Spiriva 18mcg Caps 90s & 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?
Spiriva Handihaler is an inhaled medicine used once a day to help open up your airways and make it easier to breathe if you have chronic obstructive pulmonary disease (COPD). It works by relaxing the muscles around your airways. 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
* Keep the capsules closed until you are ready to use them
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well. Be cautious not to get the medication in your eyes.
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 always 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 temperatures and humid environments, such as bathrooms. Keep 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 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
* Keep the capsules closed until you are ready to use them
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well. Be cautious not to get the medication in your eyes.
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 always 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 temperatures and humid environments, such as bathrooms. Keep 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 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 help prevent dry mouth and thrush.
- Avoid getting the powder in your eyes, as it can cause blurred vision or eye pain.
- Maintain good hydration to help with dry mouth.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
18 mcg (one capsule) inhaled once daily via Handihaler device
Dose Range:
18 - 18 mg
Condition-Specific Dosing:
COPD:
18 mcg once daily
Asthma:
Not indicated for Handihaler formulation; Spiriva Respimat is indicated for asthma.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients under 18 years for COPD)
Adolescent:
Not established (Safety and efficacy not established in pediatric patients under 18 years for COPD)
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required
Moderate:
No dosage adjustment required
Severe:
Use with caution; monitor for anticholinergic side effects
Dialysis:
Use with caution; monitor for anticholinergic side effects
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 prolonged duration of action is due to its slow dissociation from the M3 receptor.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 19.5% (systemic bioavailability after inhalation)
Tmax:
5-7 minutes (peak plasma concentration after inhalation)
FoodEffect:
Not applicable (inhaled drug)
Distribution:
Vd:
32 L/kg (after IV administration)
ProteinBinding:
Approximately 72%
CnssPenetration:
Limited
Elimination:
HalfLife:
5-6 days (terminal half-life after repeated inhalation)
Clearance:
880 mL/min (total body clearance after IV administration)
ExcretionRoute:
Renal (primarily unchanged drug), fecal (unabsorbed drug)
Unchanged:
Approximately 20% (renal excretion of unchanged drug after IV administration)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
Approximately 3 hours
DurationOfAction:
Greater than 24 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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 also 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 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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 also 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 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 or wheezing after using the inhaler (paradoxical bronchospasm)
- Eye pain or discomfort, blurred vision, seeing halos or colored images in association with red eyes (signs of narrow-angle glaucoma)
- Difficulty urinating, painful urination, or frequent urination (signs of urinary retention)
- Severe allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing/swallowing)
- Worsening of COPD symptoms despite regular use
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 symptoms you experienced.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether any of your medications belong to this category, consult your doctor.
Please note that this is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, 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 to ensure safe use of this medication.
* Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 symptoms you experienced.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether any of your medications belong to this category, consult your doctor.
Please note that this is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, 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 to ensure safe use of this medication.
* Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 medication 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 (enlarged 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 medication 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 (enlarged 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. Call 911 or Poison Control (1-800-222-1222). Treatment is generally supportive and symptomatic.
Drug Interactions
Moderate Interactions
- Other anticholinergic medications (e.g., ipratropium, atropine, benztropine, oxybutynin)
Monitoring
Baseline Monitoring
Pulmonary function tests (FEV1)
Rationale: To assess baseline lung function and severity of COPD.
Timing: Prior to initiation of therapy
Assessment for narrow-angle glaucoma or prostatic hyperplasia
Rationale: Tiotropium, an anticholinergic, can exacerbate these conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Symptoms of COPD (e.g., dyspnea, cough, exacerbation frequency)
Frequency: Regularly (e.g., at each follow-up visit)
Target: Improvement in symptoms, reduction in exacerbations
Action Threshold: Worsening symptoms or frequent exacerbations may indicate need for re-evaluation of therapy or adherence.
Anticholinergic side effects (e.g., dry mouth, urinary retention, blurred vision)
Frequency: Regularly (e.g., at each follow-up visit)
Target: Absence or mild, tolerable side effects
Action Threshold: Significant or bothersome side effects may require intervention or discontinuation.
Proper inhaler technique
Frequency: Periodically (e.g., annually or as needed)
Target: Correct use of Handihaler device
Action Threshold: Incorrect technique can lead to suboptimal drug delivery and efficacy.
Symptom Monitoring
- Worsening shortness of breath
- Increased cough or sputum production
- Chest tightness
- Signs of acute bronchospasm (paradoxical bronchospasm)
- Blurred vision or eye pain (potential narrow-angle glaucoma)
- Difficulty urinating or painful urination (potential urinary retention)
- Dry mouth
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some evidence of developmental toxicity at high doses.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies suggest potential risk at high doses.
Second Trimester:
Limited human data; animal studies suggest potential risk at high doses.
Third Trimester:
Limited human data; animal studies suggest potential risk at high doses. Anticholinergic effects could theoretically inhibit uterine contractions.
Lactation
It is not known whether tiotropium is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Unknown. Potential for anticholinergic effects in the infant.
Pediatric Use
Safety and efficacy have not been established in pediatric patients (under 18 years of age) for COPD. Spiriva Respimat is approved for asthma in children 6 years and older.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, due to increased prevalence of renal impairment and potential for anticholinergic side effects (e.g., urinary retention, glaucoma), use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Tiotropium is a maintenance bronchodilator and should not be used for acute bronchospasm.
- Ensure patients understand how to properly use the Handihaler device, as incorrect technique is a common cause of treatment failure.
- Advise patients to rinse their mouth after use to minimize dry mouth and reduce the risk of oral candidiasis.
- Caution patients about potential anticholinergic side effects, especially in those with pre-existing narrow-angle glaucoma or prostatic hyperplasia.
- Regularly assess patient adherence and inhaler technique to optimize therapeutic outcomes.
Alternative Therapies
- Other long-acting muscarinic antagonists (LAMAs) like aclidinium, glycopyrronium, umeclidinium.
- Long-acting beta-agonists (LABAs) like salmeterol, formoterol, indacaterol, olodaterol.
- LABA/LAMA combinations (e.g., Anoro Ellipta, Stiolto Respimat, Bevespi Aerosphere, Utibron Neohaler).
- Inhaled corticosteroids (ICS) for patients with frequent exacerbations or asthma-COPD overlap syndrome (ACOS).
- ICS/LABA combinations (e.g., Advair, Symbicort, Breo Ellipta).
Cost & Coverage
Average Cost:
Not available (varies widely) per 90 capsules with Handihaler
Insurance Coverage:
Tier 2 or 3 (Brand name, often requires prior authorization or step therapy)
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 this 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 overdose, including the medication taken, the amount, and the time it occurred.