What To Do In Case You Take Too Much Gemtesa
If you think youve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.
When you get Gemtesa from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date when they dispensed the medication.
The expiration date helps guarantee that the medication is effective during this time. The of the Food and Drug Administration is to avoid using expired medications. If you have unused medication, and its expiration date has passed, talk with your pharmacist about whether you might still be able to use it.
Fda Approves Gemtesa For Overactive Bladder
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The FDA recently approved a new drug application for Gemtesa, a novel treatment for overactive bladder in adults, its manufacturer announced in a press release.
Gemtesa helps relax the detrusor bladder muscle, enabling the bladder to hold more urine, thereby reducing symptoms of overactive bladder, according to the manufacturer.
Gemtesa is the first beta 3-agonist available as a once-daily pill which does not require dose titration,David Staskin, MD, a clinical trial investigator and a leading urologist at St. Elizabeths Medical Center in Boston, said in a press release.
The FDAs approval of vibegron was based on data from the 12-week, double blind, placebo-controlled, phase 3 EMPOWUR study, which included more than 4,000 patients with overactive bladder. The results showed that vibegron was associated with statistically significant reductions in daily urge urinary incontinence, micturitions and urgency episodes, according to the press release.
The most common adverse events tied to vibegron use were diarrhea, headache, nasopharyngitis, nausea and upper respiratory tract infection, Urovant Sciences said in the release.
Overactive Bladder Urinary Incontinence Common In Middle
WEDNESDAY, Dec. 22, 2021 — Nearly one in five Japanese women report urinary incontinence related to overactive bladder or stress urinary incontinence, according to a study published online Nov. 12 in Menopause.
Kazue Nagai, Ph.D., from Gunma University in Japan, and colleagues investigated the prevalence and factors associated with urinary symptoms in women. The analysis included 12,198 participants in the Japan Nurses’ Health Study .
The researchers found that the prevalence of OAB was 9.5 percent , while the prevalence of stress urinary incontinence was 13.9 percent and the prevalence of mixed urinary incontinence was 2.1 percent. There was a significant association observed between OAB and age 45 to 54 years, with a moderate association between postmenopausal status and OAB. In the multivariable-adjusted model, there were significant associations with stress urinary incontinence among age groups 45 to 49 years and 50 to 54 years, body mass index 23 to 27.4 and 27.5 kg/m2, and parous status.
“This study underscores how common urinary incontinence is in women,” Stephanie Faubion, M.D., medical director of the North American Menopause Society, said in a statement. “Given the significant negative effect on quality of life and the presence of effective strategies for management of these burdensome symptoms, clinicians should routinely ask women about urinary incontinence.”
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Fda Approves New Drug To Treat Overactive Bladder Symptoms
Susan Jaffe
June 28, 2012 A new drug approved today by the US Food and Drug Administration may bring relief to patients who suffer from an overactive bladder, when other medications fail to treat the problem.
Mirabegron is an extended-release tablet taken daily that relaxes the bladder muscle and improves the bladder’s storage capacity. When tested during 3 double-blind, placebo-controlled clinical trials, 25- and 50-mg doses of mirabegron improved bladder control and reduced urinary incontinence, urgency, and frequency, according to an FDA statement.
“An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting and potentially serious,” said Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides a new treatment option for patients with this debilitating condition.”
According to the FDA, common adverse effects that occurred during the clinical trials were increased blood pressure, symptoms of a common cold, and urinary tract infection, constipation, fatigue, elevated heart rate , and abdominal pain. The drug is not recommended for patients with severe uncontrolled high blood pressure, end-stage kidney disease, or severe liver impairment.
The drug was approved in April by a 7-to-4 vote by the FDA’s Advisory Committee for Reproductive Health Drugs, and is manufactured by Astellas Pharma, based in Northbrook, Illinois.
Rationale For Anticholinergic Use
Detrusor muscle contractions are essential for normal micturition, but involuntary contractions produce the symptoms of overactive bladder. Contractions depend on the activation of muscarinic receptors in the bladder by acetylcholine. The M3 muscarinic receptor-subtype is thought to be the most important in regulating detrusor contractions.
Anticholinergic drugs block muscarinic receptor activation and inhibit the spontaneous detrusor contractions found in overactive bladder. Drug efficacy is dose-dependent, but effectiveness is often limited by unwanted antimuscarinic effects in distant organs where other acetylcholine receptor-subtypes predominate . These adverse effects are also dose-dependent. They commonly include dry mouth, dry eyes, confusion, constipation, somnolence, blurred vision and increased heart rate.
There are no currently available drugs with pure selectivity for the muscarinic receptors in the detrusor. To try to improve the benefit:harm ratio a number of anticholinergics have been developed with greater selectivity for the detrusor or the M3 receptor, or with extended release properties.
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Treatment Options For Overactive Bladder
A diagnosis of overactive bladder may seem like very bad news. But there is some good news: Overactive bladder is treatable, and the newest treatments offer more options, different methods of delivery and side effects that some women may find easier to tolerate than those with older remedies. The bad news is that many women are reluctant to seek help and needlessly suffer physically and emotionally.
About 40 percent of women have OAB, which causes a strong, uncontrollable urge to urinate. If untreated, it can take a significant toll on a womans quality of life, interfering with her friendships, intimate relationships, work and sleep. Because of embarrassment, many women are reluctant to seek medical attention for OAB. Plus, some earlier treatment options were uncomfortable and had side effects that some women found unacceptable, making them reluctant to pursue or continue with treatment.
But OAB today is quite treatable. The new treatments give women more options and may be better tolerated by some women than earlier options. Therefore, women with overactive bladder have all the more reason to put an end to the nighttime awakenings, interrupted social events and uncomfortable car trips that go along with OAB.
Cautions With Other Medicines
Mirabegron may affect the way other medicines work, and other medicines may affect how mirabegron works.
Tell your pharmacist or doctor if you’re taking:
- digoxin, a medicine for heart failure or abnormal heart rhythm
- imipramine or desipramine, medicines for urinary incontinence or nerve pain
- dabigatran, a blood thinner
- ketoconazole or itraconazole, medicines used to treat fungal infections
- ritonavir, a medicine used to treat HIV
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Antimuscarinic Drug Class Review
We conducted a systematic review of direct comparator randomized controlled trials of antimuscarinic drugs in OAB, using Cochrane review methods. For infrequent harms, including cognitive effects in the elderly, we also reviewed RCTs in people without OAB, placebo-controlled RCTs, and non-randomized studies. Outcomes were considered in a hierarchy based on importance to the patient: mortality, serious adverse events including cognitive impairment and urinary retention, quality of life, patient-reported improvement, withdrawals due to adverse effects, urgency incontinence, nocturia, and anticholinergic effects such as dry mouth, constipation or blurred vision.
Results: We identified two recent systematic reviews6, 10 and 35 direct, active comparator RCTs in patients with OAB, mostly of 12 weeks duration. Most compared oxybutynin IR with other formulations of oxybutynin, tolterodine , darifenacin, solifenacin or trospium IR.Efficacy differences were small and of doubtful clinical relevance. For example, condition-specific quality of life did not differ or differences were below the threshold for clinical relevance, and incontinence episodes did not differ, or differed by 0.2-0.6 episodes/day. Differences between drugs in pharmacokinetics, metabolism, drug-drug interactions, bladder selectivity, and propensity to cross the blood brain barrier were not reflected in clinically meaningful differences.
Prevalence And Epidemiology Of Oab
As many as 17% to 40% of adult women in the United States have OAB.4,7This is approximately 20 million OAB patients. However, the true numberis likely to be far higher, as many patients do not enter the healthcare system. There are three major reasons for this reluctance to do so.4First, many patients view OAB as an inevitable part of aging and chooseto take various self-care measures rather than visit a physician foradvice. Second, as many as 61% of OAB sufferers do not realize that thecondition can be successfully treated with medication and therefore donot seek help. Finally, OAB can induce shame and embarrassment inpatients, and the resultant negative social stigma may cause them toavoid any mention to health care providers.
Although OAB occurs in women of all ages, it exhibits a strong age association.3,8 The median age is 52 years, and the most common age range is 45 to 60 years.4
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Fda Approval Was Anticipated
The drug’s approval follows an FDA advisory panel vote in April that recommended approval. The recommendation was made even though concerns had been raised about an increase in blood pressure and liver issues in users.
Myrbetriq is the first of a new class of drugs. It works by stimulating receptors in the bladder‘s detrusor muscle. This causes the bladder to relax, which reduces urinary urgency symptoms.
In the company-sponsored trials, conducted in the U.S. and Europe, people who took the drug had significantly fewer symptoms of urgency, urinary frequency, and urge incontinence than people who took placebo pills.
The drug was approved for sale in Japan last year and is marketed under the trade name Betanis.
New Medications For Overactive Bladder
For decades, medications available to treat OAB remained largely unchanged. But within a year, the U.S. Food and Drug Association approved two new medications and a new procedure for treatment of OAB symptoms.
The prescription drug mirabegron was approved in June 2012 for the treatment of OAB symptoms of urgency, frequency and leakage. And, starting in the fall of 2013, there will be an over-the-counter patch available to women with OAB, called Oxytrol for Women.
Heres an overview of these two new medications:
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Surgical Treatment For Overactive Bladder
Surgery may recommended for severe cases. The two most-commonly used procedures are:
- increases bladder size by removing a section of the bowel and adding it to the bladder. Increased bladder size allows someone to store more urine, reducing the urge to urinate. Possible complications include infection, blood clots, bowel obstruction, urinary fistula, and an increased risk of bladder tumors .
- Sacral Nerve Stimulation is a newer surgical technique that involves placing a small electrical device in the lower back. The device sends electrical impulses to the sacral nerve, which improves control of the muscles in the bladder and pelvic floor.
‘clear Need For New Drugs’
Urologist Elizabeth Kavaler, MD, of Lenox Hill Hospital in New York City, says there is a clear need for new types of drugs that work in new ways to treat overactive bladder.
She says the previously approved prescription medications available in the U.S. all work in the same way.
“These drugs are very effective — around 90% of patients who take them respond,” she tells WebMD. “The problem is that many patients find they can’t or don’t want to take these drugs.”
She says that’s because of common side effects that include:
- constipation
- memory issues
Kavaler recommends that people with overactive bladder first try making changes in behavior. These changes can include limiting or eliminating bladder irritants such as:
- coffee
- alcohol
- soda
People with OAB can also reduce drinking all fluids and practice Kegel exercises to strengthen pelvic muscles.
If these lifestyle changes do not improve symptoms, medication may be needed, she says.
Kavaler says Myrbetriq may prove to be easier to tolerate for patients who either can’t take the previously available drugs or who find the side effects intolerable.
“Clearly, we have a huge need in this area, as evidenced by the fact that so many companies are marketing what is essentially the same drug,” she says. “It will be nice to have something different to offer.”
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Defining The Medical Need: Tolerability
Safety and tolerability are key considerations in the treatment of non-life-threatening disorders, such as OAB. Although muscarinic receptor antagonists are generally considered to be well tolerated, AEs are one of the leading causes of discontinuation. The most frequently observed AE in patients receiving treatment with a muscarinic receptor antagonist is dry mouth. Other relevant AEs include constipation, increases in heart rate and impairments of central nervous system functions. Among the latter, impaired cognition probably is the most important, but impaired sleep is also relevant. Although the reported incidence of impaired cognition is low in most studies, this probably represents an underestimation, because most studies of muscarinic antagonists were not designed to systematically capture such events and/or were underpowered for meaningful results. Furthermore, many medications unrelated to OAB, but potentially present in such patients as comedications, also have antimuscarinic effects. These include anti-allergic, anti-emetic, obstructive airway and gastrointestinal drugs, as well as those targeting central nervous disease, such as anti-Parkinson and psychopharmacological medications. Therefore, the full impact of muscarinic antagonists on central nervous function can only be appreciated when the total antimuscarinic load is considered.
Coping Methods And Quality Of Life Issues
Most women visit their physicians without hesita-tion forsuch conditions as urinary tract infections , vaginal fungalinfections, and birth control. However, for some inexplicable reason, alarge number of those suffering from OAB postpone a medical appointment,many for as long as 6 or 7 years.4 During this time, theyemploy a variety of coping mechanisms of dubious efficacy andquestionable safety. For instance, the use of absorbent pads ispartially effective, but increases the risk of a UTI.4 Somewomen also take great pains to ascertain the location of all bathroomsin advance of an attack of OAB, a behavior known as toilet mapping.4
Women with symptoms of OAB may reduce the extent ofactivities they once found pleasurable, such as movies, walks, tennis,golf, or visiting with friends. They may voluntarily reduce fluidintake, which can lead to dehydration. They may feel forced to wearclothing that would conceal a urine leak, and only sit on furniture thatwould not be permanently stained if a leak were to occur. It becomesapparent that OAB can cause constant concern due to fear of an accidentand also the perception that odor from underclothing or absorbent padsmight be detected by others. If a patient feels forced to lead a moresedentary lifestyle, she may experience greater medical andpsychological problems.
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Overactive Bladder Causes And Symptoms
Overactive bladder is a clinical condition that happens when the muscles of the bladder contract involuntarily. When the bladder muscle contracts too frequently or at the wrong time, the person might have signs of an OAB.
The condition is marked by a sudden need to urinate that is difficult to manage with or without accidental urinary discharge and typically with elevated urinary frequency. Unintentional urinary leakage due to urgency is referred to as UUI. Excessive urination and nocturnal symptoms are some of the other symptoms of OAB.
More than 30 million people in the US suffer from troubling symptoms of OAB, which can significantly hamper the day-to-day activities of the patients.
Financial And Insurance Assistance
If you need financial support to pay for Gemtesa, or if you need help understanding your insurance coverage, help is available.
Urovant Sciences GmbH, the manufacturer of Gemtesa, offers the Gemtesa Simple Savings Program. This program offers options to help lower the cost of Gemtesa. For more information and to find out if youre eligible for support, call 833-UROVANT or visit the programs website.
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Clinical Trials On Gemtesa
FDA approval of GEMTESA was based on a 12-week, double-blind, randomised, placebo-controlled, and active-controlled clinical trial named EMPOWUR.
A total of 1,515 OAB patients were randomised in 5:5:4 ratio to receive either GEMTESA 75mg , placebo or active control orally once daily for 12 weeks.
The patients with signs of OAB for at least three months with an average of eight or more micturitions a day and at least one UUI a day, or an average of eight or more micturitions a day and at least three urgency episodes a day were eligible to enter the trial.
The study population included OAB opioid-naive patients, as well as patients who had undergone previous OAB drug therapy.
The co-primary endpoints of the trial were changes in micturition frequency and UUI episodes at week 12.
At 12 weeks, micturition reduced by an adjusted mean of 1.8 episodes a day in patients receiving GEMTESA compared to 1.3 episodes a day for placebo and 1.6 episodes a day for tolterodine.
In incontinent patients, urge incontinence episodes decreased by an adjusted mean of two episodes a day for GEMTESA versus 1.4 for placebo and 1.8 for tolterodine.
GEMTESA was also substantially superior to placebo for secondary endpoints including the number of urgency episodes, volume per urination, and proportion of incontinent patients with a 75% or higher reduction in the urge incontinence episode.
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What Is Overactive Bladder
Normally, your urinary tract functions quite well. Yourkidneys produce urine that is stored in the bladder, and your bladder isrelaxed when there is no urine present. As your bladder fills withurine, your nerves send a signal that it needs to be emptied. When youhave overactive bladder, the signals to empty the bladder are sent eventhough the bladder is not full. As a result, you may notice thefollowing: 1) you feel the need to urinate 8 or more times during theday, and 2 or more times during a typical night 2) you feel a sudden,strong, and immediate urge to urinate and 3) you leak urineuncontrollably after you have the sudden and strong urge to urinate.Further, when you attempt to urinate, there is often very little urineor no urine at all.
Overactive bladder is not the same as stress incontinence.With stress incontinence, you leak urine when sneezing, laughing, orcarrying out other physical activities.
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