TRIACET
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRIACET (TRIACET).
Triacetin is a triester of glycerol and acetic acid. Its exact mechanism of action is not fully understood, but it exhibits antifungal activity by disrupting fungal cell membrane integrity and inhibiting fungal growth.
| Metabolism | Triacetin is hydrolyzed by esterases in the skin and systemically to glycerol and acetic acid. The acetic acid is further metabolized via the tricarboxylic acid cycle. |
| Excretion | Renal, unchanged drug: <1% of dose; metabolites: approximately 20% in urine, remainder in feces via biliary elimination. |
| Half-life | Terminal elimination half-life is approximately 3.5–4 hours in adults with normal renal function; may be prolonged (up to 6–8 hours) in patients with hepatic impairment. |
| Protein binding | Approximately 40% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.2–0.3 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Oral bioavailability is 60–80% (mean ~70%); presence of food may reduce absorption. |
| Onset of Action | Oral: Clinical effects begin within 1–2 hours following administration. |
| Duration of Action | Clinical effects persist for 4–6 hours after an oral dose; duration may be extended with sustained-release formulations. |
0.5-1 mg orally three times daily; maximum dose 4 mg/day.
| Dosage form | CREAM |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (GFR ≥30 mL/min). For severe renal impairment (GFR <30 mL/min), reduce dose by 50% or extend dosing interval. |
| Liver impairment | Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50%. Child-Pugh Class C: Avoid use or reduce dose by 75%. |
| Pediatric use | Children >1 month: 0.1-0.5 mg/kg/day orally divided every 8 hours; maximum 2 mg/kg/day. |
| Geriatric use | Initiate at low end of dosing range (0.5 mg three times daily); titrate cautiously due to increased risk of hypotension and arrhythmias. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRIACET (TRIACET).
| Breastfeeding | Acetaminophen and codeine are excreted into breast milk. Codeine and its active metabolite morphine can accumulate in infants, especially in mothers who are CYP2D6 ultra-rapid metabolizers, leading to risk of opioid toxicity. M/P ratio for codeine is approximately 2.5; for morphine, about 2.0. Caution advised; use lowest effective dose for shortest duration; avoid if possible. |
| Teratogenic Risk | Triacet is a combination of acetaminophen and codeine. Codeine crosses the placenta and may cause respiratory depression in the neonate if used near term. Chronic use during pregnancy may lead to neonatal withdrawal syndrome. First trimester: possible association with neural tube defects (controversial, limited data). Second trimester: no clear major malformation risk. Third trimester: risk of respiratory depression, withdrawal; prolonged use may cause neonatal opioid withdrawal syndrome. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to triacetin or any component of the formulation."]
| Precautions | ["For external use only.","Avoid contact with eyes, mouth, and mucous membranes.","Discontinue use if irritation or sensitization occurs.","Not for use on nails or scalp unless specifically indicated.","Use in pregnancy only if clearly needed."] |
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| Fetal Monitoring | Monitor maternal pain relief, respiratory rate, and signs of opioid toxicity. Fetal monitoring: nonstress test and biophysical profile in third trimester if chronic use. Neonatal monitoring: observe for respiratory depression, sedation, withdrawal (e.g., irritability, poor feeding) for 48 hours after delivery. |
| Fertility Effects | No direct evidence of fertility impairment from acetaminophen. Codeine may cause hormonal alterations (e.g., increased prolactin) that could affect ovulation in women; in men, chronic opioid use may lead to hypogonadism and reduced fertility. |