Trospium

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid drinking alcohol within 2 hours before or after you take trospium. Drinking alcohol can increase certain side effects of trospium.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Trospium can decrease sweating, which makes it easier for you to have heat stroke. Drink plenty of fluids while you are taking this medication.

Before using trospium, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by trospium.

Tell your doctor about all other medicines you use, especially:

• atropine (Atreza, Sal-Tropine, and others);
• belladonna (Donnatal, and others);
• benztropine (Cogentin);
• dimenhydrinate (Dramamine);
• metformin (Actoplus Met, Avandamet, Glucophage, Glucovance, Janumet, Kombiglyze, Metaglip, PrandiMet);
• morphine (Kadian, MS Contin, Oramorph);
• procainamide (Procanbid, Pronestyl);
• tenofovir (Viread);
• vancomycin (Vancocin);
• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or
• ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with trospium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take trospium on an empty stomach, at least 1 hour before a meal. Extended-release trospium (Sanctura XR) should be taken once each morning, at least 1 hour before a meal.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Store at room temperature away from moisture and heat.

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

Take the missed dose 1 hour before your next meal. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Before using trospium, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by trospium.

Tell your doctor about all other medicines you use, especially:

• atropine (Atreza, Sal-Tropine, and others);

• belladonna (Donnatal, and others);

• benztropine (Cogentin);

• dimenhydrinate (Dramamine);

• metformin (Actoplus Met, Avandamet, Glucophage, Glucovance, Janumet, Kombiglyze, Metaglip, PrandiMet);

• morphine (Kadian, MS Contin, Oramorph);

• procainamide (Procanbid, Pronestyl);

• tenofovir (Viread);

• vancomycin (Vancocin);

• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

• ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with trospium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

It is very important that your doctor check your progress at regular visits to make sure trospium is working properly and to check for unwanted effects.

trospium may cause a serious type of allergic reaction called angioedema. Angioedema may be life-threatening and requires immediate medical attention. Stop taking trospium 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 trospium.

trospium, 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 trospium 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 trospium may increase your risk of having drowsiness.

trospium 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 trospium, since overheating may result in heat stroke.

trospium 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.

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:

• 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

• 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

• 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:

• Back pain
• blurred vision
• difficulty having a bowel movement (stool)
• dry mouth
• dry skin
• sleepiness or unusual drowsiness

• 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

• 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.

Hypersensitivity to trospium or any component of the formulation; patients with or at risk of urinary retention, gastric retention, uncontrolled narrow-angle glaucoma

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Applies to trospium: oral capsule extended release, oral tablet

Along with its needed effects, trospium 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 while taking trospium:

• 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

• 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

• 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 of trospium 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:

• Back pain
• blurred vision
• difficulty having a bowel movement (stool)
• dry mouth
• dry skin
• sleepiness or unusual drowsiness

• 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

• 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

Immediate-release tablets:
Greater than or equal to 75 years: 20 mg orally once daily.

Immediate-release tablets:
Greater than or equal to 75 years: 20 mg orally once daily.