PHENAZOPYRIDINE HYDROCHLORIDE TABLETS

PHENAZOPYRIDINE - phenazopyridine tablet 
Breckenridge Pharmaceutical, Inc.

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PHENAZOPYRIDINE
HYDROCHLORIDE
TABLETS

RX ONLY

DESCRIPTION

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 of Phenazopyridine Hydrochloride.

Chemical Structure

C11 H11 N5 • HCl                                    M.W. 249.70

Phenazopyridine HCl tablets contain the following Inactive Ingredients in 100 mg: Lactose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Pharmaceutical Glaze and Sodium Starch Glycolate.

Inactive Ingredients in 200 mg: FD&C Blue No.1 Lake, FD&C Red No.40 Lake, 1FD&C Yellow No.6 Lake, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.


1
This product contains FD&C Yellow No.6 as a color additive.

CLINICAL PHARMACOLOGY

Phenazopyridine HCl 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 HCl have not been determined. Phenazopyridine HCl is rapidly excreted by the kidneys, with as much as 65% of an oral dose being excreted unchanged in the urine.

INDICATIONS AND USAGE

Phenazopyridine HCl 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 2 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.)

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.

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).

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.

INFORMATION FOR PATIENTS:

Phenazopyridine Hydrochloride produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported.

Laboratory Test Interactions

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 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 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.

OVERDOSAGE

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.

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

Phenazopyridine Hydrochloride 100 mg tablets are supplied in bottles of 100 and 1000 tablets. 100 mg tablets are round, coated, deep maroon and printed "25".

Phenazopyridine Hydrochloride 200 mg tablets are supplied in bottles of 100 and 1000 tablets. 200 mg tablets are caplet-shaped, coated, deep maroon and printed CPC860.

Store at 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.

Protect from light and moisture.

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Warning: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 U.S.A.

Rx Only

Rev. 7/08

PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-520-01

Phenazopyridine HCl

100 mg

Urinary Analgesic

Rx Only

100 TABLETS

PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label

PRINCIPAL DISPLAY PANEL - 200 mg Bottle Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-525-01

Phenazopyridine HCl

200 mg

Urinary Analgesic

Rx Only

100 TABLETS

PRINCIPAL DISPLAY PANEL - 200 mg Bottle Label

PHENAZOPYRIDINE 
phenazopyridine   tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51991-520
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenazopyridine (Phenazopyridine) Phenazopyridine100 mg
Inactive Ingredients
Ingredient NameStrength
Lactose 
Magnesium Silicate 
Magnesium Stearate 
Cellulose, Microcrystalline 
Shellac 
sodium starch glycolate type a potato 
Product Characteristics
ColorRED (Deep Maroon) Score no score
ShapeROUNDSize7mm
FlavorImprint Code 25
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-520-01100 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER09/01/200503/31/2012

PHENAZOPYRIDINE 
phenazopyridine   tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51991-525
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenazopyridine (Phenazopyridine) Phenazopyridine200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C Blue No. 1 
FD&C Red No. 40 
FD&C Yellow No. 6 
Aluminum Oxide 
Hypromelloses 
Lactose 
Magnesium Silicate 
Magnesium Stearate 
Cellulose, Microcrystalline 
Mineral Oil 
Polyethylene Glycol 
Sodium Lauryl Sulfate 
sodium starch glycolate type a potato 
Stearic Acid 
Titanium Dioxide 
Product Characteristics
ColorRED (Deep Maroon) Score no score
ShapeOVAL (Capsule-shaped) Size19mm
FlavorImprint Code CPC;860
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-525-01100 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER09/01/200503/31/2012

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal057795122MANUFACTURE
Revised: 12/2010Breckenridge Pharmaceutical, Inc.