Glycopyrrolate
Par Pharmaceutical, Inc.
Human Prescription Drug
NDC 49884-065Glycopyrrolate is a human prescription drug labeled by 'Par Pharmaceutical, Inc.'. National Drug Code (NDC) number for Glycopyrrolate is 49884-065. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Glycopyrrolate drug includes Glycopyrrolate - 1 mg/1 . The currest status of Glycopyrrolate drug is Active.
Drug Information:
| Drug NDC: | 49884-065 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Glycopyrrolate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Glycopyrrolate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Par Pharmaceutical, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | GLYCOPYRROLATE - 1 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 26 Sep, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA040653 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Par Pharmaceutical, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197738
197739
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0349884066017
|
| UPC stands for Universal Product Code. |
| UNII: | V92SO9WP2I
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Anticholinergic [EPC]
Cholinergic Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 49884-065-01 | 100 TABLET in 1 BOTTLE (49884-065-01) | 26 Sep, 2006 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Glycopyrrolate glycopyrrolate glycopyrrolate glycopyrronium calcium phosphate, dibasic, dihydrate lactose, unspecified form magnesium stearate povidone sodium starch glycolate type a potato k;400 glycopyrrolate glycopyrrolate glycopyrrolate glycopyrronium calcium phosphate, dibasic, dihydrate lactose, unspecified form magnesium stearate povidone sodium starch glycolate type a potato k;401
Drug Interactions:
Drug interactions there are no known drug interactions.
Indications and Usage:
Indications and usage for use as adjunctive therapy in the treatment of peptic ulcer.
Warnings:
Warnings in the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of glycopyrrolate. diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomyor colostomy . in this instance treatment with this drug would be inappropriate and possibly harmful. glycopyrrolate may produce drowsiness and 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. pregnancy the safety of this drug during pregnancy has not been established. the use of any drug during pregnancy requires that potential benefits of the drug be weighed against possible hazards to mother and chi
Read more...ld. 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.
Dosage and Administration:
Dosage and administration the dosage of glycopyrrolate 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 1 mg. the recommended initial dosage of glycopyrrolate 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 2 mg. the recommended dosage of glycopyrrolate 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.
Contraindications:
Contraindications 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.
Adverse Reactions:
Adverse reactions 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 administra
Read more...tion of anticholinergics which are chemically tertiary amines that can cross this barrier readily.
Drug Interactions:
Drug interactions there are no known drug interactions.
Use in Pregnancy:
Pregnancy the safety of this drug during pregnancy has not been established. the use of any drug during pregnancy requires that 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.
Pediatric Use:
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.
Overdosage:
Overdosage the symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central. to guard against further absorption of the drug-use gastric lavage, cathartics and/or enemas. to combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)-utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate. to combat hypotension-use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care. to combat respiratory depression-administer oxygen; utilize a respiratory stimulant such as dopram®* i.v.; artificial respiration.
Description:
Description glycopyrrolate tablets contain the synthetic anticholinergic glycopyrrolate. glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. its empirical formula is c 19 h 28 brno 3 , its molecular weight is 398.33, and its structural formula is: each 1 mg tablet contains: glycopyrrolate, usp 1mg each 2 mg tablet contains: glycopyrrolate, usp 2mg inactive ingredients: dibasic calcium phosphate, lactose, magnesium stearate, povidone, sodium starch glycolate this is the structure
Clinical Pharmacology:
Clinical 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 but 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 s
Read more...ulfate and scopolamine hydrobromide, which are non-polar tertiary amines which penetrate lipid barriers easily.
How Supplied:
How supplied glycopyrrolate tablets 1 mg are bisected, compressed white, round tablets debossed âkâ above the bisect and â400â below the bisect on one side of the tablet, and plain on the other side. available in bottles of 100 (ndc 49884-065-01). glycopyrrolate tablets 2 mg are bisected, compressed white, round tablets debossed âkâ above the bisect and â401â below the bisect on one side of the tablet, and plain on the other side. available in bottles of 100 (ndc 49884-066-01). store at 20°-25°c (68°-77°f); excursions permitted to 15°-30°c (59°-86°f) [see usp controlled room temperature]. dispense in tight container. rx only * dopram ® is a registered trademark of baxter healthcare corporation. manufactured by: par pharmaceutical companies, inc. spring valley, ny 10977 rev: 07/2010 os065-01-1-02
Package Label Principal Display Panel:
Principal display panel - 1mg/100's label this is the 1mg label
Principal display panel - 2mg/100's label this is the 2mg label