Trospium and xanomeline

Trospium and xanomeline is a combination medicine used in adults to treat schizophrenia.

Trospium and xanomeline may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Trospium and xanomeline is usually taken twice per day.

Take on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not change your dose or stop using a medicine without your doctor's advice.

You may need liver function tests before starting treatment and while using this medicine.

You may need medical tests before starting treatment and while using this medicine to check your heart function.

Swallow the capsule whole and do not crush, chew, break, or open it.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not take trospium and xanomeline if you are allergic to it, or if you have:

• urinary retention (trouble urinating);
• slow digestion (slowed movement of food from the stomach to the small intestine);
• untreated narrow angle glaucoma; or
• moderate to severe liver disease.

Tell your doctor if you have or have ever had:

• problems with urination such as bladder obstruction or enlarged prostate;
• gallstones;
• problems with your bile ducts or pancreas;
• an intestinal disorder such as ulcerative colitis;
• a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion;
• constipation;
• myasthenia gravis;
• narrow-angle glaucoma; or
• liver or kidney disease.

It is not known if trospium and xanomeline will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of trospium and xanomeline on the baby.

Ask a doctor if it is safe to breastfeed while using trospium and xanomeline.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Trospium and xanomeline may cause serious side effects. Call your doctor right away if you have:

• racing or pounding heartbeats;
• heartburn, bloating;
• upset stomach or burning, upper stomach pain that may spread to your back;
• nausea, vomiting;
• stomach pain, constipation;
• confusion, sleep problems (insomnia), hallucinations (seeing or hearing things that are not real);
• fever, pain in your side or lower back, painful or difficult urination, increased urination, blood or pus in your urine;
• blurred vision, eye pain or redness, severe headache, seeing halos around lights; or
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your doctor may need to adjust the dose or permanently stop your treatment with trospium and xanomeline if you have certain side effects.

Common side effects of trospium and xanomeline may include:

• a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion;
• upset stomach, constipation, or diarrhea;
• stomach pain or burning;
• nausea, vomiting;
• high blood pressure; or
• dizziness, fast heart rate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Schizophrenia:

Initial dose: Xanomeline 50 mg-trospium 20 mg orally twice a day for at least 2 days. -Then, increase to xanomeline 100 mg-trospium 20 mg orally twice a day for at least 5 daysMaintenance dose: May titrate to xanomeline 125 mg-trospium 30 mg orally twice a day based on patient tolerability/response. Maximum dose: Xanomeline 125 mg-trospium 30 mg orally twice a dayComments:-It is recommended to assess hepatic and cardiac function prior to treatment initiation. -Avoid administration with food; give dose at least 1 hour before a meal or 2 hours after a meal. Use: For the treatment of schizophrenia

Usual Geriatric Dose for Schizophrenia:

Initial dose: Xanomeline 50 mg-trospium 20 mg orally twice a day. Maintenance dose: Consider a slower titration for older adults. May increase up to xanomeline 100 mg-trospium 20 mg orally twice a day based on patient tolerability/response. Maximum dose: Xanomeline 100 mg-trospium 20 mg orally twice a dayComments:-It is recommended to assess hepatic and cardiac function prior to treatment initiation. -Avoid administration with food; give dose at least 1 hour before a meal or 2 hours after a meal. Use: For the treatment of schizophrenia

Take the medicine as soon as you remember, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid driving or hazardous activity until you know how trospium and xanomeline will affect you.
• Confusion, dizziness or drowsiness can cause falls, accidents, or severe injuries.

Other drugs may affect trospium and xanomeline, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.