Phenazopyridine

Pyridium® (Phenazopyridine Hydrochloride) is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula:

Pyridium (Phenazopyridine HCl Tablets, USP) contains the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and pregelatinized starch.

Phenazopyridine is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).

Phenazopyridine is used to treat pain, burning, increased urination, and increased urge to urinate. These symptoms are usually caused by infection, injury, surgery, catheter, or other conditions that irritate the lower urinary tract.

Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection.

Phenazopyridine may also be used for other purposes not listed in this medication guide.

Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease.

Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection.

To avoid stomach upset, take phenazopyridine with food.

Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.

Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.

Stop taking this medication and call your doctor at once if you have pale skin, fever, confusion, yellowing of your skin or eyes, increased thirst, swelling, or if you urinate less than usual or not at all.

Your pharmacist can provide more information about phenazopyridine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Phenazopyridine is part of the drug class:

• Other urologicals

Serious side effects have been reported with phenazopyridine.  See the phenazopyridine precautions section.  Common side effects of phenazopyridine include the following:

• Red-orange or brown colored urine (this is not harmful, but care should be taken to avoid staining clothing or other items)
• Headache
• Itching
• Stomach upset (taking with or after meals may reduce stomach upset)

This is not a complete list of phenazopyridine side effects.  Ask your doctor or pharmacist for more information.  Tell your doctor if you have any side effect that bothers you or that does not go away.  Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are breastfeeding or planning to breastfeed.  It is not known if phenazopyridine crosses into human milk.  Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication.  Your doctor and you will decide if the benefits outweigh the risk of using phenazopyridine.

• Store phenazopyridine at room temperature (between 59 to 86 degrees F). 
• Keep this and all medicines out of the reach of children.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take phenazopyridine after meals.

Drink plenty of liquids while you are taking phenazopyridine.

Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not harmful. Darkened urine may also cause stains to your underwear that may be permanent.

Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.

This medication can cause unusual results with urine tests. Tell any doctor who treats you that you are using phenazopyridine.

Store at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

phenazopyridine 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 phenazopyridine 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 phenazopyridine. 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 phenazopyridine, 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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about phenazopyridine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about phenazopyridine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using phenazopyridine.

Review Date: October 4, 2017