Spiriva Respimat 2.5mcg Inh 4gm 10d
It is used to treat COPD (chronic obstructive pulmonary disease).It is used to treat asthma.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
Sep 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Spiriva Respimat is an inhaler that helps open up the airways in your lungs, making it easier to breathe. It's used once a day for long-term treatment of chronic obstructive pulmonary disease (COPD). It works by relaxing the muscles around your airways.
How to Use This Medicine
Proper Use of Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. For inhalation into the lungs, prepare the inhaler before first use by spraying it towards the ground until a mist is visible. Then, spray the inhaler 3 more times. If you haven't used the inhaler in more than 3 days, spray it once towards the ground before use. If it has been more than 21 days since you last used the inhaler, you will need to prepare it again by spraying until a mist is seen, followed by 3 additional sprays.
Carefully follow the instructions for cleaning the inhaler. The inhaler will lock after all sprays have been used. Continue using this medication as directed by your doctor or healthcare provider, even if you feel well. Avoid getting the medication in your eyes. If you are using multiple inhaled medications, ask your doctor which one to use first. Do not use a spacer with this inhaler. With each refill, use a new inhaler. After using your dose, replace the cap on the inhaler.
Storage and Disposal
Store the inhaler at room temperature, away from freezing temperatures and moisture. Do not store it in a bathroom. After assembling the inhaler, discard it 3 months after first use or when the inhaler locks, whichever comes first.
Missed 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 return to your regular schedule. Do not take more than one dose of this medication within a 24-hour period.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For inhalation into the lungs, prepare the inhaler before first use by spraying it towards the ground until a mist is visible. Then, spray the inhaler 3 more times. If you haven't used the inhaler in more than 3 days, spray it once towards the ground before use. If it has been more than 21 days since you last used the inhaler, you will need to prepare it again by spraying until a mist is seen, followed by 3 additional sprays.
Carefully follow the instructions for cleaning the inhaler. The inhaler will lock after all sprays have been used. Continue using this medication as directed by your doctor or healthcare provider, even if you feel well. Avoid getting the medication in your eyes. If you are using multiple inhaled medications, ask your doctor which one to use first. Do not use a spacer with this inhaler. With each refill, use a new inhaler. After using your dose, replace the cap on the inhaler.
Storage and Disposal
Store the inhaler at room temperature, away from freezing temperatures and moisture. Do not store it in a bathroom. After assembling the inhaler, discard it 3 months after first use or when the inhaler locks, whichever comes first.
Missed 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 return to 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 (rescue inhaler). Always have a fast-acting rescue inhaler available.
- Use exactly as prescribed, once daily, at the same time each day.
- Do not swallow the medication. It is for oral inhalation only.
- Learn proper inhaler technique from your healthcare provider or pharmacist.
- Rinse your mouth with water after each use to help prevent dry mouth and thrush, but do not swallow the water.
- Avoid getting the spray in your eyes, as it can cause blurred vision or eye pain.
- Do not stop using this medication without talking to your doctor, even if you feel better.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
2.5 mcg (2 inhalations of 1.25 mcg per actuation) once daily via Respimat inhaler
Dose Range:
2.5 - 2.5 mg
Condition-Specific Dosing:
COPD:
2.5 mcg (2 inhalations of 1.25 mcg per actuation) once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for COPD. For asthma, 6-11 years: 5 mcg (2 inhalations of 2.5 mcg per actuation) once daily. Not the specified dose.
Adolescent:
Not established for COPD. For asthma, ≥12 years: 5 mcg (2 inhalations of 2.5 mcg per actuation) once daily. Not the specified dose.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
Use with caution; monitor for anticholinergic side effects. No specific dose adjustment recommended.
Dialysis:
Not specifically studied, use with caution.
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Pharmacology
Mechanism of Action
Tiotropium is a long-acting, anticholinergic (antimuscarinic) agent. It inhibits the M3 muscarinic receptors located in the bronchial smooth muscle, leading to bronchodilation. This inhibition is reversible and dose-dependent. By blocking the action of acetylcholine at these receptors, it prevents bronchoconstriction.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 19.5% (systemic bioavailability after inhalation)
Tmax:
Approximately 5-7 minutes (for lung deposition, systemic Tmax is longer and variable)
FoodEffect:
Not applicable (inhalation)
Distribution:
Vd:
Approximately 32 L/kg
ProteinBinding:
Approximately 72%
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life: 25-30 hours (after multiple doses)
Clearance:
Total body clearance: 880 mL/min
ExcretionRoute:
Renal (primarily unchanged drug), fecal (unabsorbed drug)
Unchanged:
Approximately 20-25% (renal excretion of unchanged drug)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
Within 3 hours
DurationOfAction:
Approximately 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 pass urine
+ 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
Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
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 pass urine
+ 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
Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
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 around lights, or red eyes (signs of narrow-angle glaucoma)
- Difficulty urinating, painful urination (signs of urinary retention)
- Severe dry mouth, constipation
- Allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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 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 medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dosage of any medication without first consulting 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 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 medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
To ensure your safety, avoid driving and performing tasks that require alertness or clear vision 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, immediately contact your doctor.
Handling Precautions
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.
Dosage and Administration
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, may increase the risk of severe side effects.
Special Considerations
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks with their doctor to make an informed decision.
Asthma Treatment
Please note that it may take several weeks to experience the full effects of this medication when used to treat asthma.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
To ensure your safety, avoid driving and performing tasks that require alertness or clear vision 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, immediately contact your doctor.
Handling Precautions
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.
Dosage and Administration
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, may increase the risk of severe side effects.
Special Considerations
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks with their doctor to make an informed decision.
Asthma Treatment
Please note that it may take several weeks to experience the full effects of this medication when used to treat asthma.
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 or call a poison control center (1-800-222-1222). Treatment is 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 establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy
Assessment of symptoms (dyspnea, cough, wheezing)
Rationale: To establish baseline symptom burden.
Timing: Prior to initiation of therapy
Routine Monitoring
Pulmonary Function Tests (FEV1)
Frequency: Periodically, as clinically indicated (e.g., every 6-12 months)
Target: Improvement from baseline
Action Threshold: Lack of improvement or worsening of symptoms/FEV1 may indicate need for re-evaluation of therapy.
Assessment of symptoms (dyspnea, cough, wheezing)
Frequency: At each follow-up visit
Target: Reduction in symptom frequency and severity
Action Threshold: Persistent or worsening symptoms, increased rescue inhaler use.
Adverse effects (e.g., dry mouth, urinary retention, blurred vision, constipation)
Frequency: At each follow-up visit
Target: Absence or minimal severity of anticholinergic side effects
Action Threshold: Significant or bothersome anticholinergic effects may require dose adjustment or discontinuation.
Symptom Monitoring
- Worsening shortness of breath
- Increased cough or sputum production
- Chest tightness
- Increased use of rescue inhaler
- Signs of acute narrow-angle glaucoma (eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes)
- Signs of urinary retention (difficulty passing urine, painful urination)
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.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show some evidence of developmental toxicity at high doses.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data; potential for anticholinergic effects on the fetus (e.g., decreased fetal heart rate variability, urinary retention) theoretically possible, but not well-documented with inhaled use.
Lactation
It is not known whether tiotropium is excreted in human milk. Caution should be exercised when tiotropium is administered to a nursing mother. The developmental and health benefits of breastfeeding should be considered 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:
L3 - Moderately safe. Low systemic absorption suggests low infant exposure, but data are limited. Monitor infant for anticholinergic effects (e.g., constipation, dry mouth, irritability).
Pediatric Use
Not indicated for COPD in pediatric patients. For asthma, a higher dose (5 mcg) is approved for children ≥6 years. Safety and efficacy for COPD in pediatric patients have not been established.
Geriatric Use
No dose adjustment is required based on age. However, elderly patients may be more susceptible to anticholinergic side effects (e.g., dry mouth, urinary retention, constipation, blurred vision). Monitor closely for these effects.
Clinical Information
Clinical Pearls
- Spiriva Respimat is a maintenance bronchodilator and should not be used for acute bronchospasm.
- Proper inhaler technique is critical for effective drug delivery. Patients should be thoroughly instructed and periodically re-evaluated on their technique.
- Patients should be advised to rinse their mouth after each use to minimize dry mouth and reduce the risk of oral candidiasis.
- Caution should be exercised in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction due to the anticholinergic effects.
- The 2.5 mcg dose is specifically for COPD. The 5 mcg dose is for asthma (not the product specified in the prompt).
Alternative Therapies
- Other long-acting muscarinic antagonists (LAMAs): Aclidinium (Tudorza Pressair), Glycopyrronium (Seebri Neohaler), Umeclidinium (Incruse Ellipta)
- Long-acting beta-agonists (LABAs): Salmeterol (Serevent Diskus), Formoterol (Foradil Aerolizer), Indacaterol (Arcapta Neohaler), Olodaterol (Striverdi Respimat)
- Inhaled corticosteroids (ICS) in combination with LABAs or LAMAs for appropriate patients (e.g., Fluticasone/Salmeterol, Budesonide/Formoterol)
Cost & Coverage
Average Cost:
Varies widely, typically $400-$600 per 4gm (60 actuations) inhaler
Insurance Coverage:
Tier 2 or Tier 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 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.