Label: GLYCOPYRROLATE tablet

  • NDC Code(s): 60763-475-02, 60763-476-02
  • Packager: Stason Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 16, 2018

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  • INDICATIONS & USAGE

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

  • INACTIVE INGREDIENT

    Inactive Ingredients: Microcrystalline Cellulose. Lactose Monohydrate. Pregelatinized Starch and Magnesium Stearate

  • 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.

  • MECHANISM OF ACTION

    Actions:
    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 arenon-polar tertiaryamines which penetrate lipid barriers easily.

  • WARNINGS

    WARNINGS
    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.

    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 tomuscular 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 dimished 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 safely 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 drygs 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 has not been established.

  • PRECAUTIONS

    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 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.

  • 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; 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 is chemically a quarternary ammonium compound: hence. its passage across lipid
    membranes such as the blood-brain barrier. is limited to 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

    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 hydriasis, dry mouth, etc.) -
    utilize a quartenary ammonium anticholinesterase. such as neostigmine methylsulfate.
    3. To combat hypotension- use pressor amines(norepinephrine, metaraminol) i.v.; and
    supportive car.
    4. To combat respiratory depression - administer oxygen: utilize a respuarory stimulant
    such as Dopram(R) i.v., artificial respiration.

  • DOSAGE & 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 USP, 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.
    Glycopyrrolare tablets are not recommended for use in pediatric patients under the age of 12
    years.

  • DRUG INTERACTIONS

    Drug Interactions

    There are no known drug interactions.

  • HOW SUPPLIED

    Glycopyrrolate Tablets UsP, 1 mg in bottles of 100 (NDC 60763-0475-2)

  • OTHER SAFETY INFORMATION

    Store at controlled room temperature, 20C to 25C (68F to 77F); excursions permitted to
    15C-30C (59F-86F) [See USP Controlled Room Temperature]. Keep out of reach of
    children.
    Dispense In tight container.
    Rx only
    Manufactured by:
    Stason Pharmaceuticals Inc.
    Irvine, CA 92618

  • Product Label

    NDC 60763-475

    100 Tablets

    Glycopyrrolate Tablets, USP

    Rx only

    Storage: Store at controlled room temperature, 20-25C (68-77F): excursions permitted to 15-30C (59-86F) [See USP Controlled Room Temperature]. Keep out of reach of children.

    Pharmacist: Dispense in tight container.

    Usual Dosage: One or two tablets three times a day.

    See accompanying information.

    Manufactured by Stason Pharmaceuticals

    Irvine, CA 92618

    1 mg container

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 2 mg container text

    2 mg container
  • INGREDIENTS AND APPEARANCE
    GLYCOPYRROLATE 
    glycopyrrolate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60763-475
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code 0475
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60763-475-02100 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09118204/10/2017
    GLYCOPYRROLATE 
    glycopyrrolate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60763-476
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code 0476
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60763-476-02100 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09118204/10/2017
    Labeler - Stason Pharmaceuticals, Inc. (807437553)
    Registrant - Stason Pharmaceuticals, Inc. (807437553)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stason Pharmaceuticals, Inc.807437553manufacture(60763-475, 60763-476)