Pyridium (Phenazopyridine)
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Pyridium (Phenazopyridine)

Pyridium®
(phenazopyridine HCl) Tablets, USP

DRUG DESCRIPTION

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.

Pyridium® (Phenazopyridine Hydrochloride) structural formula illustration

C11H11N5 • HCl                                         M.W. 249.70

What are the possible side effects of phenazopyridine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using phenazopyridine and call your doctor at once if you have any of these serious side effects:

  • pale skin, fever, confusion or weakness;
  • jaundice (yellowing of your skin or eyes);
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath; or
  • blue...

Read All Potential Side Effects and See Pictures of Pyridium »

What are the precautions when taking phenazopyridine (Pyridium)?

Before taking phenazopyridine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic...

Read All Potential Precautions of Pyridium »

Last reviewed on RxList: 8/22/2007
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Pyridium® (phenazopyridine) 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)

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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:

Last reviewed on RxList: 8/22/2007
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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).

Read the Pyridium (phenazopyridine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 8/22/2007
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

PRECAUTIONS

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.

Last reviewed on RxList: 8/22/2007
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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.

CONTRAINDICATIONS

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.

Last reviewed on RxList: 8/22/2007
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

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.

Last reviewed on RxList: 8/22/2007
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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

Last reviewed on RxList: 8/22/2007
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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

Last reviewed on RxList: 8/22/2007
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Pyridium Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PHENAZOPYRIDINE - ORAL

(fen-ay-zoe-PIR-i-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.

Disclaimer

Pyridium Consumer (continued)

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 (especially of the face/tongue/throat), 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.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Pyridium (phenazopyridine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking phenazopyridine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. 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.

Disclaimer

Pyridium Consumer (continued)

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 May 2010. Copyright(c) 2010 First Databank, Inc.

Pyridium Patient Information Including Side Effects

Brand Names: Azo-Gesic, Azo-Standard, Baridium, Phenazo, Prodium, Pyridiate, Pyridium, Re-Azo, Uricalm, Uristat

Generic Name: phenazopyridine (Pronunciation: fen AY zoe PIR i deen)

What is phenazopyridine (Pyridium)?

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.

Phenazopyridine 100 mg-GG

round, maroon, imprinted with A 003

Phenazopyridine 200 mg-GG

round, maroon, imprinted with A 004

Phenazopyridine 200 mg-QUA

round, red, imprinted with 4972, V

What are the possible side effects of phenazopyridine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using phenazopyridine and call your doctor at once if you have any of these serious side effects:

  • pale skin, fever, confusion or weakness;
  • jaundice (yellowing of your skin or eyes);
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath; or
  • blue or purple coloring in your skin.

Less serious side effects may include:

  • headache;
  • dizziness;
  • stomach pain, upset stomach; or
  • skin itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Pyridium (phenazopyridine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about phenazopyridine?

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.

Side Effects Centers

Pyridium Patient Information including How Should I Take

What should I discuss with my health care provider before taking phenazopyridine?

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

Before using phenazopyridine, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • diabetes; or
  • a condition called G6PD (glucose-6-phosphate dehydrogenase) deficiency.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take phenazopyridine.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether phenazopyridine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take phenazopyridine?

Take phenazopyridine exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

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.

This medication can cause you to have false results with glucose or ketone urine tests. Tell any doctor who treats you that you are using phenazopyridine.

Store this medication at room temperature away from moisture and heat.

Side Effects Centers

Pyridium Patient Information including If I Miss a Dose

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include yellowed skin, fever, confusion, weakness, urinating less than usual, nausea, vomiting, swelling, numbness, or blue-colored skin.

What should I avoid while taking phenazopyridine?

Avoid wearing soft contact lenses while you are taking phenazopyridine. The medication can cause permanent staining of soft contact lenses.

What other drugs will affect phenazopyridine?

There may be other drugs that can interact with phenazopyridine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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