URIBEL - PUT RELIEF BACK IN THE PICTURE

Urinary tract symptoms can keep you on edge—Get relief from pain, burning and spasms

Do you have pain or burning when you urinate? A feeling of urgency that keeps you running to the bathroom? These could be symptoms of a lower urinary tract condition such as urinary tract infection (UTI), interstitial cystitis (IC), or painful bladder syndrome (PBS). Certain diagnostic procedures (cystoscopies, for example) can also cause urinary system irritation, inflammation, and discomfort. 

GET URIBEL® FOR AS LITTLE AS $25 †

Please Click Here to Visit the Uribel Website:

UribelInfo.com

ABOUT URIBEL

(Methenamine, Sodium Phosphate Monobasic, Phenyl Salicylate, Methylene Blue, Hyoscyamine Sulfate)

Uribel™ capsules are a multi-ingredient therapy for the treatment of local symptoms associated with irritative voiding, such as inflammation, hypermotility, and pain, which accompany urinary lower urinary tract infections

Uribel capsules are also indicated for the relief of urinary tract symptoms associated with prediagnostic and postdiagnostic procedures.

ANALGESIC, ANTISPASMODIC, AND ANTISEPTIC ACTIVITY

Uribel capsules contain a combination of analgesic, antispasmodic, and antiseptic ingredients: phenyl salicylate (relief of pain and burning); hyoscyamine sulfate (relaxation of smooth muscle tissue); methenamine (bactericidal/bacteriostatic action); methylene blue (mild antiseptic); and sodium phosphate monobasic (for methanamine degradation).

Clinical Pharmacology

PHENYL SALICYLATE releases salicylate, a mild analgesic for pain

HYOSCYAMINE SULFATE is a parasympatholytic

• Well absorbed from the gastrointestinal tract

• Rapidly distributed throughout the body tissues

• Most excreted in urine within 12 hours

• Biotransformation is hepatic

• Moderate protein binding

METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action

• Well absorbed from the gastrointestinal tract

• 70%-90% hydrolyzed in the urine if acidic

• 90% excreted within 24 hours

• Some formaldehyde binding ocurs with substances in urine and surrounding tissues

• Freely distributed to body tissue and fluids but not clinically significant (does not hydrolyze at pH greater than 6.8)

METHYLENE BLUE possesses weak antiseptic properties

• Well absorbed by the gastrointestinal tract

• Rapidly reduced to leukomethylene blue

• 75% is excreted in the urine unchanged

SODIUM PHOSPHATE MONOBASIC is an acidifier

• Helps to maintain urinary acid pH

• Necessary for degradation of methenamine

Indications

Uribel™ capsules are 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.

Dosage and Administration

It is recommended that each dose be followed by liberal amounts of fluid.

• Adults: one capsule orally 4 times per day

• Older children – Dosage must be individualized by physician. Not recommended for use in children six years of age or younger.

Description/How Supplied

Description

Each Uribel™ capsule contains:

• Methenamine 118 mg

• Sodium Phosphate Monobasic 40.8 mg

• Phenyl Salicylate 36 mg

• Methylene Blue 10 mg

• Hyoscyamine sulfate 0.12 mg

Inactive ingredients include dicalcium phosphate, FD&C Blue #1, FD&C Red #3, gelatin, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, shellac, silicon dioxide, sodium hydroxide, stearic acid, and titanium dioxide.

How supplied

Uribel capsules are purple/purple capsules and printed with S 111. They are supplied in bottles of 100 capsules or cartons of 20 individually pouched capsules.

• NDC 0076-0111-01 Bottle of 100

• NDC 0076-0111-02 Carton of 20 capsules

Storage

Store at controlled room temperature 15°-30° C (59°-86°F) in a cool, dry place. Keep container tightly closed. Dispense in a light-resistant container with child-resistant closure.

Contraindications

Uribel™ is contraindicated in patients with hypersensitivity to any of its ingredients (methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue).

For patients with the following medical conditions, the risk benefits of Uribel should be carefully considered.

• Cardiac disease (cardiac arrhythmias, congestive heart failure, coronary heart disease,and mitral stenosis)

• Gastrointestinal tract obstructive disease

• Glaucoma

• Myasthenia gravis

• Obstructive uropathy (ie, bladder neck obstruction to prostatic hypertrophy)

Pregnancy/Reproduction (FDA Pregnancy Category C)- hyoscyamine and methenamine cross the placenta. Because studies on these ingredients have not been done in humans or animals, it is not known if Uribel capsules cause fetal harm. Uribel capsules should be given to a pregnant woman only if clearly needed (see Warning & Precautions below).

Warnings & Precautions

Warnings

• Do not exceed recommended dosage.

• Discontinue use immediately if rapid pulse, dizziness, or blurred vision occur.

Precautions

• Patients who are intolerant of belladonna alkaloids or salicylates may be intolerant of Uribel™

• Uribel causes a delay in gastric emptying, which may complicate management of gastric ulcers.

• Pregnancy/Reproduction (FDA Pregnancy Category C) - hyoscyamine and methenamine cross the placenta. Because studies on these ingredients have not been done in humans or animals, it is not known if Uribel capsules cause fetal harm. Uribel capsules should be given to a pregnant woman only if clearly needed. (See Precautions.)

• Uribel should be used with caution in the elderly. Usual doses of hyoscyamine may cause excitement, agitation, drowsiness, or confusion.

Adverse Reactions

Serious reactions to Uribel™ capsules are rare. Uribel may cause urine and sometimes stools to turn blue or blue-green, a harmless effect that subsides when medication is stopped.

Adverse reactions can include rapid heartbeat, flushing, blurred vision, dizziness, drowsiness, difficult micturition, acute urinary retention, dry mouth, nausea and vomiting, shortness of breath, or trouble breathing.

Dosage & Administration

Potential effects of Uribel™ capsules on other drugs

• Uribel may decrease the absorption of other drugs because of its effect on gastrointestinal motility and gastric emptying.

Timing of Uribel dosage when used concurrently with other drugs

• Certain medications (including thiazide diuretics, antimuscarinics, and antacids/antidiarrheals) may reduce the effectiveness of methenamine and/or hyoscyamine, two of the ingredients in Uribel capsules.

  • Doses of the following medications should be spaced 1 hour apart from doses of hyoscyamine:

  • Antimyasthenics

  • Ketoconazole

  • Monoamine oxidase (MAO) inhibitors

  • Opioid medications

  • Sulfonamides

† Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Please see Program Terms, Conditions, and Eligibility Requirements