Dysuria, symptomatic relief: Oral:
OTC labeling: Two tablets (190 to 199 mg [amount varies based on product]) 3 times daily for up to 2 days.
Rx labeling: 200 mg 3 times daily for 2 days when used concomitantly with an antibacterial agent.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function:
CrCl ≥50 mL/minute: No dosage adjustment necessary (Golightly 2013; expert opinion).
CrCl <50 mL/minute: Avoid use. Cases of acute kidney injury, hemolytic anemia, and methemoglobinemia have been reported in patients with reduced kidney function (Alano 1970; Chang 2014; Eisinger 1969; Fincher 1989; Gabor 1965; Golightly 2013; Greenberg 1964; Singh 2014; manufacturer's labeling).
Hemodialysis, intermittent (thrice weekly): Dialyzability unknown. Avoid use (expert opinion).
Peritoneal dialysis: Dialyzability unknown. Avoid use (expert opinion).
CRRT: Avoid use (expert opinion).
PIRRT (eg, sustained, low-efficiency diafiltration): Avoid use (expert opinion).
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "Phenazopyridine: Pediatric drug information")
Dysuria, urinary tract pain; symptomatic relief: Note: Generally, the use of phenazopyridine is not included by experts as a therapeutic consideration for pediatric UTI management (AAP 2011; Kliegman 2016; Red Book [AAP 2015])
Children <12 years: Limited data available: Oral: 12 mg/kg/day in 3 divided doses; maximum dose: 200 mg/dose (Gearhart 2010; Gal 2007; Rudolph 1996); some experts suggest a minimum age of 6 years (Gearhart 2010). Limit therapy to 2 days if being used for UTI.
Children ≥12 years and Adolescents: Oral: OTC 95 mg/tablet formulation: 190 mg (2 tablets) 3 times daily as needed; limit therapy to 2 days if being used for UTI
Children ≥12 years and Adolescents: There are no pediatric specific recommendations; in adults, use is contraindicated.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
AZO Urinary Pain Relief: 99.5 mg [contains corn starch]
Tablet, Oral, as hydrochloride:
Pyridium: 100 mg, 200 mg
Urinary Pain Relief: 95 mg
Generic: 100 mg, 200 mg
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Phenazo: 100 mg, 200 mg
Pyridium: 100 mg, 200 mg
Oral: Administer with or after meals.
Oral: Administer with or after meals
Dysuria, symptomatic relief: 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.
Phenazopyridine may be confused with phenoxybenzamine
Pyridium may be confused with Dyrenium, Perdiem, pyridoxine, pyrithione
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Headache, dizziness
Gastrointestinal: Stomach cramps
<1%, postmarketing, and/or case reports: Acute renal failure, hemolytic anemia, hepatitis, methemoglobinemia, skin pigmentation, skin rash, vertigo
Hypersensitivity to phenazopyridine or any component of the formulation; renal insufficiency.
Concerns related to adverse effects:
• Acute renal failure: Acute renal failure has been reported with larger than recommended doses, primarily in patients with preexisting renal disease, although some reports have occurred in patients without preexisting renal disease (Alano 1970; Holmes 2014; Onder 2006). Acute renal failure secondary to phenazopyridine toxicity is usually accompanied by hemolytic anemia, yellow discoloration of the skin, and methemoglobinemia, although acute renal failure can occur in isolation (Holmes 2014). Acute renal failure has also been reported following use of usual recommended doses in patients without preexisting renal impairment (Shahani 2012; Singh 2014).
• Urine discoloration: A reddish-orange discoloration of the urine occurs.
• Yellow discoloration: Drug should be discontinued if skin or sclera develop a yellow color (may indicate drug accumulation due to impaired renal excretion).
Disease-related concerns:
• Renal impairment: Use is contraindicated in patients with renal impairment (although a specific degree of impairment is not defined in the manufacturer's labeling). Use in patients with preexisting chronic kidney disease has been associated with acute renal failure, hemolytic anemia, and methemoglobinemia (Chang 2014).
Special populations:
• Elderly: Use with caution in older adults due to potential for accumulation in patients with renal insufficiency.
• G6PD deficiency: Use caution in patients with G6PD deficiency; hemolytic anemia may occur in the setting of chronic overdose. OTC labeling recommends use only when directed by physician.
Other warnings/precautions:
• Contact lenses: Staining of contact lenses may occur if handled after touching tablets.
• Limitations of use: Does not treat urinary infection, acts only as an analgesic.
• Self-medication (OTC use): When used for self-medication, patients should be instructed to discontinue use if symptoms last for more than 2 days or if an adverse reaction occurs.
• Staining: May stain fabric or clothing.
None known.
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Adverse events have not been observed in animal reproduction studies. Phenazopyridine crosses the placenta and can be detected in amniotic fluid (Meyer 1991).
It is not known if phenazopyridine is present in breast milk.
Take with or after meals.
An azo dye which exerts local anesthetic or analgesic action on urinary tract mucosa through an unknown mechanism
Metabolism: In the liver and other tissues
Excretion: Urine (66% as unchanged drug)
Tablets (AZO Urinary Pain Relief Oral)
99.5 mg (per each): $0.60
Tablets (Phenazopyridine HCl Oral)
100 mg (per each): $1.08 - $2.70
200 mg (per each): $1.62 - $4.00
Tablets (Pyridium Oral)
100 mg (per each): $5.32
200 mg (per each): $6.84
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