AZO Urinary Pain Relief Maximum Strength

Other Similar Ocular Products
Urinary Analgesics and Anesthetics

Administer phenazopyridine with or after meals to minimize GI discomfort.
Administer with a full glass of water.
Do not administer for longer than directed; most patients will take the drug for no more than 2 days.

Extemporaneous compounding instructions for Phenazopyridine oral suspension 10 mg/mL:
An oral suspension yielding 10 mg/mL may be formulated according to the following procedure:
Crush three phenazopyridine 200 mg tablets and mix with a small amount of distilled water or glycerin.
Then, add 20 mL of Cologel and levigate until a uniform mixture is obtained.
Add sufficient 2:1 simple syrup/cherry syrup mixture to make a final volume of 60 mL.
Store in an amber container. Preparation is stable for 60 days under refrigeration.
Shake well before each use.
For accurrate dose measurement, use a calibrated oral syringe, spoon, or other calibrated oral measuring device. Give dose with or after meals and with a full glass of water.

hemolytic anemia / Delayed / 0-1.0
renal tubular necrosis / Delayed / 0-1.0
methemoglobinemia / Early / Incidence not known
aseptic meningitis / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known

hepatitis / Delayed / 0-1.0
elevated hepatic enzymes / Delayed / 0-1.0
jaundice / Delayed / 0-1.0
eosinophilia / Delayed / Incidence not known

urine discoloration / Early / 10.0
fever / Early / Incidence not known
contact lens discoloration / Delayed / Incidence not known
pruritus / Rapid / Incidence not known
rash / Early / Incidence not known
headache / Early / Incidence not known

AZO, AZO Urinary Pain Relief Maximum Strength, Azo-100, Azo-Gesic, Azo-Septic, Azo-Standard, Phenazo, Prodium, Pyridium, Similasan Stye Eye Relief, Stye Eye Relief, Urinary Analgesic, Uristat, Uristat Ultra

OTC, Rx

Oral urinary tract analgesic; an azo dye than causes urine discoloration with use
For relief of symptoms of urinary irritation as occurs with urinary tract infection (UTI); should not be used for more than 2 days when given concomitantly with an antibiotic as no benefit to longer use
May cause rare cases of methemoglobinemia; should not be used by those with G6PD deficiency or renal insufficiency

190 to 200 mg PO 3 times daily with or after meals. When used non-prescription or concomitantly with an antibacterial agent for the treatment of a urinary tract infection, use should not exceed 2 days. For short-term use only; discontinue when symptoms are controlled.

190 to 200 mg PO 3 times daily with or after meals. When used non-prescription or concomitantly with an antibacterial agent for the treatment of a urinary tract infection, use should not exceed 2 days. For short-term use only; discontinue when symptoms are controlled.

Safety and efficacy have not been established; off-label use has been described. Use should be by prescription of a health care professional; do not self-treat. Dose used: 4 mg/kg/dose PO 3 times daily with or after meals for up to 2 days.

Dosage adjustment is recommended; however, specific guidelines are not available. Phenazopyridine is metabolized in the liver to potentially active and/or toxic metabolites.

CrCl > 80 ml/min: No dosage adjustment is needed.
CrCl 50—80 ml/min: Administer dose every 8—16 hours.
CrCl < 50 ml/min: Avoid use.

There are no drug interactions associated with Phenazopyridine products.

AZO Urinary Pain Relief Maximum Strength/Azo-100/Azo-Gesic/Azo-Septic/Azo-Standard/Phenazo/Phenazopyridine/Phenazopyridine Hydrochloride/Prodium/Pyridium/Urinary Analgesic/Uristat/Uristat Ultra Oral Tab: 95mg, 97.5mg, 99.5mg, 100mg, 200mg
Stye Eye Relief Ophthalmic Drops: 6-12-12X

600 mg/day PO.

600 mg/day PO.

600 mg/day PO.

12 years: 600 mg/day PO.
6 to 11 years: Safety and efficacy have not been established; however, 12 mg/kg/day PO has been reported.
1 to 5 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

The mechanism of action of phenazopyridine has not been fully determined. Phenazopyridine is an azo dye that is excreted in the urine and exerts a topical analgesic or local anesthetic effect on the mucosa of the urinary tract. It possesses no antibacterial actions.

Phenazopyridine is administered orally. The pharmacokinetic disposition of phenazopyridine has not been fully established. Trace amounts of the drug are believed to cross the placenta and to enter the CSF. Metabolism of phenazopyridine probably occurs in the liver; one of the metabolites is acetaminophen. The drug is rapidly excreted by the kidneys, with as much as 65% of an oral dose excreted unchanged in the urine.

It is not known whether phenazopyridine is excreted in human milk. Cases of acquired methemoglobinemia in infants after phenazopyridine ingestion have been reported. Phenazopyridine and its metabolites (i.e., aniline) may have the potential to produce methemoglobinemia. Therefore, it is prudent to avoid phenazopyridine use while breast-feeding, especially with an infant less than 1 month of age or has a glucose-6-phosphate dehydrogenase (G6PD) deficiency. [45694] [45704]