Lonhala Magnair 25mcg/ml Startr Kit

Manufacturer SUNOVION Active Ingredient Glycopyrrolate Inhalation Solution(glye koe PYE roe late) Pronunciation Glye-koe-PYE-roe-late
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.
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Drug Class
Bronchodilator
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Pharmacologic Class
Long-acting muscarinic antagonist (LAMA)
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Pregnancy Category
Not available
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FDA Approved
Jun 2017
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lonhala Magnair is an inhaled medicine used to help people with chronic obstructive pulmonary disease (COPD) breathe more easily. It works by relaxing the muscles around the airways in your lungs, which helps to open them up. It is used twice a day, every day, with a special nebulizer device.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer, which delivers the medication directly into the lungs as a liquid solution. It is essential to note the following:

Do not swallow this medication.
Do not inject this medication.
Use this medication at the same time every day to maintain a consistent routine.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well.

Important Nebulizer Instructions

Only use the type of nebulizer recommended by your doctor. If you are unsure about the correct nebulizer to use, consult with your doctor.
Do not use the solution if it has changed color, as this may indicate a problem with the medication.

Storage and Disposal

To store this medication properly:
Keep it at room temperature in a dry place, avoiding bathrooms.
Store the medication in its foil pouch until you are ready to use it.
After opening the foil pouch, discard any unused portion after 7 days.

Missed Dose Instructions

If you miss a dose:
Take the missed dose as soon as you remember.
However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses on the same day, as this can increase the risk of side effects.
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Lifestyle & Tips

  • Do not use Lonhala Magnair for sudden breathing problems; it is a long-acting maintenance medication.
  • Always use the Magnair Nebulizer System as instructed by your healthcare provider. Do not use with other nebulizers.
  • Do not swallow the solution. It is for oral inhalation only.
  • Rinse your mouth with water after each use to help prevent dry mouth.
  • Avoid getting the solution in your eyes, as it can cause blurred vision or eye pain. If it gets in your eyes, rinse thoroughly with water.
  • Inform your doctor if you have glaucoma, prostate problems, or difficulty urinating before starting this medication.
  • Continue to use your rescue inhaler (e.g., albuterol) for sudden shortness of breath as needed.
  • Do not stop using Lonhala Magnair without talking to your doctor, even if you feel better.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 25 mcg (one single-use vial) administered twice daily (morning and evening), approximately 12 hours apart, using the Magnair Nebulizer System.
Dose Range: 25 - 25 mg

Condition-Specific Dosing:

COPD: 25 mcg twice daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment required.
Moderate: No dose adjustment required.
Severe: Use with caution in patients with severe renal impairment (creatinine clearance < 30 mL/min), including those with end-stage renal disease requiring dialysis. Monitor for anticholinergic adverse effects.
Dialysis: Not studied in patients with end-stage renal disease requiring dialysis; use with caution and monitor for anticholinergic effects.

Hepatic Impairment:

Mild: No dose adjustment required.
Moderate: No dose adjustment required.
Severe: No dose adjustment required (glycopyrrolate is primarily renally eliminated with minimal hepatic metabolism).

Pharmacology

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Mechanism of Action

Glycopyrrolate is a long-acting muscarinic antagonist (LAMA), often referred to as an anticholinergic. It works by blocking the action of acetylcholine at M3 muscarinic receptors in the smooth muscle of the airways, leading to bronchodilation. This antagonism is reversible and dose-dependent.
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Pharmacokinetics

Absorption:

Bioavailability: Low systemic exposure (absolute bioavailability not precisely determined but estimated to be low after inhalation).
Tmax: Approximately 5 minutes (for peak plasma concentration after inhalation).
FoodEffect: Not applicable for inhaled solution.

Distribution:

Vd: Approximately 6.2 L/kg (apparent volume of distribution after IV administration).
ProteinBinding: Approximately 38% to 41% (in vitro).
CnssPenetration: Limited (due to its quaternary ammonium structure, which limits passage across the blood-brain barrier).

Elimination:

HalfLife: Terminal half-life of approximately 15 hours (after inhalation).
Clearance: Systemic clearance approximately 1.1 L/min (after IV administration).
ExcretionRoute: Primarily renal excretion (60-70% unchanged in urine); some fecal excretion.
Unchanged: Approximately 60-70% (in urine).
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Pharmacodynamics

OnsetOfAction: Within minutes (typically 5-10 minutes).
PeakEffect: Within 1-3 hours.
DurationOfAction: Approximately 12 hours (allowing for twice-daily dosing).

Safety & Warnings

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Side Effects

Serious 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 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
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Changes in eyesight, eye pain, or severe eye irritation
Seeing halos or bright colors around lights
Red eyes
Severe upset stomach or vomiting
Trouble passing urine, pain when passing urine, weak urine stream, or frequent urination
Cloudy urine that may contain blood
Fast or abnormal heartbeat
Diarrhea, stomach pain, upset stomach, or vomiting

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 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 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 or seek medical attention:

Nose or throat irritation

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 immediately after using the nebulizer (paradoxical bronchospasm).
  • Eye pain or discomfort, blurred vision, or seeing halos around lights (especially if you have glaucoma).
  • Difficulty urinating, painful urination, or inability to urinate (especially if you have prostate enlargement).
  • Signs of an allergic reaction, such as rash, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing or swallowing.
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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, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking a similar medication or have taken one in the past. If you are unsure, consult your doctor or pharmacist for clarification.
Use of anticholinergic medications, such as ipratropium or oxybutynin. If you are unsure whether a medication you are taking is an anticholinergic, ask your doctor for confirmation.
If the patient is a child, as this medication is not approved for pediatric use.

This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to your doctor and pharmacist. This will help ensure your safety while taking 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 and your individual health profile.
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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 drug affects you.

Adhere strictly to your doctor's instructions regarding dosage and frequency of use. Using more than prescribed, or using it more often or for a longer duration than recommended, can increase the risk of severe side effects.

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.

If the medication accidentally 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 are 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:

  • Exaggerated anticholinergic effects: dry mouth, blurred vision, increased heart rate (tachycardia), urinary retention, constipation, dizziness, confusion.

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic.

Drug Interactions

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Moderate Interactions

  • Other anticholinergic drugs (e.g., tiotropium, umeclidinium, aclidinium, ipratropium, atropine, tricyclic antidepressants, phenothiazines, disopyramide, quinidine)

Monitoring

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Baseline Monitoring

Pulmonary function tests (e.g., FEV1)

Rationale: To establish baseline lung function and assess disease severity.

Timing: Prior to initiation of therapy.

Cardiac history and rhythm

Rationale: To assess for pre-existing cardiac conditions that may be exacerbated by anticholinergics (e.g., narrow-angle glaucoma, urinary retention).

Timing: Prior to initiation of therapy.

History of narrow-angle glaucoma or urinary retention

Rationale: To identify contraindications or conditions requiring caution.

Timing: Prior to initiation of therapy.

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Routine Monitoring

COPD symptoms (e.g., dyspnea, cough, wheezing)

Frequency: Regularly, 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, constipation)

Frequency: Regularly, at each follow-up visit.

Target: Absence or mild, tolerable symptoms.

Action Threshold: Significant or bothersome anticholinergic effects may require dose adjustment or discontinuation.

Inhaler technique

Frequency: Periodically, especially if symptoms are not well controlled.

Target: Correct and consistent use of the Magnair Nebulizer System.

Action Threshold: Incorrect technique can lead to suboptimal drug delivery and reduced efficacy.

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Symptom Monitoring

  • Worsening shortness of breath
  • Increased cough or sputum production
  • Chest tightness
  • Paradoxical bronchospasm (immediate worsening of breathing after inhalation)
  • Eye pain or discomfort
  • Blurred vision or halos around lights (signs of acute narrow-angle glaucoma)
  • Difficulty urinating or painful urination (signs of urinary retention)

Special Patient Groups

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Pregnancy

There are no adequate and well-controlled studies of Lonhala Magnair in pregnant women. Use during pregnancy 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 for developmental effects at high doses.
Second Trimester: Limited human data; animal studies suggest potential for developmental effects at high doses.
Third Trimester: Limited human data; animal studies suggest potential for developmental effects at high doses. Anticholinergics may inhibit uterine contractions.
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Lactation

It is not known whether glycopyrrolate is excreted in human milk. Glycopyrrolate and its metabolites are excreted in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lonhala Magnair and any potential adverse effects on the breastfed child from Lonhala Magnair or from the underlying maternal condition. Caution should be exercised when Lonhala Magnair is administered to a nursing woman.

Infant Risk: Risk unknown; potential for anticholinergic effects in the infant. Monitor for signs of anticholinergic effects (e.g., dry mouth, constipation, urinary retention, sedation).
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Pediatric Use

The safety and effectiveness of Lonhala Magnair in pediatric patients have not been established. It is not indicated for use in children.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, elderly patients may be more susceptible to anticholinergic effects (e.g., urinary retention, glaucoma exacerbation). Dose adjustment is generally not required, but monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Lonhala Magnair is a maintenance bronchodilator for COPD and should not be used for acute bronchospasm.
  • It must be administered using the Magnair Nebulizer System only; other nebulizers are not compatible.
  • Patients should be instructed on proper nebulizer technique to ensure optimal drug delivery.
  • Advise patients to report any signs of narrow-angle glaucoma (e.g., eye pain, blurred vision, halos) or urinary retention (e.g., difficulty urinating).
  • Concomitant use with other anticholinergic medications should be avoided due to the risk of additive adverse effects.
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Alternative Therapies

  • Other long-acting muscarinic antagonists (LAMAs) for COPD: tiotropium (Spiriva), umeclidinium (Incruse Ellipta), aclidinium (Tudorza Pressair), revefenacin (Yupelri).
  • Long-acting beta-agonists (LABAs) for COPD: salmeterol, formoterol, indacaterol, olodaterol.
  • Combination LAMA/LABA inhalers (e.g., Anoro Ellipta, Trelegy Ellipta, Bevespi Aerosphere, Stiolto Respimat).
  • Inhaled corticosteroids (ICS) for patients with frequent exacerbations or eosinophilic phenotype (often in combination with LABA/LAMA).
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Cost & Coverage

Average Cost: $300 - $500 per 60 single-use vials (1 month supply)
Insurance Coverage: Tier 3 or higher (Specialty/Non-preferred Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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 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 medication, including the amount taken and the time it happened, to ensure you receive the best possible care.