Uribel 118mg Capsules
It is used to ease pain from a bladder infection.It is used to treat muscle spasms of the urinary system.It is used to treat signs of urinary problems.
Drug Class
Urinary antiseptic/antispasmodic combination
Pharmacologic Class
Urinary anti-infective (Methenamine); Anticholinergic/Antispasmodic (Hyoscyamine); Urinary acidifier (Sodium Phosphate Monobasic); Analgesic/Antiseptic (Phenyl Salicylate); Antiseptic/Diagnostic dye (Methylene Blue)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Uribel is a combination medicine used to relieve discomfort, pain, urgency, and frequency associated with urinary tract infections or other irritations of the urinary tract. It contains ingredients that work as an antiseptic to fight bacteria, an acidifier to help the antiseptic work, and an antispasmodic to relax the bladder.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and swallow it with a full glass of water. It's also important to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
If you take other oral medications, this drug may interfere with their absorption. To avoid this, you may need to take your other medications at a different time. Consult with your doctor to determine the best schedule for your medications.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep the container tightly closed and out of reach of children and pets. Make sure to store all your medications in a secure location.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and swallow it with a full glass of water. It's also important to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
If you take other oral medications, this drug may interfere with their absorption. To avoid this, you may need to take your other medications at a different time. Consult with your doctor to determine the best schedule for your medications.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep the container tightly closed and out of reach of children and pets. Make sure to store all your medications in a secure location.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Drink plenty of fluids to help flush the urinary tract.
- Maintain good hygiene to prevent recurrent UTIs.
- Avoid alcohol and caffeine, which can irritate the bladder.
- Complete the full course of medication as prescribed, even if symptoms improve.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One capsule orally four times a day with water, after meals and at bedtime.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
urinarytractinfection:
One capsule four times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
Use with caution. Monitor for accumulation of methenamine or hyoscyamine.
Moderate:
Use with caution. Monitor for accumulation of methenamine or hyoscyamine. Dosage reduction may be necessary.
Severe:
Contraindicated due to risk of methenamine accumulation and potential for metabolic acidosis with sodium phosphate. Methylene blue is also renally excreted.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution. Hyoscyamine is metabolized by the liver.
Severe:
Use with caution. Consider dosage reduction for hyoscyamine component.
Pharmacology
Mechanism of Action
Uribel is a combination product. Methenamine is hydrolyzed in acidic urine to formaldehyde, which is bactericidal. Sodium Phosphate Monobasic acidifies the urine, which is necessary for methenamine's action. Phenyl Salicylate is a mild analgesic and antiseptic. Methylene Blue is a mild antiseptic and analgesic, and also contributes to urine acidification. Hyoscyamine is an anticholinergic/antispasmodic that relaxes smooth muscles of the urinary tract, reducing bladder spasms and associated pain.
Pharmacokinetics
Absorption:
Bioavailability:
Not available for combination. Methenamine is well absorbed orally. Hyoscyamine is readily absorbed.
Tmax:
Not available for combination. Methenamine: ~2 hours. Hyoscyamine: 30-60 minutes.
FoodEffect:
Administer after meals to minimize gastrointestinal upset.
Distribution:
Vd:
Not available for combination. Hyoscyamine: ~2-4 L/kg.
ProteinBinding:
Not available for combination. Hyoscyamine: ~50%.
CnssPenetration:
Limited (Hyoscyamine can cross BBB at higher doses).
Elimination:
HalfLife:
Not available for combination. Methenamine: ~3-6 hours. Hyoscyamine: ~3.5 hours.
Clearance:
Not available for combination.
ExcretionRoute:
Renal (Methenamine, Methylene Blue, Hyoscyamine and metabolites)
Unchanged:
Not available for combination. Methenamine: 10-20% unchanged. Hyoscyamine: 13-30% unchanged.
Pharmacodynamics
OnsetOfAction:
Within 30-60 minutes (Hyoscyamine for antispasmodic effect); Formaldehyde production from methenamine requires acidic urine and time.
PeakEffect:
Not available for combination.
DurationOfAction:
Approximately 4-6 hours (consistent with q.i.d. dosing).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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
A fast heartbeat
Blurred vision
Dizziness
Shortness of breath
Difficulty urinating
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
Upset stomach or vomiting
Drowsiness
Dry mouth
Flushing
* A change in the color of your urine or stool to blue or green (this is a normal and harmless effect)
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 attention 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
A fast heartbeat
Blurred vision
Dizziness
Shortness of breath
Difficulty urinating
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
Upset stomach or vomiting
Drowsiness
Dry mouth
Flushing
* A change in the color of your urine or stool to blue or green (this is a normal and harmless effect)
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dry mouth, blurred vision, or difficulty urinating (signs of too much anticholinergic effect).
- Severe constipation.
- Rash, itching, or swelling (signs of allergic reaction).
- Bluish discoloration of skin or lips, shortness of breath, unusual fatigue (signs of methemoglobinemia, rare but serious side effect of methylene blue).
- Worsening or new symptoms of urinary tract infection.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the symptoms you experienced.
Certain health conditions, such as:
+ Bowel blockage
+ Glaucoma
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Urinary retention (trouble passing urine)
+ Heart failure (weak heart) or other heart problems
* If you are taking specific medications, including:
+ Certain antidepressants like isocarboxazid, phenelzine, or tranylcypromine
+ Medications for Parkinson's disease, such as selegiline or rasagiline
Special Considerations for Children:
If your child is under 6 years of age, do not administer this medication. It is not approved for use in children younger than 6 years.
Additional Important Information:
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Your healthcare team will help determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the symptoms you experienced.
Certain health conditions, such as:
+ Bowel blockage
+ Glaucoma
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Urinary retention (trouble passing urine)
+ Heart failure (weak heart) or other heart problems
* If you are taking specific medications, including:
+ Certain antidepressants like isocarboxazid, phenelzine, or tranylcypromine
+ Medications for Parkinson's disease, such as selegiline or rasagiline
Special Considerations for Children:
If your child is under 6 years of age, do not administer this medication. It is not approved for use in children younger than 6 years.
Additional Important Information:
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Your healthcare team will help determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your chances of experiencing adverse effects.
Adhere to the prescribed treatment duration and do not take this medication for longer than specified by your doctor.
If you or someone else accidentally takes this medication, seek immediate medical attention.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.
When administering this medication to children, use it with caution, as some children may have a higher risk of experiencing side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your chances of experiencing adverse effects.
Adhere to the prescribed treatment duration and do not take this medication for longer than specified by your doctor.
If you or someone else accidentally takes this medication, seek immediate medical attention.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.
When administering this medication to children, use it with caution, as some children may have a higher risk of experiencing side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe anticholinergic effects (e.g., severe dry mouth, dilated pupils, blurred vision, rapid heart rate, fever, hallucinations, seizures, urinary retention, paralytic ileus).
- Methemoglobinemia (cyanosis, dyspnea, weakness, dizziness) from methylene blue.
- Salicylate toxicity (tinnitus, nausea, vomiting, hyperventilation, metabolic acidosis) from phenyl salicylate.
- Nausea, vomiting, diarrhea, abdominal pain.
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, potentially including activated charcoal, physostigmine for severe anticholinergic effects, or methylene blue (paradoxically) for methemoglobinemia if severe.
Drug Interactions
Contraindicated Interactions
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - reduce efficacy of methenamine.
- Potassium citrate, sodium citrate, citric acid (urinary alkalinizers) - reduce efficacy of methenamine.
- Sulfonamides (e.g., sulfamethoxazole/trimethoprim) - may form insoluble precipitates with formaldehyde from methenamine.
- Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs, TCAs, triptans) - increased risk of serotonin syndrome with methylene blue.
- Drugs that prolong QT interval (with hyoscyamine).
Major Interactions
- Anticholinergic drugs (e.g., tricyclic antidepressants, phenothiazines, antihistamines, disopyramide) - additive anticholinergic effects with hyoscyamine.
- Opioid analgesics - increased risk of severe constipation and paralytic ileus with hyoscyamine.
- Antacids - may decrease absorption of hyoscyamine.
- Drugs that affect gastric emptying (e.g., metoclopramide, domperidone) - altered absorption of other drugs due to hyoscyamine.
- Warfarin (with phenyl salicylate) - increased risk of bleeding.
Moderate Interactions
- Corticosteroids (with phenyl salicylate) - increased risk of GI ulceration.
- NSAIDs (with phenyl salicylate) - increased risk of GI ulceration and bleeding.
- Oral contraceptives (with phenyl salicylate) - may decrease salicylate levels.
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - may enhance methenamine efficacy (though Uribel already contains one).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Renal function (BUN, Creatinine)
Rationale: To assess ability to excrete components and avoid accumulation, especially methenamine and methylene blue.
Timing: Prior to initiation of therapy.
Hepatic function (ALT, AST, Bilirubin)
Rationale: To assess liver's ability to metabolize hyoscyamine.
Timing: Prior to initiation of therapy.
G6PD deficiency screen
Rationale: Methylene blue can cause hemolytic anemia in G6PD deficient patients.
Timing: Prior to initiation, especially in at-risk populations.
Routine Monitoring
Urinary symptoms (pain, frequency, urgency)
Frequency: Daily, as needed
Target: Resolution or improvement of symptoms
Action Threshold: Worsening or no improvement of symptoms after a few days may indicate treatment failure or alternative diagnosis.
Urine pH
Frequency: Periodically, if efficacy is questioned
Target: < 5.5
Action Threshold: If pH is consistently > 6, methenamine efficacy is reduced. Consider compliance or other medications.
Signs of anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention)
Frequency: Daily, as needed
Target: Absence or mild, tolerable symptoms
Action Threshold: Severe or intolerable symptoms may require dosage adjustment or discontinuation.
Symptom Monitoring
- Resolution of dysuria
- Decreased urinary frequency and urgency
- Absence of bladder spasms
- Monitoring for anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention)
- Monitoring for signs of allergic reaction (rash, itching, swelling)
- Monitoring for signs of methemoglobinemia (cyanosis, shortness of breath, fatigue) due to methylene blue, especially in overdose or G6PD deficiency.
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Hyoscyamine and Methenamine are Category C. Methylene blue has been associated with hemolytic anemia in G6PD deficient neonates.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm not ruled out. Avoid if possible.
Second Trimester:
Use with caution, monitor for fetal effects.
Third Trimester:
Use with caution. Methylene blue may cause hemolytic anemia in G6PD deficient neonates if used near term.
Lactation
L3 (Moderate risk). Hyoscyamine and methylene blue are excreted into breast milk. Methenamine is also excreted. Monitor infant for anticholinergic effects (e.g., sedation, dry mouth, constipation) or signs of methemoglobinemia (cyanosis) if G6PD deficient.
Infant Risk:
Moderate risk. Potential for anticholinergic effects, hemolytic anemia (if G6PD deficient), or gastrointestinal upset in infant.
Pediatric Use
Safety and efficacy not established in pediatric patients. Not recommended for use in children.
Geriatric Use
Use with caution due to increased sensitivity to anticholinergic effects (e.g., confusion, constipation, urinary retention) and potential for renal impairment. Start with lower doses and monitor closely.
Clinical Information
Clinical Pearls
- Uribel is a combination product, and its efficacy relies on maintaining an acidic urine pH for methenamine to be effective. Advise patients to avoid urinary alkalinizers.
- The blue color of the urine is a normal and expected side effect due to methylene blue.
- Patients should be advised about potential anticholinergic side effects (dry mouth, blurred vision, constipation) due to hyoscyamine.
- This medication is for symptomatic relief and urinary antisepsis; it is not a primary antibiotic for acute, severe UTIs. A culture and sensitivity should guide definitive antibiotic therapy.
- Caution should be exercised in patients with glaucoma (narrow-angle), myasthenia gravis, or obstructive uropathy due to the anticholinergic component.
Alternative Therapies
- Phenazopyridine (for symptomatic relief of dysuria)
- Single-agent anticholinergics (e.g., oxybutynin, tolterodine for bladder spasms)
- Antibiotics specific to the pathogen for UTI treatment (e.g., nitrofurantoin, trimethoprim/sulfamethoxazole, fluoroquinolones)
- Methenamine hippurate (single agent methenamine formulation)
Cost & Coverage
Average Cost:
$100 - $300+ per 100 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3, may require prior authorization due to combination nature or availability of single-ingredient generics.
General Drug Facts
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 your 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 taken, the amount, and the time it happened.