Hemangeol
(propranolol hydrochloride)Dosage & Administration
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Hemangeol Prescribing Information
HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.
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 |
Oral solution: 4.28 mg/mL propranolol hydrochloride.
Alcohol-, paraben- and sugar-free.
Pediatric Use
Of 460 infants with proliferating infantile hemangioma requiring systemic therapy who were treated with HEMANGEOL starting at 5 weeks to 5 months of age, 60% had complete or nearly complete resolution of their hemangioma at Week 24 [see Clinical Studies (14)].
Safety and effectiveness for infantile hemangioma have not been established in pediatric patients greater than 1 year of age.
Hepatic Impairment
There is no experience in infants with hepatic impairment .
Renal Impairment
There is no experience in infants with renal impairment .
HEMANGEOL is contraindicated in the following conditions:
- Premature infants with corrected age < 5 weeks
- Infants weighing less than 2 kg
- Known hypersensitivity to propranolol or any of the excipients [see Description (11)]
- Asthma or history of bronchospasm
- Heart rate <80 beats per minute, greater than first degree heart block, or decompensated heart failure
- Blood pressure <50/30 mmHg
- Pheochromocytoma
Hypoglycemia
HEMANGEOL prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating. HEMANGEOL can cause hypoglycemia at any time during treatment. Risk is increased during a fasting period (e.g., poor oral food intake, infection, vomiting) or when glucose demands are increased (e.g., cold, stress, infections). Withhold the dose under these conditions. Hypoglycemia may present in
the form of seizures, lethargy, or coma. Discontinue HEMANGEOL if hypoglycemia develops and treat appropriately Concomitant treatment with corticosteroids may increase the risk of hypoglycemia [ see Drug Interactions (7) ] .
Bradycardia and Hypotension
HEMANGEOL may cause or worsen bradycardia or hypotension. In the studies of HEMANGEOL for infantile hemangioma the mean decrease in heart rate was about 7 bpm with little effect on blood pressure. Monitor heart rate and blood pressure after treatment initiation or increase in dose. Discontinue treatment if severe (<80 beats per minute) or symptomatic bradycardia or hypotension (systolic blood pressure <50 mmHg) occurs.
Bronchospasm
HEMANGEOL can cause bronchospasm; do not use in patients with asthma or a history of bronchospasm. Interrupt treatment in the event of a lower respiratory tract infection associated with dyspnea and wheezing.
Cardiac Failure
Sympathetic stimulation supports circulatory function in patients with congestive heart failure, beta blockade may precipitate more severe failure.
Increased Risk of Stroke in PHACE Syndrome
By dropping blood pressure, HEMANGEOL may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies.
Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome prior to HEMANGEOL therapy.
Hypersensitivity
Beta-blockers will interfere with epinephrine used to treat serious anaphylaxis.