MUCOSIL-20
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MUCOSIL-20 (MUCOSIL-20).
Mucolytic agent that reduces mucus viscosity by breaking disulfide bonds in mucoproteins.
| Metabolism | Primarily hepatic via deacetylation to cysteine; further metabolized via various pathways. |
| Excretion | Primarily renal: 70-80% of the dose excreted unchanged in urine. Biliary/fecal elimination accounts for less than 10%. Approximately 5% is eliminated as metabolites. |
| Half-life | Terminal elimination half-life is 5-6 hours in adults with normal renal function. In patients with creatinine clearance <30 mL/min, half-life may extend to 15-20 hours, requiring dose adjustment. |
| Protein binding | Approximately 50-70% bound to plasma albumin. Binding is moderate and not clinically significant for drug interactions. |
| Volume of Distribution | 0.3-0.5 L/kg. Distributes widely into extracellular fluid; penetrates bronchial secretions and pleural fluid. In neonates, Vd may be higher (0.6-0.8 L/kg). |
| Bioavailability | Oral capsules: 6-10% due to extensive first-pass metabolism. Oral effervescent tablets: Similar low bioavailability. Intravenous: 100%. |
| Onset of Action | Oral: 30-60 minutes (mucolytic effect on sputum viscosity). Intravenous: 15-30 minutes (for acetaminophen overdose, onset of hepatic protection within 8-10 hours post-ingestion). |
| Duration of Action | Oral: 4-6 hours for mucolysis. Intravenous: 6-8 hours for protective effect in overdose; effect on sputum lasts up to 4 hours. Duration may be prolonged in hepatic impairment. |
1200 mg orally twice daily (2400 mg/day) or 600 mg orally three times daily.
| Dosage form | SOLUTION |
| Renal impairment | CrCl 30-50 mL/min: 600 mg orally twice daily; CrCl 10-29 mL/min: 600 mg orally once daily; CrCl <10 mL/min: 600 mg orally every 48 hours. |
| Liver impairment | Child-Pugh Class A: no adjustment required; Child-Pugh Class B: reduce dose by 50%; Child-Pugh Class C: use with caution, 600 mg orally once daily. |
| Pediatric use | 2-6 years: 200 mg orally twice daily; 6-12 years: 400 mg orally twice daily; >12 years: same as adult dosing. |
| Geriatric use | No specific adjustment required; monitor renal function and adjust dose accordingly based on CrCl. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MUCOSIL-20 (MUCOSIL-20).
| Breastfeeding | Not absorbed systemically; negligible transfer into breast milk. Considered compatible with breastfeeding. No M/P ratio available. |
| Teratogenic Risk | FDA Pregnancy Category B. No evidence of teratogenicity in animal studies; no adequate human studies in first trimester. No known fetal risk from secondhand exposure during maternal use. |
| Fetal Monitoring | No specific monitoring required beyond standard prenatal care. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to acetylcysteine; patients with severe asthma or history of bronchospasm (relative).
| Precautions | Potential bronchospasm, especially in asthmatics; may induce severe hypersensitivity reactions; caution in patients with peptic ulcer disease. |
Loading safety data…
| Fertility Effects | No known effects on fertility in animal or human studies. |