Ipratropium Inhal Soln 25 X 2.5ml

Manufacturer RITEDOSE Active Ingredient Ipratropium Inhalation Solution(i pra TROE pee um) Pronunciation i pra TROE pee um
It is used to open the airways in lung diseases where spasm may cause breathing problems. 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.
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Drug Class
Bronchodilator
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Pharmacologic Class
Anticholinergic; Antimuscarinic
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Pregnancy Category
Not available
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FDA Approved
Aug 1986
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ipratropium is a medicine that helps open up the airways in your lungs, making it easier to breathe. It's used for long-term lung conditions like COPD (chronic obstructive pulmonary disease), which includes chronic bronchitis and emphysema. It works by relaxing the muscles around your airways.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. It's essential to keep the medication out of your eyes. Continue using the medication as directed by your doctor or healthcare provider, even if you start feeling better.

If you're using multiple inhaled medications, consult your doctor about which one to use first. This medication is for inhalation only, using a special machine called a nebulizer, which delivers the liquid solution directly into your lungs.

Storing and Disposing of Your Medication

To maintain the medication's effectiveness, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep unused containers in their foil pouches until you're ready to use them. Always keep your medications in a safe location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Do not use this medicine for sudden breathing problems (it is not a rescue inhaler).
  • Use exactly as prescribed by your doctor, usually 3 to 4 times a day.
  • Learn and practice proper nebulizer technique to ensure the medicine reaches your lungs effectively.
  • Avoid getting the solution in your eyes, as it can cause eye pain, blurred vision, or other eye problems, especially if you have glaucoma.
  • Rinse your mouth after use if advised by your doctor to reduce dry mouth.
  • Avoid smoking and exposure to irritants that can worsen your lung condition.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.5 mg (500 mcg) via nebulizer 3 to 4 times a day
Dose Range: 0.5 - 0.5 mg

Condition-Specific Dosing:

COPD: 0.5 mg (500 mcg) via nebulizer 3 to 4 times a day, not to exceed 2.5 mg in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for COPD; off-label use for asthma exacerbations varies (e.g., 250 mcg every 20 minutes for 3 doses, then as needed)
Adolescent: Not established for COPD; off-label use for asthma exacerbations varies (e.g., 500 mcg every 20 minutes for 3 doses, then as needed)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed; minimal systemic absorption

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Ipratropium is an anticholinergic (parasympatholytic) agent that, when inhaled, inhibits vagally mediated reflexes by antagonizing the action of acetylcholine at the muscarinic receptors on bronchial smooth muscle. This leads to bronchodilation by preventing the increase in intracellular concentration of cyclic guanosine monophosphate (cGMP) that results from the interaction of acetylcholine with muscarinic receptors on bronchial smooth muscle.
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Pharmacokinetics

Absorption:

Bioavailability: <10% (systemic)
Tmax: Not applicable (local action); minimal systemic absorption
FoodEffect: Not applicable (inhaled)

Distribution:

Vd: Not available (minimal systemic distribution)
ProteinBinding: Not available (minimal systemic absorption)
CnssPenetration: Limited

Elimination:

HalfLife: 2-4 hours (for the small amount absorbed)
Clearance: Not available
ExcretionRoute: Primarily unchanged in feces (unabsorbed portion); small amount excreted renally (absorbed portion)
Unchanged: Not available (majority of inhaled dose is unabsorbed or excreted unchanged in feces)
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours

Safety & Warnings

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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 bronchitis, including:
+ Fever
+ Chills
+ Sore throat
+ Yellow or green mucus
+ Coughing
+ Wheezing
Signs of a urinary tract infection (UTI), such as:
+ 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
Seeing halos or bright colors around lights
Red eyes
Trouble passing urine, pain when passing urine, weak urine stream, or frequent urination
Severe dizziness or fainting
Fast or abnormal heartbeat
Mouth irritation or mouth sores

Respiratory Emergency

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 attention.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor 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:

Back pain
Headache
Dry mouth
Upset stomach
Flu-like symptoms
Nose or throat irritation
* Nose stuffiness

Reporting Side Effects

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.
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Seek Immediate Medical Attention If You Experience:

  • Sudden worsening of breathing or wheezing immediately after using the medicine (paradoxical bronchospasm) – stop use and seek immediate medical attention.
  • Eye pain, discomfort, blurred vision, seeing halos or colored spots around lights – seek medical attention immediately.
  • Difficulty urinating or painful urination.
  • Severe dry mouth or constipation.
  • Allergic reactions such as rash, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing.
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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, any of 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 currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine if the medications are similar.

This list is not exhaustive, and it is crucial to disclose all of your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Additionally, inform your doctor about any existing health problems. This information will help your doctor determine if it is safe for you to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
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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 you experience worsening breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increased need to use your rescue inhaler, contact your doctor immediately.

In the event that this medication comes into contact with your eyes, flush them with water immediately. If eye exposure results in blurred vision, worsened glaucoma, or eye pain, seek medical attention right away.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Dry mouth
  • Blurred vision
  • Increased heart rate (tachycardia)
  • Urinary retention
  • Constipation

What to Do:

If you suspect an overdose, contact a poison control center immediately. In the US, call 1-800-222-1222. Seek emergency medical attention if symptoms are severe.

Drug Interactions

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Moderate Interactions

  • Other anticholinergic medications (e.g., atropine, tricyclic antidepressants, some antihistamines, phenothiazines, quinidine, disopyramide): May lead to additive anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation).

Monitoring

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Baseline Monitoring

Pulmonary function tests (e.g., FEV1)

Rationale: To assess baseline lung function and severity of COPD.

Timing: Prior to initiation of therapy

Assessment of symptoms (e.g., dyspnea, cough)

Rationale: To establish baseline symptom burden.

Timing: Prior to initiation of therapy

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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, increased frequency of use, or need for rescue medication

Frequency of rescue bronchodilator use

Frequency: Regularly, at each follow-up visit

Target: Decreased or stable use

Action Threshold: Increased use of rescue medication indicates worsening control

Pulmonary function tests (e.g., FEV1)

Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)

Target: Stable or improved lung function

Action Threshold: Significant decline in FEV1

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Symptom Monitoring

  • Worsening of breathing difficulties or bronchospasm (paradoxical bronchospasm)
  • Eye pain or discomfort, blurred vision, visual halos or colored images (especially in patients with narrow-angle glaucoma)
  • Urinary retention (especially in patients with prostatic hyperplasia or bladder-neck obstruction)
  • Dry mouth, constipation

Special Patient Groups

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Pregnancy

Ipratropium is generally considered safe during pregnancy due to minimal systemic absorption. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Minimal amounts of ipratropium are expected to be excreted into breast milk due to poor systemic absorption. Considered compatible with breastfeeding.

Infant Risk: Low risk to the infant.
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Pediatric Use

Safety and effectiveness for COPD in pediatric patients have not been established. Off-label use for asthma exacerbations in children is common, but dosing should be carefully considered and individualized.

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Geriatric Use

No specific dose adjustment is required. However, elderly patients may be more susceptible to anticholinergic side effects such as dry mouth, urinary retention (especially in men with prostatic hyperplasia), and exacerbation of narrow-angle glaucoma. Monitor closely for these effects.

Clinical Information

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Clinical Pearls

  • Ipratropium is a maintenance bronchodilator for COPD and should not be used for acute bronchospasm due to its slower onset of action.
  • Patients should be instructed on proper nebulizer technique to maximize drug delivery to the lungs.
  • Caution should be exercised in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction due to potential for exacerbation of these conditions.
  • Paradoxical bronchospasm can occur; if it happens, discontinue the drug immediately and use an alternative bronchodilator.
  • Often used in combination with a short-acting beta-agonist (e.g., albuterol) for enhanced bronchodilation in acute exacerbations (e.g., Duoneb).
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Alternative Therapies

  • Long-acting muscarinic antagonists (LAMAs) e.g., Tiotropium, Aclidinium, Umeclidinium
  • Long-acting beta-agonists (LABAs) e.g., Salmeterol, Formoterol, Indacaterol, Olodaterol
  • Inhaled corticosteroids (ICS) (often in combination with LABAs/LAMAs for severe COPD)
  • Short-acting beta-agonists (SABAs) e.g., Albuterol (for rescue)
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Cost & Coverage

Average Cost: Varies, typically $30-$100 per 25 x 2.5 mL vials (0.02% solution)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and appropriate care.