Phenazopyridine
Indications
Registered South African indications:
- Short-term symptomatic relief of pain, burning, urgency and frequency arising from irritation of the lower urinary tract mucosa
Cautions
Contraindication
- Hypersensitivity to the active ingredient or any of its excipients
- Renal impairment
- Glomerulonephritis
- Uraemia
- Severe hepatitis
- Repeated or prolonged treatment without full diagnostic investigation
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency due to an increased risk of severe haemolytic anaemia
- Pregnancy
- Lactation
Caution
- Concomitant use of contact lenses
- Repeated or prolonged treatment
Adult dosage (ZA)
Forms avail. in SA and covered in this monograph: tab
South African registered indications and dosages
Short-term symptomatic relief of pain, burning, urgency and frequency arising from irritation of the lower urinary tract mucosa
- These symptoms may result from infection, trauma, surgery, endoscopic procedures, or passage of urethral or uterine sounds (in medicine, a “sound”, is an instrument for probing and dilating passages within the body) or catheters. The underlying cause of the irritation must be determined and treated (e.g. antibacterial therapy for infection)
- Oral (tab): 200mg, 3 times daily with or after meals; When used concurrently with an antibacterial medicine for the treatment of a urinary tract infection: Max duration: 2 days
Tablets should not be chewed
Paediatric dosage
No information available
Special populations
Pregnancy
- Contraindicated
Breastfeeding
- Contraindicated
Renal Impairment
- Contraindicated
Hepatic Impairment
- Severe hepatitis: Contraindicated
Elderly
- No dose adjustment recommended
Porphyria Information
- Not yet classified (NC)
Adverse reactions
Central Nervous System Disorders
- Headache
- Aseptic meningitis
Gastrointestinal Disorders
- Nausea and vomiting
- Diarrhoea
Hepatobiliary Disorders
- Hepatic toxicity
- Jaundice
Genitourinary Disorders
- Renal calculi
- Renal toxicity
- Discolouration of bodily fluids
Skin and Subcutaneous Tissue Disorders
- Rash
- Pruritus
- Discolouration
Immune, Blood and Lymphatic System Disorders
- Anaphylactoid reactions
- Hypersensitivity hepatitis
- Methaemoglobinaemia
- Haemolytic anaemia
- Potential haemolytic agent in glucose-6-phosphate dehydrogenase deficiency
- Sulfhaemoglobinaemia
Sensory Disorders
- Visual disturbances
Interactions
- Dapsone
- Nitric oxide
- Prilocaine
- Sodium nitrite
- Tetracaine
Monitoring
None routine
Mechanism of action
Phenazopyridine has a direct topical analgesic effect on the mucosa lining of the urinary tract. Its exact mechanism of action is not well known.
Dosage forms
- Tablet
Formulation
Tablet 100mg
- Pyridium (Biotech) originator
References
1. Mims_Volume 57_No.2_March 2017_Page 261 2. https://drive.google.com/drive/folders/0B0xnChtF7vduRkp1RGRYU3lBRVU (23/12/1996_Biotech_Pyridium_100mg_tab) 3. https://www.uptodate.com/contents/phenazopyridine-drug-information?source=search_result&search=phenazopyridine&selectedTitle=1~45 (as accessed on 1/6/2-17) 4. https://www.drugs.com/pregnancy/phenazopyridine.html (as accessed on 1/6/2017) 5. Pyridium, drugs.com; Downloaded online: 20 Apr 2020 [https://www.drugs.com/pregnancy/phenazopyridine.html] 6. NAPOS The Drug Database for Acute Porphyria; G04BX06 Phenazopyridine; Accessed online: 20 Apr 2020 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=G04BX06] 7. AfriTox: Phenazopyridine hydrochloride; Accessed online 15 July 2020 [https://www.afritox.co.za/hp/SingleToxin/SingleToxin.aspx?SingleToxinID=3186] 8. PI - PYRIDIUM 100 mg (tablets), Biotech Laboratories (Pty) Ltd - DATE OF REVISION OF THE TEXT 11 June 2024 Downloaded from SAHPRA 01 November 2024 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2024/07/1.3.1.1-pi-approved-pyridium-0004.pdf] **No SPC available
Brands & products
1 product · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days oldtabletGeneric· 1 product
from R7.42/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Pyridium | 100 mg | 20 | S2 | R148.42 | R7.42 | R63.23 | 758647034 |
- Pyridium
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.