Spiriva Respimat 1.25mcg In 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
Pharmacologic Class
Long-acting muscarinic antagonist (LAMA)
Pregnancy Category
Category C
FDA Approved
Sep 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tiotropium is an inhaled medicine that helps open up your airways, making it easier to breathe. It's used daily to prevent symptoms like wheezing and shortness of breath in people with asthma or COPD. It is 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 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 hasn't been used in more than 21 days, you'll need to prepare the inhaler again by spraying until a mist is seen, followed by 3 additional sprays.
Carefully follow the cleaning instructions provided. 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. Avoid getting the medication in your eyes. If you're using multiple inhaled medications, ask your doctor which one to use first. Do not use a spacer with this inhaler. When you receive a 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 dry places. 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 resume your regular dosing 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 hasn't been used in more than 21 days, you'll need to prepare the inhaler again by spraying until a mist is seen, followed by 3 additional sprays.
Carefully follow the cleaning instructions provided. 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. Avoid getting the medication in your eyes. If you're using multiple inhaled medications, ask your doctor which one to use first. Do not use a spacer with this inhaler. When you receive a 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 dry places. 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 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 fast-acting rescue inhaler (e.g., albuterol).
- Use regularly once daily, even on days you feel well, to get the full benefit.
- Do not swallow the medication; it is for inhalation only.
- Proper inhaler technique is crucial; ensure you understand how to use the Respimat device correctly.
- Avoid getting the spray in your eyes, as it can cause blurred vision or eye pain.
- Inform your doctor if you have glaucoma, prostate problems, or difficulty urinating.
- Smoking cessation is highly recommended for patients with COPD or asthma to improve lung health and treatment effectiveness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
2 inhalations of 1.25 mcg (total 2.5 mcg) once daily
Dose Range:
2.5 - 2.5 mg
Condition-Specific Dosing:
COPD:
Not the primary strength for COPD; 2 inhalations of 2.5 mcg (total 5 mcg) once daily is typically used for COPD.
Asthma:
2 inhalations of 1.25 mcg (total 2.5 mcg) once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For asthma in children 6 years of age and older: 2 inhalations of 1.25 mcg (total 2.5 mcg) once daily.
Adolescent:
For asthma: 2 inhalations of 1.25 mcg (total 2.5 mcg) once daily.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
Use with caution; monitor for anticholinergic side effects. Tiotropium is primarily renally excreted.
Dialysis:
Use with caution; monitor for anticholinergic side effects. Tiotropium is minimally dialyzable.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Pharmacology
Mechanism of Action
Tiotropium is a long-acting, anticholinergic (antimuscarinic) agent. It inhibits the bronchoconstrictor effects of acetylcholine by binding to M3 muscarinic receptors on airway smooth muscle. This binding is reversible and competitive, leading to bronchodilation. Its prolonged duration of action is due to its slow dissociation from the M3 receptor.
Pharmacokinetics
Absorption:
Bioavailability:
19.5% (relative to IV administration)
Tmax:
5-7 minutes (inhalation)
FoodEffect:
Not applicable (inhalation)
Distribution:
Vd:
32 L/kg
ProteinBinding:
72%
CnssPenetration:
Limited
Elimination:
HalfLife:
25-30 hours (terminal half-life after inhalation)
Clearance:
Not available (systemic clearance is 880 mL/min after IV administration)
ExcretionRoute:
Renal (primarily unchanged drug), fecal (unabsorbed drug)
Unchanged:
Approximately 20% of an IV dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
Within 3 hours
DurationOfAction:
At least 24 hours
Safety & Warnings
Side Effects
Urgent 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention 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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention 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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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) – stop use and seek immediate medical attention.
- Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing/swallowing) – seek immediate medical attention.
- Eye pain or discomfort, blurred vision, seeing halos or colored images around lights, or red eyes (signs of narrow-angle glaucoma) – seek immediate medical attention.
- Difficulty urinating, painful urination, or inability to urinate (signs of urinary retention) – contact your doctor.
- Severe dry mouth, constipation, or increased heart rate.
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 any of your medications belong to this category, consult your doctor for clarification.
Please note that this is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
* Your overall health status, including any existing medical conditions
To ensure your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
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 any of your medications belong to this category, consult your doctor for clarification.
Please note that this is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
* Your overall health status, including any existing medical conditions
To ensure your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
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, contact your doctor immediately.
Precautions
Avoid getting this medication in your eyes, as it may cause enlarged 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, 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, contact your doctor immediately.
Precautions
Avoid getting this medication in your eyes, as it may cause enlarged 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, 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:
Discontinue the drug and provide supportive and symptomatic treatment. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Other anticholinergic medications (e.g., atropine, ipratropium, benztropine, tricyclic antidepressants, phenothiazines, disopyramide)
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 of patient's inhaler technique
Rationale: Ensures proper drug delivery and efficacy.
Timing: At initiation and periodically thereafter.
Routine Monitoring
Symptom control (e.g., dyspnea, cough, wheezing)
Frequency: Regularly (e.g., daily symptom diary, every clinic visit)
Target: Improved or stable symptoms
Action Threshold: Worsening symptoms or increased rescue inhaler use may indicate inadequate control or exacerbation.
Pulmonary function tests (e.g., FEV1)
Frequency: Periodically (e.g., every 3-12 months, or as clinically indicated)
Target: Maintenance or improvement in lung function
Action Threshold: Significant decline may require re-evaluation of treatment plan.
Adverse effects (e.g., dry mouth, urinary retention, blurred vision)
Frequency: At each clinic visit
Target: Absence or mild, tolerable effects
Action Threshold: Persistent or severe anticholinergic effects may warrant dose adjustment or discontinuation.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing or coughing
- Increased need for rescue inhaler (e.g., albuterol)
- Signs of paradoxical bronchospasm (immediate worsening of breathing after inhalation)
- 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 urinating, 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:
Potential risk, but human data are limited. Use only if clearly needed.
Second Trimester:
Potential risk, but human data are limited. Use only if clearly needed.
Third Trimester:
Potential risk, but human data are limited. Use only if clearly needed. Anticholinergic effects could theoretically inhibit uterine contractility.
Lactation
It is not known whether tiotropium is excreted in human milk. Caution should be exercised when tiotropium is administered to a nursing woman. 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:
Risk unknown; potential for anticholinergic effects in the infant. Monitor for dry mouth, constipation, or urinary retention in the infant.
Pediatric Use
Approved for asthma in children 6 years of age and older. Safety and effectiveness in pediatric patients younger than 6 years of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, due to the higher prevalence of decreased renal function in the elderly, caution should be exercised, and renal function should be monitored. No dose adjustment is required based on age alone.
Clinical Information
Clinical Pearls
- Tiotropium is a maintenance bronchodilator and should not be used for acute bronchospasm.
- Patients should be instructed on the correct use of the Respimat inhaler device, as improper technique can lead to reduced drug delivery.
- Advise patients to avoid spraying the medication into their eyes to prevent anticholinergic ocular effects.
- Regular follow-up is important to assess symptom control, lung function, and adherence to therapy.
- For patients with COPD, the 2.5 mcg/puff strength (total 5 mcg) is typically used, while the 1.25 mcg/puff strength (total 2.5 mcg) is for asthma.
Alternative Therapies
- Other long-acting muscarinic antagonists (LAMAs) such as umeclidinium, glycopyrrolate, aclidinium.
- Long-acting beta-agonists (LABAs) such as salmeterol, formoterol, indacaterol, olodaterol.
- Inhaled corticosteroids (ICS) for asthma.
- ICS/LABA combinations for asthma or COPD.
- Oral corticosteroids (for exacerbations).
Cost & Coverage
Average Cost:
$400 - $600 per 4gm (60 doses) inhaler
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/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 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 it's a good idea to check with your pharmacist. 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.