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SEEBRI NEOHALER

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Overview

What is SEEBRI NEOHALER?

SEEBRI NEOHALER consists of SEEBRI capsules and a NEOHALER device. Each SEEBRI capsule contains a dry powder formulation of glycopyrrolate packaged in orange transparent hypromellose (HPMC) capsules for oral inhalation with the NEOHALER device only.

Each orange transparent HPMC capsule contains 15.6 mcg of glycopyrrolate blended with approximately 25 mg of lactose monohydrate (which contains trace levels of milk protein) and 0.04 mg of magnesium stearate.

Glycopyrrolate, the active component of SEEBRI NEOHALER, is chemically described as (3RS)-3-[(2SR)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl) oxy]-1,1-dimethylpyrrolidinium bromide. This synthetic quaternary ammonium compound acts as a competitive antagonist at muscarinic acetylcholine receptors, also referred to as anticholinergic. Glycopyrrolate, CHBrNO, is a white powder that is freely soluble in water and sparingly soluble in absolute ethanol. It has a molecular mass of 398.33. The structural formula is:

The NEOHALER device is an inhalation device used to inhale the dry powder within the SEEBRI capsule. The amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow rate and inspiratory time. Under standardized in vitro testing at a fixed flow rate of 90 L/min for 1.3 seconds, the NEOHALER device delivered 13.1 mcg for the 15.6 mcg dose strength (equivalent to 12.5 mcg of glycopyrronium) from the mouthpiece. This in vitro testing revealed that the NEOHALER device had a specific resistance of 0.07 cm HO/L/min. Peak inspiratory flow rates (PIFR) achievable through the NEOHALER device were evaluated in 26 adult patients with COPD of varying severity. Mean PIFR was 95 L/min (range 52 to 133 L/min) for adult patients. Twenty-five of 26 patients (96%) in this study generated a PIFR through the device exceeding 60 L/min.



What does SEEBRI NEOHALER look like?



What are the available doses of SEEBRI NEOHALER?

Inhalation powder: SEEBRI NEOHALER consists of SEEBRI capsules containing glycopyrrolate powder for oral inhalation and the NEOHALER device. SEEBRI capsules contain 15.6 mcg of glycopyrrolate in an orange transparent hypromellose (HPMC) capsule with the product code “GPL15.6” printed in black and the logo () printed with two radial black bars.

What should I talk to my health care provider before I take SEEBRI NEOHALER?

How should I use SEEBRI NEOHALER?

SEEBRI™ NEOHALER 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 SEEBRI capsules, as the intended effects on the lungs will not be obtained. SEEBRI capsules should only be used with the NEOHALER device

[see Overdosage ()]

The recommended dose of SEEBRI NEOHALER is the inhalation of the contents of one SEEBRI capsule twice-daily using the SEEBRI NEOHALER device.

SEEBRI NEOHALER should be administered at the same time of the day, (1 capsule in the morning and 1 capsule in the evening), every day. More frequent administration or a greater number of inhalations (more than 1 capsule twice-daily) of SEEBRI NEOHALER is not recommended.

Store SEEBRI capsules in the blister, and only remove IMMEDIATELY BEFORE USE with the NEOHALER device.

No dosage adjustment is required for geriatric patients, patients with hepatic impairment, or patients with mild to moderate renal impairment.


What interacts with SEEBRI NEOHALER?

Sorry No Records found


What are the warnings of SEEBRI NEOHALER?

Sorry No Records found


What are the precautions of SEEBRI NEOHALER?

Sorry No Records found


What are the side effects of SEEBRI NEOHALER?

Sorry No records found


What should I look out for while using SEEBRI NEOHALER?

SEEBRI NEOHALER is contraindicated in patients who have demonstrated hypersensitivity to glycopyrrolate or to any of the ingredients .


What might happen if I take too much SEEBRI NEOHALER?

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, repeated orally inhaled administration of SEEBRI NEOHALER at total doses of 124.8 and 249.6 mcg once-daily for 28 days were well tolerated.

Accidental ingestion:

[see Clinical Pharmacology ()]

Peak plasma levels and total systemic exposure following intravenous administration of 150 mcg glycopyrrolate (equivalent to 120 mcg active moiety) in healthy volunteers were respectively about 270-fold and 13-fold higher than the peak and total systemic exposure at steady-state achieved with the recommended daily dose of 31.2 mcg of glycopyrrolate (i.e., 15.6 mcg glycopyrrolate twice-daily) and were well-tolerated.


How should I store and handle SEEBRI NEOHALER?

Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children. Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children. Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children. Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows:WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows:WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows:WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.


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Clinical Information

Chemical Structure

No Image found
Clinical 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, glycopyrrolate 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 in vitro as well as in vivo studies, prevention of methacholine-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
SEEBRI NEOHALER is contraindicated in patients who have demonstrated hypersensitivity to glycopyrrolate or to any of the ingredients .

Ceftriaxone – see

Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids.

Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with drugs for which renal elimination is pH dependent. Due to the alkalinizing action of lactate (formation of bicarbonate), Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may interfere with the elimination of such drugs.- Renal clearance of acidic drugs such as salicylates and barbiturates may be increased. - Renal clearance of alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine) and dextroamphetamine (dexamphetamine) sulfate, may be decreased.

Renal clearance of lithium may also be increased. Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with lithium.

Because of its potassium content, administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be avoided in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. Administration of potassium in patients treated with such medications can produce severe and potentially fatal hyperkalemia, particularly in patients with severe renal insufficiency.

Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.

SEEBRI NEOHALER should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD. SEEBRI NEOHALER has not been studied in subjects with acutely deteriorating COPD. The initiation of SEEBRI NEOHALER in this setting is not appropriate.

SEEBRI NEOHALER should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. SEEBRI NEOHALER 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 SEEBRI NEOHALER no longer controls symptoms of bronchoconstriction; the patient's inhaled, short-acting beta-agonist becomes less effective; or the patient needs more inhalation 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 SEEBRI NEOHALER beyond the recommended dose is not appropriate in this situation.

The following adverse reactions are described in greater detail, in other sections

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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