HEMANGEOL Rx
Generic Name and Formulations:
Propranolol HCl 4.28mg/mL; soln; alcohol-, paraben- and sugar-free; strawberry/vanilla flavors.

Company:
Pierre Fabre Pharmaceuticals, Inc.
Indications for HEMANGEOL:
Proliferating infantile hemangioma requiring systemic therapy.

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.

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.

Warnings/Precautions:
May mask signs of hypoglycemia. Risk of hypoglycemia; withhold dose if vomiting or not feeding regularly; 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; eva luate for potential arteriopathy prior to initiation. Pregnancy (Cat.C), nursing mothers: not indicated.

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).

Pharmacological Class:
beta-blocker.

Adverse Reactions:
Sleep disorders, aggravated respiratory tract infections (eg, bronchitis, bronchiolitis, cough), diarrhea, vomiting, peripheral coldness, agitation, somnolence; hypoglycemia, bronchospasm.

How Supplied:
Bottle—120mL (w. oral syringe, adapter)