Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
AZO GANTANOL vs BACTRIM DS
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Phenazopyridine is an azo dye with local analgesic effect on urinary tract mucosa via unknown mechanism; sulfamethoxazole is a sulfonamide antibiotic that inhibits bacterial dihydropteroate synthase, blocking folate synthesis.
BACTRIM DS is a combination of sulfamethoxazole and trimethoprim. Sulfamethoxazole inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA), while trimethoprim inhibits dihydrofolate reductase, blocking reduction of dihydrofolate to tetrahydrofolate. This sequential blockade of folic acid synthesis leads to bactericidal action.
Urinary tract infections (UTIs) when sulfonamide therapy is indicated (FDA),Pain relief of urinary tract irritation (phenazopyridine component)
FDA-approved: Urinary tract infections, acute otitis media, acute exacerbations of chronic bronchitis, traveler's diarrhea, shigellosis, Pneumocystis jirovecii pneumonia (PCP), toxoplasmosis,Off-label: Methicillin-resistant Staphylococcus aureus (MRSA) infections, Stenotrophomonas maltophilia infections, nocardiosis, Wegener's granulomatosis (as second-line therapy), inflammatory bowel disease
AZO GANTANOL (phenazopyridine + sulfamethoxazole) is not a standard combination product. Assuming separate components: Sulfamethoxazole 800 mg and Trimethoprim 160 mg (as Bactrim DS) orally every 12 hours. For phenazopyridine: 200 mg orally three times daily after meals.
One double-strength tablet (trimethoprim 160 mg-sulfamethoxazole 800 mg) orally every 12 hours.
Sulfamethoxazole terminal half-life: 9-12 hours in adults with normal renal function (Cr Cl >80 m L/min); prolonged to 20-50 hours in CKD (Cr Cl <30 m L/min); phenazopyridine half-life: 9-11 hours
Sulfamethoxazole: 8-10 hours; Trimethoprim: 8-12 hours; prolonged in renal impairment (creatinine clearance <30 m L/min: up to 24-48 hours).
Sulfamethoxazole is primarily metabolized by N-acetylation in the liver (N-acetyltransferase 2); phenazopyridine is metabolized in the liver via glucuronidation and sulfation.
Sulfamethoxazole is metabolized primarily by N-acetylation and glucuronidation; trimethoprim is metabolized by O-demethylation and N-oxidation. Both are eliminated renally via glomerular filtration and tubular secretion.
Renal: 70% as sulfamethoxazole (30% acetylated), N5-acetylated metabolite accounts for 15%; fecal: 20% of dose excreted unchanged in bile; biliary: minor contribution (<5%)
Renal: 50-70% as sulfamethoxazole (unchanged and acetylated metabolite), 40-60% as trimethoprim (unchanged); biliary: <10% for both; fecal: <4%.
Sulfamethoxazole: 65-70% bound to albumin; phenazopyridine: >99% bound (mainly to albumin)
Sulfamethoxazole: 68% bound (albumin); Trimethoprim: 44% bound (albumin, alpha-1-acid glycoprotein).
Sulfamethoxazole: 0.21-0.28 L/kg (for a 70 kg person: ~15-20 L); phenazopyridine: 4.5-5.5 L/kg (extensive tissue binding, e.g., urinary tract)
Sulfamethoxazole: 0.21 L/kg; Trimethoprim: 1.3-1.8 L/kg (wide distribution, higher in tissues than plasma).
Oral sulfamethoxazole: 85-95% (well absorbed); phenazopyridine: approximately 90% absorbed
Oral: >90% for both components; IV: 100%.
Sulfamethoxazole/Trimethoprim: Cr Cl >30 m L/min: no adjustment; Cr Cl 15-30 m L/min: reduce standard dose by 50% or extend interval to 24 hours; Cr Cl <15 m L/min: contraindicated. Phenazopyridine: contraindicated in renal impairment.
Cr Cl >30 m L/min: No adjustment; Cr Cl 15-30 m L/min: 50% of usual dose every 12 hours; Cr Cl <15 m L/min: Not recommended.
Sulfamethoxazole/Trimethoprim: Child-Pugh A: no adjustment; Child-Pugh B: use with caution, no specific dose reduction; Child-Pugh C: contraindicated (risk of hepatotoxicity). Phenazopyridine: cautious use in severe hepatic impairment.
Child-Pugh Class A: No adjustment; Child-Pugh Class B: Use with caution, no specific dose recommendation; Child-Pugh Class C: Contraindicated.
Sulfamethoxazole/Trimethoprim: 6-12 mg/kg/day of trimethoprim component divided every 12 hours; maximum 320 mg trimethoprim/day. Phenazopyridine: not recommended in children <12 years.
Based on trimethoprim component: 8 mg/kg/day of trimethoprim divided every 12 hours. For severe infections, up to 20 mg/kg/day of trimethoprim divided every 6 hours.
Sulfamethoxazole/Trimethoprim: monitor renal function; reduce dose if Cr Cl <30 m L/min. Increased risk of hyperkalemia and sulfonamide-induced adverse effects. Phenazopyridine: cautious use due to potential renal impairment and CNS effects.
Monitor renal function; adjust dose based on Cr Cl. Increased risk of hyperkalemia and folate deficiency; consider folate supplementation.
Sulfonamides, including sulfamethoxazole, may cause severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and agranulocytosis.
BACTRIM DS carries a black box warning for severe hypersensitivity reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and fulminant hepatic necrosis. Also warns about fatal reactions such as agranulocytosis, aplastic anemia, and other blood dyscrasias. Additionally, use in pregnancy at term may cause kernicterus in the newborn.
Risk of hypersensitivity reactions including SJS/TEN; blood dyscrasias (agranulocytosis, aplastic anemia); hepatotoxicity; renal impairment; photosensitivity; interference with urine glucose tests.
Hypersensitivity reactions: risk of SJS/TEN, especially in patients with HIV, folate deficiency, or genetic susceptibility (e.g., HLA-B*1502, HLA-A*3101). Discontinue at first sign of rash.,Hematologic toxicity: monitor CBCs; caution in patients with folate deficiency, renal impairment, or prolonged therapy.,Hepatic toxicity: can cause cholestatic jaundice, hepatic necrosis; avoid in hepatic impairment.,Renal toxicity: maintain adequate hydration to prevent crystalluria; adjust dose in renal impairment.,Hyperkalemia: risk with high-dose trimethoprim; monitor potassium, especially in patients with renal dysfunction or on potassium-sparing diuretics.,Hypoglycemia: risk in patients with renal impairment or malnutrition; caution with sulfonylureas.,Photosensitivity: avoid excessive sun exposure.,Pregnancy: avoid at term due to risk of kernicterus; use only if benefit outweighs risk.,Lactation: caution due to potential for kernicterus in infants with G6PD deficiency.
Hypersensitivity to sulfonamides or phenazopyridine; porphyria; severe renal impairment (Cr Cl <30 m L/min); G6PD deficiency; infants <2 months; pregnancy at term; lactation.
Hypersensitivity to sulfamethoxazole, trimethoprim, or any component.,History of drug-induced immune thrombocytopenia with sulfonamides or trimethoprim.,Severe hepatic disease (e.g., acute hepatitis, cirrhosis with jaundice).,Severe renal impairment (Cr Cl <15 m L/min) unless dialysis is available.,Megaloblastic anemia due to folate deficiency.,Pregnancy at term and nursing mothers (due to risk of kernicterus).,Concurrent use with dofetilide (increased risk of arrhythmias).,Infants <2 months of age (sulfonamides can cause kernicterus).
Avoid foods high in vitamin K (e.g., leafy greens) as sulfamethoxazole may potentiate warfarin effects. Maintain adequate fluid intake; dehydration increases crystalluria risk. No specific food avoidance required beyond general hydration.
Avoid high-potassium foods (e.g., bananas, oranges, potatoes) as trimethoprim can increase serum potassium. Avoid alcohol, which may cause disulfiram-like reaction (flushing, nausea, tachycardia). No significant food-drug interactions beyond potassium and alcohol.
Phenazopyridine: No adequate studies; animal studies show no fetal harm but not conclusive. Sulfamethoxazole: First trimester – Possible increased risk of neural tube defects; second and third trimesters – Risk of kernicterus in neonate due to bilirubin displacement; avoid near term. Trimethoprim: First trimester – Folate antagonist, increased risk of neural tube defects and cardiovascular anomalies; second and third trimesters – No specific documented risks but theoretical folate antagonism.
First trimester: Folate antagonist; associated with neural tube defects, cardiovascular malformations, and cleft palate. Second trimester: Growth restriction, preterm birth. Third trimester: Kernicterus risk due to bilirubin displacement from albumin. Avoid during entire pregnancy.
Phenazopyridine: Excreted in breast milk; significance unknown; use caution. Sulfamethoxazole: Excreted in breast milk; M/P ratio ~0.2-0.3; risk of kernicterus in jaundiced or G6PD-deficient infants; avoid in nursing mothers of ill or premature infants. Trimethoprim: Excreted in breast milk; M/P ratio ~0.8-1.0; considered compatible by AAP but monitor infant for folate deficiency.
Breastfeeding safety: Both trimethoprim and sulfamethoxazole are excreted into breast milk; M/P ratio for trimethoprim ~1.25, sulfamethoxazole ~0.15. Caution in infants under 2 months or with G6PD deficiency; theoretical risk of kernicterus.
Pregnancy alters pharmacokinetics: Increased renal clearance may reduce sulfamethoxazole and trimethoprim levels; however, no dose adjustment is routinely recommended due to lack of data. Standard doses for urinary tract infection: one tablet (phenazopyridine 200 mg/sulfamethoxazole 400 mg/trimethoprim 80 mg) four times daily. Use lowest effective dose for shortest duration.
No standard dose adjustment recommended; avoid use if possible. If necessary, ensure adequate folic acid intake; may need to increase dose due to increased clearance in pregnancy, but specific data lacking.
AZO GANTANOL combines phenazopyridine (a urinary analgesic) with sulfamethoxazole (a sulfonamide antibiotic). Monitor for sulfonamide hypersensitivity reactions (e.g., Stevens-Johnson syndrome). Phenazopyridine discolors urine orange-red; advise patients to avoid confusion with hematuria. Adjust sulfamethoxazole dose in renal impairment (Cr Cl <30 m L/min contraindicated).
Bactrim DS (sulfamethoxazole/trimethoprim) is contraindicated in G6PD deficiency due to risk of hemolytic anemia. Monitor for hyperkalemia, especially in elderly or those with renal impairment. Caution with warfarin (potentiates anticoagulation). Avoid in pregnancy (teratogenic) and lactation. Use with caution in folate deficiency; supplement folate if needed.
Take with a full glass of water to reduce risk of crystalluria.,Urine may turn orange-red; this is harmless and subsides after stopping the drug.,Complete full course even if symptoms improve; do not skip doses.,Avoid prolonged sun exposure; sulfonamides cause photosensitivity.,Report rash, fever, sore throat, or unusual bruising immediately.
Take with a full glass of water and stay well-hydrated to prevent crystalluria.,Avoid prolonged sun exposure; use sunscreen as this drug may cause photosensitivity.,Complete the full course even if you feel better to prevent antibiotic resistance.,Report any skin rash, sore throat, fever, or unusual bleeding immediately.,Do not take if you are pregnant, planning to become pregnant, or breastfeeding.,Inform your doctor if you have kidney disease, G6PD deficiency, or are on blood thinners.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about AZO GANTANOL vs BACTRIM DS, answered by our medical review team.
AZO GANTANOL is a Sulfonamide Antibiotic that works by Phenazopyridine is an azo dye with local analgesic effect on urinary tract mucosa via unknown mechanism; sulfamethoxazole is a sulfonamide antibiotic that inhibits bacterial dihydropteroate synthase, blocking folate synthesis.. BACTRIM DS is a Sulfonamide Antibiotic Combination that works by BACTRIM DS is a combination of sulfamethoxazole and trimethoprim. Sulfamethoxazole inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA), while trimethoprim inhibits dihydrofolate reductase, blocking reduction of dihydrofolate to tetrahydrofolate. This sequential blockade of folic acid synthesis leads to bactericidal action.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between AZO GANTANOL and BACTRIM DS depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of AZO GANTANOL is: AZO GANTANOL (phenazopyridine + sulfamethoxazole) is not a standard combination product. Assuming separate components: Sulfamethoxazole 800 mg and Trimethoprim 160 mg (as Bactrim DS) orally every 12 hours. For phenazopyridine: 200 mg orally three times daily after meals.. The standard adult dose of BACTRIM DS is: One double-strength tablet (trimethoprim 160 mg-sulfamethoxazole 800 mg) orally every 12 hours.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between AZO GANTANOL and BACTRIM DS in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. AZO GANTANOL is classified as Category C. Phenazopyridine: No adequate studies; animal studies show no fetal harm but not conclusive. Sulfamethoxazole: First trimester – Possible increased risk of neural tube defects; seco. BACTRIM DS is classified as Category C. First trimester: Folate antagonist; associated with neural tube defects, cardiovascular malformations, and cleft palate. Second trimester: Growth restriction, preterm birth. Third . Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.