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Hemangeol

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Hemangeol

Indications
Dosage
How Supplied

INDICATIONS

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.

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].

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

HOW SUPPLIED

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.

Indications
Dosage
How Supplied
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