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Hemangeol Generic Name & Formulations
Legal Class
Rx
General Description
Propranolol HCl 4.28mg/mL; soln; alcohol-, paraben- and sugar-free; strawberry/vanilla flavors.
Pharmacological Class
Beta-blocker.
How Supplied
Soln—120mL (w. oral syringe, adapter)
Manufacturer
Generic Availability
NO
Hemangeol Indications
Indications
Proliferating infantile hemangioma requiring systemic therapy.
Hemangeol Dosage and Administration
Adult
Not applicable.
Children
Administer directly in mouth during or right after a feeding. May be diluted in small amount of milk or fruit juice, given in a baby's bottle, if needed. 5 weeks–5 months: initially 0.15mL/kg (0.6mg/kg) twice daily at least 9hrs apart. After 1 week, increase to 0.3mL/kg (1.1mg/kg) twice daily. After 2 weeks, increase to 0.4mL/kg (1.7mg/kg) twice daily and maintain dose for 6 months. Readjust dose periodically based on weight increases. May re-initiate if hemangiomas recur. >1yr: not established.
Hemangeol Contraindications
Contraindications
Premature infants (w. corrected age <5 weeks). Infants <2kg. Asthma or history of bronchospasm. Heart rate <80bpm, >1st-degree heart block, or decompensated heart failure. Blood pressure <50/30mmHg. Pheochromocytoma.
Hemangeol Boxed Warnings
Not Applicable
Hemangeol Warnings/Precautions
Warnings/Precautions
May mask signs of hypoglycemia. Increased risk of hypoglycemia esp. during poor oral food intake, vomiting, infection, cold, or stress; withhold dose under these conditions; discontinue if hypoglycemia occurs. Bradycardia. Hypotension. Monitor HR and BP for 2hrs after initiation or dose increases. Discontinue if severe (<80bpm) or symptomatic bradycardia or hypotension (SBP <50mmHg) occurs. Interrupt treatment if lower respiratory tract infection develops. CHF. Increased risk of stroke in PHACE syndrome with severe cerebrovascular anomalies; evaluate for potential arteriopathy prior to initiation. Pregnancy, nursing mothers: not indicated.
Hemangeol Pharmacokinetics
See Literature
Hemangeol Interactions
Interactions
Increased risk of hypoglycemia with concomitant corticosteroids. May interfere with epinephrine. Potentiated by CYP2D6, CYP1A2, CYP2C19 inhibitors. Antagonized by CYP1A2 inducers (eg, phenytoin, phenobarbital) and CYP2C19 inducers (eg, rifampin).
Hemangeol Adverse Reactions
Adverse Reactions
Sleep disorders, aggravated respiratory tract infections (eg, bronchitis, bronchiolitis, cough), diarrhea, vomiting, peripheral coldness, agitation, somnolence; hypoglycemia, bronchospasm.
Hemangeol Clinical Trials
See Literature
Hemangeol Note
Not Applicable
Hemangeol Patient Counseling
See Literature
