the device that comes with the medication. Only use the provided device, and do not attempt to use any other devices.
Before using the medication, make sure to:
Remove it from the blister pack immediately before use; do not store the removed medication for future use.
Not open the capsules.
* Keep the medication out of your eyes.
Continue using the medication as directed by your doctor or healthcare provider, even if you start feeling well. If you are using multiple inhaled medications, consult your doctor about which one to use first. Do not use a spacer with the inhaler, and use a new inhaler with each refill. After taking your dose, replace the cap on the inhaler.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing and moisture. Keep it in a dry place, away from bathrooms, and store it in the original blister pack.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if you don't remember until the next day, skip the missed dose and resume your regular dosing schedule. Do not take more than one dose of this medication within a 24-hour period.
Lifestyle & Tips
- Do not use for sudden breathing problems; use a rescue inhaler for acute symptoms.
- Use exactly as prescribed, once daily, at the same time each day.
- Do not swallow the capsules; they are only for inhalation using the Handihaler device.
- Rinse your mouth with water after each use to reduce the risk of dry mouth and oral thrush.
- Avoid getting the powder in your eyes, as it can cause blurred vision or eye pain.
- Report any worsening breathing, eye pain, blurred vision, or difficulty urinating to your doctor immediately.
- Continue other prescribed COPD medications unless otherwise directed by your doctor.
- Do not stop using Tiotropium suddenly without consulting your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
18 mcg (one capsule) inhaled once daily using the Handihaler device.
Dose Range:
18 - 18 mg
Condition-Specific Dosing:
COPD:
18 mcg (one capsule) inhaled once daily using the Handihaler device.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Spiriva Handihaler is not indicated for pediatric patients. Spiriva Respimat is indicated for asthma in children 6 years and older.)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required, but use with caution.
Severe:
Use with caution. Monitor for anticholinergic side effects.
Dialysis:
Use with caution. Monitor for anticholinergic side effects.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
No dose adjustment required.
Pharmacology
Mechanism of Action
Tiotropium is a long-acting, specific antagonist at muscarinic acetylcholine receptors (M1, M2, and M3 subtypes). In the airways, it inhibits M3 receptors on smooth muscle, leading to bronchodilation. It has a prolonged residence time at the M3 receptor, contributing to its once-daily dosing.
Pharmacokinetics
Absorption:
Bioavailability:
Low (2-3% after inhalation)
Tmax:
5-7 minutes (inhalation)
FoodEffect:
Not applicable (inhalation)
Distribution:
Vd:
32 L/kg (IV)
ProteinBinding:
Approximately 72%
CnssPenetration:
Limited
Elimination:
HalfLife:
25-33 hours (terminal half-life after inhalation)
Clearance:
880 mL/min (total plasma clearance)
ExcretionRoute:
Primarily renal (approximately 74% of IV dose, 14% of inhaled dose) and fecal (25% of IV dose).
Unchanged:
Approximately 14% (inhaled dose) excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
Within 3 hours
DurationOfAction:
At least 24 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Changes in eyesight, eye pain, or severe eye irritation
Eye redness
Seeing halos or bright colors around lights
Trouble passing urine, pain when passing urine, weak urine stream, or frequent urination
Chest pain
Rapid heartbeat
Swelling
This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek immediate medical help.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dry mouth
Upset stomach
Constipation
Nose or throat irritation
Runny or stuffy nose
Stomach pain
Headache
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Changes in eyesight, eye pain, or severe eye irritation
Eye redness
Seeing halos or bright colors around lights
Trouble passing urine, pain when passing urine, weak urine stream, or frequent urination
Chest pain
Rapid heartbeat
Swelling
This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek immediate medical help.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dry mouth
Upset stomach
Constipation
Nose or throat irritation
Runny or stuffy nose
Stomach pain
Headache
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden worsening of breathing problems (paradoxical bronchospasm)
- Eye pain or discomfort, blurred vision, seeing halos or colored images (signs of acute narrow-angle glaucoma)
- Difficulty urinating, painful urination, or urinary retention
- Severe allergic reactions (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing/swallowing)
- Increased heart rate or palpitations
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking anticholinergic medications, such as ipratropium or oxybutynin. If you are unsure whether a medication is an anticholinergic, consult your doctor.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
Verify with your doctor that it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking anticholinergic medications, such as ipratropium or oxybutynin. If you are unsure whether a medication is an anticholinergic, consult your doctor.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
Verify with your doctor that it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this drug affects you.
If your breathing problems worsen, your rescue inhaler becomes less effective, or you need to use it more frequently, contact your doctor immediately.
Be cautious not to get this medication in your eyes, as it may cause mydriasis (dilated pupils) and blurred vision. If accidental exposure occurs, seek medical attention.
Adhere strictly to your doctor's prescribed dosage and usage schedule. Using more than the recommended amount, or using it more frequently or for a longer duration than prescribed, may increase the risk of severe side effects.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this drug affects you.
If your breathing problems worsen, your rescue inhaler becomes less effective, or you need to use it more frequently, contact your doctor immediately.
Be cautious not to get this medication in your eyes, as it may cause mydriasis (dilated pupils) and blurred vision. If accidental exposure occurs, seek medical attention.
Adhere strictly to your doctor's prescribed dosage and usage schedule. Using more than the recommended amount, or using it more frequently or for a longer duration than prescribed, may increase the risk of severe side effects.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Exaggerated anticholinergic effects (e.g., dry mouth, blurred vision, increased heart rate, urinary retention, constipation)
What to Do:
Seek immediate medical attention. Treatment is generally supportive. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Other anticholinergic agents (e.g., atropine, ipratropium, glycopyrrolate, benztropine)
Monitoring
Baseline Monitoring
Pulmonary function tests (FEV1)
Rationale: To establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy.
Assessment of COPD symptoms (e.g., dyspnea, cough, sputum production)
Rationale: To establish baseline symptom burden.
Timing: Prior to initiation of therapy.
Routine Monitoring
Pulmonary function tests (FEV1)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Improvement from baseline
Action Threshold: Lack of improvement or worsening may indicate need for re-evaluation of therapy.
Assessment of COPD symptoms
Frequency: At each clinical visit
Target: Reduction in symptom frequency and severity
Action Threshold: Persistent or worsening symptoms may indicate inadequate control or need for exacerbation management.
Adverse effects (e.g., dry mouth, urinary retention, blurred vision)
Frequency: At each clinical visit
Target: Absence or minimal severity
Action Threshold: Significant or bothersome side effects may require dose adjustment or discontinuation.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Chest tightness
- Increased cough or sputum production
- Signs of urinary retention (difficulty urinating, painful urination)
- Blurred vision or eye pain (signs of acute narrow-angle glaucoma)
- Allergic reactions (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing/swallowing)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data available.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of anticholinergic effects.
Second Trimester:
Limited data.
Third Trimester:
Limited data, theoretical risk of anticholinergic effects on fetal heart rate or uterine contractility near term.
Lactation
Caution is advised. It is unknown if tiotropium is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for tiotropium and any potential adverse effects on the breastfed infant from tiotropium or from the underlying maternal condition.
Infant Risk:
Low (due to low systemic absorption), but potential for anticholinergic effects in infant cannot be ruled out.
Pediatric Use
Spiriva Handihaler is not indicated for pediatric patients. Safety and effectiveness have not been established in pediatric patients. Spiriva Respimat is approved for asthma in children 6 years and older.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. However, due to higher prevalence of decreased renal function in the elderly, use with caution and monitor for anticholinergic side effects.
Clinical Information
Clinical Pearls
- Tiotropium is a maintenance bronchodilator and should not be used for acute bronchospasm.
- Patients must be instructed on the correct use of the Handihaler device, including how to load the capsule and inhale the powder.
- Dry mouth is a common side effect; advise patients to rinse their mouth after use and maintain good oral hygiene.
- Monitor for signs of urinary retention and acute narrow-angle glaucoma, especially in patients with pre-existing conditions.
- Avoid concomitant use with other anticholinergic medications due to potential for additive adverse effects.
- Regular follow-up is important to assess symptom control and lung function.
Alternative Therapies
- Other long-acting muscarinic antagonists (LAMAs) like aclidinium, glycopyrronium, umeclidinium.
- Long-acting beta-agonists (LABAs) like salmeterol, formoterol, indacaterol, olodaterol.
- LAMA/LABA fixed-dose combinations (e.g., umeclidinium/vilanterol, tiotropium/olodaterol, glycopyrronium/formoterol).
- Inhaled corticosteroids (ICS) for patients with frequent exacerbations or asthma-COPD overlap syndrome (ACOS).
Cost & Coverage
Average Cost:
$350 - $500 per 30 capsules with Handihaler
Insurance Coverage:
Tier 2 or 3 (Preferred or Non-Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.