Tiotropium Br 18mcg Caps&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); Anticholinergic
Pregnancy Category
Category C
FDA Approved
Jan 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tiotropium is an inhaled medication used once daily to help open up the airways in your lungs, making it easier to breathe. It's primarily used for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). It is not a rescue inhaler 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. It's essential to use the device that comes with this medication and not any other device.
When you're ready to take your dose, remove the capsule from the blister pack, but do not swallow it. Instead, use the provided device to inhale the contents of the capsule into your lungs. Do not open the capsules or store them after they've been removed from the blister pack for future use.
Continue using this medication as directed by your doctor or healthcare provider, even if you're feeling well. Be careful not to get the medication in your eyes. If you're using multiple inhaled medications, consult your doctor about which one to use first.
Do not use a spacer with the inhaler, and make sure to use a new inhaler with each refill. After taking your dose, replace the cap on the inhaler.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from freezing temperatures and moisture. Keep it in a dry place, avoiding storage in a bathroom. Store the medication in its original blister pack.
What to Do If You Miss 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. It's essential to use the device that comes with this medication and not any other device.
When you're ready to take your dose, remove the capsule from the blister pack, but do not swallow it. Instead, use the provided device to inhale the contents of the capsule into your lungs. Do not open the capsules or store them after they've been removed from the blister pack for future use.
Continue using this medication as directed by your doctor or healthcare provider, even if you're feeling well. Be careful not to get the medication in your eyes. If you're using multiple inhaled medications, consult your doctor about which one to use first.
Do not use a spacer with the inhaler, and make sure to use a new inhaler with each refill. After taking your dose, replace the cap on the inhaler.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from freezing temperatures and moisture. Keep it in a dry place, avoiding storage in a bathroom. Store the medication in its original blister pack.
What to Do If You Miss 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; always carry a rescue inhaler (e.g., albuterol) 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 dose to reduce the risk of dry mouth and oral thrush (though less common with tiotropium than inhaled corticosteroids).
- Avoid getting the powder in your eyes, as it can cause blurred vision or eye pain.
- If you miss a dose, take it as soon as you remember, but do not take more than one dose in 24 hours.
- Continue to avoid smoking, as it significantly worsens COPD.
Available Forms & Alternatives
Available Strengths:
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.
Asthma:
Not indicated for asthma with HandiHaler formulation; Spiriva Respimat is indicated for asthma.
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 patients 6 years and older.)
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required.
Moderate:
No dosage adjustment required.
Severe:
Use with caution in patients with moderate to severe renal impairment (creatinine clearance ≤50 mL/min) as systemic exposure may increase. Monitor for anticholinergic side effects.
Dialysis:
No specific recommendations; use with caution as systemic exposure may increase.
Hepatic Impairment:
Mild:
No dosage adjustment required.
Moderate:
No dosage adjustment required.
Severe:
No dosage adjustment required (Tiotropium is minimally metabolized by the liver).
Pharmacology
Mechanism of Action
Tiotropium is a long-acting, specific antagonist at muscarinic acetylcholine receptors, particularly the M3 receptor subtype. It inhibits the bronchoconstrictor effects of acetylcholine by binding to M3 receptors on airway smooth muscle, leading to bronchodilation. Its long duration of action is due to its slow dissociation from the M3 receptor.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 19.5% (relative bioavailability of inhaled dose)
Tmax:
5-7 minutes (after inhalation)
FoodEffect:
Not applicable (inhaled drug)
Distribution:
Vd:
32 L/kg (intravenous)
ProteinBinding:
Approximately 72%
CnssPenetration:
Limited
Elimination:
HalfLife:
25-33 hours (terminal half-life after inhalation)
Clearance:
880 mL/min (total body clearance after IV administration)
ExcretionRoute:
Mainly renal (approximately 74% of IV dose), remainder via feces (unabsorbed drug)
Unchanged:
Approximately 74% (of IV dose excreted renally as unchanged drug)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
Within 3 hours
DurationOfAction:
At least 24 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 medical attention right away:
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
Difficulty 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 medical help immediately.
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 notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Dry mouth
Upset stomach
Constipation
Nose or throat irritation
Runny or stuffy nose
Stomach pain
Headache
This is not an exhaustive list of 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 medical attention right away:
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
Difficulty 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 medical help immediately.
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 notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Dry mouth
Upset stomach
Constipation
Nose or throat irritation
Runny or stuffy nose
Stomach pain
Headache
This is not an exhaustive list of 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 (paradoxical bronchospasm)
- Eye pain or discomfort, blurred vision, seeing halos or colored images (signs of acute narrow-angle glaucoma)
- Difficulty urinating or painful urination (signs of urinary retention)
- Severe allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing/swallowing)
- Chest pain or irregular heartbeat
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, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether a medication belongs to this category, consult your doctor.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all the medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
* Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether a medication belongs to this category, consult your doctor.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all the medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
* Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 dilated pupils and blurred vision. If accidental exposure occurs, seek medical attention.
Adhere strictly to your doctor's prescribed dosage and usage instructions. Using more than the recommended amount, or using it more frequently or for a longer duration than advised, can 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 dilated pupils and blurred vision. If accidental exposure occurs, seek medical attention.
Adhere strictly to your doctor's prescribed dosage and usage instructions. Using more than the recommended amount, or using it more frequently or for a longer duration than advised, can 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 such as dry mouth, blurred vision, increased heart rate, urinary retention, constipation.
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For general advice, call a poison control center at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Other anticholinergic drugs (e.g., ipratropium, atropine, benztropine, oxybutynin, solifenacin, tricyclic antidepressants, phenothiazines): May potentiate anticholinergic adverse effects (e.g., dry mouth, blurred vision, urinary retention, constipation).
Monitoring
Baseline Monitoring
Pulmonary function tests (e.g., FEV1)
Rationale: To establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy.
Assessment for pre-existing narrow-angle glaucoma or urinary retention
Rationale: Tiotropium can exacerbate these conditions due to its anticholinergic effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom control (e.g., dyspnea, cough, wheezing)
Frequency: Regularly, at each follow-up visit.
Target: Improved or stable symptoms.
Action Threshold: Worsening symptoms or lack of improvement may indicate need for re-evaluation of treatment plan.
Adverse effects (e.g., dry mouth, urinary retention, blurred vision, paradoxical bronchospasm)
Frequency: Regularly, at each follow-up visit.
Target: Absence or mild, tolerable side effects.
Action Threshold: Significant or bothersome side effects may require dose adjustment or discontinuation.
Inhaler technique
Frequency: Periodically, especially if symptoms are not well controlled.
Target: Correct and consistent use of HandiHaler device.
Action Threshold: Incorrect technique can lead to suboptimal drug delivery and efficacy.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Chest tightness
- Difficulty urinating
- Blurred vision
- Eye pain or discomfort
- Dry mouth
- Constipation
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some evidence of developmental toxicity at maternally toxic doses.
Trimester-Specific Risks:
First Trimester:
Potential risk, but human data are limited. Weigh benefits vs. risks.
Second Trimester:
Potential risk, but human data are limited. Weigh benefits vs. risks.
Third Trimester:
Potential risk, particularly for effects on labor and delivery due to anticholinergic properties. Weigh benefits vs. risks.
Lactation
It is not known whether tiotropium is excreted in human milk. Tiotropium is a large molecule, but its low oral bioavailability suggests limited systemic absorption by the infant. Caution should be exercised when tiotropium is administered to a nursing mother. 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 to unknown. Monitor infant for anticholinergic effects (e.g., dry mouth, constipation, urinary retention).
Pediatric Use
Spiriva HandiHaler is not indicated for pediatric patients. Safety and effectiveness have not been established in pediatric patients. Spiriva Respimat is indicated for asthma in patients 6 years and older.
Geriatric Use
No dosage adjustment is required based on age. However, elderly patients may be more susceptible to anticholinergic adverse effects (e.g., urinary retention, glaucoma exacerbation). Monitor closely.
Clinical Information
Clinical Pearls
- Tiotropium HandiHaler is a once-daily maintenance bronchodilator for COPD; it is NOT a rescue inhaler.
- Ensure patients understand how to correctly use the HandiHaler device, as improper technique is a common cause of treatment failure.
- Patients should be advised to rinse their mouth after use to minimize dry mouth, although this is less critical than with inhaled corticosteroids.
- Caution patients about potential worsening of narrow-angle glaucoma or urinary retention, and to seek immediate medical attention if symptoms occur.
- Paradoxical bronchospasm can occur; if it happens, discontinue tiotropium and use a rescue bronchodilator.
Alternative Therapies
- Other LAMAs (e.g., aclidinium, glycopyrronium, umeclidinium)
- Long-acting beta-agonists (LABAs) (e.g., salmeterol, formoterol, indacaterol, olodaterol)
- Inhaled corticosteroids (ICS) (often in combination with LABAs/LAMAs for severe COPD or asthma)
- LABA/LAMA fixed-dose combinations (e.g., umeclidinium/vilanterol, tiotropium/olodaterol)
- Short-acting beta-agonists (SABAs) for rescue (e.g., albuterol)
- Short-acting muscarinic antagonists (SAMAs) for rescue (e.g., ipratropium)
Cost & Coverage
Average Cost:
$350 - $500 per 30 capsules (1 month supply)
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.