NDC 60687-458 Glycopyrrolate

Glycopyrrolate

NDC Product Code 60687-458

NDC Code: 60687-458

Proprietary Name: Glycopyrrolate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Glycopyrrolate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
Y;08
Score: 2

NDC Code Structure

  • 60687 - American Health Packaging

NDC 60687-458-01

Package Description: 100 BLISTER PACK in 1 BOX, UNIT-DOSE > 1 TABLET in 1 BLISTER PACK (60687-458-11)

NDC Product Information

Glycopyrrolate with NDC 60687-458 is a a human prescription drug product labeled by American Health Packaging. The generic name of Glycopyrrolate is glycopyrrolate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: American Health Packaging

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Glycopyrrolate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GLYCOPYRROLATE 1 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: American Health Packaging
Labeler Code: 60687
FDA Application Number: ANDA202675 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-20-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Glycopyrrolate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Glycopyrrolate tablets, USP contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide.Each 1 mg tablet contains:


Glycopyrrolate, USP......... 1 mg


Inactive Ingredients: dibasic calcium phosphate dihydrate, lactose monohydrate, magnesium Stearate, povidone, and sodium starch glycolate.

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 sulfate and scopolamine hydrobromide, which are non-polar tertiary amines which penetrate lipid barriers easily.

Indications And Usage

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

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.

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

Precautions

  • Use Glycopyrrolate tablets 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 “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.

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 administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.

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.

Dosage And Administration

The dosage of glycopyrrolate tablets


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 tablets 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 are not recommended for use in pediatric patients under the age of 12 years.DRUG INTERACTIONSThere are no known drug interactions.

How Supplied

Glycopyrrolate Tablets USP, 1 mg are white to off-white, round, beveled edge uncoated tablets, debossed with 'Y' and break line on one side and '08' on the other side.


Unit dose packages of 100 (10 x 10) NDC 60687-458-01


Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].


Keep this and all medication out of the reach of children.


FOR YOUR PROTECTION: Do not use if blister is torn or broken.Trademarks are the property of their respective owners.

Packaging Information

American Health Packaging unit dose blisters (see
HOW SUPPLIED section) contain drug product from Aurobindo Pharma USA, Inc. as follows:

(1 mg / 100 UD) NDC 60687-458-01 packaged from NDC 13107-014
Distributed by:
American Health Packaging
Columbus, OH 43217
8445801/0419

Package/Label Display Panel – Carton – 1Mg

NDC 60687-
458-01
Glycopyrrolate
Tablets, USP           WHITE DYE-FREE
1 mg100 Tablets (10 x 10)              Rx OnlyEach Tablet Contains:
Glycopyrrolate, USP...........................................................1 mg
Usual Dosage: One or two tablets three times a day. See

package insert for full prescribing information.
Store at 20° to 25°C (68° to 77°F); excursions permitted

between 15° to 30°C (59° to 86°F) [see USP Controlled Room

Temperature].
Keep this and all drugs out of reach of children.FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from

NDC # 13107-014, Aurobindo Pharma USA, Inc.
Packaged and Distributed by:

American Health Packaging

Columbus, Ohio 43217
745801

0445801/0419

Package/Label Display Panel – Blister – 1Mg

Glycopyrrolate

Tablet, USP
1 mg

* Please review the disclaimer below.