VESIcare

Vesicare is a prescription medication used to treat symptoms of an overactive bladder in adults. Vesicare belongs to a group of drugs called antimuscarinic medications, which help the bladder muscles to relax.

This medication comes in tablet form and is taken once a day, with or without food.

Common side effects include dry mouth, constipation, and urinary tract infections. Vesicare can cause blurred vision or drowsiness. Do not drive or operate heavy machinery until you know how it affects you.

Vesicare is a prescription medication used to treat the symptoms of overactive bladder in adults.

Symptoms treated are:

• frequent urination
• urination leaking accidents

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Astellas Pharma US, Inc.

It is not known if Vesicare crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Vesicare.

• Potent and selective antimuscarinic agent.1 2

• Inhibits contraction of the detrusor muscle of the bladder, resulting in decreased bladder activity.2

• Demonstrates binding specificity for muscarinic M3 receptors in vitro and functional selectivity for urinary bladder over secretory (e.g., salivary) glands.2

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Swallow the tablet whole with water. Do not crush, break, or chew it. You may take this medicine with or without food.

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.

• For oral dosage form (tablets):
  • To treat bladder problems:
    • Adults—At first, 5 milligrams (mg) as a single dose once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 10 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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.

• It is used to treat an overactive bladder.

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.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• Trouble breathing.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Very bad belly pain.
• Very hard stools (constipation).
• Not sweating during activities or in warm temperatures.
• Not able to pass urine.
• Pain when passing urine.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Very bad headache.

• 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.

Potent CYP3A4 Inhibitors

Following the administration of 10 mg of VESIcare in the presence of 400 mg of ketoconazole, a potent inhibitor of CYP3A4, the mean Cmax and AUC of solifenacin increased by 1.5 and 2.7-fold, respectively. Therefore, it is recommended not to exceed a 5 mg daily dose of VESIcare when administered with therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. The effects of weak or moderate CYP3A4 inhibitors were not examined.

CYP3A4 Inducers

There were no in vivo studies conducted to evaluate the effect of CYP3A4 inducers on VESIcare. In vitro drug metabolism studies have shown that solifenacin is a substrate of CYP3A4. Therefore, inducers of CYP3A4 may decrease the concentration of solifenacin.

Drugs Metabolized by Cytochrome P450

At therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes.

Warfarin

Solifenacin has no significant effect on the pharmacokinetics of R-warfarin or S-warfarin [see Clinical Pharmacology (12.3)].

Oral Contraceptives

In the presence of solifenacin there are no significant changes in the plasma concentrations of combined oral contraceptives (ethinyl estradiol/levonorgestrel) [see Clinical Pharmacology (12.3)].

Digoxin

Solifenacin had no significant effect on the pharmacokinetics of digoxin (0.125 mg/day) in healthy subjects [see Clinical Pharmacology (12.3)].

VESIcare is supplied as round, film-coated tablets, available in bottles and unit dose blister packages as follows: 

Each 5 mg tablet is light yellow and debossed with a logo and “150” and is available as follows:

Bottle of 30                                 NDC 51248-150-01
Bottle of 90                                 NDC 51248-150-03
Unit Dose Pack of 100                NDC 51248-150-52

Each 10 mg tablet is light pink and debossed with a logo and “151” and is available as follows:

Bottle of 30                                 NDC 51248-151-01
Bottle of 90                                 NDC 51248-151-03
Unit Dose Pack of 100                NDC 51248-151-52

Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F-86ºF) [see USP Controlled Room Temperature].

Usual Adult Dose for Urinary Incontinence:

5 mg orally per day.

Usual Adult Dose for Urinary Frequency:

5 mg orally per day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

You should not use solifenacin if you are allergic to it, or if you have:

• untreated or uncontrolled narrow-angle glaucoma;

• a stomach disorder causing delayed emptying; or

• if you are unable to urinate.

To make sure solifenacin is safe for you, tell your doctor if you have:

• glaucoma;

• liver disease;

• kidney disease;

• trouble emptying your bladder (or you have a weak stream of urine);

• slow digestion;

• a blockage in your stomach or intestines; or

• a history of long QT syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether solifenacin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using solifenacin.

Solifenacin is not approved for use by anyone younger than 18 years old.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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