Sanctura XR

DRUG DESCRIPTION

SANCTURA XR is an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (l?, 3?, 5?). The empirical formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below:

SANCTURA XR
  (trospium chloride) Structural Formula Illustration

Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound's solubility in water is approximately 1 g/2 mL.

SANCTURA XR capsules contain 60 mg of trospium chloride to be given orally. Each capsule also contains the following inactive ingredients: sugar spheres, methacrylic acid copolymer, ethyl cellulose, hydroxypropyl methylcellulose, triethyl citrate, talc, and Opadry white.

What are the possible side effects of trospium (Sanctura, Sanctura XR)?

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

Stop using trospium and call your doctor at once if you urinate less than usual or not at all.

Less serious side effects may include:

  • dry mouth or throat;
  • dry eyes, blurred vision;
  • constipation;
  • stomach pain, bloating, gas;
  • drowsiness, or
  • mild skin rash.

This is not a...

Read All Potential Side Effects and See Pictures of Sanctura XR

What are the precautions when taking trospium chloride extended release capsule (Sanctura XR)?

Before taking trospium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of glaucoma (uncontrolled narrow-angle type), inability to urinate (urinary retention), delayed or slow emptying of your stomach.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, constipation, other stomach conditions (such as ulcerative colitis, intestinal atony), myasthenia...

Read All Potential Precautions of Sanctura XR


Sanctura XR Consumer (continued)

SIDE EFFECTS: Dry mouth, constipation, stomach upset, dry eyes, dry nose, dizziness, blurred vision, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: eye pain, difficulty urinating, fast heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking trospium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of glaucoma (uncontrolled narrow-angle type), inability to urinate (urinary retention), delayed or slow emptying of your stomach.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, constipation, other stomach conditions (such as ulcerative colitis, intestinal atony), myasthenia gravis.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication can reduce sweating, making you more likely to develop a serious condition called heat stroke. Avoid strenuous work or exercise in hot weather.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dry mouth, constipation, and difficulty urinating.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Sanctura XR Patient Information Including Side Effects

Brand Names: Sanctura, Sanctura XR

Generic Name: trospium (Pronunciation: tros PEE um)

  • What is trospium (Sanctura XR)?
  • What are the possible side effects of trospium (Sanctura XR)?
  • What is the most important information I should know about trospium (Sanctura XR)?
  • What should I discuss with my healthcare provider before taking trospium (Sanctura XR)?
  • How should I take trospium (Sanctura XR)?
  • What happens if I miss a dose (Sanctura XR)?
  • What happens if I overdose (Sanctura XR)?
  • What should I avoid while taking trospium (Sanctura XR)?
  • What other drugs will affect trospium (Sanctura XR)?
  • Where can I get more information?

What is trospium (Sanctura XR)?

Trospium relieves spasms of the bladder.

Trospium is used to treat overactive bladder and symptoms of urinary incontinence, frequency, and urgency.

Trospium may also be used for other purposes not listed in this medication guide.

What are the possible side effects of trospium (Sanctura XR)?

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

Stop using trospium and call your doctor at once if you urinate less than usual or not at all.

Less serious side effects may include:

  • dry mouth or throat;
  • dry eyes, blurred vision;
  • constipation;
  • stomach pain, bloating, gas;
  • drowsiness, or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about trospium (Sanctura XR)?

Do not take this medicine if you are allergic to trospium, or if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive system, or if you are unable to urinate.

Take trospium on an empty stomach, at least 1 hour before a meal.

Trospium can cause side effects that may impair your vision, thinking, or reactions. Be careful if you drive or do anything that requires you to be awake and able to see clearly.

Avoid using other medicines that make you sleepy (especially cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety). They can add to the side effects of trospium. Tell your doctor if you regularly use any of these medicines.

Avoid drinking alcohol. It can increase drowsiness caused by 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.

There may be other drugs not listed that can interact with trospium. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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