Sanctura

Generic Name: trospium (Oral route)

TROSE-pee-um

Commonly used brand name(s):

In the U.S.

• Sanctura

Available Dosage Forms:

• Capsule, Extended Release
• Tablet

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Antimuscarinic

Uses For Sanctura

Trospium is used to treat bladder problems such as a frequent need to urinate or loss of bladder control .

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

Before Using Sanctura

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.

Pediatric

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 .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of trospium in the elderly .

Pregnancy

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Bladder problems (blockage, benign prostatic hypertrophy (BPH)) or
• Intestinal atony (no movement in intestines) or
• Myasthenia gravis or
• Ulcerative colitis—Use with caution. May cause side effects to become worse .

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

• Glaucoma, narrow-angle, uncontrolled or
• Kidney problems, severe or
• Stomach problems (blockage, chronic constipation) or
• Urinary retention—Should not use in patients with these conditions .

• Kidney problems, mild or moderate or
• Liver problems—Use with caution. A lower dose of trospium may be necessary .

Proper Use of Sanctura

It is best to take this medicine on an empty stomach and at least one hour before a meal .

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

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.

• To treat 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) two 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 Sanctura

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 some people to have vision problems. Make sure your vision is clear before you drive or do anything else that could be dangerous if you are not able to see well.

This medicine, especially in high doses, may cause some people to become dizzy or drowsy. 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 or are not alert.

Do not drink alcohol within two hours of using this medicine. Alcohol may increase your risk of drowsiness .

Use caution during exercise or hot weather. 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. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist.

Sanctura Side Effects

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:

• Blistering, peeling, or loosening of the skin
• changes in vision
• chills
• clammy skin
• confusion as to time, place, or person
• cough
• dark-colored urine
• diarrhea
• difficulty with swallowing
• dizziness
• enlarged pupils
• fast or slow heartbeat
• fever
• hallucinations
• hives
• holding false beliefs that cannot be changed by fact
• increased sensitivity of eyes to light
• increased sweating, possibly with fever or cold
• itching
• joint or muscle pain
• muscle cramps or spasms
• muscle pain or 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
• sore throat
• 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
• unusual tiredness or weakness
• 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:

• Difficulty having a bowel movement (stool)
• dry mouth

• Acid or sour stomach
• belching
• bloated, full feeling
• dry eyes
• excess air or gas in the stomach or intestines
• headache
• heartburn
• indigestion
• passing gas
• stomach discomfort, upset, or pain
• trouble with urinating
• unable to have a bowel movement (stool)
• upper stomach pain

• Burning feeling in the chest or stomach
• change in taste
• dry skin
• dry throat
• fainting
• indigestion
• loss of taste
• swelling of the abdomen or stomach area
• tenderness in the stomach area
• vision blurred
• vomiting

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

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