Glycopyrrolate Oral Inhalation

What is Glycopyrrolate Oral Inhalation?

• Glycopyrrolate Oral Inhalation (Lonhala Magnair; Seebri) is an anticholinergic used as a long term treatment to control wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease.

Glycopyrrolate

Glycopyrronium bromide

What are the uses of this medicine?

• Glycopyrrolate Oral Inhalation (Lonhala Magnair; Seebri) is used for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
• Anticholinergic medicines such as Lonhala Magnair help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath. This makes it hard to breathe.

Limitations of use:

• Lonhala Magnair is not used to treat sudden symptoms of COPD.
• Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD.
• If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

How does this medicine work?

• Glycopyrrolate is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic.
• It has similar affinity to the subtypes of muscarinic receptors M1 to M5.
• In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.
• Prevention of methacholine and acetylcholine induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours.
• The bronchodilation following inhalation of glycopyrrolate is predominantly a site-specific effect.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a hypersensitivity to glycopyrrolate or any of the ingredients.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• antihistamines
• atropine (in Lomotil, Motofen)
• other medications for COPD including aclidinium (Tudorza Pressair), ipratropium (Atrovent HFA, in Combivent Respimat), tiotropium (Spiriva, in Stioloto Respimat), and umeclidinium (Incruse Ellipta, in Anoro Ellipta, Trelegy Ellipta)
• oral glycopyrrolate (Cuvposa, Robinul)
• medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems

Is this medicine FDA approved?

• Glycopyrronium was first used in 1961.

How should this medicine be used?

Recommended dosage:

• Maintenance treatment of COPD: The contents of one Lonhala vial twice-daily.

Administration:

• Glycopyrrolate oral inhalation comes as a powder-filled capsule to inhale by mouth using a special inhaler and as a solution to inhale by mouth using a special nebulizer.
• It is usually inhaled twice a day, once in the morning and once in the evening. Inhale glycopyrrolate at around the same times every day.
• Do not swallow gylcopyrrolate capsules or nebulizer solution.
• Do not use glycopyrrolate oral inhalation during a sudden COPD attack.
• Your doctor will prescribe a short-acting inhaler to use during COPD attacks.
• Before you use glycopyrrolate oral inhalation for the first time, read the written instructions that come with the inhaler or nebulizer.
• Ask your doctor, pharmacist, or respiratory therapist to show you how to assemble and use the inhaler or nebulizer.
• Practice using the inhaler or nebulizer while he or she watches.
• Do not use the nebulizer or inhaler to inhale any other medications.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a sterile solution for inhalation in a unit-dose single-use low-density polyethylene (LDPE) vial. Each 1 mL vial contains 25 mcg of glycopyrrolate.

This medicine is available in fallowing brand namesː

• Lonhala Magnair; Seebri

What side effects can this medication cause?

The most common side effects of this medicine include:

• shortness of breath, and urinary tract infections.

Glycopyrrolate Oral Inhalation can cause serious side effects, including:

• sudden shortness of breath immediately after use
• serious allergic reactions
• new or worsened eye problems including acute narrow-angle glaucoma
• urinary retention

What special precautions should I follow?

• Lonhala Magnair is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise them to treat acute symptoms with a rescue inhaler such as albuterol. Provide patients with such medicine and instruct them in how it should be used.

Instruct patients to seek medical attention immediately if they experience any of the following:

• Symptoms get worse
• Need for more inhalations than usual of their rescue inhaler

• Lonhala Magnair can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue Lonhala Magnair.
• Lonhala Magnair should be used with caution in patients with narrow-angle glaucoma. Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develop.
• Lonhala Magnair should be used with caution in patients with urinary retention. Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately if any of these signs or symptoms develop.
• There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances, or reddening of the eye), obstipation or difficulties in voiding.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Glycopyrrolate Oral Inhalation should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus.

Can this medicine be used in children?

• The safety and efficacy of Glycopyrrolate Oral Inhalation in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Lonhala Magnair:

• Active ingredient: glycopyrrolate
• Inactive ingredients: citric acid monohydrate, sodium chloride, sodium hydroxide and water for injection.

Who manufactures and distributes this medicine?

Lonhala Magnair: Manufactured for:

• Sunovion Respiratory Development Inc.,
• a wholly-owned subsidiary of Sunovion Pharmaceuticals Inc.
• Marlborough, MA

What should I know about storage and disposal of this medication?

• Store Lonhala vials in the protective foil pouch at room temperature between 68°F and 77°F (20°C and 25°C).
• Lonhala vials should be used with the Magnair device only. Do not use Magnair with any other medicine.

• Dailymed label info on Glycopyrrolate Oral Inhalation
• FDA Glycopyrrolate Oral Inhalation

Glycopyrrolate Oral Inhalation Resources
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