(glye koe pye' roe late)

Brand Name(s): Cuvposa^®, Robinul^®¶, Robinul^® Forte¶; also available generically

WHY is this medicine prescribed?

Glycopyrrolate is used in combination with other medications to treat ulcers in adults and children 12 years of age and older. 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. Glycopyrrolate is in a class of medications called anticholinergics. It decreases stomach acid and saliva production by blocking the activity of a certain natural substance in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Glycopyrrolate comes as a tablet and solution (liquid) to take by mouth. For the treatment of ulcers, the tablet is usually taken 2 or 3 times a day. To reduce saliva and drooling in children with certain medical conditions, the solution is usually taken 3 times a day. Take the solution on an empty stomach (at least 1 hour before or 2 hours after a meal). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take glycopyrrolate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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 SPECIAL PRECAUTIONS should I follow?

Before taking glycopyrrolate,

• tell your doctor and pharmacist if you are allergic to glycopyrrolate, any other medications, or any of the ingredients in glycopyrrolate tablets or solution. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking extended-release (long-acting) potassium chloride tablets or capsules. Your doctor may tell you not to take glycopyrrolate if you are taking this medication.

• some medications should not be taken with glycopyrrolate. Other medications may cause dosing changes or extra monitoring when taken with glycopyrrolate. Make sure you have discussed any medications you are currently taking or plan to take before starting glycopyrrolate with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking glycopyrrolate, please get the advice of your doctor or pharmacist. .

• tell your doctor if you have or have ever had glaucoma; difficulty urinating; a blockage or narrowing of your stomach or intestines, paralytic ileus (condition in which digested food does not move through the intestines) toxic megacolon (a serious or life-threatening widening of the intestine), or myasthenia gravis (a disorder of the nervous system that causes muscle weakness). Your doctor may tell you not to take glycopyrrolate.

• tell your doctor if you have or have ever had enlargement of the prostate, ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), overactive thyroid, high blood pressure, heart failure, irregular or rapid heartbeats, coronary artery disease, hiatal hernia with reflux, disorders of the nervous system, or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking glycopyrrolate, call your doctor.

• you should know that glycopyrrolate may make you drowsy or cause blurred vision. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that glycopyrrolate reduces the body's ability to cool off by sweating. Avoid being in hot or very warm temperatures. If you experience any of the following symptoms, call your doctor immediately: lack of sweating in hot weather; hot, red skin; decreased alertness; loss of consciousness; fast, weak pulse; fast, shallow breathing; or fever.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Glycopyrrolate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth
• blurred vision
• vision problems
• loss of taste
• headache
• nervousness
• confusion
• drowsiness
• weakness
• dizziness
• difficulty falling asleep or staying asleep
• upset stomach
• nausea
• vomiting
• constipation
• bloated feeling
• nasal congestion

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• diarrhea
• rash
• hives
• difficulty breathing or swallowing
• difficulty urinating or unable to urinate

Glycopyrrolate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 20, 2024.