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Phenazopyridine
Indications, Uses, Dosage, Drugs Interactions, Side effects
Phenazopyridine
Medicine Type :
Allopathy
Allopathy
Prescription Type:
Prescription Required
Prescription Required
Approval :
DCGI (Drugs Controller General of India)
DCGI (Drugs Controller General of India)
Schedule
Schedule H
Schedule H
Pharmacological Class:
Azo dyes, Urinary Analgesic, Therapy Class:
Analgesic, Approved Countries
India, Brazil, the United States, Canada, the United Kingdom, Australia, Germany, France, Italy, Japan, and Mexico.
Phenazopyridine is an analgesic agent belonging to the pharmacological class of azo dyes or urinary analgesics.
The FDA approves Phenazopyridine to alleviate symptoms of dysuria, burning sensations, urgency, frequency, and pain linked to lower UTIs.
Phenazopyridine absorbs in the gastrointestinal tract, reaching the cerebrospinal fluid and placenta. Liver metabolism generates acetaminophen and 5-hydroxyl PAP. The kidneys eliminate 65% through urine.
The common side effects of Phenazopyridine include headache, nausea, vomiting, diarrhea, rash, and urine discoloration.
Phenazopyridine is available as a tablets.
The molecule is available in India, Brazil, the United States, Canada, the United Kingdom, Australia, Germany, France, Italy, Japan, and Mexico.
Phenazopyridine is an analgesic agent belonging to the pharmacological class of azo dyes or urinary analgesics.
While Phenazopyridine's exact mode of action is still unknown, research on rats suggests that it may work by directly inhibiting voltage-gated sodium channels and group A nerve fibres to produce a topical analgesic effect on the urinary tract mucosa. Painful urinary symptoms are probably relieved by those previous measures.
The time required for Phenazopyridine to show its effect is usually within an hour after administration.
The time duration for Phenazopyridine generally lasts for about 3 to 4 hours.
Phenazopyridine's maximum plasma concentration (Cmax) generally occurs around 1 to 2 hours post-administration.
(Tmax)for Phenazopyridine after administration has not been established.
Phenazopyridine is available as a tablets.
Tablets: To be swallowed whole with water/liquid. Do not chew, crush or break it.
As the physician recommends, take the medication orally thrice daily, as directed.
Phenazopyridine can be used for various health conditions:
- Urinary Tract Irritation: Alleviates symptoms such as pain, burning sensation, urgency, and frequent urination caused by urinary tract irritation.
- Analgesic Properties: Acts as a urinary tract analgesic, soothing the lining of the urinary tract to reduce pain and discomfort.
In Symptomatic Pain relief
By reducing the pain, discomfort, and urgency induced by urinary tract irritation, Phenazopyridine provides symptomatic relief. While not curing the underlying problem, it reduces symptoms while a patient receives treatment. Acting as a local analgesic, it relaxes the urinary tract's lining and reduces discomfort related to urination. While treating the underlying disease, this medicine improves comfort by temporarily relieving pain, burning sensations, and frequent or urgent urinating.
Phenazopyridine is indicated in the following health conditions:
- To relieve pain, burning sensation, urgency, frequency, or discomfort.
- It targets irritation of the lower urinary tract's mucosal lining.
- Causes of irritation may include infections, surgery, trauma, catheter passage, or endoscopic procedures.
Orally: Phenazopyridine tablets are typically administered orally, with or without food. However, they are preferable to take after meals to minimize stomach upset. The doctor determines the dosage, usually taken three times a day. Drink plenty of fluids during treatment to aid in flushing the urinary tract. If a dose is missed, take it as soon as remembered; however, avoid doubling it to compensate for the missed one.
The dosage and duration of treatment should be as per the treating physician's clinical judgment.
Tablets: 95mg, 97.2mg, 100mg, 200mg
Phenazopyridine is available in the form of tablets.
Dose Adjustment in Adult Patients:
Dysuria, Irritation of Lower Urinary Tract Mucosa
Three times a day, 100–200 mg PO after meals
Dosing considerations
Never take an antibiotic for a UTI concurrently for more than two days.
Due to reduced renal function, limit dosage in the elderly group.
It is essential to avoid certain meals and beverages when using Phenazopyridine, as these include alcohol, caffeine, and spicy or acidic foods that may cause discomfort. Maintaining adequate hydration is crucial to avert methemoglobinemia and subsequent renal issues. Choose a plant-based diet, regular exercise, and pelvic floor exercises to strengthen bladder muscles and control body weight. Furthermore, while phenazopyridine medication, stopping smoking is crucial for maintaining bladder function and general health.
The dietary restriction should be individualized as per patient requirements.
Phenazopyridine may be contraindicated in the following conditions:-
- Known hypersensitivity to Phenazopyridine or any of the excipients.
- Patients with renal insufficiency (CrCl <50mL/min), severe hepatitis or pyelonephritis of pregnancy.
- Phenazopyridine alters urine colour, potentially affecting urinalysis results using colour reactions or spectrometry. It can also stain contact lenses.
- Discontinue use if yellowish discolouration appears on the skin or sclera, indicating drug accumulation due to renal failure, especially in geriatric patients who require close monitoring.
- Limit self-medication to a maximum of two days; seek medical attention if pain persists. This medication is for pain relief, not for treating urinary tract infections.
- Exercise caution in individuals with G6PD deficiency; chronic overdose may result in hemolytic anaemia. Note that Phenazopyridine is not intended to treat UTIs; its sole purpose is pain relief.
- Stop over-the-counter usage if symptoms persist beyond two days or adverse effects occur. Consider that it may cause staining on fabric or clothing.
Alcohol Warning
It is unsafe to consume alcohol.
Breast Feeding Warning
There is insufficient scientific evidence regarding the use and safety of Phenazopyridine in breastfeeding.
Pregnancy Warning
It is generally considered to be safe when used during pregnancy. Animal studies indicate minimal fetal risks; human data is limited.
Food Warning
Avoid alcohol, caffeine, and spicy food; hydrate well; quit smoking.
The adverse reactions related to Phenazopyridine can be categorized as
Common Adverse Effects: Orange-colored urine, headache, dizziness.
Less Common Adverse Effects: Upset stomach and skin rash or itching.
Rare Adverse Effects: Methemoglobinemia, hepatic/renal toxicity, staining of contact lenses and hemolytic anaemia
The clinically relevant drug interactions of Phenazopyridine are briefly summarized here.
- Sulfa medications: Potential cross-sensitivity or increased risk of allergic reactions when taken with Phenazopyridine.
- Blood thinners (anticoagulants): Phenazopyridine may increase the risk of bleeding when used concomitantly with anticoagulant medications like warfarin.
- Glucose tests: Phenazopyridine can interfere with urine glucose tests, causing false-positive results.
- Urinary Alkalinizers: Concurrent use of urinary alkalinizers may elevate Phenazopyridine's blood levels and duration.
- MAO inhibitors: Concurrent use may result in elevated blood pressure due to the inhibition of phenazopyridine metabolism.
- Other medications: Concurrent use with certain antibiotics, sulfonylureas, or drugs affecting the liver might require dosage adjustments or careful monitoring.
The common side effects of Phenazopyridine include: -
Vomiting
Headache
Dizziness
Stomach cramp
Nausea
Diarrhoea
Changes in urine colour
Upset stomach
Pregnancy
Pregnancy Category B (FDA): Could be acceptable. Either no danger has been shown by animal research, but human studies have yet to be conducted, or some risk has been shown by animal studies but not by human studies.
No evidence of harm to offspring was found in reproductive trials involving Phenazopyridine (in conjunction with sulfacytine) in rats given up to 110 mg/kg/day and in rabbits given up to 39 mg/kg/day during organogenesis.
According to a single, minimal prospective research conducted on humans, Phenazopyridine crosses the placenta and enters the fetal compartment. More reliable, well-controlled research on expectant mothers is needed. Phenazopyridine should, therefore, only be administered to expectant mothers in situations where the advantages much exceed the risks.
- Nursing Mothers
It is unknown if the drug is excreted in human milk. Because many drugs are excreted in human milk, precaution should be exercised.
- Pediatric Use
As per the FDA, the safety and efficacy of Phenazopyridine in pediatric patients have yet to be extensively studied or established.
Dosage adjustment in paediatric patients:
Dysuria and Lower Urinary Tract Mucosal Irritation
<6 Years: No safety or efficacy data available
6–12 years: divided every 8 hours, 12 mg/kg/day PO after meals
Over 12 years old: three times a day, 100–200 mg PO after meals
Considerations for dosing
If you have a UTI, do not take concurrently with antibiotics for more than two days.
Geriatrics (> 65 years old)
As per the FDA, the safety and efficacy of Phenazopyridine in elderly patients above 65 have not been extensively studied or established.
Dose Adjustment in Kidney Impairment Patients:
Phenazopyridine is contraindicated in patients with renal insufficiency.
Dose Adjustment in Hepatic Impairment Patients:
Phenazopyridine is contraindicated in patients with any liver disease.
The physician should be vigilant about the knowledge pertaining to the identification and treatment of overdosage of Phenazopyridine.
Signs and Symptoms
Overconsumption of Phenazopyridine could lead to methemoglobinemia, hemolysis, acute renal failure, and potential hepatic toxicity.
Management
There is no specific antidote or treatment for excessive Phenazopyridine, so treatment typically involves symptomatic and supportive measures. If ingestion is recent, gastric lavage or activated charcoal might be considered to limit absorption.
Unless directed by a healthcare professional, avoid inducing vomiting. Supportive care involves treating symptoms and taking steps to prevent complications. In cases of methemoglobinemia, administer methylene blue intravenously at a dose of 1 to 2 mg/kg as a 1% solution or give 100-200 mg oral ascorbic acid as required, to swiftly reduce methemoglobinemia and resolve cyanosis, aiding in diagnosis. Monitor renal function and maintain hydration to prevent acute renal failure. Hemodialysis may be necessary in severe cases or to manage potential hepatic toxicity. Regularly check for adverse effects, especially hemolysis and liver damage. Ensure sufficient hydration and monitor renal function due to potential kidney-related issues.
- Petrov SB, Slesarevskaya MN, Chibirov KH, Topuzov ME, Kagan OF, Voronova EN. [Efficiency and safety of phenazopyridine for treatment of uncomplicated urinary tract infection: results of multi-center, randomized, placebo-controlled, clinical study]. Urologiia. 2020 Jun;(3):15-21. Russian. PMID: 32597580.
- Shi CW, Asch SM, Fielder E, Gelberg L, Brook RH, Leake B, Shapiro MF, Dowling P, Nichol M. Usage patterns of over-the-counter phenazopyridine (pyridium). J Gen Intern Med. 2003 Apr;18(4):281-7. doi: 10.1046/j.1525-1497.2003.20709.x. PMID: 12709095; PMCID: PMC1494847.
- Hamza A, Nasrullah A, Singh R, DiSilvio B. Phenazopyridine-Induced Methaemoglobinaemia The Aftermath of Dysuria Treatment. Eur J Case Rep Intern Med. 2022 Feb 28;9(2):003191. doi: 10.12890/2022_003191. PMID: 35265556; PMCID: PMC8900564.
- Davidov MI, Meltsina MN, Bunova NE, Metelkin AM, O PR, Lunev AA. [Phenazopyridine and fosfomycin for the acute cystitis treatment: results of multicenter randomized study]. Urologiia. 2021 Jun;(3):20-27. Russian. PMID: 34251097.
- Onder AM, Espinoza V, Berho ME, Chandar J, Zilleruelo G, Abitbol C. Acute renal failure due to phenazopyridine (Pyridium) overdose: case report and review of the literature. Pediatr Nephrol. 2006 Nov;21(11):1760-4. doi: 10.1007/s00467-006-0196-1. Epub 2006 Aug 1. PMID: 16897003.Phenazopyridine, Phenazopyridine Overview, About Phenazopyridine, Phenazopyridine Mechanism of Action, How to Use Phenazopyridine, Phenazopyridine Dosage, Dosage strength of Phenazopyridine, Dosage Forms of Phenazopyridine, Phenazopyridine side effect, Dietary Restrictions of Phenazopyridine, Phenazopyridine Contraindications, Phenazopyridine Warnings, Adverse Reactions of Phenazopyridine, Phenazopyridine Overdosage, Pharmacology of Phenazopyridine, Phenazopyridine Duration of action.
- KD Tripathi. [link]. Seventh Edition. New Delhi, India: Jaypee Brothers Medical Publishers; 2013: Page No 761
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm
- https://pdf.hres.ca/dpd_pm/00011122.PDF
- https://www.ncbi.nlm.nih.gov/books/NBK580545/
Dr. Chumbeni E Lotha has completed her Bachelor of Pharmacy from RIPANS, Mizoram and Doctor of Pharmacy from SGRRU,Dehradun. She can be reached at editorial@medicaldialogues.in
Dr JUHI SINGLA has completed her MBBS from Era’s Lucknow Medical college and done MD pharmacology from SGT UNIVERSITY Gurgaon. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
Published on: 6 Dec 2023 4:41 PM GMT