Uro-Pain Max Strength 99.5mg Tabs
It is used to ease pain from a bladder infection.It is used to treat signs of urinary problems.
Drug Class
Urinary tract analgesic
Pharmacologic Class
Azo dye
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Phenazopyridine is a medicine that helps relieve pain, burning, urgency, and frequency caused by urinary tract infections or other irritations of the urinary tract. It works by numbing the lining of your urinary tract. It does NOT treat the infection itself, only the symptoms.
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 the medication by mouth, either with or after food, and swallow it with a full glass of water.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication by mouth, either with or after food, and swallow it with a full glass of water.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Drink plenty of fluids to help flush out the urinary tract.
- Take the medication after meals to reduce stomach upset.
- Be aware that this medication will turn your urine orange or reddish-brown. This is a normal and expected effect.
- This medication can stain clothing, contact lenses, and other surfaces. Be careful when handling it.
- Do not use for more than 2 days unless directed by your doctor, as it can mask symptoms of an untreated infection.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
200 mg orally three times daily after meals
Dose Range:
100 - 200 mg
Condition-Specific Dosing:
urinarytractpain:
100 mg or 200 mg orally three times daily after meals for up to 2 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
12 mg/kg/day orally in 3 divided doses for up to 2 days (not recommended for children under 12 years old unless specifically directed by a physician)
Adolescent:
100 mg or 200 mg orally three times daily after meals for up to 2 days (for ages 12 and older)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for accumulation
Moderate:
Contraindicated
Severe:
Contraindicated
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
Use with caution; monitor for adverse effects
Severe:
Use with caution; consider lower dose or avoidance due to potential for accumulation
Pharmacology
Mechanism of Action
Phenazopyridine is an azo dye that 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 lining to relieve pain, burning, urgency, and frequency.
Pharmacokinetics
Absorption:
Bioavailability:
Not well quantified, but readily absorbed
Tmax:
Approximately 2-3 hours
FoodEffect:
Administering after meals may reduce gastrointestinal upset.
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely established, but short (likely 2-4 hours)
Clearance:
Not available
ExcretionRoute:
Primarily renal (65% unchanged)
Unchanged:
Approximately 65%
Pharmacodynamics
OnsetOfAction:
Rapid, within 1 hour
PeakEffect:
Approximately 2-3 hours
DurationOfAction:
Approximately 6-8 hours
Safety & Warnings
Side Effects
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
+ Yellowing of the 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 discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Diarrhea
Upset stomach
* Vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
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
+ Yellowing of the 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 discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Diarrhea
Upset stomach
* Vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:
- Yellowing of the skin or eyes (jaundice)
- Blue or purple discoloration of the skin or nails (methemoglobinemia)
- Unusual tiredness or weakness
- Shortness of breath
- Fever, chills, or sore throat (signs of infection or blood dyscrasias)
- Rash, itching, or swelling (especially of the face/tongue/throat)
- Severe dizziness or trouble breathing (signs of allergic reaction)
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:
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 with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
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 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 with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
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.
Precautions & Cautions
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, as this medication can cause discoloration. Additionally, it may stain contact lenses. You may notice that your urine or stools turn orange or red in color while taking this medication, 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, consult your doctor.
If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at risk of developing anemia. This enzyme deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent.
Do not exceed the prescribed duration of treatment with this medication. It is also important to note that this drug may interfere with certain laboratory tests, so be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of action for you and your baby.
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, as this medication can cause discoloration. Additionally, it may stain contact lenses. You may notice that your urine or stools turn orange or red in color while taking this medication, 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, consult your doctor.
If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at risk of developing anemia. This enzyme deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent.
Do not exceed the prescribed duration of treatment with this medication. It is also important to note that this drug may interfere with certain laboratory tests, so be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of action for you and your baby.
Overdose Information
Overdose Symptoms:
- Methemoglobinemia (bluish discoloration of skin/lips/nails, shortness of breath, fatigue)
- Hemolytic anemia (fatigue, pale skin, dark urine, jaundice)
- Renal dysfunction
- Hepatic dysfunction
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment may involve methylene blue for methemoglobinemia, supportive care, and discontinuation of the drug.
Drug Interactions
Moderate Interactions
- Diagnostic tests (urine color interference, e.g., bilirubin, glucose, ketones, protein, urobilinogen, porphyrins, phenolsulfonphthalein (PSP) excretion tests, renal function tests)
Monitoring
Baseline Monitoring
Renal function (e.g., serum creatinine, BUN)
Rationale: Phenazopyridine is primarily renally excreted and contraindicated in severe renal impairment. Baseline assessment helps determine appropriate dosing and identify contraindications.
Timing: Prior to initiation, especially in elderly or those with suspected renal issues.
Routine Monitoring
Symptom relief (pain, burning, urgency, frequency)
Frequency: Daily
Target: Significant reduction or resolution of symptoms
Action Threshold: If symptoms persist or worsen after 2 days, discontinue and re-evaluate underlying cause.
Urine color
Frequency: Daily
Target: Orange to reddish-brown discoloration (expected effect)
Action Threshold: Unexpected color changes (e.g., blue/green, dark brown/black) or absence of expected discoloration may indicate issues or non-compliance.
Symptom Monitoring
- Skin discoloration (yellowish tinge, indicating accumulation)
- Sore throat
- Fever
- Unusual bleeding or bruising
- Fatigue or weakness (signs of methemoglobinemia or hemolytic anemia, rare but serious side effects)
Special Patient Groups
Pregnancy
Phenazopyridine is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk based on animal data, but human data are limited.
Second Trimester:
Generally considered low risk.
Third Trimester:
Generally considered low risk, but caution advised due to potential for hemolytic anemia in G6PD deficient individuals.
Lactation
Phenazopyridine is rated L3 (Moderately Safe) by LactMed. It is excreted into breast milk in small amounts. While adverse effects in breastfed infants are not commonly reported, theoretical risks include methemoglobinemia or hemolytic anemia, especially in infants with G6PD deficiency. Use with caution, monitor infant for jaundice or unusual lethargy.
Infant Risk:
Low to moderate; potential for hemolytic anemia or methemoglobinemia in G6PD deficient infants.
Pediatric Use
Not recommended for children under 12 years of age unless specifically directed by a physician. Safety and efficacy have not been fully established in younger pediatric populations. If used, dosing should be carefully calculated based on weight, and duration limited to 2 days.
Geriatric Use
Use with caution in elderly patients due to a higher likelihood of decreased renal function. Renal impairment can lead to accumulation and increased risk of adverse effects, including methemoglobinemia and hemolytic anemia. Dosage adjustment or avoidance may be necessary based on creatinine clearance.
Clinical Information
Clinical Pearls
- Phenazopyridine is an analgesic, not an antibiotic. It treats symptoms, not the underlying infection. It should always be used in conjunction with appropriate antimicrobial therapy for UTIs, or for symptomatic relief of non-infectious urinary irritation.
- Advise patients about the expected orange/red discoloration of urine, and warn them about potential staining of clothing and contact lenses.
- Limit use to a maximum of 2 days when used with an antibacterial agent for UTI, as prolonged use can mask symptoms of an untreated infection and increase the risk of adverse effects.
- Contraindicated in patients with severe renal insufficiency (CrCl < 50 mL/min) due to risk of accumulation and systemic toxicity (e.g., methemoglobinemia, hemolytic anemia).
- Rare but serious side effects include methemoglobinemia, hemolytic anemia, and sulfhemoglobinemia, especially with overdose or in patients with G6PD deficiency or renal impairment. Advise patients to report unusual fatigue, shortness of breath, or bluish discoloration of skin/lips.
Alternative Therapies
- Non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief (e.g., ibuprofen, naproxen)
- Acetaminophen for pain relief
- Topical anesthetics (for external urethral pain)
- Heat therapy (e.g., heating pad over the lower abdomen)
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (generic 200mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.