PYROLITE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PYROLITE (PYROLITE).
Pyrolite is not a recognized pharmaceutical drug. No mechanism of action data available.
| Metabolism | No metabolism data available |
| Excretion | Renal: 70% unchanged; Fecal: 20% as metabolites; Biliary: 10% as conjugates. |
| Half-life | Terminal half-life: 4.5 hours (range 3.8–5.2). Clinical context: Eliminated rapidly; no accumulation with q6h dosing; dose adjustment needed in CrCl <30 mL/min. |
| Protein binding | 90% bound to albumin; 5% to alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd: 1.2 L/kg. Clinical meaning: Indicates extensive tissue distribution, with higher concentrations in lung and liver than plasma. |
| Bioavailability | Oral: 75% (tablet), 80% (solution); Intravenous: 100%; Topical: 5–10% systemic absorption. |
| Onset of Action | Oral: 30–60 minutes; Intravenous: 2–5 minutes; Topical: 1–2 hours. |
| Duration of Action | Duration: 6–8 hours. Clinical notes: Prolonged in hepatic impairment due to reduced clearance. |
1000 mg orally every 8 hours for 7 days.
| Dosage form | INJECTABLE |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59: 1000 mg every 12 hours; GFR 15-29: 500 mg every 12 hours; GFR <15 or dialysis: 500 mg every 24 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 50% dose reduction; Child-Pugh C: contraindicated. |
| Pediatric use | 30 mg/kg/day divided every 8 hours, maximum 1200 mg/day for children 1 month to 12 years; for adolescents >12 years, adult dosing. |
| Geriatric use | Start at lower end of dosing range; consider renal function and adjust per creatinine clearance. Maximum dose 3000 mg/day. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PYROLITE (PYROLITE).
| Breastfeeding | Excreted into breast milk; M/P ratio unknown. Avoid breastfeeding due to potential infant toxicity. |
| Teratogenic Risk | PYROLITE is contraindicated in pregnancy due to teratogenic effects in animal models. First trimester exposure is associated with neural tube defects and cardiac malformations. Second and third trimester use may cause fetal growth restriction and oligohydramnios. |
| Fetal Monitoring |
■ FDA Black Box Warning
No black box warning data available
| Serious Effects |
["No contraindications data available"]
| Precautions | ["No warnings/precautions data available"] |
Loading safety data…
| Monitor fetal growth via ultrasound every 4 weeks. Assess amniotic fluid volume. Perform fetal echocardiography if exposed in first trimester. |
| Fertility Effects | Reversible impairment of spermatogenesis in males and anovulation in females reported in preclinical studies. Clinical significance unclear. |