Label: GLYCOPYRROLATE tablet

  • NDC Code(s): 23155-606-01, 23155-607-01
  • Packager: Heritage Pharmaceuticals Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated March 23, 2019

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  • 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 di-methyl bromide.

    Glycopyrrolate Tablets, USP 1 mg are white to off-white, round, flat beveled edge tablet debossed with “MCR 117” separated by break line on one side and plain on other side.
    Each tablet contains: Glycopyrrolate, USP 1 mg.

    Glycopyrrolate Tablets, USP 2 mg are white to off white, round, flat beveled edge tablet debossed with “AC 108” separated by break line on
    one side and plain on other side.
    Each tablet contains: Glycopyrrolate, USP 2 mg

    Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate.

    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 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

    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 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.

    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 Gylcopyrrolate Tablets, USP 1 mg and 2 mg 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 Tablets, USP 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, USP 2 mg: The recommended dosage of Glycopyrrolate Tablets, USP 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.

  • HOW SUPPLIED

    Glycopyrrolate Tablets, USP 1 mg are white to off-white, round, flat beveled edge tablet debossed with “MCR 117” separated by break line on one side and plain on other side. Packaged in bottles of 100.


    Glycopyrrolate Tablets, USP 1 mg tablets in bottles of 100 (NDC 23155-606-01).


    Glycopyrrolate Tablets, USP 2 mg are white to off white, round, flat beveled edge tablet debossed with “AC 108” separated by break line on one side and plain on other side. Packaged in bottles of 100.


    Glycopyrrolate Tablets, USP 2 mg tablets in bottles of 100 (NDC 23155-607-01).


    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59°- 86°F) [see USP Controlled Room Temperature].


    Keep out of reach of children.


    Dispense in tight container.


    Distributed by:
    Heritage Pharmaceuticals Inc.,
    East Brunswick, NJ 08816
    1.866.901.DRUG (3784)


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    200146


    Rev: 02/19





  • PRINCIPAL DISPLAY PANEL



    100ct1mg
    100ct2mg

  • INGREDIENTS AND APPEARANCE
    GLYCOPYRROLATE 
    glycopyrrolate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:23155-606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code MCR;117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23155-606-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20720102/27/2017
    GLYCOPYRROLATE 
    glycopyrrolate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:23155-607
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code AC;108
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23155-607-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20720102/27/2017
    Labeler - Heritage Pharmaceuticals Inc (780779901)
    Registrant - Heritage Pharmaceuticals Inc (780779901)
    Establishment
    NameAddressID/FEIBusiness Operations
    Appco Pharma LLC078510186ANALYSIS(23155-606, 23155-607) , RELABEL(23155-606, 23155-607) , REPACK(23155-606, 23155-607) , MANUFACTURE(23155-606, 23155-607) , PACK(23155-606, 23155-607)