Urised

Urised™ is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures..

Treating painful and irritating symptoms of the urinary tract due to urinary tract infections or diagnostic procedures.

Urised is a urinary antiseptic, analgesic, and anticholinergic combination. It works by helping to kill bacteria in the urine, decreasing pain and inflammation, and reducing muscle spasms in the urinary tract. These actions work together to help relieve discomfort while urinating.

Adults: Two tablets four times daily. See “PRECAUTIONS.”

Usual pediatric

Dosage: Children up to 6 years of age—Use is not recommended. Children 6 years of age and older—Dosage must be individualized by physician.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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What is the most important information I should know about Urised?

Urised™ is contraindicated in patients with a hypersensitivity to any of the ingredients. Risk- benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Use Urised as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Urised may be taken with or without food.
• Do not take antacids or antidiarrheal medicines (eg, loperamide) within 1 hour before or after taking Urised.
• Drink plenty of fluids while taking Urised.
• If you miss a dose of Urised, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Urised.

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What other drugs will affect Urised?

Some MEDICINES MAY INTERACT with Methenamine (Urised) D/S. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticholinergics (eg, benztropine) because they may increase the risk of Methenamine (Urised) D/S ’s side effects

Ketoconazole because it may decrease Methenamine (Urised) D/S ’s effectiveness

Monoamine oxidase inhibitors (MAOIs) or narcotic pain medicine (eg, codeine) because the risk of serious side effects may be increased

Medicine for myasthenia gravis (eg, ambenonium), phenothiazines (eg, chlorpromazine), sulfonamides (eg, sulfamethoxazole), thiazide diuretics (eg, hydrochlorothiazide), or urinary alkalinizers (eg, sodium bicarbonate) because their effectiveness may be decreased by Methenamine (Urised) D/S

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methenamine (Urised) D/S may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine."

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What are the possible side effects of Urised?

Cardiovascular - rapid pulse, flushing

Central Nervous System - blurred vision, dizziness, drowsiness

Respiratory - shortness of breath or troubled breathing

Genitourinary - difficult micturition, acute urinary retention

Gastrointestinal - dry mouth, nausea and vomiting

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Burel Pharmaceuticals, Inc at 1-601-706-9819 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.