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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Solifenacin Succinate
Generic Name
Solifenacin Succinate
Active Ingredient
SolifenacinCategory
Other
Salt Form
Succinate
Variants
46
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 5 mg/1 | TABLET, FILM COATED | ORAL | 63629-8867 |
| 10 mg/1 | TABLET, COATED | ORAL | 46708-193 |
| 10 mg/1 | TABLET, FILM COATED | ORAL | 65862-879 |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Solifenacin Succinate, you must consult a qualified healthcare professional.
| 5 mg/1 | TABLET, FILM COATED | ORAL | 31722-027 |
| 5 mg/1 | TABLET, COATED | ORAL | 33342-148 |
| 5 mg/1 | TABLET, FILM COATED | ORAL | 67877-527 |
| 10 mg/1 | TABLET | ORAL | 72205-021 |
| 10 mg/1 | TABLET, FILM COATED | ORAL | 71205-583 |
| 10 mg/1 | TABLET, FILM COATED | ORAL | 71335-2985 |
| 10 mg/1 | TABLET, FILM COATED | ORAL | 35561-286 |
| 5 mg/1 | TABLET, FILM COATED | ORAL | 50228-427 |
| 10 mg/1 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | 68462-387 |
+ 34 more variants
Detailed information about Solifenacin Succinate
Solifenacin is a competitive muscarinic receptor antagonist used primarily for the treatment of overactive bladder (OAB) and neurogenic detrusor overactivity. It works by relaxing the bladder muscles to improve urinary control and reduce urgency.
The standard starting dose for solifenacin in adults is 5 mg taken once daily. If the 5 mg dose is well-tolerated but does not provide sufficient symptom relief after several weeks, your healthcare provider may increase the dose to 10 mg once daily.
Research indicates that the 10 mg dose may provide additional efficacy in reducing incontinence episodes, but it is also associated with a higher incidence of anticholinergic side effects such as dry mouth and constipation. Most clinical guidelines suggest waiting at least 2 to 4 weeks before adjusting the dose to allow the steady-state concentration of the drug to be reached and to assess the full therapeutic response.
For pediatric patients (2 years and older) with neurogenic detrusor overactivity, the dose is determined based on the child's body weight.
Solifenacin is not currently approved for use in children for the treatment of 'standard' overactive bladder; its pediatric indication is strictly for neurogenic conditions.
For patients with mild to moderate renal impairment, no dose adjustment is typically required. However, for patients with severe renal impairment (Creatinine Clearance < 30 mL/min), the dose should not exceed 5 mg once daily. The drug is not efficiently removed by hemodialysis.
In patients with mild hepatic impairment, no adjustment is necessary. For those with moderate hepatic impairment (Child-Pugh Class B), the dose should not exceed 5 mg once daily. Solifenacin is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
While no specific age-based dose adjustment is mandated by the FDA, elderly patients are more susceptible to the central nervous system side effects of anticholinergics. Healthcare providers often start at the lowest effective dose (5 mg) and monitor closely for confusion or cognitive changes.
If you miss a dose, take it as soon as you remember on the same day. If you do not remember until the following day, skip the missed dose and resume your regular schedule. Do not take two doses in one day to make up for a missed one. Doubling the dose significantly increases the risk of acute side effects like urinary retention or severe constipation.
An overdose of solifenacin can lead to severe anticholinergic toxicity. Symptoms may include:
In the event of a suspected overdose, contact your local poison control center or seek emergency medical attention immediately. Treatment usually involves supportive care and, in some cases, gastric lavage or the administration of activated charcoal if caught early.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as your symptoms may return quickly.
Because solifenacin targets muscarinic receptors throughout the body, not just in the bladder, 'off-target' effects are common. The most frequently reported side effect is dry mouth (xerostomia), occurring in up to 30% of patients taking the 10 mg dose. This occurs because muscarinic receptors in the salivary glands are also inhibited. While usually mild, it can lead to dental issues over time if not managed.
Constipation is the second most common side effect. Anticholinergics slow down the movement of the digestive tract (peristalsis). Patients are encouraged to maintain adequate fiber intake and hydration while on this medication.
Solifenacin is a powerful medication that requires careful screening before use. It is not suitable for everyone, particularly those with certain pre-existing gastrointestinal or ocular conditions. Patients must be aware that while solifenacin treats the symptoms of an overactive bladder, it does not cure the underlying cause. Regular follow-ups with a urologist or primary care physician are necessary to monitor the drug's efficacy and safety.
There are currently no FDA black box warnings for Solifenacin. It is generally considered safe when prescribed correctly and monitored by a healthcare professional.
Cases of angioedema (swelling under the skin) of the face, lips, tongue, and larynx have been reported with solifenacin. In some instances, this occurred after the first dose. If you experience any swelling or difficulty breathing, stop the medication immediately and seek emergency care.
There are few absolute contraindications for drug combinations, but solifenacin should never be used with other potent anticholinergics used for the same purpose (e.g., oxybutynin, tolterodine) unless specifically directed by a specialist. The cumulative effect can lead to 'anticholinergic syndrome,' characterized by severe confusion, high fever, and urinary blockage.
Solifenacin is metabolized by the CYP3A4 enzyme. Drugs that inhibit this enzyme can significantly increase the levels of solifenacin in your blood, leading to toxicity. Examples include:
Solifenacin must NEVER be used in patients with the following conditions:
Solifenacin is classified under the former FDA Pregnancy Category C. This means that animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. In animal studies, high doses of solifenacin were associated with reduced fetal body weight and increased skeletal variations.
Solifenacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Most healthcare providers recommend discontinuing the medication during pregnancy unless the mother's symptoms are so severe that they interfere with her health or safety.
It is not known whether solifenacin is excreted in human milk. However, animal studies indicate that solifenacin and its metabolites are present in the milk of lactating rats. Furthermore, because solifenacin is an anticholinergic, it may potentially decrease milk production in the mother. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play a critical role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle and stimulation of salivary secretion. There are five identified subtypes of muscarinic receptors (M1 through M5). Solifenacin has a high affinity for the M3 receptor, which is the primary receptor responsible for the contraction of the detrusor muscle in the bladder. By binding to these receptors, solifenacin prevents acetylcholine from triggering the muscle to contract. This increases the volume of urine the bladder can hold and reduces the frequency of involuntary contractions.
The primary effect of solifenacin is on the bladder's 'storage' phase. It increases the volume at which the first involuntary contraction occurs and increases the maximum cystometric capacity (the total amount the bladder can hold). The onset of effect is typically seen within 1 to 2 weeks of consistent use, with the full clinical benefit usually realized by 4 to 8 weeks. Unlike some other medications, solifenacin does not appear to significantly affect the 'voiding' phase (the strength of the voluntary contraction) in healthy individuals, though it can cause retention in those with pre-existing obstructions.
Common questions about Solifenacin Succinate
Solifenacin is primarily used to treat symptoms of an overactive bladder (OAB) in adults, which includes urinary urgency, frequency, and urge incontinence (accidental leakage). It works by relaxing the detrusor muscle in the bladder wall, allowing the bladder to hold more urine and reducing the 'emergency' feeling of needing to go. Additionally, it is FDA-approved for children aged 2 and older who suffer from neurogenic detrusor overactivity, a condition often linked to spinal cord issues. By managing these symptoms, the medication helps patients regain control over their daily activities and improves their overall quality of life. It is important to note that solifenacin treats the symptoms but does not cure the underlying cause of bladder dysfunction. Always consult with a urologist to ensure this is the appropriate treatment for your specific urinary symptoms.
The most frequent side effects reported by patients taking solifenacin are dry mouth and constipation, which occur because the drug blocks muscarinic receptors in the salivary glands and digestive tract. Dry mouth can range from a mild nuisance to a significant discomfort that may affect speech or swallowing. Constipation occurs because the medication slows down the movement of the intestines, making it important for patients to stay hydrated and consume adequate fiber. Other common issues include blurred vision, especially when trying to focus on nearby objects, and dry eyes. Some patients also report mild stomach upset or nausea shortly after taking their daily dose. Most of these side effects are dose-dependent, meaning they are more likely to occur or be more severe at the 10 mg dose than at the 5 mg dose.
While there is no direct chemical interaction between alcohol and solifenacin that is considered toxic, healthcare providers generally recommend limiting or avoiding alcohol. Alcohol is a natural diuretic and bladder irritant, which means it increases urine production and can make the symptoms of overactive bladder worse, effectively fighting against the medication. Furthermore, both alcohol and solifenacin can cause side effects like dizziness, drowsiness, and blurred vision; combining them can significantly increase the risk of falls or accidents. If you choose to drink, do so in moderation and be aware of how the combination affects your coordination and bladder control. It is best to discuss your alcohol consumption habits with your doctor when starting a new prescription for urinary symptoms.
The safety of solifenacin during pregnancy has not been established through rigorous human clinical trials, placing it in a category where it should only be used if the benefits clearly outweigh the potential risks. Animal studies have shown that very high doses of the drug can lead to reduced fetal weight and minor skeletal abnormalities, though these doses were much higher than what humans typically take. Because overactive bladder is generally not a life-threatening condition, many doctors recommend stopping the medication while pregnant to avoid any unnecessary risk to the developing fetus. If you are pregnant or planning to become pregnant, you must discuss alternative management strategies, such as pelvic floor exercises or behavioral modifications, with your healthcare provider. There is also a concern that the drug could decrease milk production in mothers who are breastfeeding.
Most patients begin to notice a slight improvement in their bladder symptoms within the first 1 to 2 weeks of starting solifenacin. However, it takes time for the medication to reach a steady level in your system and for the bladder muscles to fully respond to the treatment. Clinical studies show that the maximum therapeutic effect is usually achieved after 4 to 8 weeks of consistent, daily use. It is important not to get discouraged if you do not see immediate results; consistency is key to the drug's success. Your doctor will likely schedule a follow-up appointment after about 4 to 6 weeks to evaluate how well the medication is working and to see if a dose adjustment is necessary. If you haven't seen any improvement after two months, your doctor may explore other treatment options.
Stopping solifenacin suddenly is not dangerous in the sense of causing physical withdrawal symptoms, but it will likely result in a rapid return of your overactive bladder symptoms. Within a few days of stopping the medication, you may notice an increase in urinary urgency, frequency, and potential episodes of incontinence. If you find the side effects intolerable or feel the medication is no longer needed, you should consult your doctor before stopping. They may suggest a lower dose or transition you to a different type of treatment, such as a beta-3 agonist, which has a different side-effect profile. Always keep your healthcare provider informed of any changes you make to your medication regimen to ensure your symptoms remain under control.
If you miss a dose of solifenacin, you should take it as soon as you remember on the same day you missed it. However, if you do not realize you missed the dose until the next day, you should skip the missed dose entirely and simply take your next scheduled dose at the usual time. You should never take two doses at once or in the same day to make up for a missed one, as this significantly increases the risk of acute side effects like urinary retention or severe blurred vision. To help you remember your medication, try taking it at the same time every morning, perhaps alongside another daily habit like brushing your teeth. If you frequently miss doses, consider using a pill organizer or a smartphone reminder app to stay on track.
Weight gain is not a commonly reported side effect of solifenacin in clinical trials or post-marketing surveillance. The medication primarily affects muscarinic receptors and does not significantly interfere with metabolic rate or appetite in most patients. However, some patients may experience peripheral edema (swelling in the ankles or legs), which can lead to a slight increase in scale weight due to fluid retention. Additionally, because constipation is a common side effect, some individuals may feel bloated or 'heavier' than usual. If you notice a significant or rapid increase in weight while taking solifenacin, you should contact your doctor to rule out other causes, such as heart or kidney issues. Maintaining a healthy diet and active lifestyle remains the best way to manage weight while on this medication.
Solifenacin can interact with several types of medications, so it is vital to provide your doctor with a complete list of everything you take. Of particular concern are 'potent CYP3A4 inhibitors' like certain antifungals (ketoconazole) and HIV medications, which can cause solifenacin levels to rise dangerously high. If you are taking these, your solifenacin dose must be limited to 5 mg. You should also be cautious when taking other anticholinergic drugs, such as certain allergy medications or antidepressants, as the 'additive effect' can cause severe dry mouth, confusion, and constipation. Conversely, drugs that speed up the gut, like metoclopramide, may have their effects canceled out by solifenacin. Always check with a pharmacist before starting any new over-the-counter supplements or herbal remedies like St. John's Wort.
Yes, solifenacin succinate is widely available as a generic medication, which is typically much more affordable than the brand-name version, Vesicare. The FDA approved the first generic versions in 2019, ensuring that the generic forms meet the same strict standards for safety, strength, and effectiveness as the original brand. Both the 5 mg and 10 mg tablets are available in generic form from various manufacturers. Choosing the generic version can significantly lower your out-of-pocket costs, especially for a medication that is often taken long-term. Your pharmacist can help you determine if a generic version is available under your specific insurance plan. Regardless of whether you take the brand or the generic, the active ingredient and the way it works in your body remain identical.
Other drugs with the same active ingredient (Solifenacin)
> Warning: Stop taking Solifenacin and call your doctor immediately if you experience any of these.
Recent longitudinal studies have raised concerns regarding the long-term use of potent anticholinergics like solifenacin and their potential link to cognitive decline and dementia in older adults. While a direct causal link is still being debated, many geriatricians recommend the 'lowest effective dose' and periodic 'drug holidays' to assess whether the medication is still necessary. Long-term use can also contribute to chronic dry mouth, which increases the risk of dental caries (cavities) and oral candidiasis (thrush).
No FDA black box warnings currently exist for solifenacin. However, the FDA has issued safety communications regarding the risk of serious central nervous system side effects and the potential for severe allergic reactions (angioedema).
Report any unusual symptoms to your healthcare provider. Even mild side effects like dry mouth should be discussed, as there are strategies (such as sugar-free lozenges or saliva substitutes) that can improve your quality of life while on the medication.
Solifenacin should be used with extreme caution in patients with decreased gastrointestinal motility or severe constipation. Because it slows the gut, it can worsen conditions like gastric retention (where the stomach doesn't empty properly) or obstructive gastrointestinal disorders.
While solifenacin is contraindicated in uncontrolled narrow-angle glaucoma, it can be used with caution in patients being treated for controlled narrow-angle glaucoma. However, regular monitoring by an ophthalmologist is mandatory, as anticholinergics can increase intraocular pressure.
Clinical data suggests that solifenacin can cause a modest prolongation of the QT interval, especially at the 10 mg dose or when combined with other QT-prolonging drugs. Patients with a history of 'Long QT Syndrome' or those taking anti-arrhythmic medications should be monitored with baseline and follow-up EKGs (electrocardiograms).
Your doctor may require the following during treatment:
Solifenacin may cause blurred vision, dizziness, or somnolence (sleepiness). Do not drive, operate heavy machinery, or engage in potentially dangerous activities until you know how this medication affects you. The risk of these effects is higher when first starting the drug or after a dose increase.
Alcohol can exacerbate the side effects of solifenacin, particularly dizziness and drowsiness. Furthermore, alcohol is a known bladder irritant and diuretic, which can counteract the beneficial effects of solifenacin by increasing urinary frequency and urgency.
There is no evidence of a 'withdrawal syndrome' with solifenacin. However, if you stop the medication abruptly, your overactive bladder symptoms will likely return within a few days. If you wish to stop the medication, discuss a plan with your doctor to ensure your symptoms are managed through other means, such as bladder training or pelvic floor exercises.
> Important: Discuss all your medical conditions, especially any history of glaucoma, liver disease, or stomach problems, with your healthcare provider before starting Solifenacin.
When taking these medications, the dose of solifenacin must not exceed 5 mg daily.
Combining solifenacin with other drugs known to prolong the QT interval increases the risk of life-threatening heart arrhythmias. These include certain antipsychotics (e.g., quetiapine, haloperidol), certain antibiotics (e.g., erythromycin), and anti-arrhythmics (e.g., amiodarone, sotalol).
Solifenacin does not have well-documented interactions with common laboratory tests (such as blood glucose or cholesterol panels). However, it may affect the results of a urodynamic study or a gastric emptying study because of its physiological effects on muscle contraction. Always inform the technician if you are taking solifenacin before undergoing these specific tests.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. A 'brown bag' review, where you bring all your bottles to your appointment, is the safest way to prevent interactions.
These conditions require a careful risk-benefit analysis by a physician:
While solifenacin is chemically distinct from other antimuscarinics like oxybutynin or darifenacin, patients who have had severe systemic allergic reactions to one drug in the 'muscarinic antagonist' class should be monitored closely if switched to solifenacin. There is no documented cross-reactivity between solifenacin and common allergens like penicillin or sulfa drugs, but the tablets do contain lactose, which may be a concern for patients with severe lactose intolerance.
> Important: Your healthcare provider will evaluate your complete medical history, including a physical exam and potentially a bladder scan, before prescribing Solifenacin.
Solifenacin is FDA-approved for the treatment of neurogenic detrusor overactivity (NDO) in children aged 2 years and older. It has not been established as safe or effective for 'standard' overactive bladder in children. Long-term effects on growth and development are still being monitored, though current data suggests it is well-tolerated in the NDO population. Weight-based dosing using the oral suspension is the standard of care.
In clinical trials, there were no overall differences in safety or effectiveness between older (65+) and younger patients. However, real-world data and the Beers Criteria (a list of medications potentially inappropriate for the elderly) flag solifenacin as a drug of concern. Older adults are at a significantly higher risk for:
Renal function is critical for the clearance of solifenacin metabolites.
Patients on dialysis should be monitored for increased side effects, as the drug's behavior in this population is not fully characterized.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are planning to become pregnant or are over the age of 65.
| Parameter | Value |
|---|---|
| Bioavailability | ~90% |
| Protein Binding | ~98% (Alpha1-acid glycoprotein) |
| Half-life | 45 - 68 hours |
| Tmax | 3 - 8 hours |
| Metabolism | Hepatic (Primary: CYP3A4) |
| Excretion | Renal 69%, Fecal 23% |
Solifenacin belongs to the therapeutic class of urinary antispasmodics, specifically the sub-class of antimuscarinics. Related medications include oxybutynin (Ditropan), tolterodine (Detrol), darifenacin (Enablex), and fesoterodine (Toviaz). Among these, solifenacin is often preferred for its long half-life and once-daily dosing regimen.