Solifenacin
Pronunciation: sol-ee-FEN-a-sin
Brand names: VESIcare, VESIcare LS
Dosage form: tablets (5 mg, 10 mg), oral suspension ( 5 mg/5 mL)
Drug class: Urinary antispasmodics
What is solifenacin?
Solifenacin tablets (Vesicare) are a prescription medication used to treat overactive bladder symptoms, including frequent urination, sudden urgency, and urine leakage (incontinence), in adults. Solifenacin oral suspension (liquid) is a treatment for overactive bladder symptoms caused by brain, spinal cord, or nerve problems in children 2 years and older. This condition is called neurogenic detrusor overactivity (NDO).
Solifenacin works by relaxing the muscles in your bladder, allowing it to hold more urine. This helps reduce the sudden urge to urinate, decreases how often you need to go, and lowers the chance of accidents.
Solifenacin brand name is Vesicare tablets and Vesicare LS oral suspension. Generic Solifenacin tablets are available.
Solifenacin is a competitive muscarinic receptor antagonist that relaxes the bladder muscle (detrusor).
Solifenacin tablets 5 mg and solifenacin 10 mg are not approved for use in children.
Solifenacin side effects
Common solifenacin side effects may include:
- blurred vision;
- dry mouth, dry eyes;
- painful urination;
- constipation; or
- heat stroke - decreased sweating, dry skin, dizziness, tiredness, nausea, feeling hot.
Serious solifenacin side effects may occur when taking this medicine. Get emergency medical help if you have signs of an allergic reaction to solifenacin, including symptoms of hives, difficulty breathing, or swelling in your face or throat, or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Stop using solifenacin succinate and call your doctor at once if you have:
- severe stomach pain, or constipation for 3 days or longer;
- pain or burning when you urinate;
- headache, confusion, drowsiness, hallucinations;
- vision changes, eye pain, or seeing halos around lights;
- little or no urination, pain or burning when you urinate;
- dehydration symptoms - dizziness, tiredness, feeling very thirsty or hot, decreased sweating, or hot and dry skin; or
- high potassium level - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Warnings
You should not use solifenacin tablets or liquid if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you have a hypersensitivity to solifenacin or any of the inactive ingredients.
You should not use solifenacin tablets if you are unable to urinate (urinary retention).
Before taking this medicine
To make sure solifenacin succinate is safe for you, tell your doctor if you have ever had:
- 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
- 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.
You should not breastfeed while using solifenacin succinate.
How should I take solifenacin succinate?
Take solifenacin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Solifenacin tablets
Solifenacin 5mg tablets and solifenacin 10mg tablets are swallowed with water once a day, with or without food. Do not crush, chew, or break the tablet. Swallow it whole.
Solifenacin oral suspension
Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). After taking Solifenacin liquid drink a glass of water or milk. Avoid taking the liquid with food or other drinks or you may have a bitter aftertaste. Throw away any unused liquid 28 days after you first opened the bottle.
Store this medicine in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.
Solifenacin dosing information
Adult solifenacin dose
Initial dose: solifenacin 5 mg tablet orally once daily
Maintenance dose: solifenacin 5 mg tablet to solifenacin 10 mg tablet orally once daily
Dose modifications:
- Renal Impairment. Do not exceed a solifenacin 5 mg once daily in patients with severe renal impairment (CLcr < 30 mL/min/1.73 m2 )
- Hepatic Impairment. Do not exceed a solifenacin 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B).
- Do not use in patients with severe hepatic impairment (Child-Pugh C)
- In patients taking CYP3A4 Inhibitors. Do not exceed solifenacin 5 mg once daily when solifenacin is administered with strong CYP3A4 inhibitors such as ketoconazole
Use: For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Pediatric solifenacin dose
Initial dose: Pediatric solifenacin doses are weight-based and are administered once daily.
Maintenance dose: After administration of the recommended starting dose, the dose may be increased to the lowest effective dose, but should not exceed the maximum recommended dose.
Use: For the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older.
A table with the recommended paediatric dosage according to the patient's body weight is available on Vesicare LS Dosage page.
Solifenacin formulations
Solifenacin is available as:
- Solifenacin 5mg tablets (Vesicare and generics)
- Solifenacin 10mg tablets (Vesicare and generics)
- Solifenacin 5 mg/5 mL oral suspesion (Vesicare LS)
What happens if I miss a dose?
Missed tablet dose. Skip the missed dose and use your next dose at the regular time. Do not take 2 doses on the same day.
Missed oral suspension dose. Do not take 2 doses of solifenacin oral suspension the same day Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking solifenacin?
Avoid driving or hazardous activities until you know how this medicine will affect you. Solifenacin may impair your reactions and your vision.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Vesicare can decrease perspiration, and you may be more prone to heat stroke.
What other drugs will affect this medicine?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
CYP3A4 Inhibitors. Do not exceed the recommended starting dose of solifenacin with concomitant use of strong CYP3A4 inhibitors. (
Many drugs can interact with solifenacin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Ingredients
Vesicare tablets
Active ingredient: solifenacin succinate
Inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000, and titanium dioxide with yellow ferric oxide (Vesicare solifenacin 5 mg tablet) or red ferric oxide (Vesicare solifenacin 10 mg tablet)
Vesicare LS (oral suspension)
Active ingredient: solifenacin succinate
Inactive ingredients: polacrilin potassium, methylparaben, propylparaben, propylene glycol, simethicone emulsion 30%, carbomer homopolymer Type B, xylitol, acesulfame potassium, natural orange flavor, sodium hydroxide, and purified water.
Storage
Vesicare tablets
Store between 59°F to 86°F (15°C to 30°C). Keep the bottle closed. • Safely throw away medicine that is out of date or no longer needed.
Vesicare LS (oral suspension)
Store at room temperature, between 68°F to 77°F (20°C to 25°C) with the cap closed. Store Vesicare LS in the original bottle.
Throw away oral suspension 28 days (4 weeks) after first opening.
Company
Vesicare Marketed and Distributed by: Astellas Pharma US, Inc., Northbrook, Illinois 60062
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.