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Solifenacin is not licensed for use in pediatric or pregnant patients Yamanouchi Pharma America Solifenacin is available in 2 dosage strengths namely a 5 or 10 mg once-daily tablet which can be taken with or without food. Phase 3 studies demonstrated a dose-dependent effect in the relief of the common symptoms of OAB namely frequency, urgency, nocturia and urgency incontinence.

Patients are normally commenced on 5 mg and titrated according to clinical need and personal preference to 10 mg after 4—6 weeks of treatment. Side effects are also dose dependent, and include dry mouth, constipation, and blurred vision. It is important to remember that in the original week phase 3 studies upon which initial efficacy and tolerability data were described, patients were randomized without choice to either the 5 mg or 10 mg dosage. Ultimately in the week extension study, patients were all recommenced on 5 mg solifenacin for the first 4 weeks of open label treatment after completion of the original week studies and 4 weeks thereafter offered the option of dose escalation.

There have been several large, randomized clinical trials evaluating the efficacy, safety, tolerability, and persistence with solifenacin Table 1. Each of these trials will be discussed. Clinical trials evaluating the efficacy of solifenacin in the treatment of overactive bladder.

Change from baseline in mean number of urgency, all incontinence, urge incontinence episodes. Chapple et al a conducted a phase 2 study to evaluate the effective dose of solifenacin for the treatment of OAB.

This was a multicenter, double blind, placebo and tolterodine controlled trial. Following a single blind 2-week placebo run in, patients were randomized to 4 weeks of either placebo, solifenacin 2. The primary outcome measure of the study was the change from baseline, in the mean number of voids per 24 hours.

Secondary outcome measures included the change in volume of urine voided per void, and the mean number of urgency and incontinence episodes per 24 hours.

Quality of life changes were assessed using the 27 item Contilife questionnaire. Results of the study showed a significant reduction in the mean number of voids per 24 hours, and an increase in the mean volume voided per void in the study group taking 5 mg, 10 mg, and 20 g of solifenacin, when compared with the placebo group.

There was no statistically significant reduction in voiding frequency, and volume voided per void in the tolterodine and 2. The efficacy and tolerability of solifenacin was found to be dose dependant, with the greatest reduction in frequency occurring with the 20 mg dose. Neither solifenacin nor tolterodine treated patients experienced a significant reduction in the number of urgency or incontinence episodes.

Quality of life assessment using the Contilife questionnaire showed an improvement in 4 domains daily life activities, emotional consequences, sexuality, and self-image in the solifenacin treated patients, compared with improvement in the daily life activities domain in the tolterodine treated group, when compared with placebo.

Dry mouth and constipation were the most commonly reported adverse events. Patients taking 20 mg of solifenacin reported the highest incidence of adverse events, followed by those patients taking tolterodine. The lowest incidence of adverse events was reported by patients taking 2. There have been 4 phase 3 trials, a 1-year open label extension study and a solifenacin and tolterodine head-to-head study assessing the safety and tolerability of solifenacin in patients with OAB.

Two initial phase 3 clinical trials were designed to evaluate the efficacy and safety of 10 mg solifenacin in double blind, placebo-controlled trials studies and The primary endpoint for both studies was the change from baseline to 12 weeks in the number of micturitions in 24 hours. The mean change in the number of incontinence episodes per 24 hours and mean volume voided per micturition, were used as secondary endpoints. Both studies showed solifenacin 10 mg to be superior to placebo in reducing micturition frequency, incontinence and urgency episodes, and the volume voided per micturition episode.

There was no statistically significant reduction in nocturia episodes in both studies. Pharmacokinetic studies were performed before drug dosing, at steady state and post-dosing. Both studies reported mild to moderate adverse events, the most commonly reported being dry mouth and constipation.

In study there was one discontinuation due to dry mouth. Cardozo et al conducted a week, multicenter, randomized, double blind placebo controlled trial assessing the efficacy of 5 and 10 mg doses of solifenacin. Safety and tolerability of solifenacin were secondary study objectives. Patients were randomized to once daily doses of placebo, 5 mg or 10 mg of solifenacin.

The primary endpoint for this week trial was the mean change in micturition episodes in 24 hours. Changes from baseline in the mean umber of urgency, nocturia and incontinence episodes, and the mean volume voided per void, were used as secondary endpoints. The mean reductions in the number of micturition, urgency, and nocturia episodes in 24 hours are shown in Figure 2.

The reductions in urinary frequency and urgency episodes with solifenacin treatment were statistically significant for both doses of solifenacin. One of the major findings of this study was the significant reduction in nocturia episodes in patients taking a 10 mg dose of solifenacin. Reduction from baseline in the number of micturition and urgency episodes in 24 hours, and episodes of nocturia in patients receiving placebo, 5 mg, or 10 mg of solifenacin in a phase 3 trial drawn from data of Cardozo et al Half of the patients who were incontinent at baseline and received treatment with solifenacin 5 mg and 10 mg were dry at the end of the study period.

Rates of dry mouth were 7. Seven patients 2. A week phase 3a study assessing the efficacy of 5 mg and 10 mg solifenacin was conducted in a multicenter, double-blind, placebo-controlled trial, using 2 mg of immediate release tolterodine as an active comparator Chapple et al b.

The primary aim was to assess the efficacy of solifenacin 5 and 10 mg whilst the secondary aims were to compare the safety and efficacy with that of 2 mg immediate release IR tolterodine. After a 2-week placebo run-in period, subjects were randomized to either 2 mg IR tolterodine twice daily, placebo, solifenacin 5 mg or 10 mg. Baseline to end of study changes in the mean number of urgency, mixed incontinence and urgency incontinence episodes were used as study outcome measures.

In addition, the mean number of voids per 24 hours and mean volume voided per void were also assessed. Results of the study showed a statistically significant reduction in the number of urgency and urgency incontinence episodes in the patients receiving solifenacin, when compared with placebo. These changes were not statistically significant in the tolterodine-treated group when compared with placebo.

There was a significant reduction in urinary frequency with all active treatments, this effect being greatest in the solifenacin 10 mg, and then the 5 mg group.

There was a statistically significant improvement in volume of urine per void in the solifenacin- and tolterodine-treated groups, when compared with placebo. The changes in study outcome measures are shown in Figure 3.

The percentage change from baseline in the mean number of urgency, incontinence, and urge incontinence episodes and mean voids in a hour period Drawn from data of Chapple et al b. Five 1. Constipation was reported in a greater number of patients receiving solifenacin than tolterodine. The study found the 5 and 10 mg doses of solifenacin to be more effective than placebo, in the treatment of OAB. These preliminary studies lead to the STAR study; a head to head clinical trial comparing the efficacy of the existing market leader tolterodine extended release with dose flexible solifenacin.

This was a prospective, double blind, 2 arm, parallel group, week study Chapple et al The study design is described in Figure 4.

In this type of study the initial analysis is one of non-inferiority of the test drug, and once established assessment of superiority may follow. The results of the study showed that solifenacin was not inferior to tolterodine in reducing the number of voids per 24 hours; 2.

Solifenacin treatment resulted in a significant improvement in urgency, nocturia, urge incontinence, and overall incontinence when compared with tolterodine.

Back to Medicines A to Z. Solifenacin is a medicine used to treat symptoms of an overactive bladder. These can include:. Solifenacin works by relaxing the muscles around your bladder.

This means your bladder can hold more liquid and you do not need to pee as often or as urgently. Solifenacin is only available on prescription. It comes as tablets and as a liquid that you swallow. Solifenacin also comes combined with tamsulosin, a medicine for prostate problems.

Solifenacin with tamsulosin is known as Vesomni. Your doctor may prescribe this to treat a sudden and urgent need to pee if you have an enlarged prostate. It's not suitable for everyone. To make sure it's safe for you, tell your doctor or pharmacist before starting solifenacin if you:. You'll usually take solifenacin once a day. You can take your dose at any time but try to take it at the same time each day.

Swallow your tablets whole with a drink of water, do not chew or crush them. You can take solifenacin with or without food. The usual dose of solifenacin is 5mg, taken once a day. If your symptoms do not improve, your doctor may increase your dose to 10mg a day.

The usual dose for solifenacin with tamsulosin Vesomni is 1 tablet once a day. If you forget to take a dose, take it as soon as you remember. If you do not remember until the following day, skip the missed dose and take your next one at the normal time. If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

The amount of solifenacin that can lead to an overdose varies from person to person, and too much solifenacin can be dangerous. If you need to go to hospital, do not drive yourself. Get someone else to drive you, or to call you an ambulance.

Take the solifenacin packet with you, or the leaflet inside it, plus any remaining medicine. Call or go to Like all medicines, solifenacin can cause side effects although not everyone gets them. Side effects often improve as your body gets used to the medicine. Common side effects happen in more than 1 in people.

They are usually mild and short-lived. Talk to your doctor or pharmacist if these side effects bother you or do not go away:. In rare cases, it's possible to have a serious allergic reaction anaphylaxis to solifenacin. These are not all the side effects of solifenacin. For a full list, see the leaflet inside your medicines packet. Solifenacin is not usually recommended in pregnancy because there's not enough information available to say if it's safe for you and your baby.

If you're trying to get pregnant or you're already pregnant, talk to your doctor about whether taking solifenacin is right for you. Solifenacin is not usually recommended while breastfeeding. However, some breastfeeding mothers may still need it. It is not known how much solifenacin gets into breast milk, but this is likely to be small. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

If you experience any other symptoms which you think may be due to the tablets, please speak with your doctor or pharmacist for further advice. Never take more than the prescribed dose.

If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty. If you are having an operation or dental treatment, tell the person carrying out the treatment which medicines you are taking. This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you. Dated November Dated July Nonmedicinal ingredients: cornstarch, hypromellose , lactose monohydrate, magnesium stearate, polyethylene glycol , red ferric oxide, talc, and titanium dioxide.

The recommended dose of solifenacin is 5 mg once daily. If there are few side effects with a 5 mg dose, the dose can be increased to 10 mg once daily. If you have severe kidney function impairment or moderate liver function impairment, or if you are taking certain medications e. Solifenacin should be taken with liquids and swallowed whole.

It may be taken with or without food. Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor. It is very important to take this medication exactly as prescribed. If you miss a dose of this medication, take your next dose at the usual time.

Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice. Do not dispose of medications in wastewater e. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

Many of these side effects can be managed, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.