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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