Glycopyrrolate

What is Glycopyrrolate?

• Glycopyrrolate (Robinul; Robinul Forte) are anticholinergics used in combination with other medications to treat ulcers in adults and children 12 years of age and older.

Glycopyrrolate

Glycopyrronium bromide

What are the uses of this medicine?

• Glycopyrrolate (Robinul; Robinul Forte) are used in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

• Glycopyrrolate (Cuvposa) is used to reduce saliva and drooling in children between 3 and16 years of age that have certain medical conditions that cause drooling.

Limitations of use:

• Robinul and Robinul Forte are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

How does this medicine work?

• Glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a hypersensitivity to glycopyrrolate or any of the inactive ingredients.

with medical condition, including:

• Glaucoma
• Obstructive uropathies, including prostatic hypertrophy
• Mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures)
• Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony)
• Bleeding gastrointestinal ulcer
• Active inflammatory or infectious colitis which can lead to toxic megacolon
• History of or current toxic megacolon
• Myasthenia gravis

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• amantadine (Symmetrel)
• atenolol (Tenormin, in Tenoretic)
• digoxin (Lanoxin)
• levodopa (in Rytary, in Sinemet, in Stavelo)
• ipratropium (Atrovent)
• mediations for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• sedatives
• tranquilizers
• tricyclic antidepressants such as amitriptyline, amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil).
• extended-release (long-acting) potassium chloride tablets or capsules

Is this medicine FDA approved?

• Glycopyrronium was first used in 1961 to treat peptic ulcers.

How should this medicine be used?

Recommended dosage:

• The recommended initial dosage of Robinul is 1 mg three times daily (in the morning, early afternoon, and at bedtime).
• Some patients may require 2 mg at bedtime to assure overnight control of symptoms.
• For maintenance, a dosage of 1 mg twice a day is frequently adequate.

• The recommended dosage of Robinul Forte for adults is 2mg two or three times daily at equally spaced intervals.
• The maximum recommended daily dosage is 8 mg.
• Use the lowest effective dosage of glycopyrrolate to control symptoms.
• If patients can be titrated to a lower dose, switch from Robinul Forte to Robinul or another 1 mg oral tablet of glycopyrrolate.

Administration:

• Glycopyrrolate comes as a tablet and solution to take by mouth.
• For the treatment of ulcers, the tablet is usually taken 2 or 3 times a day.
• Your doctor will probably start your child on a low dose of the solution and gradually increase the dose over a 4-week period.
• If you are giving the solution to a child, do not use a household spoon to measure the dose.
• Use an oral syringe that is made especially for measuring liquid medication.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet and solution (liquid)

This medicine is available in fallowing brand namesː

• Robinul; Robinul Forte

What side effects can this medication cause?

The most common side effects of this medicine include:

• Cardiac Disorders: chest, pain, hypertension, tachycardia
• Endocrine Disorders: decreased sweating
• Eye Disorders: blurred vision, cycloplegia, dilatation of the pupil, increased ocular tension
• Gastrointestinal Disorders: bloated feeling, constipation, dry mouth, dysgeusia, nausea, vomiting
• Immune System Disorders: anaphylaxis
• Nervous System Disorders: agitation, dizziness, drowsiness, headache, insomnia, mental confusion, nervousness, weakness
• Respiratory Disorders: respiratory depression, throat irritation
• Renal and Urinary Disorders: urinary hesitancy, urinary retention
• Reproductive System and Breast Disorders: impotence, suppression of lactation
• Vascular Disorders: flushing

Less common, but serious side effects may include:

• Acute Glaucoma
• Partial or Complete Mechanical Intestinal Obstruction
• Gastrointestinal Adverse Reactions due to Decreased Gastrointestinal Motility
• Cognitive and Visual Adverse Reactions
• Heat Prostration at High Environmental Temperatures
• Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients

What special precautions should I follow?

• Glycopyrrolate may cause increased intraocular pressure in patients with glaucoma and reduce the effects of antiglaucoma agents. Promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils).
• Glycopyrrolate may worsen intestinal mechanical obstruction, and diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. If partial or complete intestinal obstruction is suspected, discontinue the use of Glycopyrrolate and evaluate for potential intestinal obstruction.
• Glycopyrrolate reduces gastrointestinal motility and may result in delayed gastric emptying, constipation, and intestinal pseudo-obstruction and may precipitate or aggravate paralytic ileus and toxic megacolon. Monitor patients for symptoms of decreased gastrointestinal motility.
• Glycopyrrolate may produce drowsiness and blurred vision and impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery, or performing other hazardous work. Concomitant use of other drugs that have anticholinergic properties may increase these effects.
• Inform patients not to operate motor vehicles or other dangerous machinery or perform other hazardous tasks.
• In the presence of a high environmental temperature, heat prostration resulting in fever and heatstroke can occur with the use of glycopyrrolate due to decreased sweating, particularly in geriatric patients.
• Advise patients to avoid exposure to hot or very warm environmental temperatures when taking glycopyrrolate. Glycopyrrolate are not recommended in geriatric patients.
• Robinul and Robinul Forte are not recommended in patients with other conditions exacerbated by anticholinergic adverse reactions (e.g., autonomic neuropathy, hyperthyroidism, cardiac disease, and hiatal hernia associated with reflux esophagitis) and in patients taking other anticholinergic medications.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation, and light sensitivity due to mydriasis, but central nervous system toxicity (agitation, seizures, hyperthermia) may also occur.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Management of glycopyrrolate overdosage is based upon presenting signs and symptoms, including close observation for severe or life-threatening complications which may require respiratory and cardiovascular monitoring and support.
• Consider administration of activated charcoal and/or use of a reversible anticholinesterase as appropriate or recommended by Poison Control.

Can this medicine be used in 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• The active ingredient is glycopyrrolate
• The inactive ingredients include: dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.

Who manufactures and distributes this medicine?

Manufactured for:

• Casper Pharma LLC
• East Brunswick, NJ

Manufactured by:

• Suven Pharmaceuticals Limited,
• Telangana, India

• Robinul and Robinul Forte are registered trademarks of Casper Pharma LLC.

What should I know about storage and disposal of this medication?

• Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
• Keep out of reach of children.
• Dispense in a tight container.

anticholinergic agents

• Aclidinium
• Atropine
• Homatropine
• Darifenacin
• Dicyclomine
• Fesoterodine
• Flavoxate
• Glycopyrrolate
• Hyoscyamine
• Ipratropium
• Mepenzolate
• Methscopolamine
• Oxybutynin
• Propantheline
• Scopolamine
• Solifenacin
• Tiotropium
• Tolterodine
• Trospium

• Dailymed label info on Glycopyrrolate
• FDA Glycopyrrolate

Glycopyrrolate Resources
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