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Solifenacin Succinate

Also known as: Solifenacin Succinate

Route: Oral

Check Solifenacin Succinate Interactions →

2 interactions on record⛔ Black Box Warning

Solifenacin Succinate has 2 known drug interactions based on U.S. FDA drug labeling data. 1 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Ketoconazole, Mirabegron. Patients taking Solifenacin Succinate should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Major: 1
Moderate: 1

Major (1)

Solifenacin Succinate + Ketoconazole— Concomitant use significantly increased solifenacin exposure. Dosage of solifenacin greater than 5 mg once daily is not …

Moderate (1)

Solifenacin Succinate + Mirabegron— Drug interaction study conducted; no dose adjustment recommended when coadministered with mirabegron.

Solifenacin Succinate + Ketoconazole⚠️Major

Concomitant use significantly increased solifenacin exposure. Dosage of solifenacin greater than 5 mg once daily is not recommended.

Solifenacin Succinate + Mirabegron🟡Moderate

Drug interaction study conducted; no dose adjustment recommended when coadministered with mirabegron.

⛔ FDA Black Box Warning

BOXED WARNING

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 )

Pregnancy & Breastfeeding

8.1 Pregnancy 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 2-4% and 15-20%, 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 o

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.