Glycopyrrolate (tablet)

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# Overview
Glycopyrrolate (tablet) is a anticholinergic agent that is FDA approved for the treatment of peptic ulcer.   Common adverse reactions include flushing, constipation, vomiting, xerostomia, headache, nasal congestion.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- For use as adjunctive therapy in the treatment of peptic ulcer.
- The dosage of Glycopyrrolate tablets 1 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, 1 mg Tablets. 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.
- Glycopyrrolate, 2 mg Tablets. The recommended dosage of Glycopyrrolate 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Glycopyrrolate (tablet) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Glycopyrrolate (tablet) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Glycopyrrolate (tablet) in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Glycopyrrolate (tablet) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Glycopyrrolate (tablet) in pediatric patients.

# 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 tablets 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.

### 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.

# Adverse Reactions

## Clinical Trials Experience
- 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; mentalconfusion; 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 tablets 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.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Glycopyrrolate (tablet) in the drug label.

# Drug Interactions
- There are no known drug interactions.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- 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.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Glycopyrrolate (tablet) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Glycopyrrolate (tablet) during labor and delivery.

### 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.

### Geriatic Use
There is no FDA guidance on the use of Glycopyrrolate (tablet) with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Glycopyrrolate (tablet) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Glycopyrrolate (tablet) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Glycopyrrolate (tablet) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Glycopyrrolate (tablet) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Glycopyrrolate (tablet) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Glycopyrrolate (tablet) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral
- Intravenous
- Inhalation
- Intramuscular

### Monitoring
There is limited information regarding Monitoring of Glycopyrrolate (tablet) in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Glycopyrrolate (tablet) in the drug label.

# Overdosage
- The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central.
- To guard against further absorption of the drug--use gastric lavage, cathartics and/or enemas.
- To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)-utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.
- To combat hypotension-use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care.
- To combat respiratory depression-administer oxygen; utilize a respiratory stimulant such as Dopram i.v.; artificial respiration.

# Pharmacology

## Mechanism of Action
- lycopyrrolate, 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.

## Structure
- Glycopyrrolate tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3--1, 1-dimethylpyrrolidinium bromide.
- Each tablet for oral administration contains 1 mg or 2 mg Glycopyrrolate, USP.
- Inactive Ingredients: Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, Povidone, Sodium Starch Glycolate.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Glycopyrrolate (tablet) in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Glycopyrrolate (tablet) in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Glycopyrrolate (tablet) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Glycopyrrolate (tablet) in the drug label.

# How Supplied
- Glycopyrrolate Tablets, USP
- Glycopyrrolatetablets, USP 1 mg are scored, compressed white tablets engraved I 21.
- Glycopyrrolate Tablets, USP 2 mg are scored, compressed white tablets engraved I 22.
- Glycopyrrolate Tablets, USP 1 mg, supplied as follows:
- NDC (55111-648-01) bottles of 100s and
- NDC (55111-648-05) bottles of 500s
- Glycopyrrolate Tablets, USP 2 mg, supplied as follows:
- NDC (55111-649-01) bottles of 100s and
- NDC (55111-649-05) bottles of 500s
- Store at 20 to 25C (68 to 77F). .
- Dispense in tight container.

## Storage
There is limited information regarding Glycopyrrolate (tablet) Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Glycopyrrolate (tablet) in the drug label.

# Precautions with Alcohol
- Alcohol-Glycopyrrolate (tablet) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- Robinul
- Robinul Forte
- Cuvposa
- Glycate

# Look-Alike Drug Names
There is limited information regarding Glycopyrrolate (tablet) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price