Pyridium
Pyridium is an FDA drug label for the active ingredient PHENAZOPYRIDINE manufactured by Amneal Pharmaceuticals LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231216.
- Generic name
- PHENAZOPYRIDINE
- Manufacturer
- Amneal Pharmaceuticals LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 60846-501
- Application
- N/A
- Label effective
- 20231216
Indications & Usage
INDICATIONS AND USAGE 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.)
Dosage & Administration
DOSAGE AND 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.
Contraindications
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.
Warnings
Not available.
Adverse Reactions
ADVERSE REACTIONS 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).