Pyridium® (phenazopyridine hydrochloride) is chemically designated 2,6-Pyridinediamine, 3-(phenylazo), monohydrochloride. It is a urinary tract analgesic agent for oral administration. Phenazopyridine Hydrochloride tablets contain 100 mg or 200 mg Phenazopyridine Hydrochloride. Also contains lactose hydrous, sodium starch glycolate, corn starch, hydrogenated vegetable oil, silicon dioxide, magnesium stearate, sugar, gelatin, FD&C red #40 aluminum lake, titanium dioxide, FD&C blue #2 aluminum lake, povidone, sodium benzoate, carnauba wax and white wax.

C₁₁H₁₁N₅ • HCl                                         M.W. 249.70

Pyridium® is indicated for the symptomatic relief of pain, burning, urgency, frequency and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine Hydrochloride for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine Hydrochloride should be discontinued when symptoms are controlled.

The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine Hydrochloride should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine Hydrochloride and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION Section)

100 mg tablets: Adult dosage is two tablets 3 times a day after meals. 200 mg tablets: Adult dosage is one tablet 3 times a day after meals.

When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine Hydrochloride should not exceed 2 days.

Pyridium® (Phenazopyridine Hydrochloride Tablets, USP) is supplied as follows:

100 mg - maroon, round tablets imprinted "WC 180"

Bottles of 100: N 0430-0180-24

200 mg - maroon, round tablets imprinted "WC 181"

Bottles of 100: N 0430-0181-24

Store at controlled room temperature 15° to 30° C (59° to 86° F)[See USP].

Manufactured by: Actavis Totowa LLC Totowa, NJ 07512 USA.
Marketed by: Warner Chilcott (US), Inc. Rockaway, NJ 07866. FDA rev date:

Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdose levels (see OVERDOSAGE section).

No information provided.

No information provided.

General: A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion and the need to discontinue therapy.

The decline in renal function associated with advanced age should be kept in mind.

Laboratory Test Interactions: Due to its properties as an azo dye, Phenazopyridine Hydrochloride may interfere with urinalysis based on spectrometry or color reactions.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term administration of Phenazopyridine Hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine Hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

Pregnancy Category B: Reproduction studies have been performed in rats at doses up to 50 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine Hydrochloride. There are however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: No information is available on the appearance of Phenazopyridine Hydrochloride or its metabolites in human milk.

Exceeding the recommended dose in patients with good renal function or administering the usual dose to patients with impaired renal function (common in elderly patients), may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg body weight intravenously, should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia may also occur, and "bite cells" (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur.

Phenazopyridine Hydrochloride should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine Hydrochloride is contraindicated in patients with renal insufficiency.

Phenazopyridine Hydrochloride is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. This action helps to relieve pain, burning, urgency and frequency. The precise mechanism of action is not known.

The pharmacokinetic properties of Phenazopyridine Hydrochloride have not been determined. Phenazopyridine is rapidly excreted by the kidneys, with as much as 65% of an oral dosage being excreted unchanged in urine.

Phenazopyridine Hydrochloride produces an orange to red color in the urine and may stain fabric. Staining of contact lenses has been reported.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PHENAZOPYRIDINE - ORAL

(feh-naze-oh-PEER-ih-deen)

COMMON BRAND NAME(S): Pyridium, Urogesic

USES: This medication is used to relieve symptoms caused by irritation of the urinary tract such as pain, burning, and the feeling of needing to urinate urgently or frequently. This drug does not treat the cause of the urinary irritation, but it can help relieve the symptoms while other treatments take effect. Phenazopyridine is a dye that works as a painkiller to soothe the lining of the urinary tract.

HOW TO USE: Take this medication by mouth, usually 3 times daily after meals or as directed by your doctor. If you are taking this medication along with antibiotics for symptoms related to a urinary tract infection, or are self-treating, do not take it for more than 2 days without talking to your doctor.

Dosage is based on your medical condition and response to therapy.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Headache, dizziness, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing skin/eyes, dark/bloody urine, change in the amount of urine, stomach/abdominal pain, vomiting, fever, chills, easy bruising/bleeding, unusual tiredness, shortness of breath, fast heartbeat, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking phenazopyridine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease, blood disorders (e.g., G6PD deficiency, hemolytic anemia).

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

Phenazopyridine can dye your urine and tears orange-red. This may stain clothing and contact lenses. Do not wear contact lenses while using this medication. Urine and tears will return to normal color after the medication is stopped.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for change in amount of urine or yellowing skin/eyes.

Tell your doctor if you are pregnant before using this medication.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Phenazopyridine can interfere with certain laboratory tests (including urine tests for kidney function, bilirubin, and sugar levels), possibly causing false test results. Home urine tests (including diabetic tests) may be affected. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include unusual tiredness, skin color changes, change in the amount of urine, shortness of breath, fast heartbeat, yellowing skin/eyes, easy bleeding/bruising, or seizures.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not take it later for another pain-related condition of the urinary tract unless told to do so by your doctor. A different medication may be necessary in those cases.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.