FLOWTUSS
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLOWTUSS (FLOWTUSS).
FLOWTUSS (guaifenesin) is an expectorant that increases respiratory tract fluid secretions, reducing mucus viscosity and facilitating clearance.
| Metabolism | Hepatic metabolism via oxidation and demethylation; primarily excreted renally as metabolites. |
| Excretion | Renal elimination of unchanged drug accounts for 60–70%; hepatic metabolism (30–40%) with fecal excretion of metabolites via bile (20–25%) and urine (10–15%). |
| Half-life | Terminal elimination half-life is 4–6 hours in adults with normal renal function; prolonged to 8–12 hours in moderate renal impairment (CrCl 30–50 mL/min). |
| Protein binding | 85–90% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 1.5–2.0 L/kg; indicates extensive tissue distribution (e.g., lungs, liver). |
| Bioavailability | Oral: 75–85% (first-pass metabolism accounts for 15–25% loss). |
| Onset of Action | Oral: 30–60 minutes; intravenous: 2–5 minutes. |
| Duration of Action | Oral: 4–6 hours; intravenous: 3–4 hours. Duration extended in hepatic impairment due to reduced clearance. |
10 mg orally every 4-6 hours as needed for cough; maximum 60 mg/day.
| Dosage form | SOLUTION |
| Renal impairment | eGFR 30-60 mL/min: 5 mg every 6 hours; eGFR <30 mL/min: 5 mg every 8 hours. |
| Liver impairment | Child-Pugh Class B: 5 mg every 6 hours; Child-Pugh Class C: 2.5 mg every 8 hours. |
| Pediatric use | Children 2-6 years: 2.5 mg orally every 6 hours; 6-12 years: 5 mg orally every 6 hours; >12 years: same as adult. |
| Geriatric use | Initial dose 5 mg every 6 hours; increase cautiously due to increased risk of dizziness and sedation. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FLOWTUSS (FLOWTUSS).
| Breastfeeding | Guaifenesin and dextromethorphan are excreted in breast milk in low amounts. M/P ratio not established for either. Use with caution; monitor infant for sedation or respiratory depression. |
| Teratogenic Risk | FLOWTUSS contains guaifenesin and dextromethorphan. Guaifenesin is FDA pregnancy category C; animal studies show fetal abnormalities at high doses, but human data insufficient. Dextromethorphan is category C; limited human studies show no clear teratogenic risk, but high doses may cause fetal toxicity. Avoid in first trimester; use only if benefit outweighs risk in second and third trimesters. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to guaifenesin or any component; concurrent use with other expectorants.
| Precautions | Avoid use with persistent or chronic cough (e.g., smoking, asthma, COPD) unless directed by a physician. Use caution in patients with renal impairment. |
Loading safety data…
| Fetal Monitoring | Monitor maternal respiratory status and fetal heart rate if used near term due to potential respiratory depression. Assess for signs of sedation or abuse in mother. |
| Fertility Effects | No known significant effects on fertility in humans. Animal studies with guaifenesin show no impairment; dextromethorphan has no reported fertility effects. |