Spiriva Respimat 2.5mcg Inh 4gm 60d
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, Long-acting muscarinic antagonist (LAMA)
Pharmacologic Class
Anticholinergic
Pregnancy Category
Not available
FDA Approved
Sep 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tiotropium is an inhaled medication that helps open up the airways in your lungs, making it easier to breathe. It's used once a day to help manage conditions like COPD (chronic obstructive pulmonary disease) and asthma, but it's not for sudden breathing problems.
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 the 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.
It's essential to follow the cleaning instructions carefully. 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're feeling well. Be cautious 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 this inhaler. When you receive a refill, use a new inhaler. After each use, replace the cap on the inhaler.
Storage and Disposal
Store the medication at room temperature, avoiding freezing and humid environments. Do not store it in a bathroom. After assembling the inhaler, discard it 3 months after the 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 resume 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 the 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.
It's essential to follow the cleaning instructions carefully. 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're feeling well. Be cautious 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 this inhaler. When you receive a refill, use a new inhaler. After each use, replace the cap on the inhaler.
Storage and Disposal
Store the medication at room temperature, avoiding freezing and humid environments. Do not store it in a bathroom. After assembling the inhaler, discard it 3 months after the 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 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; always have a rescue inhaler available.
- Use exactly as prescribed, once daily, at the same time each day.
- Do not swallow the medication; it is for inhalation only.
- Learn and practice proper inhaler technique with your healthcare provider.
- Rinse your mouth with water after each use to help prevent dry mouth and thrush (though less common with Respimat than dry powder inhalers).
- Avoid getting the spray in your eyes, as it can cause blurred vision or eye pain.
- Smoking cessation is crucial for individuals with COPD and asthma.
- Avoid known triggers for your respiratory condition.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
2.5 mcg (2 inhalations of 1.25 mcg per actuation) once daily
Dose Range:
2.5 - 2.5 mg
Condition-Specific Dosing:
COPD:
2.5 mcg (2 inhalations of 1.25 mcg per actuation) once daily
Asthma:
2.5 mcg (2 inhalations of 1.25 mcg per actuation) once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Asthma (6-11 years): 2.5 mcg (2 inhalations of 1.25 mcg per actuation) once daily
Adolescent:
Asthma (≥12 years): 2.5 mcg (2 inhalations of 1.25 mcg per actuation) once daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Monitor closely for anticholinergic side effects (e.g., urinary retention, blurred vision, dry mouth) in patients with creatinine clearance < 50 mL/min.
Dialysis:
Monitor closely for anticholinergic side effects; tiotropium is minimally dialyzable.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Tiotropium is a long-acting, anticholinergic (antimuscarinic) agent. It competitively and reversibly inhibits the action of acetylcholine at M3 muscarinic receptors in the bronchial smooth muscle, leading to bronchodilation. The bronchodilatory effect is dose-dependent and lasts for at least 24 hours.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 19.5% (relative to intravenous administration) for Respimat
Tmax:
5-7 minutes (inhalation)
FoodEffect:
Not applicable (inhaled)
Distribution:
Vd:
32 L/kg (intravenous)
ProteinBinding:
Approximately 72%
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life: 25-30 hours
Clearance:
880 mL/min (total body clearance)
ExcretionRoute:
Primarily renal (approximately 20% unchanged after inhalation), remainder via feces (unabsorbed drug)
Unchanged:
Approximately 20% (renal excretion after inhalation)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
Approximately 3 hours
DurationOfAction:
At least 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 or 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you're bothered by any of the following:
Dry mouth
Upset stomach
Constipation
Nose or throat irritation
Runny or stuffy nose
Stomach pain
Headache
This list is not exhaustive, and you may experience other 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 or 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you're bothered by any of the following:
Dry mouth
Upset stomach
Constipation
Nose or throat irritation
Runny or stuffy nose
Stomach pain
Headache
This list is not exhaustive, and you may experience other 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 immediately after using the inhaler (paradoxical bronchospasm)
- Eye pain or discomfort, blurred vision, or seeing halos around lights (may indicate acute narrow-angle glaucoma)
- Difficulty urinating or painful urination (may indicate urinary retention)
- Severe dry mouth
- Allergic reactions (e.g., rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing)
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 you experienced, including any symptoms that occurred.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether a particular medication belongs to this category, consult your doctor for clarification.
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 any existing health problems with your doctor.
Verify that it is safe to take this medication in conjunction with your other medications and health conditions.
Never start, stop, 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, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether a particular medication belongs to this category, consult your doctor for clarification.
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 any existing health problems with your doctor.
Verify that it is safe to take this medication in conjunction with your other medications and health conditions.
Never start, stop, or modify 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.
Precautions
Be careful 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 prescribed, 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.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Asthma Treatment
* It may take several weeks to experience the full effects of this medication.
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.
Precautions
Be careful 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 prescribed, 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.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Asthma Treatment
* It may take several weeks to experience the full effects of this medication.
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 poison control, call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Other anticholinergic medications (e.g., atropine, ipratropium, benztropine, oxybutynin, tricyclic antidepressants, some antihistamines)
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
Patient education on inhaler technique
Rationale: Crucial for effective drug delivery and therapeutic benefit.
Timing: At initiation of therapy and periodically thereafter
Routine Monitoring
Symptom control (e.g., dyspnea, cough, wheezing)
Frequency: Regularly (e.g., at each follow-up visit)
Target: Improvement in symptoms, reduction in exacerbations
Action Threshold: Worsening symptoms or lack of improvement may indicate need for re-evaluation of therapy or adherence.
Adverse 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 anticholinergic side effects may require dose adjustment or discontinuation.
Pulmonary function tests (e.g., FEV1)
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)
Target: Maintenance or improvement in lung function
Action Threshold: Decline in lung function may indicate disease progression or inadequate therapy.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing or coughing
- Chest tightness
- Paradoxical bronchospasm (acute worsening of breathing immediately after inhalation)
- Dry mouth
- Blurred vision
- Eye pain or discomfort
- Urinary retention or difficulty urinating
- Constipation
Special Patient Groups
Pregnancy
Limited data on tiotropium use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, potential risk unknown.
Second Trimester:
Limited data, potential risk unknown.
Third Trimester:
Limited data, potential risk unknown.
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:
Low to moderate risk, based on limited data and low systemic absorption.
Pediatric Use
Approved for asthma in children aged 6 years and older. Not indicated for COPD in pediatric patients. Safety and efficacy in children younger than 6 years with asthma 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., urinary retention, glaucoma, constipation). Monitor closely.
Clinical Information
Clinical Pearls
- Tiotropium is a maintenance bronchodilator and should not be used for acute relief of 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 use to minimize local side effects like dry mouth, although this is less critical with Respimat than with dry powder inhalers.
- Monitor for signs of paradoxical bronchospasm, which can be life-threatening.
- Caution should be exercised in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction due to the anticholinergic effects.
- Spiriva Respimat delivers a fine mist, which may be easier for some patients to inhale compared to dry powder inhalers.
Alternative Therapies
- Other long-acting muscarinic antagonists (LAMAs) like umeclidinium, glycopyrrolate, aclidinium
- Long-acting beta-agonists (LABAs) like salmeterol, formoterol, indacaterol, olodaterol
- Inhaled corticosteroids (ICS) for asthma or in combination with LABA/LAMA for severe COPD
- Short-acting beta-agonists (SABAs) for rescue relief (e.g., albuterol)
Cost & Coverage
Average Cost:
$400 - $600 per 4gm (60 doses)
Insurance Coverage:
Tier 2 or Tier 3 (Specialty)
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.