HEMANGEOL

HEMANGEOL- propranolol hydrochloride solution
Pierre Fabre Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.

2 DOSAGE AND ADMINISTRATION

Initiate treatment at ages 5 weeks to 5 months.

The recommended starting dose of HEMANGEOL is 0.15 mL/kg (0.6 mg/kg) (see Table 1) twice daily, taken at least 9 hours apart. After 1 week, increase the daily dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks of treatment, increase the dose to 0.4 mL/kg (1.7 mg/kg) twice daily and maintain this for 6 months. Readjust the dose periodically as the child’s weight increases.

To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding. Skip the dose if the child is not eating or is vomiting [see Warnings and Precautions (5.1)] .

Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases [see Warnings and Precautions (5.2)].

If hemangiomas recur, treatment may be re-initiated [see Clinical Studies (14)] .

HEMANGEOL is supplied with an oral dosing syringe for administration. Administration directly into the child’s mouth is recommended. Nevertheless, if necessary, the product may be diluted in a small quantity of milk or fruit juice, given in a baby’s bottle.

Table 1. Dose Titration According to Weight

	Week 1	Week 2	Week 3 (maintenance)
Weight (kg)	Volume administered	Volume administered	Volume administered
	twice a day	twice a day	twice a day
2 to <2.5	0.3 mL	0.6 mL	0.8 mL
2.5 to <3	0.4 mL	0.8 mL	1 mL
3 to <3.5	0.5 mL	0.9 mL	1.2 mL
3.5 to <4	0.5 mL	1.1 mL	1.4 mL
4 to <4.5	0.6 mL	1.2 mL	1.6 mL
4.5 to <5	0.7 mL	1.4 mL	1.8 mL
5 to <5.5	0.8 mL	1.5 mL	2 mL
5.5 to <6	0.8 mL	1.7 mL	2.2 mL
6 to <6.5	0.9 mL	1.8 mL	2.4 mL
6.5 to <7	1 mL	2 mL	2.6 mL
7 to <7.5	1.1 mL	2.1 mL	2.8 mL
7.5 to <8	1.1 mL	2.3 mL	3 mL
8 to <8.5	1.2 mL	2.4 mL	3.2 mL
8.5 to <9	1.3 mL	2.6 mL	3.4 mL
9 to <9.5	1.4 mL	2.7 mL	3.6 mL
9.5 to <10	1.4 mL	2.9 mL	3.8 mL
10 to <10.5	1.5 mL	3 mL	4 mL
10.5 to <11	1.6 mL	3.2 mL	4.2 mL
11 to <11.5	1.7 mL	3.3 mL	4.4 mL
11.5 to <12	1.7 mL	3.5 mL	4.6 mL
12 to <12.5	1.8 mL	3.6 mL	4.8 mL