Your browser does not support JavaScript! GLYCOPYRROLATE TABLET [RANBAXY PHARMACEUTICALS INC.]
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GLYCOPYRROLATE tablet
[Ranbaxy Pharmaceuticals Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.

Its molecular structure is as follows:This is the molecular structure

Each tablet for oral administration contains 1 mg or 2 mg glycopyrrolate, USP. Inactive Ingredients: Dibasic calcium phosphate anhydrous, lactose monohydrate, magnesium stearate, povidone, 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, USP 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.

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 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 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.

PRECAUTIONS

Use glycopyrrolate 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.

Drug Interactions

There are no known drug interactions.

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.

  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.

DOSAGE AND ADMINISTRATION

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 1 mg tablets. The recommended initial dosage of glycopyrrolate tablets, USP 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 2 mg tablets. The recommended dosage of glycopyrrolate tablets, USP for adults is one tablet two or three times daily at equally spaced intervals.

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

HOW SUPPLIED

Glycopyrrolate tablets, USP 1 mg are white to off-white, round, flat faced, beveled edge, uncoated tablets debossed with ‘RE’ and ‘28’on one side and bisect on the other side. Glycopyrrolate tablets, USP 1 mg are available as

NDC 63304-210-30 Bottles of 30

NDC 63304-210-01 Bottles of 100

NDC 63304-210-10 Bottles of 1000

NDC 63304-210-69 Box of 10 Unit-dose

Glycopyrrolate tablets, USP 2 mg are white to off-white, round, flat faced, beveled edge, uncoated tablets debossed with ‘RE’ and ‘29’on one side and bisect on the other side. Glycopyrrolate tablets, USP 2 mg are available as

NDC 63304-211-30 Bottles of 30

NDC 63304-211-01 Bottles of 100

NDC 63304-211-10 Bottles of 1000

NDC 63304-211-69 Box of 10 Unit-dose

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

Dispense in tight container.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

* Dopram® is a registered trademark of Baxter Healthcare Corporation.

Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

January 2013 FDA-03

PATIENT PACKAGE PRINCIPAL DISPLAY PANEL

This is the 1mg-100s label

1 mg 100’s bottle label

This is the 2 mg-100s label

2 mg 100’s bottle label

GLYCOPYRROLATE 
glycopyrrolate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63304-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE1 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
Colorwhite (white to off-white) Score2 pieces
ShapeROUND (flat faced, beveled edge) Size8mm
FlavorImprint Code RE28
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63304-210-3030 in 1 BOTTLE
2NDC:63304-210-01100 in 1 BOTTLE
3NDC:63304-210-101000 in 1 BOTTLE
4NDC:63304-210-691 in 1 BOX
4NDC:63304-210-1110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04084408/18/2009
GLYCOPYRROLATE 
glycopyrrolate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63304-211
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE2 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
Colorwhite (white to off-white) Score2 pieces
ShapeROUND (flat faced, beveled edge) Size10mm
FlavorImprint Code RE29
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63304-211-3030 in 1 BOTTLE
2NDC:63304-211-01100 in 1 BOTTLE
3NDC:63304-211-101000 in 1 BOTTLE
4NDC:63304-211-691 in 1 BOX
4NDC:63304-211-1110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04084408/18/2009
Labeler - Ranbaxy Pharmaceuticals Inc. (937890044)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(63304-210, 63304-211)

Revised: 1/2013
 
Ranbaxy Pharmaceuticals Inc.

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