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Glycopyrrolate
Overview
What is Glycate?
Glycopyrrolate Tablets, USP 1.5 mg contains the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyacetyl)oxy]-1,1-dimethylpyrrolidinium bromide.
Each tablet contains:
Glycopyrrolate, USP………..1.5 mg
Inactive Ingredients
What does Glycate look like?
What are the available doses of Glycate?
Sorry No records found.
What should I talk to my health care provider before I take Glycate?
Sorry No records found
How should I use Glycate?
For use as adjunctive therapy in the treatment of peptic ulcer.
The dosage of Glycopyrrolate Tablets, USP 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.
For maintenance, a dosage of one tablet twice a day is frequently adequate.
Glycopyrrolate Tablets, USP 2 mg.
Glycopyrrolate Tablets, USP 1.5 mg.
Glycopyrrolate Tablets, USP are not recommended for use in pediatric patients under the age of 12 years.
What interacts with Glycate?
Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (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.
What are the warnings of Glycate?
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of Glycopyrrolate Tablets, USP.
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 Tablets, USP may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness 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.
What are the precautions of Glycate?
Use Glycopyrrolate Tablets, USP with caution in the elderly and in all patients with:
• Autonomic neuropathy.
• Hepatic or renal disease.
• Ulcerative colitis - large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate the "toxic megacolon," a serious complication of the disease.
• Hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, hypertension and prostatic hypertrophy.
• Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition.
Interactions
There are no known drug interactions.
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 know 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.
What are the side effects of Glycate?
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; dilation 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 Tablets, USP 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.
What should I look out for while using Glycate?
Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (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 the use of Glycopyrrolate Tablets, USP.
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 Tablets, USP may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness 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.
What might happen if I take too much Glycate?
The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central.
1. To guard against further absorption of the drug - use gastric lavage, cathartics, and/or enemas.
2. To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.) - utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.
3. To combat hypotension - use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care.
4. To combat respiratory depression - administer oxygen; utilize a respiratory stimulant such as Dopram® i.v.; artificial respiration.
How should I store and handle Glycate?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097Glycate™ (Glycopyrrolate Tablets, USP) 1.5 mg are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 59547-210-19).Store at 20ºC to 25ºC (68ºF to 77ºF);excursions permitted to 15ºC to 30ºC(59ºF to 86ºF) [See USP ControlledRoom Temperature]. Keep out ofreach of children.Dispense in tight container.Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Manufactured for:Nuro Pharma, Inc.Las Vegas, NV 89118Rev. 09/137097
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 by lack cholinergic innervation. These peripheral cholinergic receptors are 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 excessive pharyngeal, 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.
Non-Clinical Toxicology
Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (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 the use of Glycopyrrolate Tablets, USP.
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 Tablets, USP may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness 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.
There are no known drug interactions.
Use Glycopyrrolate Tablets, USP with caution in the elderly and in all patients with:
• Autonomic neuropathy.
• Hepatic or renal disease.
• Ulcerative colitis - large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate the "toxic megacolon," a serious complication of the disease.
• Hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, hypertension and prostatic hypertrophy.
• Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition.
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; dilation 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 Tablets, USP 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.
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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