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Pyridium

Pyridium contains phenazopyridine, an analgesic, and is registered in 12 countries spread across the Americas, parts of Asia, and southern Africa. It is used in the management of urinary tract discomfort — specifically the pain, burning, and irritation that can accompany lower urinary tract infections, certain procedures, or post-surgical recovery involving the urinary tract.

Phenazopyridine is classified as a urinary analgesic. It does not act on the underlying cause of a urinary tract infection — antimicrobial therapy, where indicated, is a separate decision — but it addresses the symptomatic component of urinary discomfort. For that reason it is often prescribed alongside other treatments rather than on its own, and the structured indication block further down this page lists each registered use in the markets where Pyridium is sold.

The brand's footprint clusters notably in Central America and the Andean region — Guatemala, Honduras, Nicaragua, Panama, Costa Rica, El Salvador, and Peru — alongside Brazil, the United States, India, Hong Kong, and South Africa. A traveller arriving from one of these markets into Western Europe, East Asia, or Australasia may not encounter the Pyridium brand specifically, although phenazopyridine itself is available in several other countries under different commercial names and, in some markets, as a generic.

Brand availability, prescription status, and packaging vary meaningfully between these regions, and what is sold over the counter in one country may require a prescription in another. A local pharmacist is well placed to confirm whether a phenazopyridine-containing product is sold in a particular market and under what name. Any decision about starting, continuing, or substituting urinary analgesic therapy is best made together with a healthcare provider familiar with the patient's situation.

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 or ascorbic acid 100 to 200 mg given orally 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 HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.

Undesirable 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 overdosage levels (see OVERDOSAGE section).

Therapeutic indications

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 HCl 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 HCl 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 HCl should not exceed two days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after two days. (See DOSAGE AND ADMINISTRATION section.)

Name of the medicinal product

Pyridium

Qualitative and quantitative composition

100 mg Tablets: Supplied in bottles of 100 (NDC 60846-517-01) counts.

Appearance: Deep brown to maroon colored, round, film coated tablets debossed “AN” above “1” on one side and plain on the other.

200 mg Tablets: Supplied in bottles of 100 (NDC 60846-520-01) counts.

Appearance: Deep brown to maroon colored, round, film coated tablets debossed “AN” above “2” on one side and plain on the other.

DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

STORE at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Manufactured for: Gemini Laboratories , LLC, Bridgewater, NJ 08807. Rev. Feb 2014

Special warnings and precautions for use

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.

NOTE: Patients should be informed that Phenazopyridine HCl produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported.

Laboratory Test Interaction

Due to its properties as an azo dye, Phenazopyridine HCl may interfere with urinalysis based on spectrometry or color reactions.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl 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 HCl. 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 HCl, or its metabolites in human milk.

Dosage (Posology) and method of administration

100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals.

200 mg Tablets: Average 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 HCl should not exceed 2 days.

Interaction with other medicinal products and other forms of interaction

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 overdosage levels (see OVERDOSAGE section).

DRUG INTERACTIONS

No information provided.

Frequently asked questions

What conditions does Pyridium treat?

Pyridium is used for the symptomatic relief of pain, burning, and irritation associated with the lower urinary tract — including discomfort linked to urinary tract infection, certain procedures, and post-surgical recovery. As a urinary analgesic it addresses the symptomatic component rather than the underlying cause, which is why it is often prescribed alongside other treatments. The structured indication list below this introduction details the registered uses recognised in the markets where Pyridium is sold.

Which active substance is in Pyridium?

Pyridium contains phenazopyridine, classified as a urinary analgesic. The same molecule circulates internationally under a number of different commercial names, and in some markets is also available as a generic. Phenazopyridine acts specifically on urinary tract discomfort and is distinct from the broader category of systemic pain relievers, which is worth keeping in mind when comparing it to other analgesics on a pharmacy shelf.

In how many countries is Pyridium available?

Pyridium is registered in 12 countries, with a notable concentration across Central America and parts of Latin America. Examples include Brazil, Guatemala, Panama, Peru, the United States, India, Hong Kong, and South Africa. If your country is not on this list, a local pharmacist can usually confirm whether phenazopyridine is sold in that market under a different brand name or as a generic equivalent.

Are there other medications with the same active ingredient as Pyridium?

Phenazopyridine is sold under several brand names in different regional markets and, in some countries, as a generic. Within the wider category of medications used for urinary tract symptoms, other approaches exist as well — including antimicrobial therapy where an infection is the underlying cause — but they are not interchangeable with a urinary analgesic. To identify a local phenazopyridine product, search the active ingredient on Pill2Trip or ask a pharmacist.

Should I consult a doctor before taking Pyridium?

Yes. Although phenazopyridine is available without a prescription in some countries, its regulatory status varies, and urinary symptoms can be a sign of a condition that needs separate evaluation rather than symptomatic relief alone. Travellers and people relocating between countries should also be aware that brand availability and prescription rules differ markedly. A healthcare provider can confirm whether Pyridium is appropriate and what other steps may be needed.