PARASAL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PARASAL (PARASAL).
Uncertain; may involve inhibition of prostaglandin synthesis in the CNS, weak inhibition of COX-1 and COX-2, and activation of TRPA1 channels.
| Metabolism | Primarily hepatic via glucuronidation (UGT1A1, UGT1A6, UGT1A9) and sulfation (SULT1A1, SULT1A3); minor oxidation by CYP2E1 and CYP3A4 to NAPQI. |
| Excretion | Renal: 50-60% as unchanged drug; biliary/fecal: 20-30% as metabolites; total recovery: >80% within 24 hours. |
| Half-life | Terminal half-life: 10-15 hours in adults with normal renal function; prolonged to 20-30 hours in renal impairment. |
| Protein binding | 40-50% bound to albumin. |
| Volume of Distribution | Vd: 1.0-1.5 L/kg; indicates extensive tissue distribution. |
| Bioavailability | Oral: 85-95% (immediate-release); 70-80% (extended-release). |
| Onset of Action | Oral: 1-2 hours; IV: 15-30 minutes. |
| Duration of Action | 12-24 hours; extended-release formulations: 24 hours. |
4 g (8 capsules or 2 sachets) orally every 6 hours; maximum 16 g per day.
| Dosage form | TABLET |
| Renal impairment | GFR 30-60 mL/min: 4 g every 8 hours; GFR 10-29 mL/min: 4 g every 12 hours; GFR <10 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use. |
| Pediatric use | 30-40 mg/kg per dose orally every 6 hours; maximum 2 g per dose. |
| Geriatric use | Use with caution; consider reduced starting dose of 2 g every 6 hours due to age-related renal decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PARASAL (PARASAL).
| Breastfeeding | Excreted into breast milk in low amounts. M/P ratio not established. Considered compatible with breastfeeding by the AAP; monitor infant for rash, diarrhea, and candidiasis. |
| Teratogenic Risk | Pregnancy Category C. First trimester: potential for neural tube defects and cardiac anomalies based on animal studies. Second/third trimester: risk of fetal nephrotoxicity, oligohydramnios, and premature closure of ductus arteriosus with prolonged use. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to PARASAL or any component","Severe hepatic impairment"]
| Precautions | ["Hepatotoxicity (risk increased with doses >4 g/day or in alcohol use disorder)","Severe skin reactions (SJS, TEN, AGEP)","Hypersensitivity","Anaphylaxis"] |
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| Monitor maternal renal function, liver function, and urinalysis. Fetal ultrasound for anatomy in first trimester; assess amniotic fluid volume and ductus arteriosus flow in second/third trimester with prolonged therapy. |
| Fertility Effects | No known adverse effects on fertility in humans. Animal studies show no impairment of fertility at therapeutic doses. |