Pronunciation:

flay-VOX-ate

Brand Names:

• Urispas

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Urinary Antispasmodic

Pharmacologic—

Antimuscarinic

Uses of This Medicine:

Flavoxate belongs to the group of medicines called antispasmodics. It is taken by mouth to help decrease muscle spasms of the bladder and relieve difficult urination.

Flavoxate is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies on this medicine have been done only in adult patients and in children over 12 years of age. Flavoxate is not recommended for children younger than 12 years of age because safety and efficacy have not been established.

Older adults—

Confusion may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of flavoxate.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium Chloride
• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amantadine
• Amifampridine
• Benzhydrocodone
• Buprenorphine
• Bupropion
• Clozapine
• Codeine
• Dihydrocodeine
• Donepezil
• Fentanyl
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Hydrocodone
• Hydromorphone
• Hydroxychloroquine
• LetibotulinumtoxinA-wlbg
• Meperidine
• Methacholine
• Methadone
• Morphine
• Morphine Sulfate Liposome
• Olanzapine
• Oliceridine
• Oxycodone
• Oxymorphone
• Promethazine
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Sofpironium
• Sufentanil
• Tapentadol
• Tiotropium
• Tramadol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding (severe) or
• Glaucoma or
• Intestinal blockage or other intestinal or stomach problems or
• Urinary tract blockage—Use of flavoxate may make these conditions worse

• Enlarged prostate—Use of flavoxate may cause difficult urination

Proper Use of This Medicine:

This medicine is usually taken with water on an empty stomach. However, your doctor may want you to take it with food or milk to lessen stomach upset.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• Adults and children 12 years of age and older: 100 to 200 milligrams three or four times a day.
• Children up to 12 years of age: Use and dose must be determined by the doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses may help lessen the discomfort from bright light.

This medicine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.

Flavoxate may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Your mouth and throat may feel very dry while you are taking this medicine. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Confusion

eye pain

skin rash or hives

sore throat and fever

Symptoms of overdose

Clumsiness or unsteadiness

dizziness (severe)

drowsiness (severe)

fever

flushing or redness of face

hallucinations (seeing, hearing, or feeling things that are not there)

shortness of breath or troubled breathing

unusual excitement, nervousness, restlessness, or irritability

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness

dryness of mouth and throat

Less common or rare

Blurred vision

constipation

difficult urination

difficulty concentrating

dizziness

fast heartbeat

headache

increased sensitivity of eyes to light

increased sweating

nausea or vomiting

nervousness

stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.