Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
BACTRIM PEDIATRIC vs AZO GANTANOL
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Bactrim (sulfamethoxazole/trimethoprim) is a combination of two antifolate agents. Sulfamethoxazole inhibits dihydropteroate synthase, blocking the conversion of PABA to dihydrofolic acid. Trimethoprim inhibits dihydrofolate reductase, preventing the reduction of dihydrofolic acid to tetrahydrofolic acid. Sequential blockade of folate synthesis leads to bacteriostasis.
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.
Urinary tract infections due to susceptible strains of E. coli, Klebsiella, Enterobacter, Morganella, Proteus, and Providencia,Acute otitis media in children,Acute exacerbations of chronic bronchitis in adults,Shigellosis,Pneumocystis jirovecii pneumonia (PCP) prophylaxis and treatment,Traveler's diarrhea (FDA-approved),Toxoplasmosis (off-label),Nocardiosis (off-label),Chancroid (off-label),Brucellosis (off-label)
Urinary tract infections (UTIs) when sulfonamide therapy is indicated (FDA),Pain relief of urinary tract irritation (phenazopyridine component)
Oral: 160 mg trimethoprim / 800 mg sulfamethoxazole (one DS tablet) every 12 hours for 14 days. For Pneumocystis jirovecii pneumonia: 15-20 mg/kg/day of trimethoprim component divided every 6-8 hours.
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.
Sulfamethoxazole: 9-12 hours (prolonged in renal impairment; up to 30 hours with Cr Cl <30 m L/min). Trimethoprim: 8-10 hours (prolonged to 20-30 hours in severe renal impairment).
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 is metabolized via acetylation and glucuronidation; trimethoprim is metabolized via oxidation (demethylation) and conjugation. CYP450 enzymes have minor involvement.
Sulfamethoxazole is primarily metabolized by N-acetylation in the liver (N-acetyltransferase 2); phenazopyridine is metabolized in the liver via glucuronidation and sulfation.
Renal: sulfamethoxazole 85% (30% unchanged, rest as acetylated and glucuronide conjugates), trimethoprim 60-80% (10-30% unchanged). Fecal/biliary: <4%.
Renal: 70% as sulfamethoxazole (30% acetylated), N5-acetylated metabolite accounts for 15%; fecal: 20% of dose excreted unchanged in bile; biliary: minor contribution (<5%)
Sulfamethoxazole: 70% bound to albumin. Trimethoprim: 42-46% bound to albumin and alpha-1-acid glycoprotein.
Sulfamethoxazole: 65-70% bound to albumin; phenazopyridine: >99% bound (mainly to albumin)
Sulfamethoxazole: 0.15-0.3 L/kg. Trimethoprim: 1.3-2.0 L/kg indicating extensive tissue distribution.
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)
Oral: sulfamethoxazole 100%; trimethoprim 100% (both well absorbed).
Oral sulfamethoxazole: 85-95% (well absorbed); phenazopyridine: approximately 90% absorbed
Cr Cl >30 m L/min: No adjustment. Cr Cl 15-30 m L/min: Reduce dose by 50% (e.g., one DS tablet every 24 hours). Cr Cl <15 m L/min: Contraindicated (unless with hemodialysis). For PJP: Cr Cl 15-29 m L/min: 15-20 mg/kg/day (trimethoprim) divided every 8 hours; Cr Cl <15 m L/min: Not recommended.
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.
Child-Pugh Class A: No adjustment. Child-Pugh Class B: Caution; consider reducing dose or monitoring liver function. Child-Pugh Class C: Avoid use due to potential hepatotoxicity and altered metabolism.
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.
Trimethoprim component dosing: 8 mg/kg/day divided every 12 hours for urinary tract infection or otitis media. For Pneumocystis jirovecii pneumonia (PJP) prophylaxis: 150 mg/m2/day of trimethoprim divided every 12 hours, given 3 times per week. For PJP treatment: 15-20 mg/kg/day of trimethoprim divided every 6-8 hours. Maximum daily dose: 960 mg trimethoprim.
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.
Monitor renal function and adjust dose based on Cr Cl. Increased risk of hyperkalemia, hematologic toxicity, and adverse reactions. Consider starting at lower end of dosing range. Avoid in patients with Cr Cl <15 m L/min.
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.
Fatalities associated with sulfonamide hypersensitivity reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias have been reported. Use in pregnant women at term and in nursing mothers may cause kernicterus.
Sulfonamides, including sulfamethoxazole, may cause severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and agranulocytosis.
Monitor for hypersensitivity reactions, blood dyscrasias, and hepatic injury. Caution in elderly, folate deficiency, impaired renal/hepatic function, G6PD deficiency, and severe allergies or bronchial asthma. Avoid in infants <2 months of age. Use with caution in patients with porphyria or thyroid dysfunction.
Risk of hypersensitivity reactions including SJS/TEN; blood dyscrasias (agranulocytosis, aplastic anemia); hepatotoxicity; renal impairment; photosensitivity; interference with urine glucose tests.
Hypersensitivity to any component (sulfonamides, trimethoprim), severe liver damage, marked renal impairment (Cr Cl <15 ml/min), megaloblastic anemia due to folate deficiency, pregnancy at term, nursing mothers, infants <2 months of age.
Hypersensitivity to sulfonamides or phenazopyridine; porphyria; severe renal impairment (Cr Cl <30 m L/min); G6PD deficiency; infants <2 months; pregnancy at term; lactation.
Avoid high-potassium foods if at risk for hyperkalemia (e.g., bananas, oranges, salt substitutes). May reduce folic acid levels; encourage folate-rich foods (leafy greens, legumes). Take with food if GI upset occurs. Avoid alcohol due to disulfiram-like reaction.
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.
First trimester: associated with increased risk of neural tube defects, cardiovascular malformations, and urinary tract anomalies due to folate antagonism (trimethoprim). Second and third trimesters: risk of kernicterus in the newborn due to sulfamethoxazole displacing bilirubin from albumin. Avoid during pregnancy, especially in the first and third trimesters.
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.
Both components are excreted in breast milk. M/P ratio for sulfamethoxazole is approximately 0.3; for trimethoprim, approximately 1.1. Caution in infants with G6PD deficiency, hyperbilirubinemia, or jaundice. Consider alternatives, especially in preterm or sick infants.
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.
Dose adjustments are not specifically recommended for pregnancy, but use with caution. Monitor serum drug levels if prolonged therapy. Avoid sulfamethoxazole near term due to risk of kernicterus. Ensure adequate folic acid supplementation (5 mg daily) to mitigate folate antagonism.
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.
Bactrim Pediatric (sulfamethoxazole/trimethoprim) is contraindicated in infants <2 months due to risk of kernicterus. Monitor for hyperkalemia, especially in elderly or renal impairment. Use with caution in folate deficiency; supplement folinic acid if prolonged therapy. Avoid in G6PD deficiency due to hemolytic anemia risk.
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).
Take with a full glass of water to prevent crystalluria.,Complete full course even if symptoms improve.,Avoid prolonged sun exposure; use sunscreen.,Report rash, fever, sore throat, or bruising immediately.,Do not use if allergic to sulfa drugs or thiazide diuretics.
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.
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 BACTRIM PEDIATRIC vs AZO GANTANOL, answered by our medical review team.
BACTRIM PEDIATRIC is a Sulfonamide Antibiotic Combination that works by Bactrim (sulfamethoxazole/trimethoprim) is a combination of two antifolate agents. Sulfamethoxazole inhibits dihydropteroate synthase, blocking the conversion of PABA to dihydrofolic acid. Trimethoprim inhibits dihydrofolate reductase, preventing the reduction of dihydrofolic acid to tetrahydrofolic acid. Sequential blockade of folate synthesis leads to bacteriostasis.. 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.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between BACTRIM PEDIATRIC and AZO GANTANOL 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 BACTRIM PEDIATRIC is: Oral: 160 mg trimethoprim / 800 mg sulfamethoxazole (one DS tablet) every 12 hours for 14 days. For Pneumocystis jirovecii pneumonia: 15-20 mg/kg/day of trimethoprim component divided every 6-8 hours.. 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.. 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 BACTRIM PEDIATRIC and AZO GANTANOL 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. BACTRIM PEDIATRIC is classified as Category C. First trimester: associated with increased risk of neural tube defects, cardiovascular malformations, and urinary tract anomalies due to folate antagonism (trimethoprim). Second an. 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. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.