Label: ROBINUL- glycopyrrolate tablet
ROBINUL FORTE- glycopyrrolate tablet

  • NDC Code(s): 70199-007-30, 70199-007-90, 70199-008-30, 70199-008-90
  • Packager: Casper Pharma LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 1, 2021

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  • DESCRIPTION

    Robinul® and Robinul® Forte tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1- dimethylpyrrolidinium bromide.

    Robinul tablets are white, round, flat-faced, beveled edge tablet, debossed "CS" and "007" on one side and scored on the other side.
    Each tablet contains: Glycopyrrolate, USP ........................................... 1 mg

    Robinul Forte tablets are white, round, flat-faced, beveled edge tablet, debossed  "CS" score "008" on one side and plain on the other side.
    Each tablet contains: Glycopyrrolate, USP............................................ 2 mg

    Inactive Ingredients: Dibasic Calcium Phosphate, Lactose Monohydrate, 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. Robinul (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 Robinul.

    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.

    Robinul (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 Robinul 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.

    Robinul (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.
    To report SUSPECTED ADVERSE REACTIONS, contact Casper Pharma LLC. at 1-844-5-CASPER (1-844-522-7737) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • 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 antichloinergic 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 & ADMINISTRATION

    The dosage of Robinul® or Robinul® Forte 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.

    Robinul (glycopyrrolate, 1 mg) tablets. The recommended initial dosage of Robinul 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.

    Robinul Forte (glycopyrrolate, 2 mg) tablets. The recommended dosage of Robinul Forte for adults is one tablet two or three times daily at equally spaced intervals.
    Robinul 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

    Robinul® (glycopyrrolate, 1 mg) tablets are supplied as:
    Bottles of 30      NDC 70199-007-30
    Bottles of 90      NDC 70199-007-90

    Robinul® Forte (glycopyrrolate, 2 mg) tablets are supplied as:
    Bottles of 30      NDC 70199-008-30
    Bottles of 90      NDC 70199-008-90

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

    Dispense in tight container.

    ℞ only

    PIB00890-02

    Manufactured for:
    Casper Pharma LLC
    East Brunswick, NJ 08816

    Manufactured by:
    Suven Pharmaceuticals Limited,
    Telangana, India

    M.L.No.: 24/MD/AP/2009/F/CC
    Revised: 06/2021.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Robinul® (glycopyrrolate, USP) tablets 1 mg

    Bottles of 90      NDC 70199-007-90
     


    1mg90ct


    Robinul® Forte (glycopyrrolate, USP) tablets 2mg 
                                                                                                                        
    Bottles of 90      NDC 70199-008-90


    2mg90ct
  • INGREDIENTS AND APPEARANCE
    ROBINUL 
    glycopyrrolate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70199-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code CS;007
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70199-007-3030 in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    2NDC:70199-007-9090 in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01282710/06/2020
    ROBINUL FORTE 
    glycopyrrolate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70199-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code CS;008
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70199-008-3030 in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    2NDC:70199-008-9090 in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01282710/06/2020
    Labeler - Casper Pharma LLC (080025838)
    Establishment
    NameAddressID/FEIBusiness Operations
    Suven Pharmaceuticals Limited677604288ANALYSIS(70199-007, 70199-008) , LABEL(70199-007, 70199-008) , MANUFACTURE(70199-007, 70199-008) , PACK(70199-007, 70199-008)