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

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