SECREFLO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SECREFLO (SECREFLO).
SecReFlo is a selective serotonin reuptake inhibitor (SSRI) that potentiates serotonergic activity by inhibiting presynaptic serotonin reuptake.
| Metabolism | Primarily hepatic via CYP2D6; active metabolite N-desmethylsecreflo; half-life approximately 24 hours. |
| Excretion | Renal: 75% as unchanged drug; fecal: 20%; biliary: 5%. Total clearance is 0.8 L/h/kg, with renal clearance accounting for 0.6 L/h/kg, indicating active tubular secretion. |
| Half-life | Terminal elimination half-life is 2.5 hours in patients with normal renal function. In moderate renal impairment (CrCl 30-50 mL/min), half-life increases to 4.5 hours; in severe impairment (<30 mL/min), half-life is 8 hours, requiring dosage adjustment. |
| Protein binding | Plasma protein binding is 95%, primarily to albumin (98% of bound fraction) with minor binding to alpha-1-acid glycoprotein. |
| Volume of Distribution | Volume of distribution is 0.5 L/kg (range 0.4-0.6 L/kg), indicating moderate tissue distribution. Central compartment Vd is 0.15 L/kg, peripheral compartment Vd is 0.35 L/kg. |
| Bioavailability | Oral bioavailability is 60% (range 50-70%) due to first-pass metabolism. Food reduces bioavailability by 20% (absolute difference), so administer on an empty stomach. |
| Onset of Action | Oral: 1-2 hours; Intravenous: 0.5-1 hour. Clinical effect correlates with plasma concentration above 0.5 mcg/mL. |
| Duration of Action | Duration is 6-8 hours following oral administration, consistent with dosing every 8 hours. For IV, duration is 4-6 hours. Continuous infusion may be used for sustained effect. |
One inhalation (200 mcg albuterol sulfate/80 mcg ipratropium bromide) orally 4 times daily via metered-dose inhaler. May increase to 2 inhalations 4 times daily if needed.
| Dosage form | FOR SOLUTION |
| Renal impairment | No specific dose adjustment recommended based on GFR; use caution if GFR < 30 mL/min due to potential systemic accumulation of ipratropium. |
| Liver impairment | No specific dose adjustment recommended based on Child-Pugh class; use caution in severe hepatic impairment. |
| Pediatric use | Not indicated for children <18 years. For pediatric use, alternative formulations should be used. |
| Geriatric use | No specific dose adjustment recommended; monitor for anticholinergic side effects (e.g., confusion, constipation, urinary retention) in elderly patients. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SECREFLO (SECREFLO).
| Breastfeeding | Unknown if excreted in human milk. Fluticasone furoate: low potential for milk excretion due to high protein binding and large volume of distribution. Umeclidinium: unlikely to be excreted due to quaternary ammonium structure. Vilanterol: likely excreted in trace amounts. Benefit of breast-feeding should be weighed against potential for infant effects. M/P ratio not available for any component. |
| Teratogenic Risk | SECREFLO (fluticasone furoate/umeclidinium/vilanterol) is an ICS/LAMA/LABA combination. No adequate human studies; animal studies show no teratogenicity at exposures >100x MRHD. Use only if benefit outweighs risk. First trimester: Avoid unless necessary; no known major malformations. Second/third trimester: May use if needed for asthma/COPD control; monitor for fetal growth restriction. Late third trimester: Risk of neonatal hypoglycemia, bradycardia, and respiratory depression from LABA component. |
■ FDA Black Box Warning
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for clinical worsening and emergence of suicidality.
| Serious Effects |
["Concomitant use with MAOIs","Concomitant use with pimozide","Hypersensitivity to secreflo or any component"]
| Precautions | ["Serotonin syndrome","Increased risk of bleeding","Activation of mania/hypomania","Seizures","Angle-closure glaucoma","Hyponatremia"] |
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| Fetal Monitoring | Monitor maternal pulmonary function, asthma symptoms, and peak expiratory flow. During pregnancy: fetal growth scans (serial ultrasound), nonstress test in third trimester. Monitor for signs of preterm labor (LABA may cause uterine relaxation). Regular blood pressure and heart rate monitoring due to LABA. Check serum glucose in diabetic mothers. In neonates: observe for hypoglycemia, bradycardia, respiratory depression. |
| Fertility Effects | No human data. Animal studies: fluticasone furoate had no effect on fertility in rats; umeclidinium showed no impairment; vilanterol at oral doses up to 10 mg/kg/day (approx. 500x MRHD) showed no effect on fertility in rats. Clinical relevance unknown. LABA may theoretically affect uterine contractility. |