The Convenience of BID Dosing

HEMANGEOL (propranolol hydrochloride) 4.28 mg/mL Pediatric Oral Solution Dosing

Monitoring Your Patients

It is recommended as stated in the prescribing information that patient’s heart rate and blood pressure should be monitored for 2 hours after each dose increase.

Dose Readjustment

After the titration phase, it is recommended that the dose be readjusted periodically as infant’s weight increases.

BID Dosing

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Reducing the Risk of Hypoglycemia

HEMANGEOL should be administered during or immediately after feeding to reduce the risk of hypoglycemia.

  • The dose of HEMANGEOL should be skipped if the infant is vomiting or not eating
  • HEMANGEOL is supplied with an oral dosing syringe and syringe adapter for convenience
    • If necessary, HEMANGEOL can be diluted in a small quantity of milk or fruit juice and given in a baby’s bottle

Discontinuing Treatment

HEMANGEOL should be discontinued if severe or symptomatic bradycardia (less than 80 beats per minute) or hypotension (systolic blood pressure less than 50 mmHg) occurs.

Parents and caregivers should be instructed to recognize signs of hypoglycemia. If a child has clinical signs of hypoglycemia, they should discontinue HEMANGEOL and call their health care provider immediately or take the child to the emergency room.

Interrupt treatment in the event of a lower respiratory infection associated with dyspnea and wheezing.



HEMANGEOL® (propranolol hydrochloride) oral solution is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.

Important Safety Information

CONTRAINDICATIONS

HEMANGEOL® (propranolol hydrochloride) oral solution 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
  • 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

WARNINGS AND PRECAUTIONS

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 in children, especially when they are not feeding regularly or are vomiting; withhold the dose under these conditions. Hypoglycemia may present in the form of seizures, lethargy, or coma. If a child has clinical signs of hypoglycemia, parents should discontinue HEMANGEOL and call their health care provider immediately or take the child to the emergency room.

Concomitant treatment with corticosteroids may increase the risks of hypoglycemia.

HEMANGEOL may cause or worsen bradycardia or hypotension. 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.

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.

HEMANGEOL may worsen circulatory function in patients with congestive heart failure or 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.

HEMANGEOL will interfere with epinephrine used to treat serious anaphylaxis.

ADVERSE REACTIONS

The most frequently reported adverse reactions to HEMANGEOL were sleep disorders, aggravated respiratory tract infections, diarrhea, and vomiting. Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients.

Adverse events such as cardiac disorders, urticaria, alopecia, hypogylcemia, and bradycardia occurred in less than 1%.

Safety and effectiveness for infantile hemangioma have not been established in pediatric patients greater than 1 year of age.

Please see Full Prescribing Information and Medication Guide
Important Safety Information