Solifenacin

Solifenacin is a prescription medicine used to treat the symptoms of overactive bladder such as frequent or urgent urination and incontinence.

• Solifenacin is available under the following different brand names: VESIcare, VESIcare LS

Adult dosage

Tablet

• 5mg (VESIcare)
• 10mg (VESIcare)

Pediatric dosage

Oral suspension

• 1mg/mL (VESIcare LS)

Overactive Bladder

Adult dosage

• VESIcare only: 5 mg orally once daily, may increase to 10 mg/day if well tolerated

Neurogenic Detrusor Overactivity

Pediatric dosage

VESIcare LS only

• Children below 2 years: Safety and efficacy not established
• Children above 2 years:
  • Oral suspension concentration 1 mg/mL
  • Children weighing between 9 to 15 kg: 2 mL orally once daily initially; not to exceed 4 mL/day
  • Children weighing between 15 to 30 kg: 3 mL orally once daily initially; not to exceed 5 mL/day
  • Children weighing between 30 to 45 kg: 3 mL orally once daily initially; not to exceed 6 mL/day
  • Children weighing between 45 to 60 kg: 4 mL orally once daily initially; not to exceed 8 mL/day
  • Children weighing more than 60 kg: 5 mL orally once daily initially; not to exceed 10 mL/day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Solifenacin include:

• blurred vision,
• dry mouth,
• pain or burning when urinating,
• constipation,
• decreased sweating,
• dizziness,
• tiredness,
• nausea, and
• feeling hot.

Serious side effects of Solifenacin include:

• severe stomach pain,
• constipation for 3 days or longer,
• confusion,
• hallucination,
• vision changes,
• eye pain,
• seeing halos around lights,
• little or no urination,
• feeling very thirsty or hot
• being unable to urinate,
• heavy sweating,
• hot and dry skin,
• weakness,
• tingly feeling,
• chest pain,
• irregular heartbeats, and
• loss of movement.

Rare side effects of Solifenacin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Solifenacin has severe interactions with the following drugs:
  • itraconazole
  • lefamulin
• Solifenacin has serious interactions with at least 47 other drugs.
• Solifenacin has moderate interactions with at least 196 other drugs.
• Solifenacin has minor interactions with the following drugs:
  • azithromycin
  • chloroquine
  • dimenhydrinate
  • donepezil
  • galantamine
  • levodopa

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Gastric retention
• Uncontrolled narrow-angle glaucoma
• Tablets only
• Urinary retention

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Solifenacin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Solifenacin?”

Cautions

• Reports of angioedema of face, lips, and/or larynx, in some cases occurring after the first dose, described; anaphylactic reactions reported rarely
• Administer with caution with clinically significant bladder outflow obstruction
• Caution with decreased gastrointestinal motility
• Somnolence reported; advise patients not to drive or operate heavy machinery until they know how therapy affects them
• Caution in patients being treated for narrow-angle glaucoma
• Caution with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval
• Associated with antimuscarinic CNS adverse reactions; monitor for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose
• Drug interaction overview
  • Solifenacin is a CYP3A4 substrate
  • Coadministration of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin; modify solifenacin dose if coadministered with strong CYP3A4 inhibitors

Pregnancy and Lactation

• There are no studies on use in pregnant females
• Lactation
  • No information available
  • Solifenacin is present in mouse milk
  • When a drug is present in animal milk, it is likely to be present in human milk