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Phenazopyridine Tablets

Generic Name: phenazopyridine hydrochloride
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

For further information about unapproved drugs, click here.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain.

Following is the structural formula:

Phenazopyridine HCI oral tablets contain the following inactive ingredients: pregelatanized starch, corn starch, silicon dioxide, micro crystalline cellulose , croscarmellose sodium, magnesium stearate and PVPK30

Phenazopyridine hydro chloride 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 unknown.

The pharmacokinetic properties of Phenazopyridine hydrochloride have not been determined. Phenazopyridine and its metabolites are rapidly excreted by the kidneys. In a small number o f healthy subjects, 9 0 % o f a 6 0 0 mg /day oral dose of Phenazopyridine hydrochloride was eliminated in the urine in 24 hours, 4 1% as unchanged drug and 4 9 % as metabolites.

Phenazopyridine HCL is indicated for the symptomatic relief o f pain, burning , urgency frequency, and other discomforts arising fro m irritation o f the mucosa o f the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures , o r the passage e o f sounds, o r catheters.

T he use o f Phenazopyridine for relief o f symptoms should no t delay definitive diagnosis and treatment o f causative conditions. T he drug should be used for symptomatic relief o f pain and no t as a substitute fo r specific surgery o r antimicrobial therapy.

Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection .

Treatment o f a urinary tract infection with Phenazopyridine should no t exceed 2 days. T here is no evidence that the combined administration o f Phenazopyridine and an antimicrobial provides greater benefit than administration o f the antimicrobial alone after 2 days. (See Do sag e and Administration.)

In patients who are hypersensitive to the drug o r its ingredients. Phenazopyridine is contraindicated in patients with renal insufficiency, severe liver disease, severe hepatitis o r pyelonephritis o f pregnancy.

It should be used cautiously in the presence o f GI disturbances.

Phenazopyridine hydrochloride is reasonably anticipated to be a human carcinog en based o n sufficient evidence o f carcinogenicity in experimental animals (IARC 19 8 0 , 19 8 2, 19 8 7, NCI 19 78 ). When administered in the diet, Phenazopyridine hydrochloride increased the incidences o f hepatocellular adenomas and carcinomas in female mice and adenomas and adenocarcinomas o f the co lo n and rectum in rats o f both sexes.

T here is inadequate evidence for the carcinogenicity o f Phenazopyridine hydrochloride in humans (T ARC 19 8 7). In o ne limited epidemiological study, no significant excess o f any cancer was observed among 2,214 patients who received Phenazopyridine hydrochloride and were followed for a minimum o f 3 years.

PRECAUT IONS General:

T he patient should be advised that Phenazopyridine produces an o rang e to red co lo r in the urine and feces, and may cause staining . Phenazopyridine may cause disco lo ratio n o f body fluids and staining o f contact lenses has been reported. A yellowish co lo r o f the skin o r sclera may indicate accumulation o f Phenazopyridine resulting fro m impaired renal function and necessitates discontinuance o f the drug . It should be no ted that a decline in renal function is common in elderly patients. Phenazopyridine may mask pathological conditions and interfere with laboratory test values using colorimetric, spectrophotometric o r fluorometric analysis methods.

Cautious use in patients with G-6 -PD deficiency is advised since these patients are susceptible to oxidative hemolysis and may have greater potential to develop hemolytic anemia.

Information for Patients :

T he patient should be advised to take Phenazopyridine with o r following foo d o r after eating a snack to reduce stomach upset.

T he patients should be aware that Phenazopyridine causes a reddish o rang e disco lo ratio n o f the urine and feces, and may stain clothing . Phenazopyridine may cause disco lo ratio n o f body fluids and staining o f contact lenses has been reported. T here have been reports o f teeth disco lo ratio n when the pro duct

has been bro ken o r held in the mouth prior to swallowing .

Patients should be instructed to take Phenazopyridine for only 2 days if an antibacterial agent is administered concurrently for the treatment o f a urinary tract infection. If symptoms persist beyond those

2 days, the patient should be instructed to contact his o r her physician.

Laboratory Tests :

Phenazopyridine may interfere with laboratory test values using colorimetric, pho to metric o r fluorometric analysis methods.

Altered urine laboratory test values may include ketone (sodium nitroprusside) , bilirubin (foam test,

talc-disk-Fouchet-spot test, Franklin 's tablet-Fouchet test, p-nitro benzene diazonium p-toluene sulfonate reag ent), diacetic acid (Gerhardt ferric chloride test), free hydrochloric acid, glucose (glucose

oxidase tests), 17-hydroxycorticosteroids (modified Glenn-Nelson), 17-keto steroids (Holtorff Koch modification o f Zimmerman), porphyrins, albumin (disco lo rs bro mophenol blue test areas o f commercial reagent strips, nitric acid ring test), phenolsulfophthalein , urobilinogen (co lo r interference with

Ehrlich 's reagent), and urinalysis (spectrophotometric o r co lo r-based tests). Phenazopyridine also imparts an o rang e-red co lo r to stools which may interfere with co lo r tests.

Drug Interactions :

T he interaction o f Phenazopyridine with other drug s has no t been studied in a systematic manner. However, the medical literature to date suggests that no significant interactions have been reported.

Carcinogenesis , Mutagenesis , Impairment o f Fertility:

Long -term administration o f Phenazopyridine has been associated with tumors o f the large intestine in rats and o f the liver in mice. Available epidemiological data are insufficient to evaluate the carcinogenicity o f Phenazopyridine in humans. In vitro studies indicate that Phenazopyridine in the presence o f metabolic activation is mutagenic in bacteria and mutagenic and clastogenic in mammalian cells.

Pregnancy Cate gory B:

Reproductive studies with Phenazopyridine (in combination with sulfacytine) in rats given up to 110 mg /kg /day and in rabbits given up to 39 mg /kg /day during organogenesis revealed no evidence o f harm to offspring.

One prospective study in human s demonstrated that Phenazopyridine traverses the placenta into the fetal compartment. T here are no adequate and well-controlled studies in pregnant women. Therefore, Phenazopyridine should be used in pregnant women only if the benefit clearly outweighs the risk.

Nursing Mothers :

It is no t known whether Phenazopyridine o r its metabolites arc excreted in human milk. Because many drug s are excreted in human milk, a decision should be made to discontinue nursing o r to discontinue the drug , taking into account the importance o f drug therapy to the mother.

Children:

Adequate and well-controlled studies have no t been performed in the pediatric population. No pediatric-specific problems have been documented.

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

200 mg Tablets: Average adult do sag e is o ne tablet 3 times a day after meals.

When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration o f Phenazopyridine Hydrochloride should no t exceed 2 days.

T he following adverse events have been reported: CNS: headache.

Gastro intestinal: nausea, vomiting and diarrhea.

Dermatologic and Hypersensitivity: rash, pruritus, disco lo ratio n, anaphylactoid-like reaction and hypersensitivity hepatitis.

Hematologic: methemoglobinemia, hemolytic anemia, potential hemolytic agent in G-6 -PD deficiency, sulfhemoglobinemia.

Other: visual disturbances, renal and hepatic toxicity usually associated with overdose, renal calculi, jaundice, disco lo ratio n o f body fluids and aseptic meningitis.

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 (6 8 ° to 77° F) [See USP Controlled Ro o m Temperature].

Dis tribute d in 1 bottle o f 10 0 tablets.

NDC 6 9 36 7- 16 2-0 4 10 0 mg , 10 0 count - Appearance : Reddish-brown, round, film coated tablets

NDC 6 9 36 7- 16 3 -0 4 20 0 mg , 10 0 count - Appearance : Reddish-brown, round, film coated tablets

KEEP THIS AND ALL MEDICAT ION OUT OF T HE REACH OF CHILDREN. Manufactured for:

Sola Pharmaceuticals , LLC

18169 E. Petroleum Dr. Suite B

Baton Rouge, LA, 70809

Rev: 0 2 /18

NDC 70512-003-10

Phenazopyridine Hydrochloride , USP

200 mg

Rx only

100 Tablets

NDC 70512-002-10

Phenazopyridine Hydrochloride , USP

100 mg

Rx only

100 Tablets

PHENAZOPYRIDINE 
phenazopyridine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70512-003
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 200 mg  in 1 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30  
STARCH, PREGELATINIZED CORN  
SILICON DIOXIDE  
MICROCRYSTALLINE CELLULOSE  
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)  
MAGNESIUM STEARATE  
Product Characteristics
Color red Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 2
Contains     
Packaging
# Item Code Package Description
1 NDC:70512-003-10 200 mg in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/2018
PHENAZOPYRIDINE 
phenazopyridine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70512-002
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 100 mg  in 1 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30  
STARCH, PREGELATINIZED CORN  
SILICON DIOXIDE  
MICROCRYSTALLINE CELLULOSE  
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)  
MAGNESIUM STEARATE  
Product Characteristics
Color red Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 2
Contains     
Packaging
# Item Code Package Description
1 NDC:70512-002-10 100 mg in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/2018
Labeler - SOLA Pharmaceuticals (080121345)
Establishment
Name Address ID/FEI Operations
Ion Labs, Inc 106499791 manufacture(70512-003, 70512-002)
 
SOLA Pharmaceuticals
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