Sanctura

• Allergan, Inc.

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

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.

Genitourinary antispasmodic; quaternary ammonium antimuscarinic.1 3

Minimally metabolized by CYP isoenzymes; does not inhibit CYP1A2, 3A4, 2A6, 2C9, 2C19, 2D6, or 2E1 in vitro.1 2 7 Pharmacokinetic interactions unlikely with drugs metabolized by CYP isoenzymes or with CYP enzyme inducers or inhibitors.1 2 7

Drugs Eliminated by Active Tubular Secretion

Possible competition for renal secretion, decreased renal elimination, and increased serum concentrations of trospium and/or other drug.1 Use concomitantly with caution; monitor carefully.1

Drugs Affected by GI Motility

Potential for altered absorption because of decreased GI motility.1

Specific Drugs

Storage

Oral

20–25°C.1

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Dry mouth.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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

The recommended dose is 20 mg twice daily. Sanctura® should be dosed at least one hour before meals or given on an empty stomach.

Dosage modification is recommended in the following patient populations:

• For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
• 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 [see Use in Specific Populations (8.5)].

Sanctura® is supplied as 20 mg tablets (brownish yellow, biconvex, glossy coated tablets printed with S in black ink).

Sanctura® is contraindicated in patients with:

• urinary retention
• gastric retention
• uncontrolled narrow-angle glaucoma.
• known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: Carcinogenicity studies with trospium chloride were conducted in mice and rats for 78 weeks and 104 weeks, respectively, at maximally tolerated doses. No evidence of a carcinogenic effect was found in either mice or rats administered up to 200 mg/kg/day, approximately 9 times the expected clinical exposure levels at the maximum recommended human dose (MRHD) of 40 mg.

Mutagenesis: Trospium chloride was not mutagenic nor genotoxic in tests in vitro in bacteria (Ames test) and mammalian cells (L5178Y mouse lymphoma and CHO cells) or in vivo in the rat micronucleus test.

Impairment of Fertility: No evidence of impaired fertility was observed in rats administered doses up to 200 mg/kg/day (about 16 times the expected clinical exposure at the MRHD, based on AUC).

Sanctura (trospium) relieves spasms of the bladder.

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

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

Take Sanctura 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 Sanctura 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 Sanctura at room temperature away from moisture and heat.

Before using Sanctura, 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 Sanctura.

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 Sanctura. 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.