TM Owner Amneal Pharmaceuticals (Amneal Specialty, a division of Amneal Pharmaceuticals LLC)
Pyridium 200mg Tablet
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Indications & Clinical Uses
- Pyridium 200 mg tablets contain phenazopyridine hydrochloride, a urinary tract analgesic (azo dye), not an antibiotic.
- It is indicated for the symptomatic relief of pain, burning, urgency and frequency caused by irritation of the lower urinary tract, such as that due to infection, trauma, surgery, endoscopic procedures or catheter placement.
- Pyridium only relieves symptoms; it does not treat the underlying infection, so when used alongside an antibacterial for a urinary tract infection, treatment should be limited to 2 days, since further treatment does not provide additional benefit once an antibacterial has taken effect.
- It is approved for use in adults; safety and effectiveness in children have not been established for this tablet strength.
- Pyridium is marketed in the United States; outside the US, phenazopyridine is sold under various brand and generic names for the same short-term symptomatic use.
Side Effects
- Side effects of Pyridium are generally mild and include headache, dizziness, stomach upset, and a harmless reddish-orange discoloration of urine and other body fluids, which can stain fabric and soft contact lenses.
- Skin rash or itching can occur and should be reported to a healthcare provider, since they may signal an allergic reaction requiring the medicine to be stopped.
- There is no boxed warning on the current label.
- A yellowish tinge of the skin or the whites of the eyes may indicate that phenazopyridine is accumulating because the kidneys are not clearing it properly; this is a sign to stop the medicine and contact a healthcare provider promptly, as it can point to worsening kidney function or, rarely, haemolytic anaemia.
- Seek urgent medical attention for shortness of breath, unusual paleness, or a bluish tinge to the skin or lips, which can indicate a rare but serious blood problem.
Precautions & Warnings
- Pyridium should not be used by anyone with a known hypersensitivity to phenazopyridine, and it is contraindicated in people with significant renal insufficiency because the drug accumulates when the kidneys cannot clear it, increasing the risk of toxicity.
- Older adults and anyone with declining kidney function need closer monitoring during use.
- Because phenazopyridine only masks symptoms, it should be used for the shortest time needed, and persistent or worsening urinary symptoms, fever, or back pain should be reported promptly so the underlying cause can be properly investigated and treated.
- The orange-red colour of urine can interfere with urinalysis tests that rely on colour reactions or spectrometry, so tell laboratory staff that you are taking Pyridium before any urine test.
- Store tablets at 20°C to 25°C, with excursions permitted between 15°C and 30°C, in a tightly closed, child-resistant container.
Avoid Interactions
- Phenazopyridine is generally compatible with antibacterial therapy prescribed for a urinary tract infection and is often used alongside it for the first 2 days of treatment.
- Because it works only as a symptom reliever and not an antibiotic, do not rely on Pyridium alone to treat an infection, and do not exceed the recommended duration when taking it with an antibacterial.
- Tell your healthcare provider about all other medicines you take, particularly anything else that affects the kidneys, since reduced kidney clearance can raise phenazopyridine levels and the risk of side effects.
- Inform laboratory staff that you are taking Pyridium before giving a urine sample, as the dye can distort colour-based urine tests and blood glucose or ketone strip readings.
- There is no specific food interaction, but phenazopyridine should be taken with food or milk if it upsets your stomach.
References
Frequently Asked Questions
Pyridium (phenazopyridine) relieves the pain, burning, urgency and frequent urination caused by irritation of the urinary tract, such as from an infection or catheter. It is a symptom reliever, not an antibiotic, so it does not treat the infection itself.
Pyridium tablets are taken by mouth, usually three times a day after meals with a full glass of water. When used with an antibiotic for a urinary infection, Pyridium is normally limited to the first 2 days of treatment, since it only masks symptoms.
Pyridium commonly turns urine and other body fluids reddish-orange, which can stain clothing and contact lenses. It can also cause headache, dizziness and stomach upset. Stop it and see a healthcare provider if your skin or eyes turn yellow, or if you develop a rash.
Avoid relying on Pyridium alone for a urinary infection; it treats symptoms, not the cause. Tell laboratory staff you are taking it before any urine test, since the dye interferes with colour-based results. People with significant kidney problems should not take it.
The orange-red urine colour is a normal, expected effect of Pyridium and is not a reason to stop. Only stop and contact a healthcare provider if your skin or the whites of your eyes turn yellow, which can signal drug build-up from reduced kidney clearance.
No. Pyridium is meant for short-term symptom relief, typically no more than 2 days when combined with an antibiotic, and it is approved for use in adults; safety in children has not been established for this tablet. Ongoing urinary symptoms need medical review.
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