Prodium (Oral)

Phenazopyridine helps relieve pain, burning, and discomfort caused by infection or irritation in the urinary tract. It is not an antibiotic and will not treat the infection itself.

In the U.S., you can only get phenazopyridine with a doctor's prescription.

Check with your doctor if you notice symptoms like bloody urine, painful or difficult urination, a frequent urge to urinate, or a sudden decrease in urine amount while you are taking this medicine.

Phenazopyridine will make your urine turn reddish orange. This is normal when you are using it. This effect is harmless and will go away after you stop taking the medicine. Be aware that it may also stain clothing.

For patients who wear soft contact lenses:

• It is best not to wear soft contact lenses while using this medicine. Phenazopyridine may discolor or stain contact lenses, and the stain may not be removable.

For diabetic patients:

• This medicine may cause false results in urine sugar tests and urine ketone tests. If you have questions about this, consult your health care professional, especially if your diabetes is not well controlled.

Before you undergo any medical tests, inform the person conducting the tests that you are taking this medicine. The results of some tests may be influenced by this medicine.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important things to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you might have, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing how phenazopyridine works in children versus adults, but it is not expected to cause different side effects or issues in children compared to adults.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be clear if they work the same way in older adults as they do in younger adults. There is no specific information comparing how phenazopyridine works in elderly patients versus other age groups, but it is not expected to cause different side effects or issues in older individuals than in younger adults.

Breast Feeding

There are not enough studies to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In such cases, your doctor might adjust the dose or take other precautions. Let your healthcare professional know if you are taking any other prescription or over-the-counter (OTC) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used close to mealtimes or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to inform your doctor about any other medical issues you have, especially:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Hepatitis or
• Kidney disease—This may increase the risk of side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Blue or blue-purple color of skin
• fever and confusion
• shortness of breath, tightness in chest, wheezing, or troubled breathing
• skin rash
• sudden decrease in the amount of urine
• swelling of face, fingers, feet, and/or lower legs
• unusual tiredness or weakness
• weight gain
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

• Dizziness
• headache
• indigestion
• itching of the skin
• stomach cramps or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Azo-Gesic
• Azo-Septic
• Azo-Standard
• Baridium
• Phenazo 95
• Prodium
• Pyridiate
• Pyridium
• RE-Azo
• Urinary Pain Relief
• Uristat
• UTI Relief

Available Dosage Forms:

• Tablet

Therapeutic Class: Analgesic

This medicine is best taken with food or after eating a meal or a snack to lessen stomach upset.

Do not use any leftover medicine for future urinary tract problems without first checking with your doctor. An infection may require additional medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For relieving pain, burning, and discomfort in the urinary tract: Adults and teenagers—200 milligrams (mg) three times a day. Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 4 mg per kilogram (kg) (about 1.8 mg per pound) of body weight three times a day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

• Why do you not take phenazopyridine for more than two days?