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.