Trospium

What is Trospium?

• Trospium (Sanctura; Sanctura XR) is a muscarinic antagonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Trospium chloride

Trospium

What are the uses of this medicine?

Trospium (Sanctura; Sanctura XR) is a prescription medicine used to treat adults with overactive bladder who have the following symptoms:

• a strong need to urinate right away;
• leaking or wetting accidents due to a strong need to urinate right away;
• a need to urinate often.

How does this medicine work?

• Trospium chloride is an antispasmodic, antimuscarinic agent.
• Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder.
• Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.
• The selectivity of trospium chloride for muscarinic over nicotinic receptors, and similar affinity for the M2 and M3 muscarinic receptor subtypes.
• M2 and M3 receptors are found in the bladder and may play a role in the pathogenesis of overactive bladder.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have trouble emptying your bladder;
• have delayed or slow emptying of your stomach;
• have an eye problem called “uncontrolled narrow-angle glaucoma”;
• are allergic to Trospium Chloride or any of its ingredients.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antacids
• antihistamines
• cold medications
• ipratropium (Atrovent)
• medications for depression or mental illness
• medications for inflammatory bowel disease or diarrhea, motion sickness, Parkinson's disease, ulcers, urinary problems
• metformin (Glucophage)
• morphine (MSIR, Oramorph, others)
• muscle relaxants
• procainamide
• tenofovir (Viread)
• vancomycin (Vancocin)

Is this medicine FDA approved?

• Trospium was approved for use in the United States in 1975 and indications include urinary urge incontinence and symptoms of overactive bladder such as urinary urgency and frequency.
• Trospium is available in tablets of 20 mg in generic forms and under the brand name Sanctura.

How should this medicine be used?

Recommended dosage: Trospium chloride tablet:

• The recommended dose of trospium chloride tablet is one 20 mg tablet twice daily.
• For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime.
• In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability.

Trospium Chloride Extended- Release Capsules:

• The recommended dosage of Trospium Chloride Extended- Release Capsules is one 60 mg capsule daily in the morning.
• Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute).

Administration:

• Trospium comes as a tablet and an extended-release capsule to take by mouth.
• Trospium chloride tablets should be dosed with water on an empty stomach, at least one hour before a meal.
• Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal.
• To help you remember to take trospium, take it around the same time every day.
• Do not take alcohol within 2 hours of taking Trospium Chloride Extended-Release Capsules.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 20 mg tablets
• 60 mg capsules

This medicine is available in fallowing brand namesː

• Sanctura; Sanctura XR

What side effects can this medication cause?

The most common side effects with trospium chloride tablets are:

• Dry mouth
• Constipation
• Abdominal pain upper
• Constipation aggravated
• Dyspepsia
• Flatulence
• Headache
• Fatigue
• Urinary retention
• Dry eyes

The most common side effects with Trospium Chloride Extended-Release Capsules are:

• dry mouth
• constipation

Trospium Chloride Extended-Release Capsules may cause other less common side effects, including:

• trouble emptying the bladder
• blurred vision and drowsiness
• heat prostration
• allergic reactions that may be serious

• Anticholinergic agents can precipitate acute narrow angle glaucoma and acute urinary retention.

What special precautions should I follow?

• Trospium chloride should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
• Angioedema of the face, lips, tongue, and/or larynx has been reported with trospium chloride. Patients should be advised to promptly discontinue trospium chloride tablets and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.
• Trospium chloride should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
• In patients being treated for narrow-angle glaucoma, trospium chloride tablets should only be used if the potential benefits outweigh the risks and in that circumstance only with careful monitoring.
• Trospium chloride is associated with anticholinergic central nervous system (CNS) effects.
• Trospium is substantially excreted by the kidney. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate renal impairment.
• Prior to treatment, patients should fully understand the risks and benefits of trospium chloride tablets. In particular, patients should be informed not to take trospium chloride tablets if they:
• have urinary retention;
• gastric retention;
• uncontrolled narrow-angle glaucoma;
• are allergic to any component of trospium chloride tablets.

• Because anticholinergics, such as trospium chloride tablets, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effects have been determined.
• Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.
• Alcohol should not be consumed within 2 hours of Trospium Chloride Extended-Release Capsules administration.
• Because many drugs are excreted in human milk, trospium chloride tablets should be used during lactation only if the potential benefit justifies the potential risk to the newborn.
• Trospium has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• antimuscarinic effects
• tachycardia (fast heartbeat)
• mydriasis
• sensitivity to light

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Supportive treatment should be provided according to symptoms.
• In the event of overdosage, electrocardiographic monitoring is recommended.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies of trospium chloride in pregnant women.
• Trospium chloride should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus.

Can this medicine be used in children?

• The safety and effectiveness of trospium chloride in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Trospium Chloride Extended-Release Capsules:

• Active Ingredient: trospium chloride.
• Inactive Ingredients: colloidal silicon dioxide, magnesium aluminum silicate, magnesium stearate, methacrylic acid copolymer dispersion, polyethylene glycol 400, povidone, sodium chloride, stearic acid, talc, FD&C yellow no. 6.
• The capsule shell contains: black iron oxide, gelatin, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide.

Trospium Chloride tablets:

• Active Ingredient: trospium chloride.
• Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose 2910, titanium dioxide, polyethylene glycol 400, polysorbate 80, xylitol, sucralose, red iron oxide and yellow iron oxide.

Who manufactures and distributes this medicine?

Trospium Chloride Extended-Release Capsules: Manufactured For:

• Perrigo
• Minneapolis, MN

Manufactured By:

• Sidmak Laboratories (India) Pvt. Ltd.
• Plot No. 20, Pharmacity,
• Selaqui Industrial Area,
• Dehradun
• Uttarakhand, India

Trospium Chloride tablets: Manufactured by:

• InvaGen Pharmaceuticals, Inc.
• (a subsidiary of Cipla Ltd.)
• Hauppauge, NY

Manufactured for:

• Cipla USA, Inc.
• 10 Independence Boulevard, Suite 300
• Warren, NJ

What should I know about storage and disposal of this medication?

Trospium Chloride Extended-Release Capsules:

• Keep Trospium Chloride Extended-Release Capsules and all other medicines out of the reach of children.
• Store Trospium Chloride Extended-Release Capsules at room temperature, 68° to 77°F (20° to 25°C).
• Safely dispose of Trospium Chloride Extended-Release Capsules that are out of date or that you no longer need.

Trospium Chloride tablets:

• Store at 20° to 25°C (68° to 77°F).

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• Dailymed label info on Trospium
• FDA Trospium

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