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LONHALA MAGNAIR
Overview
What is LONHALA MAGNAIR?
LONHALA MAGNAIR consists of LONHALA vials and a MAGNAIR nebulization system. LONHALA (glycopyrrolate) Inhalation Solution is a sterile, clear, colorless, aqueous solution for oral inhalation.
Glycopyrrolate USP, the active component of LONHALA Inhalation Solution, is chemically described as (3RS)-3-[(2SR)-(2-cyclopentyl-2-hydroxy-2-penylacetyl)oxy]-1,1-dimethlypyrrolidinium bromide. Glycopyrrolate is a synthetic quaternary ammonium compound that acts as a competitive antagonist at muscarinic acetylcholine receptors, also referred to as an anticholinergic. Glycopyrrolate, CHBrNO is a white, odorless, crystalline powder that is soluble in water and in alcohol. It has a molecular mass of 398.33. The structural formula is:
The inactive ingredients in LONHALA are: citric acid monohydrate, sodium chloride, sodium hydroxide and water for injection.
LONHALA Inhalation Solution is supplied in low-density polyethylene (LDPE) unit dose vials, each containing 1.0 mL of the solution. Each unit-dose vial contains 25 mcg of glycopyrrolate in a sterile, isotonic saline solution, pH-adjusted to 4.0 with citric acid and sodium hydroxide.
Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors. Under standardized testing per USP<1601> adult breathing pattern (500 mL tidal volume, 15 breaths per minute, and inhalation: exhalation ratio of 1:1), the mean delivered dose from the mouthpiece was approximately 14.2 mcg of glycopyrrolate (equivalent to 11.4 mcg glycopyrronium and 56.8% label claim). The mass median aerodynamic diameter (MMAD) of the nebulized aerosol particles/droplets is 3.71 μm 95% CI (2.92 - 4.49 μm) as determined using the Next Generation Impactor (NGI) method. The mean nebulization time was approximately 2 to 3 minutes.
What does LONHALA MAGNAIR look like?
What are the available doses of LONHALA MAGNAIR?
LONHALA Inhalation Solution is supplied 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. ()
What should I talk to my health care provider before I take LONHALA MAGNAIR?
Use in patients with severe renal impairment should be considered if the potential benefit of the treatment outweighs the risk. ()
How should I use LONHALA MAGNAIR?
LONHALA MAGNAIR is indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
For oral inhalation only. Do not swallow LONHALA solution. LONHALA vials should only be used with MAGNAIR
[see Overdosage ()]
The recommended dose of LONHALA is the inhalation of the contents of one LONHALA vial twice-daily using MAGNAIR. LONHALA vials should only be administered with MAGNAIR. Patients should be instructed on the correct use of this drug product and device.
LONHALA MAGNAIR should be administered at the same time of the day, (1 vial in the morning and 1 vial in the evening), every day. More frequent administration or a greater number of inhalations (more than 1 vial twice daily) of LONHALA MAGNAIR is not recommended.
Store LONHALA vials in the foil pouch, and only remove IMMEDIATELY BEFORE USE with MAGNAIR.
No dosage adjustment is required for geriatric patients, patients with hepatic impairment, or patients with mild to moderate renal impairment.
What interacts with LONHALA MAGNAIR?
Sorry No Records found
What are the warnings of LONHALA MAGNAIR?
Sorry No Records found
What are the precautions of LONHALA MAGNAIR?
Sorry No Records found
What are the side effects of LONHALA MAGNAIR?
Sorry No records found
What should I look out for while using LONHALA MAGNAIR?
LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity to glycopyrrolate or any of the ingredients [].
What might happen if I take too much LONHALA MAGNAIR?
An overdose of glycopyrrolate may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances, or reddening of the eye), obstipation or difficulties in voiding.
In COPD patients, orally inhaled administration of LONHALA MAGNAIR at a total daily dose of 200 mcg for 28 consecutive days (maximum of 1 mg) was well tolerated. Pharmacokinetic results from several studies conducted in COPD patients showed that a single, well tolerated dose of 1000 mcg had a C of 1534 pg/mL and AUC of 5271 pg*hr/mL. These values are approximately 44 fold and 21 fold higher, respectively, than the estimated daily C of 34.5 pg/mL and AUC of 255 pg*hr/mL for a 25 mcg BID dose regimen at steady-state.
How should I store and handle LONHALA MAGNAIR?
Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children. Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children. Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children. Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 90. Bottles of 90 NDC 43063-549-90 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 90. Bottles of 90 NDC 43063-549-90 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 90. Bottles of 90 NDC 43063-549-90 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 90. Bottles of 90 NDC 43063-549-90 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 90. Bottles of 90 NDC 43063-549-90 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 90. Bottles of 90 NDC 43063-549-90 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 90. Bottles of 90 NDC 43063-549-90 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical as well as studies, prevention of methacholine and acetylcholine induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of glycopyrrolate is predominantly a site-specific effect.
Non-Clinical Toxicology
LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity to glycopyrrolate or any of the ingredients [].When given concurrently the following drugs may interact with thiazide diuretics.
Alcohol, barbiturates, or narcotics
Antidiabetic drugs
Other antihypertensive drugs
Cholestyramine and colestipol resins
Corticosteroids, ACTH
Pressor amines (e.g., norepinephrine)
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)
Lithium
Non-steroidal Anti-inflammatory Drugs
LONHALA MAGNAIR should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD. LONHALA MAGNAIR has not been studied in subjects with acutely deteriorating COPD. The initiation of LONHALA MAGNAIR in this setting is not appropriate.
LONHALA MAGNAIR should not be used as rescue therapy for the treatment of acute episodes of bronchospasm. LONHALA MAGNAIR has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta-agonist.
COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If LONHALA MAGNAIR no longer controls symptoms of bronchoconstriction the patient's inhaled, short-acting beta-agonist becomes less effective; or the patient needs more inhalations of a short-acting beta-agonist than usual, these may be markers of deterioration of disease. In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dose of LONHALA MAGNAIR beyond the recommended dose is not appropriate in this situation.
The following adverse reactions are described in greater detail in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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