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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
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