Solifenacin Succinate 10 mg Tablet, Coated, 30-count
Other active recalls for Solifenacin Succinate (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Cholinergic Muscarinic Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- It helps calm an overactive bladder. If you're rushing to the bathroom constantly, waking up at night to urinate, or sometimes not making it in time, solifenacin works by blocking...
- What exactly is solifenacin supposed to do for me?
- Dry mouth is the most common side effect, and it's more noticeable at higher doses. Sipping water throughout the day, chewing sugar-free gum, or using a saliva substitute can all h...
- The dry mouth is really bothering me — is there anything I can do?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Solifenacin succinate — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
9 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.175 | $5.26 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3747 | $11.24 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Solifenacin succinate 10 mg 00591-3796-19 | Actavis | 90 tablets | $0.175 | AB | Availability likely | — |
| solifenacin succinate 10 mg 31722-0028-30 | Camber | 30 tablets | $0.175 | AB | Availability likely | — |
| Solifenacin Succinate 10 mg 60505-4703-03 | Apotex | 30 tablets | $0.175 | AB | Availability likely | — |
| Solifenacin Succinate 10 mgthis 62332-0193-30 | Alembic | 30 tablets | $0.175 | AB | Availability likely | — |
| Solifenacin Succinate 10 mg 67877-0528-30 | Ascend | 30 tablets | $0.175 | AB | Availability likely | — |
| Solifenacin Succinate 10 mg 72205-0021-30 | Novadoz | 30 tablets | $0.175 | AB | Availability likely | — |
| solifenacin succinate 10 mg 27241-0038-03 | Ajanta | 30 tablets | $0.217 | — | FDA listed | +24% |
| VESIcare 10 mg 51248-0151-01 | Astellas | 30 tablets | $12.310 | — | Discontinued | +6919% |
| Solifenacin Succinate 10 mg 29300-0329-05 | Unichem | 500 tablets | — | AB | FDA listed | — |
| solifenacin succinate 10 mg 33342-0149-07 | Macleods | 30 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 35561-0286-10 | Bostal | 30 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 42291-0740-30 | AvKARE | 30 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 46708-0193-08 | Alembic | 80 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 50228-0428-05 | ScieGen | 500 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 51407-0472-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 63629-8869-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 63629-8870-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 65862-0879-03 | Aurobindo | 10 tablets | — | AB | FDA listed | — |
| solifenacin succinate 10 mg 68462-0387-14 | Glenmark | 10 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 71335-2985-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 72162-1849-03 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Solifenacin succinate 10 mg 82804-0058-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 82804-0266-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Solifenacin Succinate 10 mg 71205-0583-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Solifenacin succinate 10 mg 72303-0832-01 | HEC | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 62332-0193-08 | 80 TABLET, COATED in 1 CARTON (62332-193-08) | — | — | 2019-05-20 | Active |
| 62332-0193-30 You're viewing this | 30 TABLET, COATED in 1 BOTTLE (62332-193-30) | $0.1754 / ea | $5.26 | 2019-05-20 | Active |
| 62332-0193-90 | 90 TABLET, COATED in 1 BOTTLE (62332-193-90) | $0.1754 / ea | $15.79 | 2019-05-20 | Active |
| 62332-0193-91 | 1000 TABLET, COATED in 1 BOTTLE (62332-193-91) | — | — | 2019-05-20 | Active |
You're viewing the smallest of 4 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1754 NADAC).
Pack size FAQ
What quantity is in NDC 62332-0193-30?
What is the difference between NDC 62332-0193-30 and NDC 62332-0193-08?
What NDC number is used to bill for this package of Solifenacin Succinate 10 mg Tablet, Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Solifenacin succinate tablet is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION ● 5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily. (2.1) ● Do not exceed the 5 mg dose of solifenacin succinate tablets in patients with: o Severe renal impairment creatinine clearance <30 mL/min/1.73 m 2 (2.2, 8.6). o Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate tablets are not recommended in patient with severe hepatic impairment (Child-Pugh C).
(2.3, 8.7). o Concomitant use of strong CYP3A4 inhibitors. (2.4, 7.1)
2.1Dosing Information The recommended oral dose of solifenacin succinate tablet is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. Solifenacin succinate tablets should be taken with water and swallowed whole. Solifenacin succinate tablets can be administered with or without food.
2.2Dosing Recommendations in Patients with Renal Impairment Do not exceed 5 mg once daily in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) [see Use in Specific Populations (8.6)] .
2.3Dosing Recommendations in Patients with Hepatic Impairment Do not exceed 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Do not use solifenacin succinate tablets in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7)] .
2.4Dosing Recommendations in Patients Taking CYP3A4 Inhibitors Do not exceed 5 mg once daily when solifenacin succinate tablets are administered with strong CYP3A4 inhibitors such as ketoconazole [see Drug Interactions (7.1)].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS The 5 mg tablets are creamish to light yellow, round, film-coated tablets, debossed with “L” on one side and “431” on other side. The 10 mg tablets are light pink, round, film-coated tablets, debossed with “L” on one side and “432” on other side. Tablets: 5 mg and 10 mg. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Solifenacin succinate tablets are contraindicated in patients: With urinary retention [see Warnings and Precautions (5.2)], With gastric retention [see Warnings and Precautions (5.3)], With uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5)], and Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions (6.2)]. Urinary retention.
(4, 5.2) Gastric retention. (4, 5.3) Uncontrolled narrow-angle glaucoma. (4, 5.5) Hypersensitivity to this product or any of its components.
(4, 5.1, 6.2)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Angioedema and Anaphylactic Reactions : Promptly discontinue solifenacin succinate tablets and provide appropriate therapy. (5.1) Urinary Retention : Solifenacin succinate tablets are not recommended for use in patients with clinically significant bladder outlet obstruction. (5.2) Gastrointestinal Disorders : Solifenacin succinate tablets are not recommended for use in patients with decreased gastrointestinal motility.
(5.3) Central Nervous System Effects : Somnolence has been reported with solifenacin succinate tablets. Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate tablets affect them. (5.4) Controlled Narrow-Angle Glaucoma : Use solifenacin succinate tablets with caution in patients being treated for narrow-angle glaucoma.
(5.5) QT Prolongation in Patients at High Risk of QT Prolongation : Solifenacin succinate tablets are not recommended for use in patients at high risk of QT prolongation, including patient with a known history of QT prolongation and patients taking medication known to prolong the QT interval. (5.6)
5.1Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin succinate. In some cases, angioedema occurred after the first dose, however, cases have been reported to occur hours after the first dose or after multiple doses. Anaphylactic reactions have also been reported in patients treated with solifenacin succinate.
Angioedema associated with upper airway swelling and anaphylactic reaction may be life-threatening. Solifenacin succinate tablets are contraindicated in patients with a known or suspected hypersensitivity to solifenacin succinate [see Contraindications (4)] . If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue solifenacin succinate tablets and provide appropriate therapy and/or measures necessary to ensure a patent airway.
5.2Urinary Retention The use of solifenacin succinate tablets, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction including patients with urinary retention, may result in further urinary retention and kidney injury. The use of solifenacin succinate tablets are not recommended in patients with clinically significant bladder outlet obstruction and are contraindicated in patients with urinary retention [see Contraindications (4)].
5.3Gastrointestinal Disorders The use of solifenacin succinate tablets, like other antimuscarinic drugs, in patients with conditions associated with decreased gastrointestinal motility may result in further decreased gastrointestinal motility. Solifenacin succinate tablets are contraindicated in patients with gastric retention [see Contraindications (4)]. The use of solifenacin succinate tablets are not recommended in patients with conditions associated with decreased gastrointestinal motility.
5.4Central Nervous System Effects Solifenacin succinate tablets are associated with antimuscarinic central nervous system (CNS) adverse reactions [see Adverse Reactions (6.2)]. A variety of CNS antimuscarinic adverse reactions have been reported, including headache, confusion, hallucinations, and somnolence. Monitor patients for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose.
Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate tablets affect them. If a patient experiences antimuscarinic CNS adverse reactions, consider dose reduction or drug discontinuation.
5.5Controlled Narrow-Angle Glaucoma Solifenacin succinate tablets should be used with caution in patients being treated for narrow-angle glaucoma [see Contraindications (4)].
5.6QT Prolongation in Patients at High Risk of QT Prolongation In a study of the effect of solifenacin succinate on the QT interval conducted in 76 healthy women [see Clinical Pharmacology (12.2)], solifenaci…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (>4% in solifenacin succinate tablets-treated patients and >placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical 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. Solifenacin succinate tablets have been evaluated for safety in 1811 adult patients in four randomized, placebo-controlled trials (Studies 1 to 4) [see Clinical Studies (14)] . 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 solifenacin succinate tablets was higher in the 10 mg dose group 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 solifenacin succinate tablets 10 mg group. Angioneurotic edema was reported in one patient taking solifenacin succinate tablets 5 mg.
Compared to 12 weeks of treatment with solifenacin succinate tablets, the incidence and severity of adverse reactions were similar in patients who remained on drug for up to 12 months in Study 5 [see Clinical studies (14)]. The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified adverse reactions, in the four randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with solifenacin succinate tablets 5 or 10 mg once daily for up to 12 weeks.
Table 1: Adverse Reactions Reported by ≥ 1% of Patients and Exceeding Placebo in Studies 1, 2, 3 and 4 Placebo (%) Solifenacin Succinate Tablets 5 mg (%) Solifenacin Succinate Tablets 10 mg (%) Number of Patients 1216 578 1233 GASTROINTESTINAL DISORDERS Dry Mouth 4.2 10.9
27.6Constipation 2.9 5.4
13.4Nausea 2 1.7
3.3Dyspepsia 1 1.4
3.9Abdominal Pain Upper 1 1.9
1.2Vomiting NOS 0.9 0.2
1.1INFECTIONS AND INFESTATIONS Urinary Tract Infection NOS 2.8 2.8
4.8Influenza 1.3 2.2
0.9Pharyngitis NOS 1 0.3
1.1NERVOUS SYSTEM DISORDERS Dizziness 1.8 1.9
1.8EYE DISORDERS Vision Blurred 1.8 3.8
4.8Dry Eyes NOS 0.6 0.3
1.6RENAL AND URINARY DISORDERS Urinary Retention 0.6 0
1.4GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Edema Lower Limb 0.7 0.3
1.1Fatigue 1.1 1
2.1PSYCHIATRIC DISORDERS Depression NOS 0.8 1.2
0.8RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Cough 0.2 0.2
1.1VASCULAR DISORDERS Hypertension NOS 0.6 1.4 0.5
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of solifenacin succinate in the U.S. and/or outside of the U.S. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site conditions : peripheral edema, hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, anaphylactic reaction); Nervous system disorders : dizziness, headache, confusion, hallucinations, delirium, somnolence; Cardiac disorders : QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, palpitations; Hepatobiliary disorders : liver disorders mostly characterized by abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyl trans…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS CYP3A4 Inhibitors : Do not exceed the 5 mg dose of solifenacin succinate tablets with concomitant use of strong CYP3A4 inhibitors. (7.1)
7.1Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology (12.3)] . The dosage of solifenacin succinate tablets greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors [see Dosage and Administration (2.4)] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day. However, administration of doses 3.6 times and greater than the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see Data] .
In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Oral administration of 14 C-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier. In pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the MRHD of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality.
Administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the MRHD, resulted in reduced fetal body weights and reduced maternal body weight gain. No embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD). Administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (<1 times and 1.8 times the systemic exposure at the MRHD, respectively), resulted in no findings of embryo-fetal toxicity.
Oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency). An increase in the percentage of male offspring was also observed in litters from offspring (F2 generation) exposed to maternal doses of 250 mg/kg/day. There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the MRHD.
8.2Lactation Risk Summary There is no information on the presence of solifenacin in human milk, the effects on the breastfed child, or the effects on milk production. Solifenacin is present in mouse milk [see Data] . When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for solifenacin succinate tablets and any potential adverse effects on the breastfed child from solifenacin succinate tablets or from the underlying maternal condition. Data Animal Data Oral administration of 14 C-solifenacin succinate to lactating mice resulted in the recovery of radioactivity in maternal milk. Lactating female mice orally administered solifenacin succinate at a maternally toxic dose of 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) had increased postpartum pup mortality, pups with reduced body weights, or delays in the onset of reflex and physical development.
Pups from lactating dams orally administered solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD) had no discernible adverse findings. The concentrations of solifenacin in animal milk does not necessarily predict the concentration of drug in human…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day. However, administration of doses 3.6 times and greater than the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see Data] .
In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Oral administration of 14 C-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier. In pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the MRHD of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality.
Administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the MRHD, resulted in reduced fetal body weights and reduced maternal body weight gain. No embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD). Administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (<1 times and 1.8 times the systemic exposure at the MRHD, respectively), resulted in no findings of embryo-fetal toxicity.
Oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency). An increase in the percentage of male offspring was also observed in litters from offspring (F2 generation) exposed to maternal doses of 250 mg/kg/day. There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the MRHD.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of solifenacin succinate tablets have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use In placebo-controlled clinical studies, similar safety and effectiveness were observed between geriatric patients (623 patients ≥65 years and 189 patients ≥75 years) and younger adult patients (1188 patients <65 years) treated with solifenacin succinate tablets [see Clinical Pharmacology (12.3)].
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage with solifenacin succinate tablets can potentially result in severe antimuscarinic effects and should be treated accordingly. The highest dose ingested in an accidental overdose of solifenacin succinate was 280 mg (28 times the maximum dosage) in a 5-hour period. This case was associated with mental status changes.
Some cases reported a decrease in the level of consciousness. Intolerable antimuscarinic adverse reactions (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 solifenacin succinate tablets, treat with gastric lavage and appropriate supportive measures.
ECG monitoring is also recommended.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics Cardiac Electrophysiology The effect of 10 mg and 30 mg solifenacin succinate (three times the maximum recommended dose) 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 [see Warnings and Precautions (5.6)] . After receiving placebo and moxifloxacin sequentially, subjects were randomized to one of two treatment groups. One group (n=51) completed 3 additional sequential periods of dosing with solifenacin succinate 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 coadministration of 10 mg solifenacin succinate tablets with strong CYP3A4 inhibitors (e.g., ketoconazole, 400 mg). Due to the sequential dose escalating nature of the study, baseline ECG 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 T max (relative to placebo) 1 Drug/Dose Fridericia method (using mean difference) Solifenacin succinate 10 mg 2 (-3, 6) Solifenacin succinate 30 mg 8 (4, 13) 1. 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 of the highest solifenacin succinate dose (three times the maximum therapeutic dose) studied was not as large as that of the positive control moxifloxacin at its recommended dose. However, the confidence intervals overlapped, and this study was not designed to draw direct statistical conclusions between the drugs or the dose levels.
12.3Pharmacokinetics Absorption After oral administration of solifenacin succinate tablets in healthy volunteers, peak plasma concentrations (C max ) of solifenacin were 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 solifenacin succinate tablets, respectively. The absolute bioavailability of solifenacin is approximately 90%, with plasma concentrations of solifenacin proportional to the dose administered. Effect of Food Solifenacin succinate tablets may be administered without regard to meals.
A single 10 mg dose administration of solifenacin succinate tablets with food increased C max and AUC of solifenacin by 4% and 3%, respectively. Distribution Solifenacin is approximately 98% ( in vivo ) bound to human plasma proteins, principally to α 1 -acid glycoprotein. Solifenacin is highly distributed to non-CNS tissues, having a mean steady-state volume of distribution of 600L.
Elimination The elimination half-life (t1/2) of solifenacin follow…
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Solifenacin succinate tablets 5 mg are creamish to light yellow, round, film-coated tablets, debossed with “L” on one side and “431” on other side. They are supplied as follows: NDC 62332-192-30 Bottle of 30 NDC 62332-192-90 Bottle of 90 NDC 62332-192-91 Bottle of 1000 NDC 62332-192-08 Carton of 80 (10 x 8) unit-dose tablets Solifenacin succinate tablets 10 mg are light pink, round, film-coated tablets, debossed with “L” on one side and “432” on other side. They are supplied as follows: NDC 62332-193-30 Bottle of 30 NDC 62332-193-90 Bottle of 90 NDC 62332-193-91 Bottle of 1000 NDC 62332-193-08 Carton of 80 (10 x 8) unit-dose tablets Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S )-(3 R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23 H 26 N 2 O 2 •C 4 H 6 O 4 , and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to off white powder.
It is freely soluble in water, methanol, acetic acid and dimethyl sulfoxide. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inert ingredients: lactose monohydrate, hypromellose, corn starch, magnesium stearate,titanium dioxide, polyethylene glycol, talc, iron oxide yellow with D&C Yellow #10 Aluminum Lake (5 mg solifenacin succinate tablet) or iron oxide red (10 mg solifenacin succinate tablet).
Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Angioedema and Anaphylactic Reactions Inform patients that angioedema and anaphylactic reactions have been reported in patients treated with solifenacin succinate tablets. Angioedema and anaphylactic reactions may be life-threatening.
Advise patients to promptly discontinue solifenacin succinate tablets therapy and seek immediate attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing [see Contraindications (4) and Warnings and Precautions (5.1)] . Urinary Retention Inform patients that solifenacin succinate tablets may cause urinary retention in patients with conditions associated with bladder outlet obstruction [see Warnings and Precautions (5.2)] . Gastrointestinal Disorders Inform patients that solifenacin succinate tablets may cause further decrease in gastrointestinal motility in patients with conditions associated with decreased gastrointestinal motility.Solifenacin succinate tablet has been associated with constipation and dry mouth.
Advise patients to contact their health care providers if they experience severe abdominal pain or become constipated for 3 or more days [see Warnings and Precautions (5.3)] . Central Nervous System Effects Because solifenacin succinate tablets, like other antimuscarinic agents, may cause central nervous system effects or blurred vision, advise patients to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effect on the patient has been determined [see Warnings and Precautions (5.4)] .
Narrow-Angle Glaucoma Inform patients that solifenacin succinate tablets, like other antimuscarinics, may cause worsening of the glaucoma condition in patients with narrow-angle glaucoma [see Warnings and Precautions (5.5)] . Dry Skin Inform patients that solifenacin succinate tablets, like other antimuscarinics, may cause dry skin due to decreased sweating. Heat prostration due to decreased sweating can occur when solifenacin succinate tablet is used in a hot environment [see Adverse Reactions (6.2)] .