Hemangeol
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.
History
There is currently no drug history available for this drug.
Other Information
HEMANGEOL is an oral solution of propranolol that is alcohol free, paraben free and sugar free. Each mL of HEMANGEOL contains 4.28 mg of propranolol hydrochloride, USP equivalent to 3.75 mg of propranolol.
Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (2RS)1-[(1-methylethyl)amino]-3-(naphthalene-1-yloxy)-propan-2-ol hydrochloride. Its structural formula is shown in Figure 1:
Figure 1. Propranolol HCl Structure
Molecular formula: C16H21NO2-HCl
Propranolol hydrochloride is a stable, white, crystalline solid with a molecular weight of 295.8. It is readily soluble in water and ethanol.
HEMANGEOL contains the following inactive ingredients: strawberry/vanilla flavorings, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water.
Sources
Hemangeol Manufacturers
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Pierre Fabre Pharmaceuticals, Inc.
![Hemangeol (Propranolol Hydrochloride) Solution [Pierre Fabre Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hemangeol | Pierre Fabre Pharmaceuticals, Inc.
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 1Week 2
Week 3 (maintenance)
Weight (kg)
Volume administered
Volume administered
Volume administered
twice a day twice a day twice a day2 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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