Clinical Profile

Indications

Uribel capsules are indicated for:

The treatment of symptoms of irritative voiding.
The relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections.
The relief of urinary tract symptoms caused by diagnostic procedures.

Clinical Pharmacology

Uribel relieves urinary tract symptoms with 5 integrated analgesic, antispasmodic, and antiseptic ingredients:

HYOSCYAMINE SULFATE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect.
METHENAMINE degrades in an acidic urine environment releasing formaldehyde, which provides bactericidal or bacteriostatic action. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at a pH greater than 6.8.
METHYLENE BLUE possesses weak antiseptic properties.
PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.
SODIUM PHOSPHATE MONOBASIC, an acidifier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

For more information about Uribel’s clinical pharmacology, please see the full Prescribing Information.

Case Studies

Learn how Uribel can help the following patient types:

Important Safety Information

CONTRAINDICATIONS: Hypersensitivity to any of the ingredients is possible. Risk benefits should be carefully considered with certain medical conditions: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

WARNINGS: Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue use immediately.

PRECAUTIONS: Uribel should be used with caution in:

patients who are intolerant of belladonna alkaloids or salicylates.

patients with gastric ulcers. Delay in gastric emptying could complicate management.

pregnant women. It is not known whether Uribel causes fetal harm or can affect reproductive capacity. Only use if clearly needed.

nursing mothers. Only use if clearly needed as methenamine and hyoscyamine are excreted in breast milk.

patients who require prolonged use. There have been no studies to establish the safety of long-term use in humans or animal studies to evaluate carcinogenic potential.

infants and young children as they are especially susceptible to the toxic effects of belladonna alkaloids.

elderly patients as they may experience excitement, agitation, drowsiness or confusion.

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

Serious allergic reactions to this drug are rare. Patients should be instructed to seek immediate medical attention if they experience 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, however, patients should be advised.

DRUG INTERACTIONS: Because Uribel can alter gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications such as:

urinary alkalizers

thiazide diuretics (may reduce the effectiveness of methenamine)

antimuscarinics (may intensify antimuscarinic effects of hyoscyamine)

antacids/antidiarrheals (may reduce absorption of hyoscyamine; may reduce effectiveness of methenamine)
Doses of these medications should be spaced 1 hour apart from doses of Uribel

antimyasthenics (concurrent use may further reduce intestinal motility)

ketoconazole (patients should be advised to take Uribel at least 2 hours after ketoconazole)

monoamine oxidase (MAO) inhibitors (may intensify antimuscarinic side effects)

opioids (may result in increased risk of severe constipation)

sulfonamides (may increase the danger of crystalluria)

Methylene blue inhibits a range of CYP isozymes in vitro (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5). Interactions may be more pronounced with narrow therapeutic margin drugs that are metabolized by one of these enzymes (e.g., digoxin, warfarin, phenytoin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus. The clinical relevance of these in vitro interactions is unknown.