What is Gemtesa?

Gemtesa is used to treat overactive bladder (OAB) symptoms, including urinary urgency, urinary frequency, and urge incontinence, which is when you have a strong need to urinate with leaking or wetting accidents. Gemtesa is used to relieve these symptoms in adults with overactive bladder or men taking medicine for benign prostatic hyperplasia (BPH).

Gemtesa works by relaxing the bladder muscle so the bladder can hold more urine and this may reduce the urgency to use the bathroom and decrease the frequency of urinary leaks. 

 Gemtesa generic name is vibegron.

Gemtesa is a once-daily tablet that is swallowed whole with water or may be crushed, mixed with a tablespoon (~15 mL) of applesauce and taken immediately with a glass of water. The tablet can be taken with or without food. 

Gemtesa FDA approval

Gemtesa’s FDA approval is to treat adults with: 

• Overactive bladder symptoms of urge urinary incontinence, urgency, and urinary frequency 
• Overactive bladder symptoms of urge urinary incontinence, urgency, and urinary frequency in men taking medicines for benign prostatic hyperplasia (BPH). 

How does Gemtesa work?

Gemtesa’s mechanism of action (MOA) is a selective human beta-3 adrenergic receptor agonist (β3-AR agonist). Gemtesa works by binding and activating β3-adrenergic receptor, which relaxes the muscles in the wall of the bladder (detrusor muscle), which increases bladder volume. Gemtesa is from a class of medications called beta-3 agonists.

Gemtesa Clinical trial results 

In the 12-week clinical trial called Study 3003 (NCT03492281) used for overactive bladder symptoms, Gemesa patients had:

• 2 fewer daily leakage episodes (compared with 1.4 fewer episodes for placebo)
• 1.8 fewer bathroom visits per day (compared to 1.3 fewer episodes for placebo)
• 2.7 fewer “need to urinate immediately” episodes (compared to 2 fewer episodes for placebo

Gemtesa side effects

Common Gemtesa side effects

The most common Gemtesa side effects for OAB include: 

• headache (22%)
• cold symptoms -nasopharyngitis (15%)
• diarrhea (12%)
• nausea (12%) 

These common side effects occurred in 2% or more of the Gemtesa patients in the 12-week clinical trial for OAB called Study 3003. 

The long-term 52-week study had the same side effects as above and also included urinary tract infection (6.6%) and bronchitis (2.9%).

The most common Gemtesa side effects for OAB with BPH include: 

In a 12-week clinical trial (Study 3005) evaluating Gemtesa in males with overactive bladder (OAB) who were also taking medication for benign prostatic hyperplasia (BPH), the most common side effects occurring in more than 2% of patients were:

• Hypertension: 9% (compared to 8.3% with placebo)
• Urinary tract infection: 2.5% (compared to 2.2% with placebo)

Serious Gemtesa side effects

Get emergency medical help if you have signs of an allergic reaction to Gemtesa with symptoms of hives; difficulty breathing; and swelling of your face, lips, tongue, or throat.

Call your doctor at once if:

• you are unable to completely empty your bladder; or
• you have pain or burning when you urinate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Warnings

Gemtesa should not be taken if you have hypersensitivity to the active ingredient vibegron or any of the inactive ingredients in this medicine.

Urinary Retention: It is important to monitor for urinary retention, especially in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for OAB, as the risk of urinary retention may be greater. If urinary retention develops, discontinue Gemtesa. 

Angioedema: Angioedema of the face and/or larynx has been reported with this medicine.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not take Gemtesa if you are allergic to the active ingredient vibegron, or any inactive ingredients.

To make sure Gemtesa is safe for you, tell your doctor if you have ever had:

• trouble emptying your bladder;
• a weak stream of urine;
• liver disease; or
• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Gemtesa?

The normal dose of Gemtesa 75mg is one tablet, taken by mouth, once daily. Take this medicine with a full glass of water. You may take Gemtesa with or without food.

If you cannot swallow a tablet whole, you may crush the tablet and mix it with 1 tablespoon of applesauce. Swallow the mixture right away with a glass of water. Do not save the mixture for later use.

Use Gemtesa exactly as prescribed by your doctor. Follow all directions on your prescription label and use the medicines exactly as directed. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Gemtesa Dosing information 

Dosing Information for Gemtesa

• Usual Adult Gemtesa Dose: One Gemtesa 75 mg tablet orally once a day.
• How to take: Take Gemtesa tablet with a glass of water with or without food.
• Crushing Option: If you cannot swallow a tablet whole, you may crush the tablet and mix it with 1 tablespoon of applesauce. Swallow the mixture right away with a glass of water. Do not save the mixture for later use.

Missed Dose

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Overdose

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Gemtesa?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What other drugs will affect Gemtesa?

Tell your doctor about all your other medicines, especially:

• digoxin or digitalis.

What is mirabegron?

Mirabegron is used in adults to treat overactive bladder with symptoms of frequent or urgent urination and urinary incontinence. Mirabegron is sometimes used together with another medicine called solifenacin (Vesicare).

Mirabegron is used in children to treat neurogenic detrusor overactivity (NDO). Urinary incontinence caused by NDO is related to permanent nerve damage from conditions such as multiple sclerosis or spinal injury.

Mirabegron tablets may be used in children at least 3 years old. Mirabegron granules are for use in children at least 3 years old who also weigh at least 77 pounds (35 kilograms).

Mirabegron may also be used for purposes not listed in this medication guide.

Mirabegron side effects

Stop using mirabegron and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mirabegron may cause serious side effects. Call your doctor at once if you have:

• pain or burning when you urinate; or
• dangerously high blood pressure–severe headache, blurred vision, pounding in your neck or ears.

Common side effects of mirabegron may include:

• painful urination;
• increased blood pressure;
• sinus pain, sore throat;
• constipation;
• headache; or
• dry mouth or fast heartbeats (when taken with solifenacin).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

Warnings

You should not use mirabegron if you have uncontrolled hypertension (high blood pressure).

Before taking this medicine

You should not use mirabegron if you are allergic to it.

Tell your doctor if you have ever had:

• high blood pressure;
• a bladder obstruction;
• trouble emptying your bladder (very little urine or a weak stream of urine);
• kidney disease; or
• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Mirabegron should not be given to a child younger than 3 years old.

How should I take mirabegron?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

If you take mirabegron with solifenacin, take both medicines at the same time each day.

Take the mirabegron tablet with a full glass of water. Swallow the tablet whole and do not crush, chew, or break it.

An adult may take a mirabegron tablet with or without food. However, a child should take the tablet with food.

Both adults and children should take mirabegron granules with food.

A pharmacist will mix mirabegron granules into a suspension (liquid) before you receive the medicine.

Shake the suspension before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If the suspension will not be used for 2 days or longer, shake the bottle vigorously for 1 minute each day to keep the granules thoroughly mixed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Your dose needs may change if you switch from using mirabegron tablets to using the suspension. Avoid medication errors by using only the form and strength your doctor prescribes.

Your blood pressure will need to be checked often.

It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Throw away any unused mirabegron suspension after the expiration date on the medicine label has passed.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose may cause pounding heartbeats or fluttering in your chest.

What should I avoid while taking mirabegron?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What is Myrbetriq?

Myrbetriq relaxes the muscles of the urinary bladder, reducing bladder spasms. It is used alone or with solifenacin succinate to treat the symptoms of overactive bladder, such as frequent or urgent urination and urinary incontinence.

Myrbetriq is used in adults to treat overactive bladder with symptoms of frequent or urgent urination and urinary incontinence. It is sometimes used together with another medicine called solifenacin (Vesicare).

Myrbetriq is used in children to treat neurogenic detrusor overactivity (NDO). Urinary incontinence caused by NDO is related to permanent nerve damage from conditions such as multiple sclerosis or spinal injury.

Myrbetriq tablets may be used in children at least 3 years old. Myrbetriq granules are for use in children at least 3 years old who also weigh at least 77 pounds (35 kilograms).

Warnings

You should not use Myrbetriq if you have

• end stage renal disease (kidney failure)
• severe kidney disease; or
• severe uncontrolled high blood pressure.

A condition called angioedema can occur after taking Myrbetriq. Angioedema is a condition that leads to face, lip, tongue, throat swelling, difficulty breathing and can be fatal. Seek emergency attention immediately if these symptoms occur.

It may take up to 8 weeks before your symptoms improve. Keep using this medicine as directed and tell your doctor if your symptoms do not improve after 8 weeks of treatment.

Before taking this medicine

You should not use Myrbetriq if you are allergic to mirabegron.

To make sure this medicine is safe for you, tell your doctor if you have:

• high blood pressure;
• a bladder obstruction;
• trouble emptying your bladder (very little urine or a weak stream of urine);
• kidney disease; or
• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Myrbetriq should not be given to a child younger than 3 years old.

How should I take Myrbetriq?

Take Myrbetriq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

If you take Myrbetriq with solifenacin, take both medicines at the same time each day.

Take the Myrbetriq tablet with a full glass of water. Swallow the tablet whole and do not crush, chew, or break it.

An adult may take a Myrbetriq tablet with or without food. However, a child should take the tablet with food.

Both adults and children should take Myrbetriq granules with food.

A pharmacist will mix the granules into a suspension (liquid) before you receive the medicine.

Shake the suspension before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If the suspension will not be used for 2 days or longer, shake the bottle vigorously for 1 minute each day to keep the granules thoroughly mixed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Your dose needs may change if you switch from using tablets to using the suspension. Avoid medication errors by using only the form and strength your doctor prescribes.

Your blood pressure will need to be checked often.

It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Throw away any unused Myrbetriq suspension after the expiration date on the medicine label has passed.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose may cause pounding heartbeats or fluttering in your chest.

What should I avoid while taking Myrbetriq?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Myrbetriq side effects

Stop using Myrbetriq and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain or burning when you urinate; or
• dangerously high blood pressure – severe headache, blurred vision, pounding in your neck or ears.

Common Myrbetriq side effects may include:

• painful urination;
• increased blood pressure;
• sinus pain, sore throat;
• constipation;
• headache; or
• dry mouth or fast heartbeats (when taken with solifenacin).

What is oxybutynin?

Oxybutynin reduces muscle spasms of the bladder and urinary tract.

Oxybutynin is used to treat symptoms of overactive bladder, such as frequent or urgent urination, incontinence (urine leakage), and increased night-time urination.

Oxybutynin is also used in children at least 5 years old with overactive bladder related to a neurologic condition such as spina bifida.

Oxybutynin extended-release tablets are also used in children at least 6 years old with overactive bladder related to a neurologic condition such as spina bifida.

Warnings

You should not use oxybutynin if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.

Before using oxybutynin, tell your doctor if you have glaucoma, liver or kidney disease, an enlarged prostate, myasthenia gravis, ulcerative colitis, a blockage in your stomach or intestines, or a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Oxybutynin can decrease perspiration and you may be more prone to heat stroke.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

There are many other medicines that can interact with oxybutynin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, extreme thirst, severe stomach pain or constipation, pain or burning when you urinate, or if you stop urinating.

Before taking this medicine

You should not use oxybutynin if you are allergic to it, or if you have:

• untreated or uncontrolled narrow-angle glaucoma;
• a blockage in your digestive tract (stomach or intestines); or
• if you are unable to urinate.

To make sure you can safely take oxybutynin, tell your doctor if you have ever had:

• glaucoma;
• heart disease, hypertension;
• trouble urinating;
• ulcerative colitis;
• dementia, Parkinson’s disease;
• overactive thyroid;
• prostate disorder;
• a nerve disorder that affects your heart rate, blood pressure, or digestion;
• myasthenia gravis; or
• a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion.

Serious side effects may be more likely in older adults, in those who are ill or debilitated, or in those with kidney or liver disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take oxybutynin?

Take oxybutynin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take the extended-release tabletswith a full glass of water, at the same time each day.

You may take oxybutynin with or without food.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

You may take oxybutynin with or without food.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

Store tightly closed at room temperature away from moisture, light, and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include restlessness, tremor, irritability, convulsions, delirium, hallucinations, flushing, fever, dehydration, heart rhythm disorders, vomiting, and urinary retention.

What should I avoid while taking oxybutynin?

Avoid driving or hazardous activity until you know how oxybutynin will affect you. Your reactions could be impaired.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Oxybutynin can decrease sweating and you may be more prone to heat stroke.

Drinking alcohol with this medicine can cause side effects.

Oxybutynin side effects

Get emergency medical help if you have signs of an allergic reaction to oxybutynin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe stomach pain or constipation;
• hallucinations, agitation, confusion, or somnolence;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• little or no urination;
• painful or difficult urination; or
• dehydration – dizziness, confusion, feeling very thirsty, or less urination.

Common oxybutynin side effects may include:

• dizziness, drowsiness;
• headache;
• dry mouth; or
• diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect oxybutynin?

Using oxybutynin with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• antibiotic, antifungal, or antiviral medicine;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat overactive bladder;
• medicine to treat dementia;
• medicine to treat Parkinson’s disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.