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hemangeol-product

Infantile Hemangioma
About HEMANGEOL
Dosing & Administration
- Dose Titration Adjustment
- Dosing Chart
Prescribing HEMANGEOL
- Resources

Infantile Hemangioma
About HEMANGEOL
Dosing & Administration
- Dose Titration Adjustment
- Dosing Chart
Prescribing HEMANGEOL
- Resources

Video Resources

21925 W. Field Pkwy #235,
Deer Park, IL 60010
(847) 787-7361

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Medication guide

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Terms of use
Medication guide

21925 W Field Pkwy #235, Deer Park, IL 60010 | (841) 187-7361

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Full Prescribing Information
Medication Guide
Instructions for Use

Important Safety Information for Hemangeol.

Important Safety Information for Hemangeol. Hemangeol can cause serious side effects for your child. Please read our important safety information regarding Hemangeol and speak with your doctor before taking Hemangeol.

Hemangeol Important Safety Information

Important Safety Information for Hemangeol

USE

HEMANGEOL (propranolol hydrochloride) oral solution is a prescription medicine used to treat proliferating infantile hemangioma (a type of birthmark) requiring treatment throughout the body.

Who should NOT take HEMANGEOL?

Do not give HEMANGEOL to your child if they:

Were born early and are less than 5 weeks corrected age
Weigh less than 4.5 lbs
Have asthma or a history of breathing problems (bronchospasm)
Have certain heart conditions (such as slow heart rate, heart block, or heart failure)
Have very low blood pressure
Have high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma”
Are allergic to propranolol or any of the ingredients in HEMANGEOL

IMPORTANT SAFETY INFORMATION

HEMANGEOL may cause serious side effects, including:

Low blood sugar (hypoglycemia), which can be serious and may lead to seizures, loss of consciousness, or even death. This is more likely if your child is not eating well, is vomiting, or is sick. Always give HEMANGEOL during or right after feeding. Do not give a dose if your child is not eating. Signs of low blood sugar may include pale skin, sweating, irritability, unusual sleepiness, or seizures.

Bradycardia and hypotension. HEMANGEOL may slow your child’s heart rate or lower their blood pressure. Call your healthcare provider if your child seems unusually tired, dizzy, faints, or has pale or cold skin.

Bronchospasm. HEMANGEOL can cause breathing problems or make them worse. Get medical help right away if your child has wheezing or trouble breathing.

Cardiac failure. In certain patients with preexisting heart conditions, HEMANGEOL can worsen the heart’s ability to pump blood.

Increased risk of stroke. HEMANGEOL may increase the risk of stroke in children with certain blood vessel conditions (such as PHACE syndrome). Your healthcare provider may check for these conditions, especially in infants with large facial hemangiomas, before starting treatment.

Hypersensitivity. HEMANGEOL may make severe allergic reactions worse and may make it harder to treat these reactions with epinephrine (a medicine used in emergencies).

What are the most common side effects of HEMANGEOL?

The most common side effects include trouble sleeping, respiratory infections (such as colds or bronchitis), diarrhea, and vomiting.

Drug interactions

Tell your healthcare provider about all medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect how HEMANGEOL works or increase the risk of side effects, including medicines that affect how the body processes propranolol or increase the risk of low blood sugar (such as corticosteroids).

You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at https://www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for more information.

INDICATION

HEMANGEOL oral solution is a beta-adrenergic blocker indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.

IMPORTANT SAFETY INFORMATION

Contraindications

HEMANGEOL is contraindicated in:

Premature infants with corrected age <5 weeks
Infants weighing <2 kg
Hypersensitivity to propranolol or excipients
Asthma or history of bronchospasm
Bradycardia (<80 bpm), greater than first-degree heart block, or decompensated heart failure
Blood pressure <50/30 mmHg
Pheochromocytoma

Warnings and Precautions

Hypoglycemia. Propranolol can cause hypoglycemia and mask adrenergic warning signs. Risk is increased during fasting, illness, or increased metabolic demand. Severe hypoglycemia may result in seizures, lethargy, or coma. Administer during or after feeding and withhold doses if oral intake is reduced.

Bradycardia and hypotension. HEMANGEOL may cause or worsen bradycardia and hypotension. Monitor heart rate and blood pressure after initiation and dose increases. Discontinue if severe or symptomatic.

Bronchospasm. May cause bronchospasm; avoid in patients with asthma or history of bronchospasm. Interrupt treatment during respiratory illness with wheezing or dyspnea.

Cardiac failure. Beta-blockade may precipitate cardiac failure in susceptible patients.

Risk of stroke in PHACE syndrome. May increase stroke risk due to blood pressure reduction in patients with severe cerebrovascular abnormalities. Evaluate infants with large facial infantile hemangiomas for arteriopathy associated with PHACE syndrome prior to initiating HEMANGEOL.

Hypersensitivity. Beta-blockers may increase the severity of hypersensitivity reactions and may interfere with the response to epinephrine used to treat anaphylaxis.

Adverse Reactions

Serious adverse reactions include hypoglycemia and bronchospasm. The most common adverse reactions (≥10%) are sleep disorders, aggravated respiratory infections, diarrhea, and vomiting. Other reported adverse reactions include agitation, somnolence, decreased appetite, and cold extremities.

Drug Interactions
Propranolol concentrations may be increased by CYP2D6, CYP1A2, and CYP2C19 inhibitors and decreased by CYP inducers. Concomitant use of corticosteroids may increase the risk of hypoglycemia. Nonsteroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effects of propranolol.

To report a suspected adverse event related to HEMANGEOL, contact Eton Pharmaceuticals, Inc. at

1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at https://www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for more information.