Uribel 81.6mg Tablets

Uribel is a combination product with multiple mechanisms of action:
- **Methenamine:** Hydrolyzes in acidic urine (pH < 5.5) to formaldehyde, which is a non-specific bactericidal agent.
- **Phenyl Salicylate:** Hydrolyzes in the gastrointestinal tract to salicylic acid (mild analgesic and anti-inflammatory) and phenol (mild antiseptic).
- **Methylene Blue:** Has mild antiseptic properties and acts as an analgesic for bladder irritation. It also acts as a dye.
- **Benzoic Acid:** Acts as a urinary acidifier, enhancing the conversion of methenamine to formaldehyde, and has mild antifungal/antiseptic properties.
- **Hyoscyamine:** An anticholinergic (antimuscarinic) agent that inhibits the action of acetylcholine at postganglionic parasympathetic receptor sites, leading to relaxation of smooth muscles in the urinary tract, reducing bladder spasms, urgency, and frequency.

Serious Side Effects: Seek Medical Attention Immediately

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
Difficulty urinating
Rapid heartbeat
Blurred vision
Dizziness or fainting

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

Upset stomach or vomiting
Dry mouth
Change in urine or stool color to blue or green (this is a normal and harmless effect)
Flushing
* Drowsiness

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have experienced.
Certain health conditions, such as:
+ Bowel blockage
+ Glaucoma
+ Myasthenia gravis
+ Slow movement of the gastrointestinal (GI) tract
+ Difficulty urinating
A history of heart failure (weak heart) or other heart problems
Current or recent use of medications for mental or mood disorders, such as depression. Some medications cannot be taken with this drug, so it is essential to discuss this with your doctor if you are unsure.

Special Considerations:

This medication is not suitable for children under 6 years of age. Do not administer it to a child younger than 6 years old.
This list is not exhaustive, and it is essential to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use.
* Always consult your doctor before starting, stopping, or changing the dose of any medication to avoid potential interactions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. You may be required to monitor the acid content (pH) of your urine using a dipstick test as part of your treatment.

If you are 65 years or older, it is crucial to use this medication with caution, as you may be more susceptible to experiencing side effects. Similarly, when using this medication in children, it is vital to exercise caution, as they may also be at a higher risk of side effects. Be sure to consult with your doctor to discuss the potential risks and benefits.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential to notify your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.

• Sulfonamides (with methenamine: antagonism, crystalluria)
• Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, some antacids) (with methenamine: reduce efficacy)
• Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs, TCAs, triptans, fentanyl, tramadol) (with methylene blue: risk of serotonin syndrome)
• Drugs that prolong QT interval (with hyoscyamine: theoretical risk)
• Potassium chloride (wax matrix formulations) (with anticholinergics: increased risk of GI lesions)

• Other anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, phenothiazines, quinidine, disopyramide, amantadine) (additive anticholinergic effects with hyoscyamine)
• Antacids (calcium carbonate, aluminum/magnesium hydroxide) (may decrease absorption of hyoscyamine if given concurrently; may alkalinize urine, reducing methenamine efficacy)
• Opioid analgesics (additive CNS depression and constipation with hyoscyamine)
• Digoxin (oral) (hyoscyamine may increase digoxin levels by delaying gastric emptying)
• Drugs metabolized by CYP2D6 (with hyoscyamine: potential for altered metabolism, though hyoscyamine is a weak inhibitor)
• Salicylates (other) (additive effects/toxicity with phenyl salicylate)
• Anticoagulants (e.g., warfarin) (phenyl salicylate may increase bleeding risk)
• NSAIDs (phenyl salicylate may increase GI side effects and bleeding risk)
• G6PD deficient patients (with methylene blue: risk of hemolytic anemia)

• Corticosteroids (with hyoscyamine: increased intraocular pressure)
• Ketoconazole, Itraconazole (hyoscyamine may decrease absorption due to increased gastric pH)
• Metoclopramide (antagonistic effects with hyoscyamine)
• Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) (enhance methenamine efficacy, but may increase risk of crystalluria with sulfonamides if co-administered)
• Alcohol (additive CNS depression with hyoscyamine)

• None specifically identified for this combination that are not covered by other categories.

• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Dizziness
• Tachycardia
• Confusion (especially in elderly)
• Nausea/vomiting
• Skin rash
• Blue/green discoloration of urine (expected)
• Blue discoloration of stool (expected)
• Signs of hemolytic anemia (fatigue, pallor, dark urine, jaundice) - rare but serious

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Hyoscyamine and Methenamine are Category C. Methylene blue is also Category C and should be avoided near term due to theoretical risk of hemolytic anemia in the neonate.

L3 (Moderate risk). Components are excreted into breast milk. Methylene blue can cause hemolytic anemia in G6PD deficient infants and may color breast milk. Hyoscyamine can reduce milk production and cause anticholinergic effects in the infant. Use with caution; monitor infant for adverse effects (e.g., drowsiness, dry mouth, constipation, feeding difficulties, cyanosis). Consider alternative if possible.

Safety and efficacy not established in pediatric patients. Generally not recommended for use in children.

Use with caution. Elderly patients are more susceptible to anticholinergic side effects (e.g., dry mouth, constipation, urinary retention, confusion, cognitive impairment, falls). Start with the lowest effective dose and monitor closely. Renal and hepatic function should be assessed.

• Uribel is a combination product designed to address both the antiseptic and antispasmodic aspects of urinary discomfort.
• The effectiveness of methenamine relies on acidic urine (pH < 5.5). Patients should be advised against consuming large amounts of urinary alkalinizers (e.g., citrus fruits, milk, antacids) while on this medication.
• Patients should be counseled that their urine (and sometimes stool) will turn blue or green due to methylene blue, which is a normal and harmless effect.
• Due to the hyoscyamine component, patients should be warned about potential anticholinergic side effects such as dry mouth, blurred vision, and constipation. These effects may be more pronounced in the elderly.
• Contraindicated in patients with severe renal or hepatic impairment, glaucoma, myasthenia gravis, or obstructive uropathy due to the anticholinergic and excretion properties of its components.
• Methylene blue carries a risk of serotonin syndrome when combined with serotonergic drugs and hemolytic anemia in G6PD deficient individuals. Screen for G6PD deficiency if clinically indicated.

• Single-agent urinary antiseptics (e.g., methenamine hippurate, nitrofurantoin)
• Anticholinergics/Antispasmodics (e.g., oxybutynin, tolterodine, solifenacin for overactive bladder)
• Urinary analgesics (e.g., phenazopyridine)
• Antibiotics (for underlying urinary tract infections)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.