Drugs Details

Drugs Info of VESIcare
Drugs Details
  • Drugs Type  : Multum
  • Date : 14th Jul 2015 08:41 am
  • Brand Name : VESIcare
  • Generic Name : solifenacin (Pronunciation: sol ee FEN a sin)
Descriptions

VESIcare® (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2•C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:

 

VESIcare (solifenacin succinate) Structural Formula Illustration

Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each VESIcare tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each VESIcare tablet also contains the following inert ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg VESIcare tablet) or red ferric oxide (10 mg VESIcare tablet).

What are the possible side effects of solifenacin (VESIcare)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using solifenacin and call your doctor at once if you have a serious side effect such as:

  • hot, dry skin and extreme thirst;
  • severe stomach pain, or constipation for 3 days or longer;
  • pain or burning when you urinate;
  • vision changes, eye pain, or seeing halos around lights;
  • urinating less than usual or not at all;
  • confusion, hallucinations;
  • high potassium...

Read All Potential Side Effects and See Pictures of VESIcare »

What are the precautions when taking solifenacin succinate (VESIcare)?

Before taking solifenacin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: difficulty urinating (urinary retention), other bladder problems (such as bladder outflow obstruction), stomach/intestinal blockage (gastric retention), personal or family history of glaucoma (angle-closure type), liver disease, bowel disease (such as ulcerative colitis), slowed movement of stomach/intestines, constipation, kidney disease, enlarged prostate, a certain muscle/nerve disease (myasthenia gravis).

This...

Indications

VESIcare is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Dosage Administration

Dosing Information

The recommended dose of VESIcare is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. VESIcare should be taken with water and swallowed whole. VESIcare can be administered with or without food.

Dose Adjustment in Patients with Renal Impairment

For patients with severe renal impairment (CLcr < 30 mL/min), a daily dose of VESIcare greater than 5 mg is not recommended [see WARNINGS AND PRECAUTIONS; Use in Specific Populations].

Dose Adjustment in Patients with Hepatic Impairment

For patients with moderate hepatic impairment (Child-Pugh B), a daily dose of VESIcare greater than 5 mg is not recommended. Use of VESIcare in patients with severe hepatic impairment (Child-Pugh C) is not recommended [see WARNINGS AND PRECAUTIONS; Use in Specific Populations].

Dose Adjustment in Patients Taking CYP3A4 Inhibitors

When administered with potent CYP3A4 inhibitors such as ketoconazole, a daily dose of VESIcare greater than 5 mg is not recommended

How Supplied

Dosage Forms And Strengths

The 5 mg tablets are round, light yellow, debossed with 150.

The 10 mg tablets are round, light pink, debossed with 151.

Storage And Handling

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

Side Effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

VESIcare has been evaluated for safety in 1811 patients in randomized, placebo-controlled trials. Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The incidence of dry mouth and constipation in patients treated with VESIcare was higher in the 10 mg compared to the 5 mg dose group.

In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the VESIcare 10 mg group. Angioneurotic edema has been reported in one patient taking VESIcare 5 mg. Compared to 12 weeks of treatment with VESIcare, the incidence and severity of adverse reactions were similar in patients who remained on drug for up to 12 months.

The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified adverse reactions, derived from all reported adverse events, in randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with VESIcare 5 or 10 mg once daily for up to 12 weeks.

Table 1: Percentages of Patients with Identified Adverse Reactions, Derived from All Adverse Events Exceeding Placebo Rate and Reported by 1% or More Patients for Combined Pivotal Studies

  Placebo (%) VESIcare 5 mg (%) VESIcare 10 mg (%)
Number of Patients 1216 578 1233
GASTROINTESTINAL DISORDERS
  Dry Mouth 4.2 10.9 27.6
  Constipation 2.9 5.4 13.4
  Nausea 2 1.7 3.3
  Dyspepsia 1 1.4 3.9
  Abdominal Pain Upper 1 1.9 1.2
  Vomiting NOS 0.9 0.2 1.1
INFECTIONS AND INFESTATIONS
  Urinary Tract Infection NOS 2.8 2.8 4.8
  Influenza 1.3 2.2 0.9
  Pharyngitis NOS 1 0.3 1.1
NERVOUS SYSTEM DISORDERS
  Dizziness 1.8 1.9 1.8
EYE DISORDERS
  Vision Blurred 1.8 3.8 4.8
  Dry Eyes NOS 0.6 0.3 1.6
RENAL AND URINARY DISORDERS
  Urinary Retention 0.6 0 1.4
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
  Edema Lower Limb 0.7 0.3 1.1
  Fatigue 1.1 1 2.1
PSYCHIATRIC DISORDERS
  Depression NOS 0.8 1.2 0.8
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
  Cough 0.2 0.2 1.1
VASCULAR DISORDERS
  Hypertension NOS 0.6 1.4 0.5

Post-Marketing Experience

Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of solifenacin in their causation cannot be reliably determined.

The following events have been reported in association with solifenacin use in worldwide postmarketing experience:

General:peripheral edema, hypersensitivity reactions, including angioedema with airway obstruction, rash, pruritus, urticaria, and anaphylactic reaction;

Central Nervous:headache, confusion, hallucinations, delirium and somnolence;

Cardiovascular:QT prolongation; Torsade de Pointes, atrial fibrillation, tachycardia, palpitations;

Hepatic:liver disorders mostly characterized by abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyl transferase);

Renal:renal impairment;

Metabolism and nutrition disorders: decreased appetite, hyperkalemia;

Dermatologic:exfoliative dermatitis and erythema multiforme;

Eye disorders:glaucoma;

Gastrointestinal disorders:gastroesophageal reflux disease and ileus;

Respiratory, thoracic and mediastinal disorders: dysphonia;

Musculoskeletal and connective tissue disorders: muscular weakness;

Interactions

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 and CLINICAL PHARMACOLOGY]. 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].

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].

Digoxin

Solifenacin had no significant effect on the pharmacokinetics of digoxin (0.125 mg/day) in healthy subjects

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Angioedema and Anaphylactic Reactions

Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin. In some cases angioedema occurred after the first dose. Cases of angioedema have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, solifenacin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. Anaphylactic reactions have been reported rarely in patients treated with solifenacin succinate. Solifenacin succinate should not be used in patients with a known or suspected hypersensitivity to solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.

Urinary Retention

VESIcare, like other anticholinergic drugs, should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see CONTRAINDICATIONS].

Gastrointestinal Disorders

VESIcare, like other anticholinergics, should be used with caution in patients with decreased gastrointestinal motility [see CONTRAINDICATIONS].

Central Nervous System Effects

VESIcare is associated with anticholinergic central nervous system (CNS) effects [see ADVERSE REACTIONS]. A variety of CNS anticholinergic effects have been reported, including headache, 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 VESIcare affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

Controlled Narrow-Angle Glaucoma

VESIcare should be used with caution in patients being treated for narrow-angle glaucoma [see CONTRAINDICATIONS].

Hepatic Impairment

VESIcare should be used with caution in patients with hepatic impairment. Doses of VESIcare greater than 5 mg are not recommended in patients with moderate hepatic impairment (Child-Pugh B). VESIcare is not recommended for patients with severe hepatic impairment (Child-Pugh C) [see DOSAGE AND ADMINISTRATION and Use In Specific Populations].

Renal Impairment

VESIcare should be used with caution in patients with renal impairment. Doses of VESIcare greater than 5 mg are not recommended in patients with severe renal impairment (CLcr < 30 mL/min) [see DOSAGE AND ADMINISTRATION and Use In Specific Populations].

Patients with Congenital or Acquired QT Prolongation

In a study of the effect of solifenacin on the QT interval in 76 healthy women [see CLINICAL PHARMACOLOGY] the QT prolonging effect appeared less with solifenacin 10 mg than with 30 mg (three times the maximum recommended dose), and the effect of solifenacin 30 mg did not appear as large as that of the positive control moxifloxacin at its therapeutic dose. This observation should be considered in clinical decisions to prescribe VESIcare for patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION).

Patients should be informed that antimuscarinic agents such as VESIcare have been associated with constipation and blurred vision. Patients should be advised to contact their physician if they experience severe abdominal pain or become constipated for 3 or more days. Because VESIcare may cause blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug's effect on the patient's vision has been determined. Heat prostration (due to decreased sweating) can occur when anticholinergic drugs, such as VESIcare, are used in a hot environment. Patients should read the patient leaflet entitled “Patient Information VESIcare” before starting therapy with VESIcare.

Patients should be informed that solifenacin may produce angioedema, which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue solifenacin therapy and seek immediate attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No increase in tumors was found following the administration of solifenacin succinate to male and female mice for 104 weeks at doses up to 200 mg/kg/day (5 and 9 times, respectively, of the exposure at the maximum recommended human dose [MRHD] of 10 mg), and male and female rats for 104 weeks at doses up to 20 and 15 mg/kg/day, respectively ( < 1 times the exposure at the MRHD).

Solifenacin succinate was not mutagenic in the in vitro Salmonella typhimurium or Escherichia coli microbial mutagenicity test or chromosomal aberration test in human peripheral blood lymphocytes with or without metabolic activation, or in the in vivo micronucleus test in rats.

Solifenacin succinate had no effect on reproductive function, fertility or early embryonic development of the fetus in male and female mice treated with 250 mg/kg/day (13 times the exposure at the MRHD) of solifenacin succinate, and in male rats treated with 50 mg/kg/day ( < 1 times the exposure at the MRHD) and female rats treated with 100 mg/kg/day (1.7 times the exposure at the MRHD) of solifenacin succinate.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women.

Reproduction studies have been performed in mice, rats and rabbits. After oral administration of 14C-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier. No embryotoxicity or teratogenicity was observed in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD] of 10 mg. Administration of solifenacin succinate to pregnant mice at 3.6 times and greater (100 mg/kg/day and greater) the exposure at the MRHD, during the major period of organ development resulted in reduced fetal body weights. Administration of 7.9 times (250 mg/kg/day) the MRHD to pregnant mice resulted in an increased incidence of cleft palate. In utero and lactational exposures to maternal doses of solifenacin succinate of 3.6 times (100 mg/kg/day) the MRHD resulted in reduced peripartum and postnatal survival, reductions in body weight gain, and delayed physical development (eye opening and vaginal patency). An increase in the percentage of male offspring was also observed in litters from offspring exposed to maternal doses of 250 mg/kg/day. No embryotoxic effects were observed in rats at up to 50 mg/kg/day ( < 1 times the exposure at the MRHD) or in rabbits at up to 1.8 times (50 mg/kg/day) the exposure at the MRHD. Because animal reproduction studies are not always predictive of human response, VESIcare should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

The effect of VESIcare on labor and delivery in humans has not been studied.

There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD] of 10 mg. Administration of solifenacin succinate at 3.6 times (100 mg/kg/day) the exposure at the MRHD or greater increased peripartum pup mortality.

Nursing Mothers

After oral administration of 14C-solifenacin succinate to lactating mice, radioactivity was detected in maternal milk. There were no adverse observations in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD]. Pups of female mice treated with 3.6 times (100 mg/kg/day) the exposure at the MRHD or greater revealed reduced body weights, postpartum pup mortality or delays in the onset of reflex and physical development during the lactation period.

It is not known whether solifenacin is excreted in human milk. Because many drugs are excreted in human milk, VESIcare should not be administered during nursing. A decision should be made whether to discontinue nursing or to discontinue VESIcare in nursing mothers.

Pediatric Use

The safety and effectiveness of VESIcare in pediatric patients have not been established.

Geriatric Use

In placebo-controlled clinical studies, similar safety and effectiveness were observed between older (623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger patients (1188 patients < 65 years) treated with VESIcare.

Multiple dose studies of VESIcare in elderly volunteers (65 to 80 years) showed that Cmax, AUC and t1/2 values were 20-25% higher as compared to the younger volunteers (18 to 55 years).

Renal Impairment

VESIcare should be used with caution in patients with renal impairment. There is a 2.1-fold increase in AUC and 1.6-fold increase in t1/2 of solifenacin in patients with severe renal impairment. Doses of VESIcare greater than 5 mg are not recommended in patients with severe renal impairment (CLcr < 30 mL/min) [see WARNINGS AND PRECAUTIONS; DOSAGE AND ADMINISTRATION].

Hepatic Impairment

VESIcare should be used with caution in patients with reduced hepatic function. There is a 2-fold increase in the t1/2 and 35% increase in AUC of solifenacin in patients with moderate hepatic impairment. Doses of VESIcare greater than 5 mg are not recommended in patients with moderate hepatic impairment (Child-Pugh B). VESIcare is not recommended for patients with severe hepatic impairment (Child-Pugh C)

OverDose

Overdosage with VESIcare can potentially result in severe anticholinergic effects and should be treated accordingly. The highest dose ingested in an accidental overdose of solifenacin succinate was 280 mg in a 5-hour period. This case was associated with mental status changes. Some cases reported a decrease in the level of consciousness.

Intolerable anticholinergic side effects (fixed and dilated pupils, blurred vision, failure of heel-to-toe exam, tremors and dry skin) occurred on day 3 in normal volunteers taking 50 mg daily (5 times the maximum recommended therapeutic dose) and resolved within 7 days following discontinuation of drug.

In the event of overdose with VESIcare, treat with gastric lavage and appropriate supportive measures. ECG monitoring is also recommended.

ContrainDications

VESIcare is contraindicated in patients with:

  • urinary retention [see WARNINGS AND PRECAUTIONS],
  • gastric retention [see WARNINGS AND PRECAUTIONS],
  • uncontrolled narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS], and
  • in patients who have demonstrated hypersensitivity to the drug [see ADVERSE REACTIONS].

Clinical Pharamacology

Mechanism of Action

Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle and stimulation of salivary secretion.

Pharmacodynamics

Cardiac Electrophysiology

The effect of 10 mg and 30 mg solifenacin succinate on the QT interval was evaluated at the time of peak plasma concentration of solifenacin in a multi-dose, randomized, double-blind, placebo and positive-controlled (moxifloxacin 400 mg) trial. Subjects were randomized to one of two treatment groups after receiving placebo and moxifloxacin sequentially. One group (n=51) went on to complete 3 additional sequential periods of dosing with solifenacin 10, 20, and 30 mg while the second group (n=25) in parallel completed a sequence of placebo and moxifloxacin. Study subjects were female volunteers aged 19 to 79 years. The 30 mg dose of solifenacin succinate (three times the highest recommended dose) was chosen for use in this study because this dose results in a solifenacin exposure that covers those observed upon co-administration of 10 mg VESIcare with potent CYP3A4 inhibitors (e.g. ketoconazole, 400 mg). Due to the sequential dose escalating nature of the study, baseline EKG measurements were separated from the final QT assessment (of the 30 mg dose level) by 33 days.

The median difference from baseline in heart rate associated with the 10 and 30 mg doses of solifenacin succinate compared to placebo was -2 and 0 beats/minute, respectively. Because a significant period effect on QTc was observed, the QTc effects were analyzed utilizing the parallel placebo control arm rather than the pre-specified intra-patient analysis. Representative results are shown in Table 2.

Table 2: QTc changes in msec (90%CI) from baseline at Tmax (relative to placebo)*

Drug/Dose Fridericia method (using mean difference)
Solifenacin 10 mg 2 (-3,6)
Solifenacin 30 mg 8 (4,13)
*Results displayed are those derived from the parallel design portion of the study and represent the comparison of Group 1 to time-matched placebo effects in Group 2

Moxifloxacin was included as a positive control in this study and, given the length of the study, its effect on the QT interval was evaluated in 3 different sessions. The placebo subtracted mean changes (90% CI) in QTcF for moxifloxacin in the three sessions were 11 (7, 14), 12 (8, 17), and 16 (12, 21), respectively.

The QT interval prolonging effect appeared greater for the 30 mg compared to the 10 mg dose of solifenacin. Although the effect of the highest solifenacin dose (three times the maximum therapeutic dose) studied did not appear as large as that of the positive control moxifloxacin at its therapeutic dose, the confidence intervals overlapped. This study was not designed to draw direct statistical conclusions between the drugs or the dose levels.

Pharmacokinetics

Absorption

After oral administration of VESIcare to healthy volunteers, peak plasma levels (Cmax) of solifenacin are reached within 3 to 8 hours after administration, and at steady state ranged from 32.3 to 62.9 ng/mL for the 5 and 10 mg VESIcare tablets, respectively. The absolute bioavailability of solifenacin is approximately 90%, and plasma concentrations of solifenacin are proportional to the dose administered.

Effect of food

VESIcare may be administered without regard to meals. A single 10 mg dose administration of VESIcare with food increased Cmax and AUC by 4% and 3%, respectively.

Distribution

Solifenacin is approximately 98% (in vivo) bound to human plasma proteins, principally to ∞1-acid glycoprotein. Solifenacin is highly distributed to non-CNS tissues, having a mean steady-state volume of distribution of 600L.

Metabolism

Solifenacin is extensively metabolized in the liver. The primary pathway for elimination is by way of CYP3A4; however, alternate metabolic pathways exist. The primary metabolic routes of solifenacin are through N-oxidation of the quinuclidin ring and 4R-hydroxylation of tetrahydroisoquinoline ring. One pharmacologically active metabolite (4R-hydroxy solifenacin), occurring at low concentrations and unlikely to contribute significantly to clinical activity, and three pharmacologically inactive metabolites (N-glucuronide and the N-oxide and 4R-hydroxy-N-oxide of solifenacin) have been found in human plasma after oral dosing.

Excretion

Following the administration of 10 mg of 14C-solifenacin succinate to healthy volunteers, 69.2% of the radioactivity was recovered in the urine and 22.5% in the feces over 26 days. Less than 15% (as mean value) of the dose was recovered in the urine as intact solifenacin. The major metabolites identified in urine were N-oxide of solifenacin, 4R-hydroxy solifenacin and 4R-hydroxy-N-oxide of solifenacin and in feces 4R-hydroxy solifenacin. The elimination half-life of solifenacin following chronic dosing is approximately 45-68 hours.

Drug Interactions

Potent CYP3A4 Inhibitors

In a crossover study, following blockade of CYP3A4 by coadministration of the potent CYP3A4 inhibitor, ketoconazole 400 mg, once daily for 21 days, the mean Cmax and AUC of solifenacin increased by 1.5 and 2.7-fold, respectively [see DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS].

Warfarin

In a crossover study, subjects received a single oral dose of warfarin 25 mg on the 10th day of dosing with either solifenacin 10 mg or matching placebo once daily for 16 days. For R-warfarin when it was coadministered with solifenacin, the mean Cmax increased by 3% and AUC decreased by 2%. For S-warfarin when it was coadministered with solifenacin, the mean Cmax and AUC increased by 5% and 1%, respectively [see DRUG INTERACTIONS].

Oral Contraceptives

In a crossover study, subjects received 2 cycles of 21 days of oral contraceptives containing 30 ug ethinyl estradiol and 150 ug levonorgestrel. During the second cycle, subjects received additional solifenacin 10 mg or matching placebo once daily for 10 days starting from 12th day of receipt of oral contraceptives. For ethinyl estradiol when it was administered with solifenacin, the mean Cmax and AUC increased by 2% and 3%, respectively. For levonorgestrel when it was administered with solifenacin, the mean Cmax and AUC decreased by 1% [see DRUG INTERACTIONS].

Digoxin

In a crossover study, subjects received digoxin (loading dose of 0.25 mg on day 1, followed by 0.125 mg from days 2 to 8) for 8 days. Consecutively, they received solifenacin 10 mg or matching placebo with digoxin 0.125 mg for additional 10 days. When digoxin was coadministered with solifenacin, the mean Cmax and AUC increased by 13% and 4%, respectively [see DRUG INTERACTIONS].

Clinical Studies

VESIcare was evaluated in four twelve-week, double-blind, randomized, placebo-controlled, parallel group, multicenter clinical trials for the treatment of overactive bladder in patients having symptoms of urinary frequency, urgency, and/or urge or mixed incontinence (with a predominance of urge). Entry criteria required that patients have symptoms of overactive bladder for ≥ 3 months duration. These studies involved 3027 patients (1811 on VESIcare and 1216 on placebo), and approximately 90% of these patients completed the 12-week studies. Two of the four studies evaluated the 5 and 10 mg VESIcare doses and the other two evaluated only the 10 mg dose. All patients completing the 12-week studies were eligible to enter an open label, long term extension study and 81% of patients enrolling completed the additional 40-week treatment period. The majority of patients were Caucasian (93%) and female (80%) with a mean age of 58 years.

The primary endpoint in all four trials was the mean change from baseline to 12 weeks in number of micturitions/24 hours. Secondary endpoints included mean change from baseline to 12 weeks in number of incontinence episodes/24 hours, and mean volume voided per micturition. The efficacy of VESIcare was similar across patient age and gender. The mean reduction in the number of micturitions per 24 hours was significantly greater with VESIcare 5 mg (2.3; p < 0.001) and VESIcare 10 mg (2.7; p < 0.001) compared to placebo, (1.4).

The mean reduction in the number of incontinence episodes per 24 hours was significantly greater with VESIcare 5 mg (1.5; p < 0.001) and VESIcare 10 mg (1.8; p < 0.001) treatment groups compared to placebo (1.1). The mean increase in the volume voided per micturition was significantly greater with VESIcare 5 mg (32.3 mL; p < 0.001) and VESIcare 10 mg (42.5 mL; p < 0.001) compared with placebo (8.5 mL).

The results for the primary and secondary endpoints in the four individual 12-week clinical studies of VESIcare are reported in Tables 3 through 6.

Table 3: Mean Change from Baseline to Endpoint for VESIcare (5 mg and 10 mg daily) and Placebo: Study 1

Parameter Placebo
(N=253)
Mean (SE)
VESIcare 5 mg
(N=266)
Mean (SE)
VESIcare 10 mg
(N=264)
Mean (SE)
Urinary Frequency (Number of Micturitions/24 hours) *
Baseline 12.2 (0.26) 12.1 (0.24) 12.3 (0.24)
Reduction 1.2 (0.21) 2.2 (0.18) 2.6 (0.20)
P value vs. placebo   < 0.001 < 0. 001
Number of Incontinence Episodes/24 hours†
Baseline 2.7 (0.23) 2.6 (0.22) 2.6 (0.23)
Reduction 0.8 (0.18) 1.4 (0.15) 1.5 (0.18)
P value vs. placebo   < 0.01 < 0.01
Volume Voided per micturition [mL]†
Baseline 143.8 (3.37) 149.6 (3.35) 147.2 (3.15)
Increase 7.4 (2.28) 32.9 (2.92) 39.2 (3.11)
P value vs. placebo   < 0.001 < 0.001
* Primary endpoint
† Secondary endpoint

Table 4: Mean Change from Baseline to Endpoint for VESIcare (5 mg and 10 mg daily) and Placebo: Study 2

Parameter Placebo
(N=281)
Mean (SE)
VESIcare 5 mg
(N=286)
Mean (SE)
VESIcare 10 mg
(N=290)
Mean (SE)
Urinary Frequency (Number of Micturitions/24 hours) *
  Baseline 12.3 (0.23) 12.1 (0.23) 12.1 (0.21)
  Reduction 1.7 (0.19) 2.4 (0.17) 2.9 (0.18)
  P value vs. placebo   < 0.001 < 0. 001
Number of Incontinence Episodes/24 hours†
  Baseline 3.2 (0.24) 2.6 (0.18) 2.8 (0.20)
  Reduction 1.3 (0.19) 1.6 (0.16) 1.6 (0.18)
  P value vs. placebo   < 0.01 0.016
Volume Voided per micturition [mL]†
  Baseline 147.2 (3.18) 148.5 (3.16) 145.9 (3.42)
  Increase 11.3 (2.52) 31.8 (2.94) 36.6 (3.04)
  P value vs. placebo   < 0.001 < 0.001
* Primary endpoint
† Secondary endpoint

Table 5: Mean Change from Baseline to Endpoint for VESIcare (10 mg daily) and Placebo: Study 3

Parameter Placebo
(N=309)
Mean (SE)
VESIcare 10 mg
(N=306)
Mean (SE)
Urinary Frequency (Number of Micturitions/24 hours) *
  Baseline 11.5 (0.18) 11.7 (0.18)
  Reduction 1.5 (0.15) 3.0 (0.15)
  P value vs. placebo   < 0. 001
Number of Incontinence Episodes/24 hours†
  Baseline 3.0 (0.20) 3.1 (0.22)
  Reduction 1.1 (0.16) 2.0 (0.19)
  P value vs. placebo   < 0.001
Volume Voided per micturition [mL]†
  Baseline 190.3 (5.48) 183.5 (4.97)
  Increase 2.7 (3.15) 47.2 (3.79)
  P value vs. placebo   < 0.001
*Primary endpoint
† Secondary endpoint

Table 6: Mean Change from Baseline to Endpoint for VESIcare (10 mg daily) and Placebo: Study 4

Parameter Placebo
(N=295)
Mean (SE)
VESIcare 10 mg
(N=298)
Mean (SE)
Urinary Frequency (Number of Micturitions/24 hours) *
  Baseline 11.8 (0.18) 11.5 (0.18)
  Reduction 1.3 (0.16) 2.4 (0.15)
  P value vs. placebo   < 0. 001
Number of Incontinence Episodes/24 hours†
  Baseline 2.9 (0.18) 2.9 (0.17)
  Reduction 1.2 (0.15) 2.0 (0.15)
  P value vs. placebo   < 0.001
Volume Voided per micturition [mL]†
  Baseline 175.7 (4.44) 174.1 (4.15)
  Increase 13.0 (3.45) 46.4 (3.73)
  P value vs. placebo   < 0.001
* Primary endpoint
† Secondary endpoint

 

Patient Information

VESIcare®
(VES-ih-care)
(solifenacin succinate) Tablet

Read the Patient Information that comes with VESIcare before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

What is VESIcare?

VESIcare is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

  • Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
  • Urgency: a strong need to urinate right away
  • Frequency: urinating often

It is not known if VESIcare is safe and effective in children.

Who should NOT take VESIcare?

Do not take VESIcare if you:

  • are not able to empty your bladder (urinary retention)
  • have delayed or slow emptying of your stomach (gastric retention)
  • have an eye problem called “uncontrolled narrow-angle glaucoma”
  • are allergic to solifenacin succinate or any of the ingredients in VESIcare. See the end of this leaflet for a complete list of ingredients.

What should I tell my doctor before taking VESIcare?

Before you take VESIcare, tell your doctor if you:

  • have any stomach or intestinal problems or problems with constipation
  • have trouble emptying your bladder or you have a weak urine stream
  • have an eye problem called “narrow angle glaucoma”
  • have liver problems
  • have kidney problems
  • have a rare heart problem called “QT prolongation”
  • are pregnant or plan to become pregnant. It is not known if VESIcare will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if VESIcare passes into your breast milk. You and your doctor should decide if you will take VESIcare or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. VESIcare may affect the way other medicines work, and other medicines may affect how VESIcare works.

How should I take VESIcare?

  • Take VESIcare exactly as your doctor tells you to take it.
  • You should take 1 VESIcare tablet 1 time a day.
  • You should take VESIcare with water and swallow the tablet whole.
  • You can take VESIcare with or without food.
  • If you miss a dose of VESIcare, begin taking VESIcare again the next day. Do not take 2 doses of VESIcare the same day.
  • If you take too much VESIcare, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking VESIcare?

VESIcare can cause blurred vision or drowsiness. Do not drive or operate heavy machinery until you know how VESIcare affects you.

What are the possible side effects of VESIcare?

VESIcare may cause serious side effects including:

  • Serious allergic reaction. Stop taking VESIcare and get medical help right away if you have:
    • hives, skin rash or swelling
    • severe itching
    • swelling of your face, mouth or tongue
    • trouble breathing

The most common side effects of VESIcare include:

  • dry mouth
  • constipation. Call your doctor if you get severe stomach area (abdominal) pain or become constipated for 3 or more days.
  • urinary tract infection
  • blurred vision
  • heat exhaustion or heat-stroke. This can happen when VESIcare is used in hot environments. Symptoms may include:
  • decreased sweating
    • dizziness
    • tiredness
    • nausea
    • increase in body temperature

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

These are not all the possible side effects of VESIcare. For more information, ask your doctor or pharmacist.

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

How should I store VESIcare?

  • Store VESIcare at 59°F to 86°F (15°C to 30°C). Keep the bottle closed.
  • Safely throw away medicine that is out of date or that you no longer need.

Keep VESIcare and all medicines out of the reach of children.

General information about VESIcare.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use VESIcare for a condition for which it was not prescribed. Do not give VESIcare to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about VESIcare. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about VESIcare that is written for health professionals.

For more information, go to www.vesicare.com or call (800) 727-7003.

What are the ingredients in VESIcare?

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 (5 mg VESIcare tablet) or red ferric oxide (10 mg VESICARE tablet)

What is overactive bladder?

Overactive bladder occurs when you cannot control your bladder contractions. When these muscle contractions happen too often or cannot be controlled you can get symptoms of overactive bladder, which are urinary frequency, urinary urgency, and urinary incontinence (leakage).

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

SOLIFENACIN - ORAL

 

(SOE-li-FEN-a-sin)

 

COMMON BRAND NAME(S): Vesicare

 

USES: Solifenacin is used to treat an overactive bladder. By relaxing the muscles in the bladder, solifenacin improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using solifenacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once a day. Take it with a full glass of liquid. Swallow this medication whole because the powder in the tablet has a strong bitter taste.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Dry mouth, constipation, drowsiness, stomach upset, blurred vision, dry eyes, headache, or unusual tiredness/weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, constipation for 3 or more days, difficulty urinating, signs of kidney infection (such as burning/painful/frequent urination, fever, pink/bloody urine), mental/mood changes (such as confusion, hallucinations).

Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

PRECAUTIONS: Before taking solifenacin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: difficulty urinating (urinary retention), other bladder problems (such as bladder outflow obstruction), stomach/intestinal blockage (gastric retention), personal or family history of glaucoma (angle-closure type), liver disease, bowel disease (such as ulcerative colitis), slowed movement of stomach/intestines, constipation, kidney disease, enlarged prostate, a certain muscle/nerve disease (myasthenia gravis).

This drug may make you drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, constipation, or trouble urinating. Drowsiness and confusion can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: pramlintide, potassium tablets/capsules.

Other medications can affect the removal of solifenacin from your body, which may affect how solifenacin works. Examples include certain azole antifungals (such as itraconazole, ketoconazole), among others.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include fast/irregular heartbeat, agitation.

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Patient Detailed Side Effect

Brand Names: VESIcare

Generic Name: solifenacin (Pronunciation: sol ee FEN a sin)

  • What is solifenacin (VESIcare)?
  • What are the possible side effects of solifenacin (VESIcare)?
  • What is the most important information I should know about solifenacin (VESIcare)?
  • What should I discuss with my health care provider before taking solifenacin (VESIcare)?
  • How should I take solifenacin (VESIcare)?
  • What happens if I miss a dose (VESIcare)?
  • What happens if I overdose (VESIcare)?
  • What should I avoid while taking solifenacin (VESIcare)?
  • What other drugs will affect solifenacin (VESIcare)?
  • Where can I get more information?

What is solifenacin (VESIcare)?

Solifenacin reduces muscle spasms of the bladder and urinary tract.

Solifenacin is used to treat symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage).

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

What are the possible side effects of solifenacin (VESIcare)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using solifenacin and call your doctor at once if you have a serious side effect such as:

  • hot, dry skin and extreme thirst;
  • severe stomach pain, or constipation for 3 days or longer;
  • pain or burning when you urinate;
  • vision changes, eye pain, or seeing halos around lights;
  • urinating less than usual or not at all;
  • confusion, hallucinations;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • headache, dizziness, drowsiness, feeling tired;
  • dry mouth, hoarse voice;
  • dry eyes, blurred vision;
  • nausea, loss of appetite, upset stomach, heartburn;
  • mild constipation; or
  • fever, sore throat, body aches, or other flu symptoms.

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 FDA at 1-800-FDA-1088.

Read the VESIcare (solifenacin succinate) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about solifenacin (VESIcare)?

You should not use this medication if you are allergic to solifenacin, or if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.

Before using solifenacin, tell your doctor if you have glaucoma, liver disease, kidney disease, a blockage in your stomach or intestines, or a history of Long QT syndrome.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Solifenacin can decrease perspiration and you may be more prone to heat stroke.

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.

There are many other medicines that can interact with solifenacin. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, extreme thirst, severe stomach pain or constipation, pain or burning when you urinate, or if you stop urinating.

Patient Detailed How Take

What should I discuss with my health care provider before taking solifenacin (VESIcare)?

You should not use this medication if you are allergic to solifenacin, or have certain conditions. Be sure your doctor knows 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 you can safely take solifenacin, tell your doctor if you have any of these other conditions:

  • glaucoma;
  • liver disease;
  • kidney disease;
  • a blockage in your stomach or intestines; or
  • a history of Long QT syndrome.

FDA pregnancy category C. It is not known whether solifenacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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.

How should I take solifenacin (VESIcare)?

Take 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.

Solifenacin is usually taken once per day. Follow your doctor's instructions.

Take this medicine with water.

Do not crush, chew, or break the tablet. Swallow it whole.

Solifenacin can be taken with or without food.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Patient Detailed Avoid Taking

What happens if I miss a dose (VESIcare)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (VESIcare)?

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.

What should I avoid while taking solifenacin (VESIcare)?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Solifenacin can decrease perspiration and you may be more prone to heat stroke.

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.

What other drugs will affect solifenacin (VESIcare)?

Tell your doctor about all other medicines you use, especially:

  • arsenic trioxide (Trisenox);
  • carbamazepine (Carbatrol, Equetro, Tegretol);
  • conivaptan (Vaprisol);
  • nefazodone;
  • phenytoin (Dilantin);
  • tacrolimus (Prograf);
  • vandetanib (Caprelsa);
  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend);
  • the hepatitis C medications boceprevir (Victrelis) or telaprevir (Incivek);
  • HIV/AIDS medicine such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), or saquinavir (Invirase);
  • an antibiotic such as azithromycin (Zithromax, Zmax, Z-Pack), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifampin (Rifadin, Rifater, Rifamate), or telithromycin (Ketek);
  • an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), citalopram (Celexa), clomipramine (Anafranil), or desipramine (Norpramin);
  • anti-malaria medications such as chloroquine (Aralen), halofantrine (Halfan), or mefloquine (Lariam);
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), flecainide (Tambocor), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);
  • medicine to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
  • migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig); or
  • narcotic medication such as methadone (Methadose, Diskets, Dolophine).

This list is not complete and other drugs may interact with solifenacin. 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.

Where can I get more information?

Your pharmacist can provide more information about solifenacin.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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