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HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.
DOSAGE AND ADMINISTRATION
Initiate treatment at age 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.
Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases [see WARNINGS AND PRECAUTIONS].
If hemangiomas recur, treatment may be re-initiated [see Clinical Studies].
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
|Weight (kg)||Week 1||Week 2||Week 3 (maintenance)|
|Volume administered twice a day||Volume administered twice a day||Volume administered 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||1.0 mL||2.0 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||3.0 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|
Dosage Forms And Strengths
Oral solution: 4.28 mg/mL propranolol hydrochloride
Alcohol, paraben and sugar free.
HEMANGEOL is supplied as an oral solution. Each 1 mL contains 4.28 mg propranolol hydrochloride (equivalent to 3.75 mg propranolol). HEMANGEOL is supplied in a carton containing one 120 mL bottle with syringe adapter and one 5 mL oral dosing syringe.
NDC 64370-375-01 Bottle 120 mL
Storage And Handling
Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
Do not freeze.
Do not shake the bottle before use.
Dispense in original container with enclosed oral dosing syringe.
The product can be kept for 2 months after first opening.
See instructions for using enclosed oral dosing syringe.
Manufactured for: Pierre Fabre Pharmaceuticals, Inc. Parsippany, NJ 07054. Issued: March 2014
Last reviewed on RxList: 4/3/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Hemangeol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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