Uro-Pain 95mg Tablets

Phenazopyridine HCl is an azo dye which exerts a local anesthetic or analgesic action on the mucosa of the urinary tract. Its exact mechanism is not fully understood, but it is believed to act directly on the urinary tract mucosa to relieve pain, burning, urgency, and frequency.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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
Signs of methemoglobinemia, a rare but potentially deadly condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Signs of a meningococcal infection, such as:
+ Severe headache with or without nausea, vomiting, fever, or stiff neck or back
+ Confusion
+ High fever
+ Fever with a rash
+ Sensitivity to light
+ Severe muscle aches or pain with or without flu-like symptoms
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Feeling extremely tired or weak
Difficulty urinating or changes in urine output
Changes in vision

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you're bothered by any of the following:

Headache
Diarrhea
Upset stomach or vomiting

This is not an exhaustive list of possible 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.

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

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Kidney problems
+ Kidney infection during pregnancy
+ Liver problems

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure your safety, please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

This drug is not a substitute for an antibiotic and will not cure a bladder infection. To avoid staining, take precautions to protect your clothing and fabrics. Additionally, this medication may stain contact lenses. You may notice that your urine or stools turn orange or red, but this is a normal and harmless side effect.

When taking this medication, be aware that breaking or holding the tablet in your mouth before swallowing can cause tooth discoloration. If you have concerns, discuss them with your doctor.

If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at risk of developing anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent.

Do not exceed the prescribed duration of treatment. This medication may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this drug.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

• Interference with laboratory tests (e.g., urine bilirubin, urobilinogen, ketones, protein, glucose, porphyrins, albumin, phenolsulfonphthalein (PSP) excretion tests, urine specific gravity, urine colorimetric tests).
• Prilocaine (increased risk of methemoglobinemia)

• Relief of urinary pain, burning, urgency, and frequency
• Urine discoloration (orange to reddish-brown)
• Signs of allergic reaction (rash, itching, swelling)
• Signs of methemoglobinemia (bluish skin/nails, shortness of breath, dizziness, fatigue)
• Signs of hemolytic anemia (unusual tiredness, pale skin, yellowing of skin/eyes, dark urine)
• Gastrointestinal upset (nausea, vomiting, diarrhea)

Category B. While animal studies have not shown harm, there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and potential benefits outweigh risks.

Excreted in breast milk. Use with caution. The American Academy of Pediatrics considers it compatible with breastfeeding, but monitor infant for adverse effects (e.g., jaundice, methemoglobinemia).

Generally not recommended for children under 12 years of age due to lack of established safety and efficacy, and increased risk of methemoglobinemia in infants and young children.

Use with caution due to increased likelihood of impaired renal function, which can lead to accumulation and increased risk of adverse effects like methemoglobinemia and hemolytic anemia. Lower doses or avoidance may be necessary.

• Inform patients that phenazopyridine will turn urine orange or reddish-brown, and may stain clothing or contact lenses.
• Emphasize that this drug is for symptomatic relief only and does not treat the underlying infection; it should be used in conjunction with an appropriate antibiotic for UTIs.
• Advise patients to take the medication with or after food to minimize gastrointestinal upset.
• Instruct patients to discontinue the drug and seek medical attention immediately if they experience bluish discoloration of skin/nails, yellowing of skin/eyes, or unusual fatigue.
• Limit use to a maximum of 2 days when co-administered with an antibiotic for UTI, as prolonged use increases the risk of adverse effects without additional benefit.

• Non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief (e.g., ibuprofen, naproxen)
• Acetaminophen for pain relief
• Antispasmodics (e.g., oxybutynin, tolterodine) for bladder spasms (different mechanism)
• Antibiotics (for the underlying infection, not for symptomatic relief)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It's also important to note that some medications may come with additional patient information leaflets, so be sure to check with your pharmacist if you have any questions. If you are unsure about any aspect of your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider for personalized guidance. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.