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Hemangeol

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Hemangeol

PATIENT INFORMATION

HEMANGEOL™
(he-man je-ohl)
(propranolol hydrochloride) Oral Solution

What is the most important information I should know about HEMANGEOL?

HEMANGEOL can cause serious side effects, including:

  • Low blood sugar (hypoglycemia), especially if your child is not taking feedings, or is vomiting. HEMANGEOL may make it more difficult to recognize the signs and symptoms of low blood sugar in your child.

To help reduce the risk of low blood sugar with HEMANGEOL:

  • Give HEMANGEOL during or shortly after feeding your child.
  • Feed your child regularly during treatment. Tell your doctor if your child has a poor appetite.
  • If your child is not taking feedings, for example, due to an illness or vomiting, do not give HEMANGEOL until your child is taking feedings normally again.

If your child has any of the signs or symptoms of low blood sugar listed below during treatment with HEMANGEOL, stop giving your child HEMANGEOL and call your doctor or go to the nearest emergency room right away.

Signs or symptoms of low blood sugar include: pale, blue or purple skin color, sweating, irritability, crying for no apparent reason, irregular or fast heartbeat, poor feeding, low body temperature, unusual sleepiness, seizures, breathing stops for short periods of time, and loss of consciousness.

What is HEMANGEOL?

HEMANGEOL is a prescription medicine used to treat proliferating infantile hemangioma that requires treatment with a medicine that spreads throughout the body.

Who should not take HEMANGEOL?

Do not give HEMANGEOL 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. See the end of this Medication Guide for a list of 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 should I tell my doctor before giving my child HEMANGEOL?

Before you start giving HEMANGEOL to your child, tell your doctor about all of your child's medical conditions.

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.

If you are breastfeeding your child, it is important to tell your doctor about all the medicines you take. Certain medicines may pass to your child through your breast-milk and interact with HEMANGEOL. Your doctor should tell you if you should stop breastfeeding.

How should I give HEMANGEOL to my child?

Follow the detailed Instructions for Use that come with HEMANGEOL for information about the correct way to prepare and give a dose of HEMANGEOL.

  • Give HEMANGEOL to your child exactly as your doctor tells you.
  • Your doctor may change the dose until it is right for your child, and as your child's weight changes.
  • 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 possible side effects of HEMANGEOL?

See “What is the most important information I should know about HEMANGEOL?”

HEMANGEOL can cause serious side effects, including:

  • New or worsening slow heart rate (bradycardia) or low blood pressure (hypotension). Call your doctor if your child has any of these symptoms: pale skin color, slow or uneven heartbeats, arms or legs feel cold, blue or purple skin color, or fainting.
  • Breathing problems or wheezing. HEMANGEOL can cause spasms of your child's airway. Call your doctor or go to the nearest hospital emergency room if your child has breathing problems or wheezing during treatment with HEMANGEOL.
  • Stroke. HEMANGEOL may increase the risk of stroke in certain children who have severe problems with the blood vessels in their brain, particularly if your child has a large hemangioma that affects the face or head.

The most common side effects include: sleep problems, worsening respiratory tract infections, diarrhea, and vomiting.

These are not all the possible side effects of HEMANGEOL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store HEMANGEOL?

  • Store HEMANGEOL at room temperature between 68°F to 77°F (20°C to 25°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.

Keep HEMANGEOL and all medicines out of the reach of children.

General information about the safe and effective use of HEMANGEOL.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about HEMANGEOL that is written for health professionals. Do not use HEMANGEOL for a condition for which it was not prescribed. Do not give HEMANGEOL to other people, even if they have the same symptoms your child has. It may harm them.

What are the ingredients in HEMANGEOL?

Active ingredient: propranolol hydrochloride

Inactive ingredients: strawberry flavor, vanilla flavor, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water.

Instruction for Use

HEMANGEOL™
(he-man je-ohl)
(propranolol hydrochloride oral solution)

Read these Instructions for Use before giving a dose of HEMANGEOL to your child for the first time and each time you get a refill. There may be new information. Your doctor or pharmacist should show you how to correctly measure and give a dose of HEMANGEOL to your child before you give it for the first time.

Important: Read the Medication Guide that comes with HEMANGEOL.

  • To reduce the risk of your child getting low blood sugar (hypoglycemia), you must give HEMANGEOL either during a feeding or right away after a feeding.
  • Do not give a dose of HEMANGEOL if your child is vomiting, is not taking feedings, or is showing signs or symptoms of low blood sugar.

When you get HEMANGEOL from your doctor or pharmacist, you will receive a box that contains the supplies needed to give HEMANGEOL to your child, including:

  • One glass bottle of HEMANGEOL
  • One 5 mL oral dosing syringe (inside a plastic bag) that is marked to help you correctly measure a dose of HEMANGEOL (See Figure A). If the carton does not contain the oral dosing syringe, ask your pharmacist to give you an oral dosing syringe that can be used to measure HEMANGEOL.

Figure A

Contents of HEMANGEOL box - Illustration

Preparing to give your child a dose of HEMANGEOL:

Step 1. Place your box of supplies on a clean flat work surface, such as a table.

Step 2. Remove the HEMANGEOL bottle and oral dosing syringe from the box (See Figure A above). Do not shake the bottle before use. Keep the box for storage.

Step 3. Remove the oral dosing syringe from the plastic bag. Safely throw the plastic bag away. The barrel of the syringe has markings in milliliters (mL). Look at the markings on the barrel of the oral dosing syringe and find the mL marking that matches the HEMANGEOL dose in mL prescribed by your doctor (See Figure B).

Figure B

Markings on the barrel of the syringe - Illustration

Step 4. Open the bottle of HEMANGEOL by pushing down on the plastic cap while turning the cap to the left (See Figure C).

  • Write down on the box the date when you first open the bottle.

Figure C

Opening the bottle - Illustration

Step 5. Place the bottle on your work surface. Use one hand to hold the bottle upright. Use your other hand to insert the tip of the oral dosing syringe into the syringe adapter at the top of the bottle. Push the plunger all the way down (See Figure D).

  • Do not remove the syringe adapter. If the syringe adapter is missing talk to your pharmacist.

Figure D

Insert the tip of the oral dosing syringe into the syringe adapter - Illustration

Step 6: Use one hand to hold the oral dosing syringe in place. With your other hand, turn the bottle upside down. Pull back on the plunger until the top of the plunger lines up with the marking on the barrel of the syringe that matches the dose of HEMANGEOL prescribed by your doctor (See Figure E). Your child's dose may be different than the dose shown in Figure E.

Figure E

Pull back on the plunger - Illustration

Step 7: Check for air bubbles in the oral dosing syringe. If you see air bubbles, push up on the plunger towards the bottle just enough to remove any large air bubbles and then pull back to the measured dose (See Figure F).

Figure F

Push up on the plunger - Illustration

Step 8. Turn bottle upright again and place it in on your work surface. Remove the oral dosing syringe from the bottle (See Figure G). Do not push the plunger in during this step. The syringe adapter should stay attached to the bottle.

Figure G

Remove the oral dosing syringe from the bottle - Illustration

Giving your child a dose of HEMANGEOL:

Step 9. Slowly squirt HEMANGEOL into your child's mouth after placing the oral dosing syringe against the inside of the cheek (See Figure H).

  • Keep your child in an upright position for a few minutes right after giving a dose of HEMANGEOL.

Figure H

Slowly squirt HEMANGEOL into your child’s mouth - Illustration

  • If needed, you can dilute the dose of HEMANGEOL in a small amount of milk or fruit juice and give it to your child in a baby's bottle. 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.

Step 10. Replace the plastic cap on the bottle. Close the bottle by turning the plastic cap to the right (See Figure I).

Figure I

Replace the plastic cap on the bottle -  Illustration

Cleaning the oral dosing syringe:

Step 11: Clean the oral dosing syringe after each use by rinsing with clean tap water (See Figure J).

  • Do not take apart the oral dosing syringe.
  • Do not use any soap or alcohol based product to clean. Wipe the outside dry.
  • Do not put the oral dosing syringe through a sterilizer or dishwasher.

Figure J

Clean the oral dosing syringe - Illustration

Step 12: Place the bottle and the oral dosing syringe in the box.

How should I store HEMANGEOL?

  • When not in use, keep the bottle of HEMANGEOL and the oral dosing syringe in the box it comes in.
  • Store HEMANGEOL at room temperature, between 68°F to 77° F (20° C to 25°C). Do not freeze.
  • Safely throw away any opened bottle of HEMANGEOL after 2 months, even if there is medicine left in the bottle.

Keep HEMANGEOL and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 4/3/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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