Uribel - Drug Monograph

Introduction

Uribel is a combination urinary tract analgesic and antispasmodic medication indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from urinary tract irritation. It contains multiple active ingredients that work synergistically to provide comprehensive relief from lower urinary tract symptoms.

Mechanism of Action

Uribel combines several mechanisms of action through its active components:

• Methenamine: Converted to formaldehyde in acidic urine, providing antibacterial properties
• Sodium phosphate monobasic: Acidifies urine to enhance methenamine's conversion to formaldehyde
• Methylene blue: Provides mild antiseptic properties and urinary tract analgesia
• Phenyl salicylate: Offers analgesic and anti-inflammatory effects
• Hyoscyamine: An anticholinergic that reduces smooth muscle spasm in the urinary tract

Indications

Uribel is indicated for:

• Symptomatic relief of pain, burning, urgency, frequency, and other discomforts related to urinary tract irritation
• Adjunctive therapy in urinary tract infections
• Relief of lower urinary tract symptoms associated with procedures such as cystoscopy or catheterization

Dosage and Administration

• Take with or after meals to minimize gastrointestinal upset
• Tablets should be swallowed whole with adequate fluid
• Maintain adequate hydration during therapy
• Duration typically limited to 2 days when used for analgesic effects

• Renal impairment: Use with caution; contraindicated in severe renal impairment
• Hepatic impairment: No specific dosage adjustment recommended
• Geriatric patients: Monitor for anticholinergic effects
• Pediatric patients: Safety and effectiveness not established

Pharmacokinetics

• Methenamine metabolized to formaldehyde in acidic urine
• Hyoscyamine metabolized in liver
• Methylene blue partially reduced to leukomethylene blue

Contraindications

• Hypersensitivity to any component of the formulation
• Glaucoma (particularly narrow-angle)
• Obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy)
• Severe renal impairment (CrCl < 10 mL/min)
• Gastrointestinal obstruction
• Myasthenia gravis
• Concomitant use of monoamine oxidase inhibitors

Warnings and Precautions

• Urine discoloration: Methylene blue may cause blue-green urine discoloration
• Anticholinergic effects: May cause dry mouth, blurred vision, tachycardia
• Renal function: Use with caution in patients with mild to moderate renal impairment
• Phenyl salicylate: Contains salicylate component; use caution in salicylate-sensitive patients
• Pregnancy: Category C - Use only if potential benefit justifies potential risk
• Lactation: Components may be excreted in breast milk

Drug Interactions

• Monoamine oxidase inhibitors: Contraindicated due to risk of hypertensive crisis
• Anticholinergic agents: Additive effects with other anticholinergics
• Urinary alkalinizers: May reduce effectiveness by increasing urine pH
• Salicylates: Additive effects with other salicylate-containing products
• Drugs affected by urine acidification: May affect excretion of other medications

Adverse Effects

• Dry mouth
• Nausea
• Abdominal discomfort
• Headache
• Dizziness
• Blurred vision

• Acute urinary retention
• Tachycardia
• Allergic reactions
• Worsening of narrow-angle glaucoma
• Gastrointestinal obstruction

Monitoring Parameters

• Urinary symptoms and pain relief
• Renal function (in patients with pre-existing renal impairment)
• Anticholinergic side effects (especially in elderly patients)
• Urine pH (if optimal acidification is desired)
• Signs of urinary retention
• Vision changes (particularly in patients with glaucoma risk factors)

Patient Education

• Take as directed, typically with meals
• Expect blue-green discoloration of urine - this is normal and harmless
• Maintain adequate fluid intake unless contraindicated
• Report any vision changes, difficulty urinating, or persistent gastrointestinal symptoms
• Avoid activities requiring mental alertness until effects are known
• Inform all healthcare providers about Uribel use, especially before surgical procedures
• Do not use for more than 2 days without medical supervision
• Store at room temperature away from moisture

References

1. Uribel Prescribing Information. Mission Pharmacal Company. 2. Hooton TM. Uncomplicated urinary tract infection. N Engl J Med. 2012;366(11):1028-1037. 3. Gupta K, Hooton TM, Naber KG, et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52(5):e103-e120. 4. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-178. 5. Micromedex Solutions. Uribel drug monograph. Truven Health Analytics.