Solifenacin

Adults with overactive bladder symptoms of urgency, urinary frequency and urge urinary incontinence. Tablet pediatric safety/effectiveness are not established. Current selected generic 5/10 mg tablets remain Prescription.

VESIcare LS 1 mg/mL was approved for neurogenic detrusor overactivity at age ≥ 2, not ordinary pediatric OAB. Current FDA NDA209529 lists it Discontinued; NDA021518 also lists branded VESIcare 5/10 mg tablets Discontinued while selected generic tablets remain Prescription. The retrieved October 2022 manufacturer PI is approved-product provenance, not evidence of current LS supply or an automatically equivalent compounded liquid.

5 mg orally once daily; if tolerated, may increase to 10 mg once daily. Swallow whole with water, with or without food. If a tablet dose is missed, resume the next day; do not take two doses the same day. No fixed treatment-course duration is specified; reassess response and tolerance.

Maximum 5 mg daily with severe renal impairment (label CLcr < 30 mL/min/1.73 m²), moderate hepatic impairment (Child-Pugh B) or a strong CYP3A4 inhibitor such as ketoconazole. Mild/moderate renal and mild hepatic impairment need no adjustment. Do not use with severe hepatic impairment (Child-Pugh C); it has not been studied.

Historical approved 1 mg/mL suspension regimen at age ≥ 2: dose once daily by body weight, titrated to the lowest effective dose within the limits below. These are retained to distinguish formulations and approval; they are not a current supply or home-preparation recommendation. No labeled dose is provided below 9 kg. A specialist/pharmacist must verify an available appropriate product and current directions before any pediatric treatment.

Approved LS PI: severe renal impairment, Child-Pugh B or strong CYP3A4 inhibition limits the dose to the weight-band starting dose; do not use in Child-Pugh C. Shake well and measure with an oral syringe; give followed by water/milk rather than mixed simultaneously with food/liquid, which can taste bitter. Its missed-dose rule differs: take when remembered unless > 12 hours late, then skip; never two doses the same day. Do not transfer this liquid rule or salt/base conversion to tablets.

Current tablets: urinary retention, gastric retention, uncontrolled narrow-angle glaucoma and hypersensitivity to solifenacin/product ingredients. The approved LS PI lists gastric retention, uncontrolled narrow-angle glaucoma and hypersensitivity; it does not list urinary retention as a formal contraindication, but warns against significant outlet obstruction without clean intermittent catheterization. Do not merge these different product lists.

Selected current generic tablet and retrieved approved LS labels have no boxed warning. Serious retention, CNS, allergy and QT precautions remain relevant; this does not establish current LS marketing.

Tablets commonly cause dry mouth and constipation, with blurred vision, dry eyes and urinary infection also reported; dry mouth/constipation rise at 10 mg. Rare reports include severe allergy, ileus, delirium, QT prolongation/torsades and urinary/renal problems; postmarketing frequencies are uncertain. LS trials most often reported constipation, dry mouth and UTI. Overdose can produce severe antimuscarinic toxicity and altered consciousness; seek emergency/poison-center care, with hospital supportive treatment and ECG monitoring. No safe self-treatment threshold is inferred from overdose reports.

Strong CYP3A4 inhibitors (e.g., ketoconazole) increase exposure: current tablet maximum 5 mg daily; approved LS reference maximum is the starting weight-band dose. CYP3A4 inducers may lower concentration, but no automatic dose-escalation algorithm is supplied. Review QT-prolonging drugs and avoid high-risk combinations as specified in the warning. Review other medicines causing sedation, confusion, constipation or retention rather than assume the effects are harmless.

Adult studies found small PK changes with selected warfarin, ethinyl-estradiol/levonorgestrel contraception and digoxin regimens. These specific findings are not proof of no interaction with every anticoagulant, contraceptive or transplant regimen. Solifenacin is mainly a CYP3A4 substrate; the label’s in-vitro enzyme findings do not remove inhibitor dose limits.

Tablets are not approved in children; do not extrapolate adult OAB doses. Approved LS evidence covered NDO at age ≥ 2; trials enrolled ages 2–17 practicing clean intermittent catheterization, and use below 2 was unestablished. Current LS status is Discontinued. Tablet trials found similar efficacy/safety in older adults, though exposure was 20–25% higher in geriatric PK studies; assess cognition, constipation, retention and co-medication risks individually.

Severe renal impairment raises exposure and requires a 5 mg tablet ceiling; no adjustment in mild/moderate renal impairment. Child-Pugh B also limits tablets to 5 mg; Child-Pugh C is not recommended and unstudied. Do not assume dialysis or severe organ disease has a verified alternative regimen. Historical LS restrictions are separate and stated above.

No adequate human pregnancy data establish fetal risk; high-exposure animal studies show developmental toxicity. Human milk, infant-effect and milk-production data are unavailable; animal milk exposure is reported. Consider breastfeeding benefits, maternal need and potential infant risk with the clinician. Do not claim established pregnancy/lactation safety from the product’s adult OAB approval.

Solifenacin competitively antagonizes muscarinic receptors, including those mediating urinary bladder smooth-muscle contraction. Adult tablet bioavailability about 90%, peak 3–8 hours, protein binding about 98% and chronic-dose half-life 45–68 hours. It is extensively metabolized, mainly through CYP3A4; one active metabolite occurs at low concentrations. Radiolabeled recovery was about 69% urine and 23% feces; < 15% was urinary unchanged solifenacin. Food effects are small.

Approved LS pediatric NDO studies: peak 2–6 hours and median half-life about 26 hours; do not use adult half-life as a universal pediatric value. A 30 mg adult QT-study dose increased corrected QT more than 10 mg and is above therapeutic limits; study dosing is not an allowable clinical maximum. Suspension concentration 1 mg/mL refers to solifenacin succinate, not an instruction to recalculate prescribed mL as free base.

Follow urinary urgency/frequency/leakage response and emptying/retention symptoms; assess bowel function, severe abdominal pain, dry mouth/eyes, blurred vision, cognition/somnolence and heat tolerance. Review organ function and interacting drugs before escalation. Consider ECG/clinical evaluation for relevant QT risks or overdose; no routine serum solifenacin-level monitoring is prescribed.

Swallow the current tablet whole once daily; resume missed doses the next day without doubling. Report inability to urinate, severe abdominal pain or constipation lasting ≥ 3 days. Stop and obtain emergency help for tongue/throat swelling or breathing difficulty. Avoid driving until effects are known and watch for heat illness from reduced sweating. Do not replace a discontinued pediatric suspension with a split tablet or home mixture; seek an exact specialist/pharmacist plan.

Macleods 5 mg solifenacin succinate: light-yellow round biconvex film-coated tablet, L22 on one side, plain reverse; 30-tablet bottle NDC 33342-148-07. This identifies the selected current generic, not local stock.

Current selected generic tablets 5/10 mg (Macleods 10 mg pinkish-white L 27). FDA ANDA204374 lists both Prescription. Branded VESIcare 5/10 mg and LS 1 mg/mL are currently Discontinued; the approved LS reference describes a 150 mL bottle, NDC 51248-250-99. No currently marketed generic suspension, injectable product, extended-release distinction or automatic mg-for-mL substitution is inferred.

Current tablets: 20–25°C, excursions 15–30°C, bottle closed. Approved LS reference: 20–25°C, excursions 15–30°C, original bottle protected from degradation, discard 28 days after opening; those instructions do not establish current supply or compounded-liquid stability. Follow actual expiry, discard unused/expired medicine safely and keep away from children.