Hemangeol

What is Hemangeol?

• Hemangeol (propranolol hydrochloride) is a beta-adrenergic blocker used for the treatment of proliferating infantile hemangioma.

Propranolol

Propranolol-3D-balls

What are the uses of this medicine?

• Hemangeol (propranolol hydrochloride) used to treat proliferating infantile hemangioma that requires treatment with a medicine that spreads throughout the body.

How does this medicine work?

• The mechanism of Hemangeol’s effects on infantile hemangiomas is not well understood.
• Propranolol (proe pran' oh lol) was the prototype beta-blocker developed for therapy of hypertension and is considered nonselective, acting on both the beta-1 and beta-2 adrenergic receptors. Beta-1 adrenergic blockade reduces the heart rate and myocardial contractility by slowing AV conduction and suppressing automaticity.
• Beta-2 blockade also affects peripheral vascular resistance and can cause bronchospasm and hypoglycemia.

Who Should Not Use this medicine ?

This medicine cannot be given to your child if your child:

• was born prematurely and has not reached the corrected age of 5 weeks
• weighs less than 4 ½ pounds
• is allergic to propranolol or any of the other ingredients in Hemangeol.
• has asthma or a history of breathing problems
• has a heart problem, slow heart rate (less than 80 heart beats per minute), very low blood pressure
• is at risk for low blood sugar, for example is vomiting or unable to take feedings
• has high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma”

What drug interactions can this medicine cause?

• Tell your doctor about all of the medicines that your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Hemangeol and some medicines may interact with each other and cause serious side effects.
• Especially tell your doctor if your child takes a steroid medicine.
• Taking a steroid medicine during treatment with Hemangeol may increase your child’s risk of low blood sugar.

Is this medicine FDA approved?

• Propranolol was patented in 1962 and approved for medical use in 1964.

How should this medicine be used?

• Initiate treatment at ages 5 weeks to 5 months.

Recommended dosage:

• Starting dose is 0.15 mL/kg (0.6 mg/kg) twice daily.
• After 1 week, increase dose to 0.3 mL/kg (1.1 mg/kg) twice daily.
• After 2 weeks, increase to a maintenance dose of 0.4 mL/kg (1.7 mg/kg) twice daily.
• Administer doses at least 9 hours apart during or after feeding.
• Readjust dose for changes in the child’s weight.
• Monitor heart rate and blood pressure for 2 hours after the first dose or increasing dose.

Administration:

• Always give Hemangeol with a feeding or right away after a feeding.
• Hemangeol is given 2 times each day, at least 9 hours apart.
• If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose. Wait until the next scheduled dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Oral solution: 4.28 mg/mL propranolol hydrochloride

This medicine is available in fallowing brand namesː

• Hemangeol

What side effects can this medication cause?

The most common side effects of this medicine include:

• sleep problems
• worsening respiratory tract infections
• diarrhea
• vomiting

Hemangeol can cause serious side effects, including:

• New or worsening slow heart rate (bradycardia) or low blood pressure (hypotension)
• Breathing problems or wheezing
• Stroke
• hypoglycemia

What special precautions should I follow?

• 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. Discontinue Hemangeol if hypoglycemia develops and treat appropriately Concomitant treatment with corticosteroids may increase the risk of hypoglycemia.
• Hemangeol may cause or worsen bradycardia or hypotension. 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.
• Inform parents or caregivers that changes in sleep patterns may occur during Hemangeol therapy.
• By dropping blood pressure, Hemangeol may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension
• hypoglycemic seizure
• restlessness/euphory/insomnia
• decreased heart rate
• Atrioventricular blocks
• intraventricular conduction delays
• congestive heart failure
• Bronchospasm
• Hypoglycemia

Treatment of overdosage:

• Place the patient on a cardiac monitor, and monitor vital signs, mental status and blood glucose.
• Give intravenous fluids for hypotension and atropine for bradycardia.
• Glucagon then catecholamines should be considered if the patient does not respond appropriately to IV fluid.
• Isoproterenol and aminophylline may be used for bronchospasm.
• Propranolol is not dialyzable.

Can this medicine be used in pregnancy?

• Hemangeol cannot be used during pregnancy.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: propranolol hydrochloride
• Inactive ingredients: strawberry flavor, vanilla flavor, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water.

Who manufactures and distributes this medicine?

• Manufactured for: Pierre Fabre Pharmaceuticals, Inc., Parsippany, NJ

What should I know about storage and disposal of this medication?

• Store Hemangeol at room temperature between 68 o F to 77 o F (20 o C to 25 o C).
• Do not freeze.
• Do not shake before use.
• Safely throw away any opened bottle of Hemangeol after 2 months, even if there is medicine left in the bottle.

• Dailymed label info on Hemangeol
• FDA Hemangeol

Hemangeol Resources
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