Sanctura XR

Serious side effects have been reported with Sanctura XR. See the “Sanctura XR Precautions” section.

Common side effects of Sanctura XR include the following:

• dry mouth
• constipation
• headache
• upset stomach
• dry eyes

This is not a complete list of Sanctura XR side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sanctura XR, there are no specific foods that you must exclude from your diet when receiving this medication.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• your kidney function
• how you respond to this medication
• your age

The recommended dose of Sanctura XR (trospium) is 60 mg in the morning. 

If you take too much Sanctura XR, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Sanctura XR at room temperature, 68° to 77°F (20° to 25°C).
• Keep this and all medicines out of the reach of children.
• Safely dispose of Sanctura XR capsules that are out of date or that you no longer need.

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Not sweating during activities or in warm temperatures.
• Dizziness or passing out.
• Feeling sleepy.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Trouble passing urine.
• Very hard stools (constipation).
• Change in eyesight, eye pain, or very bad eye irritation.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Risk of Urinary Retention

Sanctura XR® capsules should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4)].

Angioedema

Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, trospium chloride should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

Decreased Gastrointestinal Motility

Sanctura XR® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications (4)]. Sanctura XR®, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis.

Controlled Narrow-angle Glaucoma

In patients being treated for narrow-angle glaucoma, Sanctura XR® should only be used if the potential benefits outweigh the risks, and in that circumstance only with careful monitoring [see Contraindications (4)].

Central Nervous System Effects

Sanctura XR® and SANCTURA® are associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.2)]. A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Sanctura XR® affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

Patients with Severe Renal Impairment

Sanctura XR® is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Dosage and Administration (2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

Alcohol Interaction

Alcohol should not be consumed within 2 hours of Sanctura XR® administration. In addition, patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.

Pregnancy

Teratogenic Effects

Pregnancy Category C: There are no adequate and well-controlled studies of Sanctura XR® in pregnant women. Sanctura XR® should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Sanctura XR® treatment are encouraged to contact their physician.

Trospium chloride was not teratogenic at statistically significant levels in rats or rabbits administered doses up to 200 mg/kg/day. This corresponds to systemic exposures up to approximately 16 and 32 times, respectively (based on AUC), the clinical exposure at the maximum recommended human dose (MRHD) of 60 mg. However, in rabbits, one fetus in each of the three treated dose groups (1, 1, and 32 times the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A no effect level for maternal and fetal toxicity was observed at levels approximately equivalent to the clinical exposure at the MRHD (20 mg/kg/day in rats and rabbits). No developmental toxicity was observed in the offspring of female rats exposed pre- and post-natally to up to 200 mg/kg/day.

Labor and Delivery

The effect of Sanctura XR® capsules on labor and delivery is unknown.

Nursing Mothers

Trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, Sanctura XR® should be used during lactation only if the potential benefit justifies the potential risk.

Pediatric Use

The safety and effectiveness of Sanctura XR® in pediatric patients have not been established.

Geriatric Use

Of 1165 patients in Phase 3 clinical studies of Sanctura XR®, 37% (n=428) were ages 65 and over, while 12% (n=143) were ages 75 and over.

No overall differences in effectiveness were observed between those subjects aged 65 and over and younger subjects. In Sanctura XR® subjects ages 65 and over compared to younger subjects, the following adverse reactions were reported at a higher incidence: dry mouth, constipation, abdominal pain, dyspepsia, urinary tract infection and urinary retention. In subjects ages 75 and over, three reported a fall and in one of them a relationship to the event could not be excluded.

Renal Impairment

Severe renal impairment (creatinine clearance less than 30 mL/minute) may significantly alter the disposition of Sanctura XR®. In a study of immediate-release trospium chloride, 4.2-fold and 1.8-fold increases in mean AUC(0-∞) and Cmax, respectively, were detected in patients with severe renal impairment. Use of Sanctura XR® is not recommended in patients with severe renal impairment [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)]. The pharmacokinetics of trospium chloride have not been studied in patients with creatinine clearance ranging from 30-80 mL/min.

Trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.

Hepatic Impairment

There is no information regarding the effect of severe hepatic impairment on exposure to Sanctura XR®. In a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release trospium chloride, mean Cmax increased 12% and 63%, respectively, and mean AUC(0-∞) decreased 5% and 15%, respectively, compared to healthy subjects. The clinical significance of these findings is unknown. Caution is advised, however, when administering Sanctura XR® to patients with moderate to severe hepatic impairment.