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Glycopyrrolate Tablets, USP 1 mg and Glycopyrrolate Tablets, USP 2 mg | Glycopyrrolate [Heritage Pharmaceuticals Inc] | BioPortfolio

12:54 EST 27th January 2019 | BioPortfolio
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Glycopyrrolate Tablets, USP contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compoundwith the following chemical name:

3-[(cyclopentylhydroxyphenylacetyl) oxy]-1, 1 di-methyl bromide.

Glycopyrrolate Tablets, USP 1 mg are white to off-white, round, flat beveled edge tablet debossed with “MCR 117” separated by break line on one side and plain on other side.Each tablet contains: Glycopyrrolate, USP 1 mg.

Glycopyrrolate Tablets, USP 2 mg are white to off white, round, flat beveled edge tablet debossed with “AC 108” separated by break line onone side and plain on other side.Each tablet contains: Glycopyrrolate, USP 2 mg

Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate.

ACTIONS Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptorsare present in the autonomic effector cells of smooth muscle, cardiac muscle, the sino-atrial node, the atrioventricular node, exocrine glands,and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessivepharyngeal, tracheal, and bronchial secretions.

Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea,  bronchospasm, bradycardia, and intestinal hypermotility) induced by  cholinergic drugs such as the anticholinesterases.

The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are non-polar tertiary amines which penetrate lipid barriers easily.

For use as adjunctive therapy in the treatment of peptic ulcer.

Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinaltract (as in achalasia, pyloroduodenal stenosis,etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Glycopyrrolate Tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of Glycopyrrolate Tablets.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

Glycopyrrolate may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mentalalertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug.

Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.

Pregnancy

The safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child. Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning,in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such experience has revealed no reports of teratogenic or other fetus-damaging potential. No controlled studies to establish the safety of the drug in pregnancy have been performed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Pediatric Use

Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.

Use Glycopyrrolate Tablets with caution in the elderly and in all patients

with:

There are no known drug interactions.

Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions. Adverse reactions to anticholinergics in general may include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations.

Glycopyrrolate is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier, is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.

The symptoms of overdosage of glycopyrrolate are peripheral in  nature rather than central.

The dosage of Gylcopyrrolate Tablets, USP 1 mg and 2 mg should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of glycopyrrolate is 8 mg.

Glycopyrrolate Tablets, USP 1 mg: The recommended initial dosage of Glycopyrrolate Tablets, USP 1 mg for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate.

Glycopyrrolate Tablets, USP 2 mg: The recommended dosage of Glycopyrrolate Tablets, USP 2 mg for adults is one tablet two or three times daily at equally spaced intervals.

Glycopyrrolate Tablets are not recommended for use in pediatric patients under the age of 12 years.

Glycopyrrolate Tablets, USP 1 mg are white to off-white, round, flat beveled edge tablet debossed with “MCR 117” separated by break line on one side and plain on other side. Packaged in bottles of 100.

Glycopyrrolate Tablets, USP 1 mg tablets in bottles of 100 (NDC 23155-606-01).

Glycopyrrolate Tablets, USP 2 mg are white to off white, round, flat beveled edge tablet debossed with “AC 108” separated by break line on one side and plain on other side. Packaged in bottles of 100.

Glycopyrrolate Tablets, USP 2 mg tablets in bottles of 100 (NDC 23155-607-01).

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59°- 86°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

Dispense in tight container.

Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 088161.866.901.DRUG (3784)

200146

Rev: 02/18

Manufacturer

Heritage Pharmaceuticals Inc.

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A group of 6 able-bodied healthy volunteers will receive Neostigmine (NEO) and Glycopyrrolate (GLY) intravenously and via 3 different methods of Iontophoresis (ION) with subsequent blood d...

Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®)

This study is intended to evaluate the efficacy and safety of glycopyrrolate as an antisialagogue prior to intubation with the rigid-videostylet(Optiscope®) in the general anesthesia sett...

Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children

Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and blood pressure in children.To differentiate between contractility and the effect of the circulati...

Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Glycopyrrolate (AIDES-G)

The study consists of measurement of antidepressant-induced excessive sweating and its treatment with an experimental medication, glycopyrrolate (approved to treat ulcers), which will be a...

Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary

The study assessed the safety and ability of an orally inhaled medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered using an eFlow nebul...

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Effect of smoking status on lung function, patient-reported outcomes, and safety among patients with COPD treated with indacaterol/glycopyrrolate: Pooled analysis of the FLIGHT1 and FLIGHT2 studies.

Smoking continues to be a major risk factor for COPD and may impact the efficacy of COPD treatments, with guidelines supporting the crucial importance for current smokers of smoking cessation. A post-...

Identification of major esterase involved in hydrolysis of soft anticholinergic (2R3'R-SGM) designed from glycopyrrolate in human and rat tissues.

The glycopyrrolate soft analogue, SGM, designed to be easily hydrolyzed into the significantly less active zwitterionic metabolite, SGa, typifies soft drug that reduces systemic side effects (a proble...

A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 μg and 160/18/9.6 μg using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol.

Single inhaler triple therapies providing an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting β-agonist (ICS/LAMA/LABAs) are an emerging treatment option for chronic obs...

The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease.

Chronic cough, dyspnea, and excessive sputum production, the characteristic symptoms of chronic obstructive pulmonary disease (COPD), can negatively affect patients' health-related quality of life (HR...

Hypersalivation - Update of the S2k guideline (AWMF) in short form.

Hypersalivation describes a relatively excessive salivary flow, which wets the patient himself and his surroundings. It may result because of insufficient oro-motor function, dysphagia, decreased cent...

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