Pronunciation:

TROSE-pee-um

Brand Names:

• Sanctura

Dosage Forms:

• Tablet
• Capsule, Extended Release

Classifications:

Therapeutic—

Urinary Antispasmodic

Pharmacologic—

Antimuscarinic

Uses of This Medicine:

Trospium is used to treat the symptoms of an overactive bladder, such as a frequent need to urinate or incontinence (loss of bladder control). It helps to relax the muscles in the bladder and reduce the daily episodes of incontinence. Trospium is a urinary antispasmodic agent.

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 trospium 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 trospium in the elderly. However, elderly patients are more likely to have some unwanted effects (eg, constipation, dry mouth, indigestion, stomach pain, or trouble passing urine) which may require an adjustment in the dose for patients receiving trospium.

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
• 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
• Buprenorphine
• Bupropion
• Clozapine
• Codeine
• Donepezil
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Methacholine
• Oxycodone
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Tapentadol
• Tiotropium

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:

• Benign prostatic hyperplasia (BPH) or
• Bladder problems (eg, blockage) or
• Intestinal atony (no movement in the intestines) or
• Myasthenia gravis (severe muscle weakness) or
• Stomach problems (eg, chronic constipation) or
• Ulcerative colitis (inflamed bowel)—Use with caution. May cause side effects to become worse.

• Gastric retention (stomach or bowel blockage) or
• Glaucoma, narrow-angle, uncontrolled or
• Urinary retention (problems passing urine)—Should not be used in patients with these conditions.

• Glaucoma, narrow-angle, controlled—Use with caution. Patients will need to be carefully monitored.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only 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. To do so may increase the chance of side effects.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

It is best to take this medicine with water on an empty stomach, or at least one hour before a meal.

Swallow the extended-release capsule whole with water. Do not open, crush, or chew it.

If you take the extended-release capsule, do not drink alcohol in the first 2 hours after taking the capsule. Alcohol may increase your risk of having drowsiness.

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 bladder problems:
  • For oral dosage form (extended-release capsules):
    • Adults—60 milligrams (mg) once a day in the morning.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—20 milligrams (mg) 2 times per 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 and to check for unwanted effects.

This medicine may cause a serious type of allergic reaction called angioedema. Angioedema may be life-threatening and requires immediate medical attention. Stop taking this medicine and check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or chest tightness while you are using this medicine.

This medicine, especially in high doses, may cause some people to become dizzy, drowsy, confused, or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well. Drinking alcohol with this medicine may increase your risk of having drowsiness.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.

This medicine may cause a dry mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. If your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

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

Bladder pain

bloody or cloudy urine

decrease in the frequency of urination

decrease in urine volume

difficult or burning urination

difficulty in passing urine (dribbling)

frequent urge to urinate

lower back or side pain

painful urination

Less common

Chills

cough

diarrhea

fast, pounding, or irregular heartbeat or pulse

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

runny nose

shivering

sore throat

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Incidence not known

Blistering, peeling, or loosening of the skin

changes in vision

clammy skin

confusion as to time, place, or person

dark-colored urine

difficulty with swallowing

dizziness

enlarged pupils

fainting

fast or slow heartbeat

hallucinations

hives

holding false beliefs that cannot be changed by fact

increased sensitivity of the eyes to light

increased sweating, possibly with fever or cold

itching

muscle cramps or spasms

muscle stiffness

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

red skin lesions, often with a purple center

red, irritated eyes

seeing, hearing, or feeling things that are not there

severe chest pain

severe headache

shortness of breath

skin rash

sores, ulcers, or white spots in the mouth or on the lips

stiff or sore neck

tightness in the chest

unusual excitement, nervousness, or restlessness

wheezing

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

Back pain

blurred vision

difficulty having a bowel movement (stool)

dry mouth

dry skin

sleepiness or unusual drowsiness

Less common

Acid or sour stomach

belching

bloated or full feeling

dry eyes

excess air or gas in the stomach or intestines

heartburn

indigestion

passing gas

stomach discomfort, upset, or pain

stuffy nose

trouble with urinating

unable to have a bowel movement (stool)

upper stomach pain

Incidence not known

Burning feeling in the chest or stomach

change in taste

dry throat

indigestion

loss of taste

swelling of the abdomen or stomach area

tenderness in the stomach area

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.