FDA

Hemangeol

Approved 14 Mar 2014OralSolution

Indications

HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. HEMANGEOL oral solution is a beta-adrenergic blocker indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. (1)

Contraindications

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
Premature infants with corrected age <5 weeks(4)
Infants weighing less than 2 kg (4)
Known hypersensitivity to propranolol or excipients(4)
Asthma or history of bronchospasm (4, 5.3, 6, 10, 17)
Bradycardia (<80 beats per minute), greater than first degree heartblock, decompensated heart failure (4, 5.2, 5.4, 10, 17)
Blood pressure <50/30 mmHg (4, 5.2, 10, 17)
Pheochromocytoma (4)

Warnings and precautions

5.1Hypoglycemia

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)].

5.2Bradycardia 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.

At a glance

Brand name: Hemangeol
Active substance: propranolol hydrochloride
Route: Oral
Dosage form: Solution
Applicant: Eton
Status: Prescription
FDA approval: 14 Mar 2014
Application: NDA205410-001

Indications

Contraindications

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
Premature infants with corrected age <5 weeks(4)
Infants weighing less than 2 kg (4)
Known hypersensitivity to propranolol or excipients(4)
Asthma or history of bronchospasm (4, 5.3, 6, 10, 17)
Bradycardia (<80 beats per minute), greater than first degree heartblock, decompensated heart failure (4, 5.2, 5.4, 10, 17)
Blood pressure <50/30 mmHg (4, 5.2, 10, 17)
Pheochromocytoma (4)

Warnings and precautions

5.1Hypoglycemia

5.2Bradycardia and Hypotension

Adverse reactions

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in clinical practice. Clinical Trials Experience with HEMANGEOL in Infants with proliferating infantile hemangioma In clinical trials for proliferating infantile hemangioma, the most frequently reported adverse reactions (>10%) in infants treated with HEMANGEOL were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting.

Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients. Overall, 479 patients in the pooled safety population were exposed to study drug in the clinical study program (456 in placebo-controlled trials). A total of 424 patients were treated with HEMANGEOL at doses 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months. Of these, 63% of patients were aged 91-150 days and 37% were aged 35-90 days at randomization.

The following table lists according to the dosage the most common adverse reactions (treatment-emergent adverse events with an incidence at least 3% greater on one of the two doses than on placebo). The following adverse events have been observed during clinical studies, with an incidence of less than 1%: Cardiac disorders: Second degree atrioventricular heart block, in a patient with underlying conduction disorder, required definitive treatment discontinuation [see Warnings and Precautions (5.4)].

Skin and subcutaneous tissue disorders: Urticaria, alopecia Investigations: Decreased blood glucose, decreased heart rate Compassionate Use Program More than 600 infants received HEMANGEOL in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of HEMANGEOL was 2.2 mg/kg/day and mean treatment duration was 7.1 months. The adverse reactions reported in the CUP were similar to the ADRs observed during clinical trials but some were more severe.

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of propranolol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows: Blood and lymphatic system disorders: Agranulocytosis Psychiatric disorders: Hallucination Skin and subcutaneous tissues disorders: Purpura, dermatitis psoriasiform The most common adverse reactions to HEMANGEOL (occurring ≥ 10% of patients) were sleep disorders, aggravated respiratory tract infections, diarrhea, and vomiting.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and Medication Guide Revised: 04/2026 Table 2

Hemangeol

Indications

Contraindications

Warnings and precautions

5.1Hypoglycemia

5.2Bradycardia and Hypotension

At a glance

Two medicines in one question?

Hemangeol

Indications

Contraindications

Warnings and precautions

5.1Hypoglycemia

5.2Bradycardia and Hypotension

At a glance

Two medicines in one question?

5.3Bronchospasm

5.4Cardiac Failure

5.5Increased Risk of Stroke in PHACE Syndrome

5.6Hypersensitivity

Interactions

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information