TM Owner Mission Pharmacal Company (mfd. for Star Pharmaceuticals, LLC)
Uribel Methenamine 118 mg / sodium phosphate monobasic 40.8 mg / phenyl salicylate 36 mg / methylene blue 10 mg / hyoscyamine sulfate 0.12 mg Capsule
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Indications & Clinical Uses
- Uribel capsules (combination of five active ingredients) are a US unapproved urinary antiseptic, antispasmodic and analgesic combination product.
- Each capsule contains methenamine 118 mg, sodium phosphate monobasic 40.8 mg, phenyl salicylate 36 mg, methylene blue 10 mg and hyoscyamine sulfate 0.12 mg.
- It is used for the treatment of symptoms of irritative voiding, and for the relief of local symptoms such as inflammation, hypermotility and pain that accompany lower urinary tract infections or follow diagnostic urinary tract procedures.
- The usual adult dose is one capsule four times a day followed by plenty of fluids; it is not recommended under 6 years of age.
- The Uribel label is distributed by Mission Pharmacal Company and manufactured for Star Pharmaceuticals, LLC; a DailyMed listing dated November 2023 is used here.
Side Effects
- Reported effects of this combination include rapid pulse, flushing, blurred vision, dizziness, drowsiness, shortness of breath, difficulty passing urine, dry mouth, nausea and vomiting.
- Methylene blue commonly turns urine, and sometimes stools, blue or blue-green, which is harmless.
- The label warns that if rapid pulse, dizziness or blurred vision occurs, you should stop using it immediately and contact your healthcare provider.
- Overdose may cause severe antimuscarinic effects and needs emergency treatment; in the US call poison control on 1-800-222-1222.
- The label has no boxed warning.
- Take each dose with plenty of fluid.
Precautions & Warnings
- Do not exceed the recommended dose.
- The label advises careful weighing of benefit and risk, or avoiding the product, in people with cardiac disease (arrhythmias, heart failure, coronary disease, mitral stenosis), gastrointestinal obstruction, glaucoma, myasthenia gravis, or where acute urinary retention could be caused, such as bladder neck obstruction from an enlarged prostate.
- Do not use if you are allergic to any ingredient; cross-sensitivity to belladonna alkaloids or salicylates is possible.
- Pregnancy Category C; ingredients pass into breast milk.
- Use caution in older adults, and infants are especially sensitive to belladonna-type toxicity.
- No long-term safety studies exist.
- This product is an unapproved drug in the US, meaning FDA has not evaluated its safety or effectiveness.
- Keep out of reach of children.
Avoid Interactions
- Medicines that can reduce effectiveness include urinary alkalinisers (such as sodium bicarbonate or citrates), which make methenamine less active, and antacids or antidiarrhoeals, which can reduce absorption.
- Ketoconazole absorption may be impaired.
- Medicines that can add to side effects include other antimuscarinics and thiazide diuretics (as listed on the label), MAO inhibitors (which intensify antimuscarinic effects) and opioids (greater risk of constipation).
- Sulfonamides taken with methenamine can increase the risk of crystals in the urine (crystalluria).
- Tell your healthcare provider about all prescription medicines, over-the-counter medicines and supplements you use.
References
Frequently Asked Questions
Uribel capsules combine methenamine, phenyl salicylate, methylene blue, hyoscyamine sulfate and sodium phosphate to relieve painful, urgent urination and bladder spasm with lower urinary tract infections or after urinary procedures. It is an unapproved drug in the US It relieves symptoms only.
Adults take one Uribel capsule four times a day, followed by plenty of fluids. The label does not recommend it for children under 6. Do not exceed the recommended dose, and follow your healthcare provider's instructions on how long to use it.
Uribel can cause rapid pulse, flushing, blurred vision, dizziness, drowsiness, dry mouth, nausea and difficulty passing urine. Methylene blue often turns urine blue or blue-green, which is harmless. Stop taking it and contact your provider if you get a rapid pulse, dizziness or blurred vision.
Avoid taking Uribel with urinary alkalinisers such as sodium bicarbonate, which weaken methenamine, or with sulfonamide antibiotics, which raise the risk of urine crystals. Tell your provider about antacids, ketoconazole, MAO inhibitors, opioids, other antimuscarinics and thiazide diuretics before using it.
Yes. Uribel contains methylene blue, so your urine, and sometimes your stools, may turn blue or blue-green while you take it. The label describes this as harmless. Tell your healthcare provider if you also notice pain, fever or blood in your urine, because the capsules only ease symptoms.
Uribel needs special caution or avoidance in people with heart rhythm problems or heart failure, gastrointestinal obstruction, glaucoma, myasthenia gravis, or difficulty emptying the bladder, and in those allergic to any ingredient. Stop it at once if you develop a rapid pulse, dizziness or blurred vision.
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