Gemtesa relieves the symptoms of overactive bladder.
Tablets are taken once daily with or without food.
The recommended dosage is 75 mg daily.
Gemtesa is a brand-name prescription drug that relieves overactive bladder (OAB) symptoms. Its active ingredient is vibegron, a drug that relaxes the muscle that squeezes urine out of the bladder (called the detrusor muscle). This allows the bladder to fill with more urine before people feel the need to go. Gemtesa tablets are taken once daily.
Gemtesa comes in only one dosage form and one dosage strength:
Tablets: 75 mg
Gemtesa relieves three symptoms of overactive bladder: urinary urgency, frequent urination, and incontinence.
Gemtesa is a relatively safe drug without serious side effects other than allergic reactions. Because of the risk of serious or life-threatening allergic reactions, Gemtesa cannot be used in anyone who has had an allergic reaction to vibegron or any of the other ingredients in the tablet.
Gemtesa dosage chart |
|||
|---|---|---|---|
| Indication | Starting dosage | Standard dosage | Maximum dosage |
| Overactive bladder | 75 mg tablet taken once daily | 75 mg tablet taken once daily | Not specified |
An overactive bladder causes people to urinate more frequently than normal. In mild cases, it’s a nuisance. In more severe cases, it can significantly lower the quality of life.
Bladder overactivity manifests in three major ways: frequent urination, urinary urgency, and incontinence.
Frequent urination occurs when people urinate more often than normal. That’s the usual sign of an overactive bladder. Urinary urgency involves the sudden, intense, and often unexpected need to urinate. Urinary incontinence is any involuntary leakage of urine. It is often associated with urinary urgency. In those cases, it’s called “urge incontinence.”
Another possible symptom of an overactive bladder is nocturia—having to get up frequently during the night to urinate. Gemtesa does not relieve nocturia.
Overactive bladders are caused by the activity of the detrusor muscle, the smooth muscle that contracts and squeezes urine out of the bladder. Doctors sometimes call overactive bladders “detrusor overactivity.”
About 17% of adults in the U.S. have an overactive bladder, but only a third experience urinary urgency or urge incontinence. The other two-thirds just urinate more than other people. Urinary urgency and incontinence are more serious and intrusive symptoms than frequent peeing. They are the primary reasons people seek medical help for their bladder dysfunction.
Behavioral, dietary, and other lifestyle changes are the first-line treatments for OAB. Something as simple as quitting caffeine or smoking can make a big difference.
When medications are used, the first-line treatments are anticholinergic (or antimuscarinic) drugs like oxybutynin. These drugs relax all the smooth muscles in the bladder, including the detrusor muscle. This allows the bladder to fill with more urine before the detrusor muscle contracts, allowing the patient to hold their urine more easily. They are very effective but often cause side effects in other parts of the body.
If muscarinic antagonists don’t work or the side effects are intolerable, the second-line choices are beta-3 agonists: Myrbetriq (mirabegron) and Gemtesa (vibegron), which we have been discussing. These drugs specifically relax the detrusor muscle. They also have fewer side effects than the antimuscarinic drugs.
Daily doses of Gemtesa relieve OAB symptoms of urinary frequency, urinary urgency, and incontinence. Gemtesa can be used alone, but men with benign prostatic hyperplasia (BPH) must also be on medications for that condition if they take Gemtesa, as Gemtesa may worsen symptoms of BPH.
The starting dosage of Gemtesa is the same as the maintenance dosage of Gemtesa. There is no need for doses to increase at the beginning of therapy.
Standard dosage for overactive bladder: 75 mg once daily
Gemtesa is not FDA-approved for use in children.
Dosage reductions are not necessary in people with kidney disease or mild to moderate liver impairment. Gemtesa is not recommended for use in people with severe liver problems or cirrhosis.
Gemtesa tablets are relatively simple to take. Here are a few tips:
Follow the prescriber’s instructions.
Please read the Patient Information sheet that comes with the medicine.
Take only one tablet daily. If you miss a dose, simply take your next scheduled dose at the usual time.
Doses can be taken with or without food.
Swallow the tablets whole with a glass of water.
People who can’t swallow a tablet can crush the tablet and then mix it with one tablespoon of applesauce. Eat the mixture immediately with a glass of water.
Store Gemtesa tablets at room temperature.
In clinical studies, participants taking Gemtesa experienced symptom improvement almost immediately. Gemtesa showed significant improvements in OAB symptoms in the first two weeks of daily doses. However, it took twelve weeks to reach maximum symptom relief.
With a half-life of 31 hours, vibegron takes about six days to be completely cleared from the system.
Don’t double up on doses, simply take your next scheduled dose at the usual time.
Gemtesa is a long-term treatment that can be taken for months or years.
Stopping Gemtesa will not cause withdrawal symptoms or other complications.
If the drug isn’t working or causes troublesome adverse effects, talk to the prescriber. The treatment of overactive bladder can involve other drugs such as anticholinergic drugs, antispasmodic drugs, or antidepressants such as desipramine or imipramine. Certain hormones and even botulinum toxin can be used as options.
The recommended dosage of 75 mg daily should be considered the maximum dosage.
Healthcare professionals haven’t had much experience with Gemtesa overdoses. However, a drug from the same drug class called Myrbetriq (mirabegron) can cause racing heartbeats or palpitations when overdosed. If too much Gemtesa is taken, call a poison helpline or get medical help.
To avoid potential drug interactions, make sure the prescriber has a complete history of the drugs and supplements you take, including other drugs taken for overactive bladder as well as the heart medication digoxin.
Alcohol isn’t known to interact with Gemtesa. However, ask the prescriber if it’s advisable to drink alcohol when being treated for overactive bladder. Alcohol is a diuretic that can worsen the symptoms of OAB.
Ask the prescriber for medical advice. Healthcare professionals don’t know if it’s safe for pregnant women to take Gemtesa. In animal studies, the drug did not cause birth defects even when given in excessively high doses.
Ask the prescriber for medical advice before taking Gemtesa while breastfeeding. Healthcare professionals have not studied Gemtesa in women who are nursing. They don’t know if it’s present in breast milk, affects lactation, or causes side effects in a nursing baby.
The most common side effects of Gemtesa are headache, urinary tract infection, runny nose, sore throat, nausea, diarrhea, and upper respiratory tract infection. Other possible side effects include dry mouth, urinary retention, and constipation.
Gemtesa can rarely cause severe and potentially life-threatening allergic reactions such as angioedema.
Unlike other beta-3 adrenergic agonists like Myrbetriq (mirabegron), Gemtesa does not have an FDA-mandated warning about increased blood pressure. In clinical trials, Gemtesa caused elevated blood pressure at the same rate as the placebo.
Anyone who has had an allergic reaction to Gemtesa cannot safely take the drug.Some medical conditions can be worsened by Gemtesa. The risk of urinary retention is heightened in people with bladder outlet obstruction or problems urinating. For that reason, men with BPH (enlarged prostate) must also take medications for that condition and use caution when taking Gemtesa.
Gemtesa HCP, Sumitomo Pharma America
Gemtesa vibegron tablet drug information, DailyMed (NIH National Library of Medicine)
Relationship between alcohol use and overactive bladder disease: a cross-sectional study of the NHANES 2005–2016, Frontiers in Public Health
The burden of overactive bladder on US public health, Current Bladder Dysfunction Reports
Urge incontinence, StatPearls
Jesse P. Houghton, MD, FACG, was born and raised in New Jersey, becoming the first physician in his entire family. He earned his medical degree from New Jersey Medical School (Now Rutgers Medical School) in 2002. He then went on to complete his residency in Internal Medicine and his fellowship in Gastroenterology at the Robert Wood Johnson University Hospital in 2005 and 2008, respectively. He moved to southern Ohio in 2012 and has been practicing at Southern Ohio Medical Center as the Senior Medical Director of Gastroenterology since that time.
Dr. Houghton is the author of What Your Doctor Doesn't (Have the Time to) Tell You: The Gastrointestinal System. He is also an Adjunct Clinical Associate Professor of Medicine at the Ohio University School of Osteopathic Medicine. He has been in practice since 2008 and has remained board-certified in both Internal Medicine and Gastroenterology for his entire career. He has lent his expertise to dozens of online articles in the medical field.
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