Label: GLYCOPYRROLATE tablet

  • NDC Code(s): 15955-305-01, 15955-318-01
  • Packager: ORIT LABORATORIES LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 17, 2019

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  • 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.

     
    Glycopyrrolate Tablets 1 mg are white, round-shape, flat face bevel edge, scored, with “OL” above bisect and “305” below bisect. Each tablet contains:
    Glycopyrrolate, USP..........................1 mg
     
    Glycopyrrolate Tablets 2 mg are white, round-shape, flat face bevel edge, scored, with “OL” above bisect and “318” below bisect.  Each tablet contains:
    Glycopyrrolate, USP..........................2 mg
     
    Inactive Ingredients: Copovidone, Dibasic Calcium Phosphate, Lactose Anhydrous, Magnesium Stearate, 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.
    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 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 Tablets 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 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 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 2 mg.  The recommended dosage of Glycopyrrolate Tablets 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.

    DRUG INTERACTIONS

    There are no known drug interactions.

  • HOW SUPPLIED

    Glycopyrrolate Tablets USP, 1 mg are white, round tablets with debossing of “OL” above bisect and “305” below bisect on one side and plain on the other side.

    They are supplied as follows:

    Bottles of 100 Tablets     (NDC 15955-305-01)


    Glycopyrrolate Tablets USP, 2 mg are white, round tablets with debossing of “OL” above bisect and “318” below bisect on one side and plain on the other side.

    They are supplied as follows:

    Bottles of 100 Tablets     (NDC 15955-318-01)

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

    Dispense in a tight container as defined in the USP.

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

    Rx only  

    Manufactured By:
    Appco Pharma LLC

    Piscataway, NJ 08854


    Manufactured For:

    Orit Laboratories LLC

    West Caldwell, NJ 07006


    Rev. 10/15

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1 mg Strength

    NDC 15955-305-01
    Glycopyrrolate
    Tablets, USP
    1 mg
    Rx only

    100 Tablets
    ORIT®
    100 Tablets

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-2 mg Strength

    NDC 15955-318-01
    Glycopyrrolate
    Tablets, USP
    2 mg
    Rx only
    100 Tablets
    ORIT®


    100 Tablets
  • INGREDIENTS AND APPEARANCE
    GLYCOPYRROLATE 
    glycopyrrolate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:15955-305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code OL;305
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15955-305-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20365710/19/2012
    GLYCOPYRROLATE 
    glycopyrrolate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:15955-318
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code OL;318
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15955-318-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20365710/19/2012
    Labeler - ORIT LABORATORIES LLC (167618912)
    Establishment
    NameAddressID/FEIBusiness Operations
    Appco Pharma LLC078510186MANUFACTURE(15955-305, 15955-318)