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Basic Drug Info
Drug Name:Glycopyrrolate
Manufacturer:Kali Laboratories, Inc. A Wholly Owned Subsidiary of Par Pharmaceutical Companies Inc.
Other Info:



Clinical Trials:


Indications and Usage
For use as adjunctive therapy in the treatment of peptic ulcer.
Peptic Ulcer -- Ulcer that occurs in the regions of the GASTROINTESTINAL TRACT which come into contact with GASTRIC JUICE containing PEPSIN and GASTRIC ACID. It occurs when there are defects in the MUCOSA barrier. The common forms of peptic ulcers are associated with HELICOBACTER PYLORI and the consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).

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.
Obstructive Uropathy --

Bladder neck obstruction -- Blocked urine flow through the bladder neck, the narrow internal urethral opening at the base of the URINARY BLADDER. Narrowing or strictures of the URETHRA can be congenital or acquired. It is often observed in males with enlarged PROSTATE GLAND.

Diseases, Obstructive --

Esophageal achalasia -- A motility disorder of the ESOPHAGUS in which the LOWER ESOPHAGEAL SPHINCTER (near the CARDIA) fails to relax resulting in functional obstruction of the esophagus, and DYSPHAGIA. Achalasia is characterized by a grossly contorted and dilated esophagus (megaesophagus).

Acquired stenosis --

Stenosis -- The condition of an anatomical structure's being constricted beyond normal dimensions.

Stenosis, unspecified --

Myasthenia Gravis -- A disorder of neuromuscular transmission characterized by weakness of cranial and skeletal muscles. Autoantibodies directed against acetylcholine receptors damage the motor endplate portion of the NEUROMUSCULAR JUNCTION, impairing the transmission of impulses to skeletal muscles. Clinical manifestations may include diplopia, ptosis, and weakness of facial, bulbar, respiratory, and proximal limb muscles. The disease may remain limited to the ocular muscles. THYMOMA is commonly associated with this condition. (Adams et al., Principles of Neurology, 6th ed, p1459)

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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.Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomyor colostomy.

In this instance treatment with this drug would be inappropriate and possibly harmful.Glycopyrrolate may produce drowsiness and 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.
Branded Drugs
The following US Branded drugs contain Glycopyrrolate


ROBINUL -- BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

ROBINUL -- AH ROBINS CO

ROBINUL -- SCIELE PHARMA INC

ROBINUL FORTE -- SCIELE PHARMA INC


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