Xanomeline and trospium chloride

WHY is this medicine prescribed?

Xanomeline and trospium is used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Xanomeline and trospium is in a class of medications called muscarinic agonists. How it works to treat schizophrenia is not known.

HOW should this medicine be used?

Xanomeline and trospium comes as a capsule to take by mouth. It is usually taken one hour before or two hours after a meal twice a day. Take xanomeline and trsopium at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take xanomeline and trospium exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, split, chew, or crush them.

Your doctor will probably/may start you on a low dose of xanomeline and trospium and gradually increase your dose.

Xanomeline and trospium controls schizphrenia but does not cure it. Continue to take xanomeline and trospium even if you feel well. Do not stop taking xanomeline and trospium without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking xanomeline and trospium,

• tell your doctor and pharmacist if you are allergic to xanomeline, trospium, any other medications, or any of the ingredients in xanomeline and trospium capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• some medications should not be taken with xanomeline and trospium while others may require additional monitoring or dose adjustments. Make sure you have discussed any medications you are currently taking or plan to take before starting xanomeline and trospium with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking xanomeline and trospium, please get the advice of your doctor or pharmacist.
• tell your doctor if you have or have ever had problems urinating such as benign prostatic hypertension (BPH; enlarged prostate that causes difficulty with urinating), bladder problems, diabetic cystopathy; kidney disease; liver disease; gallstones or gallbladder disease; stomach issues; glaucoma. Your doctor may tell you not to take xanomeline and trospium.
• tell your doctor if you have or have ever had ulcerative colitis, myasthenia gravis, or problems with your intestines.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking xanomeline and trospium, call your doctor.
• you should know that this medication may cause increased risk of side effects in elderly patients. If you are 65 years of age or older, talk to your doctor about the risks and benefits of taking this medication. Your doctor may need to start you on a lower dose, increase your dose slowly and monitor you extra closely for side effects.
• you should know that xanomeline and trospium may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking xanomeline and trospium. Alcohol can make the side effects from xanomeline and trospium worse.

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?

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hesitant urinating, weak urine stream, feeling like bladder isn't emptying all the way, or painful urination
• yellowing of skin or whites of eyes, dark urine, lower abdominal pain
• heartburn, bloating or belching; nausea and/or vomiting; upper abdominal pain
• constipation or diarrheal feeling full early in eating a meal; bloating, cramping, or pain
• swelling of the face, throat, tongue, orlips
• rash, hives, itching, wheezing or difficulty breathing
• dizziness, confusion, sleepiness, hallucinations

Xanomleing and trospium 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).

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

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.

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.

Symptoms of overdose may include:

• seizures, vomiting, diarrhea, abdominal pain, excessive sweating, and excess saliva
• confusion, distorted thoughts or seeing visions, agitation, garbled speech, dizziness, racing heart, dry mouth, dry eyes, blurry vision, difficulty urinating

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to xanomeline and trospium.

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 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: November 15, 2024.