HEMANGEOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HEMANGEOL (HEMANGEOL).
Hemangeol (propranolol hydrochloride) is a non-selective beta-adrenergic receptor antagonist that competitively blocks beta-1 and beta-2 receptors. In infantile hemangioma, the exact mechanism is not fully understood, but proposed actions include vasoconstriction, inhibition of angiogenesis by downregulating VEGF and bFGF, and induction of apoptosis in endothelial cells.
| Metabolism | Primarily hepatic metabolism via CYP2D6, CYP1A2, and CYP2C19 to active metabolites (e.g., 4-hydroxypropranolol). |
| Excretion | Primarily hepatic metabolism via UGT1A9 and CYP2C9; <5% excreted unchanged in urine. Biliary/fecal elimination of metabolites; exact % not defined. |
| Half-life | 3-4 hours in infants (0-1 year) and 3.5-4.5 hours in children (1-6 years); clinical context: requires TID dosing to maintain therapeutic effect. |
| Protein binding | 90-95% primarily to albumin. |
| Volume of Distribution | 0.5-1.2 L/kg; suggests extensive tissue distribution, especially to highly perfused organs. |
| Bioavailability | Oral bioavailability approximately 25-30% due to extensive first-pass metabolism. |
| Onset of Action | 2-4 hours after oral administration for reduction in heart rate, 4-6 weeks for infantile hemangioma involution. |
| Duration of Action | Approximately 8-12 hours for hemodynamic effects; clinical notes: maximal effect on hemangioma growth cessation after 4-6 weeks of therapy. |
3 mg/kg/day orally divided into 2 doses for pediatric patients; adult use not indicated
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment recommended. Monitor renal function in patients with renal impairment. |
| Liver impairment | Avoid use in patients with severe hepatic impairment (Child-Pugh class C). Use with caution in moderate impairment (Child-Pugh class B). |
| Pediatric use | Initial dose 0.5 mg/kg twice daily, then increase weekly by 0.5 mg/kg/dose to target 1 mg/kg twice daily if tolerated. Treat for minimum 6 months. |
| Geriatric use | Not indicated for geriatric use; no specific recommendations. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HEMANGEOL (HEMANGEOL).
| Breastfeeding | Propranolol is excreted into breast milk. M/P ratio approximately 0.5-1.0. Infant dose ~1-5% of maternal weight-adjusted dose; usually considered safe but monitor infant for bradycardia, hypotension, and hypoglycemia. Use caution in preterm or low birth weight infants. |
| Teratogenic Risk | FDA Pregnancy Category C. In animal studies, propranolol (active metabolite) caused embryotoxicity (increased resorptions) and fetotoxicity (reduced fetal growth) at doses 10-30 times the maximum human dose. No adequate human studies. First trimester: theoretical risk of beta-blocker-induced fetal bradycardia and hypoglycemia. Second/third trimester: risk of intrauterine growth restriction (IUGR), neonatal bradycardia, hypoglycemia, and respiratory depression due to beta-blockade. Avoid in first trimester if possible; use only if benefit outweighs risk. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to propranolol or any component of the formulation","Bronchial asthma or history of bronchospasm","Sinus bradycardia, sick sinus syndrome, or heart block greater than first degree (unless pacemaker present)","Cardiogenic shock or decompensated heart failure","Hypotension","Pheochromocytoma (without alpha-blockade)","Premature infants with corrected gestational age < 5 weeks or weight < 2 kg"]
| Precautions | ["Risk of bradycardia and hypotension; monitor heart rate and blood pressure","Bronchospasm in patients with asthma or reactive airway disease","Hypoglycemia, especially in infants; monitor blood glucose","Masking signs of hyperthyroidism or hypoglycemia","Abrupt withdrawal may exacerbate symptoms of hyperthyroidism or cause myocardial ischemia","Use with caution in patients with renal or hepatic impairment","May exacerbate symptoms of peripheral vascular disease"] |
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| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and glucose. Fetal ultrasound for growth and amniotic fluid index during second/third trimester. Fetal heart rate monitoring for bradycardia. Neonatal observation for hypoglycemia, bradycardia, and respiratory distress for 48-72 hours after delivery. |
| Fertility Effects | No known adverse effects on human fertility. In animal studies, no impairment of fertility observed at doses up to 30 times the MRHD. |