Hemangeol

What is Hemangeol used for?

Hemangeol is a prescription medicine that is used to treat proliferating infantile hemangioma.

Description

HEMANGEOL is an oral solution of propranolol that is alcohol free, paraben free and sugar free. Each mL of HEMANGEOL contains 4.28 mg of propranolol hydrochloride, USP equivalent to 3.75 mg of propranolol.

Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (2RS)1-[(1-methylethyl)amino]-3-(naphthalene-1-yloxy)-propan-2-ol hydrochloride. Its structural formula is shown in Figure 1:

Figure 1. Propranolol HCl Structure

Molecular formula: C 16H 21NO 2-HCl

Propranolol hydrochloride is a stable, white, crystalline solid with a molecular weight of 295.8. It is readily soluble in water and ethanol.

HEMANGEOL contains the following inactive ingredients: strawberry/vanilla flavorings, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water.

Mechanism of Action

The mechanism of HEMANGEOL’s effects on infantile hemangiomas is not well understood.

Before taking Hemangeol, tell your doctor:

• If your child is allergic to Hemangeol; any part of this medicine; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child was born premature and has not reached the corrected age of 5 weeks.
• If your child weighs less than 4 ½ pounds (2 kilograms).
• If your child has asthma or has had breathing problems.
• If your child has any of these health problems: Certain heart problems, a slow heartbeat, or very low blood pressure.
• If your child has high blood pressure caused by a tumor of the adrenal gland (pheochromocytoma).
• If your child is at risk for low blood sugar, like if your child is throwing up or not able to take feedings.

This is not a list of all drugs or health problems that interact with this medicine.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take Hemangeol with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while I take Hemangeol?

• Tell all of your child’s health care providers that your child is taking Hemangeol. This includes your child’s doctors, nurses, pharmacists, and dentists.
• Have your child’s blood pressure and heart rate checked often.
• This medicine may hide the signs of low blood sugar. Talk with the doctor.
• If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
• If your child has had a very bad allergic reaction, talk with the doctor. Your child may have a chance of an even worse reaction if your child comes into contact with what caused the allergy. If your child uses epinephrine to treat very bad allergic reactions, talk with the doctor. Epinephrine may not work as well while your child is taking Hemangeol.
• This medicine may raise the chance of stroke in some children who have very bad problems with the blood vessels in their brain. The risk is higher in children with a large hemangioma that affects the face or head. Talk with the doctor.
• If you are breast-feeding your child, tell the doctor about all the drugs you are taking. Certain drugs may pass to your child through breast milk and may interact with Hemangeol.
• Make sure you have the right liquid; there is more than one strength.

How is Hemangeol best taken?

Give Hemangeol as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

• Measure liquid doses carefully. Use the measuring device that comes with Hemangeol. If there is none, ask the pharmacist for a device to measure Hemangeol.
• Do not shake the solution.
• Give Hemangeol right into your child’s mouth. If needed, Hemangeol may be mixed with a little bit of milk or fruit juice and given in a baby’s bottle.
• Give Hemangeol with or right after a feeding.
• Give doses of Hemangeol at least 9 hours apart.
• If giving Hemangeol to your child and your child’s weight changes, talk with the doctor. The dose of Hemangeol may need to be changed.
• If your child spits up a dose or if you are not sure your child got all of the drug, do not give another dose. Wait until your child’s next dose to give again.
• Keep giving Hemangeol to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.

What do I do if I miss a dose?

• Give a missed dose as soon as you think about it.
• If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Hemangeol that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Feeling cold in the arms or legs.
• Fever, chills, or sore throat.
• Feeling fussy.
• Change in color of skin.
• Wheezing or coughing.
• Pale skin.
• Feeling very tired or weak.
• This medicine may lower blood sugar levels. The chance is higher if your child is not taking feedings or is throwing up. Feed your child on a regular basis while giving Hemangeol. Tell the doctor if your child has a poor appetite. If your child is not taking feedings due to an illness or throwing up, do not give Hemangeol until your child is feeding normally again unless told to do so by the doctor. Call the doctor or get medical help right away if your child has signs of low blood sugar like pale, blue, or purple skin color; sweating; feeling fussy; crying that is not normal; fast heartbeat; a heartbeat that does not feel normal; poor feeding; low body temperature; sleeping more than normal; seizures; or breathing stops for a short time.

What are some other side effects of Hemangeol?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Diarrhea.
• Throwing up.
• Feeling sleepy.
• Trouble sleeping.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Hemangeol?

• Store at room temperature. Do not freeze.
• Protect from heat, cold, and light.
• Keep lid tightly closed.
• Store in a dry place. Do not store in a bathroom.
• Throw away any part of the solution not used after 2 months.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

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