Glycopyrrolate

Glycopyrrolate

Glycopyrrolate Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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

History

There is currently no drug history available for this drug.

Other Information

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. Its emprical formula is C19H8BrNO3, its molecular weight is 398.33, and its structural formula is:

structure

Each 1 mg tablet contains: Glycopyrrolate, 1 mg

Each 2 mg tablet contains: Glycopyrrolate, 2 mg

Inactive ingredients:
Dibasic Calcium Phosphate, Lactose Anhydrous, Magnesium Stearate, Povidone, and Sodium Starch Glycolate

Glycopyrrolate Manufacturers


  • Avkare, Inc.
    Glycopyrrolate Tablet [Avkare, Inc.]
  • American Health Packaging
    Glycopyrrolate Tablet [American Health Packaging]
  • Bryant Ranch Prepack
    Glycopyrrolate Tablet [Bryant Ranch Prepack]
  • Dr. Reddy’s Laboratories Limited
    Glycopyrrolate Tablet [Dr. Reddy’s Laboratories Limited]
  • Rising Pharmaceuticals Inc
    Glycopyrrolate Tablet Glycopyrrolate (Glycopyrrolate ) Tablet [Rising Pharmaceuticals Inc]
  • Baxter Healthcare Corporation
    Glycopyrrolate Injection, Solution [Baxter Healthcare Corporation]
  • General Injectables & Vaccines, Inc
    Glycopyrrolate Injection, Powder, For Solution [General Injectables & Vaccines, Inc]
  • Physicians Total Care, Inc.
    Glycopyrrolate Injection, Solution [Physicians Total Care, Inc.]
  • American Health Packaging
    Glycopyrrolate Tablet [American Health Packaging]
  • Par Pharmaceutical Inc.
    Glycopyrrolate Tablet [Par Pharmaceutical Inc.]
  • General Injectables & Vaccines, Inc
    Glycopyrrolate Injection, Solution [General Injectables & Vaccines, Inc]
  • Nexgen Pharma, Inc.
    Glycopyrrolate Tablet [Nexgen Pharma, Inc.]
  • West-ward Pharmaceutical Corp
    Glycopyrrolate Tablet [West-ward Pharmaceutical Corp]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Glycopyrrolate Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Cardinal Health
    Glycopyrrolate Injection, Solution [Cardinal Health]
  • West-ward Pharmaceutical Corp.
    Glycopyrrolate Injection [West-ward Pharmaceutical Corp.]
  • United Research Laboratories, Inc.
    Glycopyrrolate Tablet [United Research Laboratories, Inc.]
  • Excellium Pharmaceutical, Inc.
    Glycopyrrolate Tablet [Excellium Pharmaceutical, Inc.]
  • Qualitest Pharmaceuticals
    Glycopyrrolate Tablet [Qualitest Pharmaceuticals]
  • Ranbaxy Pharmaceuticals Inc.
    Glycopyrrolate Tablet [Ranbaxy Pharmaceuticals Inc.]
  • West-ward Pharmaceutical Corp
    Glycopyrrolate Injection [West-ward Pharmaceutical Corp]
  • Cardinal Health
    Glycopyrrolate Injection [Cardinal Health]
  • Aurolife Pharma, Llc
    Glycopyrrolate Tablet [Aurolife Pharma, Llc]
  • Remedyrepack Inc.
    Glycopyrrolate Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Glycopyrrolate Tablet [Remedyrepack Inc. ]
  • Cardinal Health
    Glycopyrrolate Injection [Cardinal Health]
  • Bryant Ranch Prepack
    Glycopyrrolate Tablet [Bryant Ranch Prepack]
  • Carilion Materials Management
    Glycopyrrolate Tablet [Carilion Materials Management]
  • Cardinal Health
    Glycopyrrolate Injection, Solution [Cardinal Health]
  • Cantrell Drug Company
    Glycopyrrolate Injection, Solution [Cantrell Drug Company]
  • Cantrell Drug Company
    Glycopyrrolate Injection, Solution [Cantrell Drug Company]
  • Cantrell Drug Company
    Glycopyrrolate Injection, Solution [Cantrell Drug Company]
  • American Regent, Inc.
    Glycopyrrolate Injection, Solution [American Regent, Inc.]
  • Mylan Institutional Inc.
    Glycopyrrolate Tablet [Mylan Institutional Inc.]

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