Pronunciation:

zan-OH-me-leen, TROSE-pee-um KLOR-ide

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antipsychotic

Pharmacologic—

Cholinergic System

Uses of This Medicine:

Xanomeline and trospium combination is used to treat schizophrenia.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of xanomeline and trospium combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of xanomeline and trospium combination in the elderly. However, elderly patients are more likely to have serious unwanted effects (eg, problems with passing urine), which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium Chloride
• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amantadine
• Amifampridine
• Benzhydrocodone
• Buprenorphine
• Bupropion
• Clozapine
• Codeine
• Dihydrocodeine
• Donepezil
• Fentanyl
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Hydrocodone
• Hydromorphone
• Hydroxychloroquine
• LetibotulinumtoxinA-wlbg
• Meperidine
• Methacholine
• Methadone
• Morphine
• Morphine Sulfate Liposome
• Olanzapine
• Oliceridine
• Oxycodone
• Oxymorphone
• Promethazine
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Sofpironium
• Sufentanil
• Tapentadol
• Tiotropium
• Tramadol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Enlarged prostate (eg, benign prostatic hyperplasia) or
• Glaucoma, narrow-angle or
• Kidney disease, mild or
• Myasthenia gravis (severe muscle weakness) or
• Pancreatitis (swelling of the pancreas) or
• Stomach or bowel problems (eg, constipation, ulcerative colitis) or
• Urinary problems (eg, blockage)—Use with caution. May make these conditions worse.

• Gallbladder problems (eg, gallstones) or
• Kidney disease, moderate or severe or
• Liver disease, mild—Use is not recommended in patients with these conditions.

• Gastric retention (problems with food emptying from your stomach) or
• Glaucoma, narrow-angle, untreated or
• Liver disease, moderate to severe or
• Urinary retention (problems with passing urine)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine at least 1 hour before a meal or at least 2 hours after a meal. Do not open the capsules.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules):
  • For treatment of schizophrenia:
    • Adults—At first, 50 milligrams (mg) xanomeline and 20 mg trospium 2 times a day for at least 2 days. Then, the dose may be increased to 100 mg xanomeline and 20 mg trospium 2 times a day for at least 5 days. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 125 mg xanomeline and 30 mg trospium 2 times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase the risk of urinary retention (problems with passing urine), especially in elderly patients or in patients with bladder problems or enlarged prostate. Check with your doctor if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine (dribbling), or painful urination.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder problems which may lead to gallstones and pancreatitis (swelling of the pancreas). Check with your doctor right away if you have bloating, chills, constipation, dark urine, fast heartbeat, fever, indigestion, loss of appetite, nausea, pains in the stomach, side, or abdomen, possibly radiating to the back, severe stomach pain, vomiting, or yellow eyes or skin.

This medicine may cause stomach or bowel problems (slow emptying of food in the stomach). Check with your doctor right away if you have constipation, nausea, vomiting, or stomach pain or bloating.

This medicine may cause a serious allergic reaction, including angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.

This medicine may increase your heart rate. Check with your doctor right away if you have a fast, pounding, or uneven heartbeat.

This medicine may cause some people to become confused, dizzy, drowsy, or see, hear, or feel things that are not there. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Acid or sour stomach

belching

blurred vision

dizziness

fast, pounding, or irregular heartbeat or pulse

headache

heartburn

indigestion

nervousness

pounding in the ears

slow heartbeat

stomach discomfort, upset, or pain

vomiting

Less common

Change in how much or how often you urinate

chills

cold sweats

confusion

difficulty in speaking

dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting position

drooling

inability to move the eyes

increased blinking or spasms of the eyelid

loss of balance control

muscle trembling, jerking, or stiffness

painful or difficult urination

restlessness

shuffling walk

sleepiness or unusual drowsiness

sticking out of the tongue

stiffness of the limbs

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

unusual facial expressions

Incidence not known

Abnormal vision

bloating

burning feeling in the chest or stomach

chest pain or tightness

confusion as to time, place, or person

constipation

cough

dark urine

difficulty swallowing

enlarged pupils

fever

hives, itching, skin rash

holding false beliefs that cannot be changed by fact

increased sensitivity of the eyes to light

increased sweating, possibly with fever or cold, clammy skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss of appetite

muscle cramps, pains, or spasms

pains in the stomach, side, or abdomen, possibly radiating to the back

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seeing, hearing, or feeling things that are not there

stiff or sore neck

tenderness in the stomach area

trouble breathing

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

nausea

Less common

Blurred vision

dry mouth

watering of the mouth and drooling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.