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Hemangiol

(propranolol oral solution)

How does this medication work? What will it do for me?

Propranolol belongs to the class of medications called beta-adrenergic blockers. While higher doses of propranolol are used to control blood pressure for adults, propranolol oral solution is used to treat hemangiomas for infants.

Hemangiomas are noncancerous growths that develop due to an abnormal collection of blood vessels. They usually develop before a child is born. A hemangioma may form on an organ inside the body, such as the liver or lung, or it may form on the skin outside the body. Most hemangiomas do not need to be treated, and vanish by the time the child is 5 years old.

Propranolol oral solution is used to treat hemangiomas that affect the ability of an organ to function normally, or that have developed sores and are not responding to wound care, or those that may leave a permanent scar.

How propranolol oral solution works to treat hemangiomas is not clear. It may reduce the blood flow to the growth, it may interfere with the growth of the cells that create the hemangioma, or it may contribute to the death of the cells forming the hemangioma. Improvement in the hemangioma should be noticed within 2 months of starting this medication.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended dose of propranolol oral solution is based on the child's body weight. The usual starting dose is calculated as 0.5 mg per kilogram of body weight, taken by mouth, 2 times a day. After 1 week, the doctor will increase the dose to 1 mg per kilogram of body weight, taken 2 times a day. After 1 week at this dose, the doctor will increase the dose to 1.5 mg per kilogram of body weight. This medication should be continued for 6 months and then stopped.

With the first dose and every time the dose is increased, the doctor may want you to wait for at least 2 hours, so the baby can be monitored to make sure heart rate and blood pressure remain normal and there are no severe reactions to the medication.

Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons. Do not shake the bottle before measuring the dose of medication.

Propranolol doses should be separated by at least 9 hours and given with feeds or immediately after the baby feeds to avoid low blood sugar levels. The medication may be mixed with 5 mL (for children weighing up to 5 kg) to 15 mL (for children weighing more than 5 kg) of milk or fruit juice in a baby bottle if necessary. This mixture should be used within 2 hours of preparation. To ensure the child gets the full dose of medication, do not put the dose in a full bottle.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to give this medication exactly as prescribed by your doctor. If your child vomits or spits up after a dose, do not give another dose. Continue with the next dose at the regular time.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. This medication should be discarded 60 days after opening the bottle.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each 1 mL of clear, colourless-to-pale-yellow, sugar-free, strawberry-vanilla-flavoured solution contains 4.28 mg of propranolol hydrochloride, equivalent to 3.75 mg of propranolol. Nonmedicinal ingredients: citric acid monohydrate, hydroxyethylcellulose, purified water, sodium saccharin, strawberry flavour, and vanilla flavour.

Who should NOT take this medication?

Do not give this medication if your child:

  • is allergic to propranolol or any ingredients of the medication
  • is premature and has not reached 5 weeks of corrected age
  • weighs less than 2.5 kg
  • is breast-fed, if the mother is taking any medications that should not be taken with propranolol
  • is in cardiogenic shock
  • is prone to low blood glucose
  • has low blood pressure
  • has a severely slow heart rate
  • has asthma or airways that easily spasm and close
  • has serious heart block (second- and third-degree AV block) or sick sinus syndrome
  • has severe circulatory disorders
  • has a form of chest pain known as Prinzmetal's angina
  • has uncontrolled heart failure
  • has a tumor diagnosed as pheochromocytoma

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • agitation or irritability
  • cold hands and feet
  • constipation
  • decreased appetite
  • diarrhea
  • drowsiness
  • hair loss
  • nightmares
  • skin redness
  • sleep problems
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • blood circulation problems (e.g., cold, bluish, or numb fingers or toes)
  • hallucinations (hearing or seeing things that aren't there)
  • inflammation of the lungs (e.g., cough, wheeze, fever, shortness of breath, trouble feeding, grunting, blue tinge to skin)
  • low blood pressure (e.g., bluish skin, pale skin, fatigue, coldness)
  • purple or reddish-brown spots visible under the skin
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • symptoms of low blood sugar (e.g., sweating, paleness, tiredness, irritability, fast heartbeat, poor feeding, hunger, nightmares)
  • symptoms of too much potassium in the body (e.g., muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, nausea)
  • symptoms of psoriasis (e.g., pinpoint-sized red spots on skin, red, scaling, or crusted skin)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • abnormally low heart rate (e.g., fainting, paleness or bluish coloured skin, tiredness)
  • serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • breathing problems (e.g., asthma, cough, fast or difficult breathing, wheezing, blue skin, shortness of breath)
  • severe low blood sugar (e.g., decrease in body temperature, seizures, loss of consciousness, coma)
  • symptoms of Raynaud's phenomenon (e.g., pale, painful, numb or cold fingers, toes, nose or earlobes)
  • symptoms of slow or irregular heart rate (e.g., fainting, fatigue, coldness, paleness or bluish-coloured skin)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Breathing problems: In general, people who have asthma and certain other breathing problems or chronic lung disease should use propranolol with caution, as it can also have the effect of causing breathing difficulty. If your child develops a cold with shortness of breath and wheezing, treatment should be temporarily stopped. If your child has breathing problems, discuss with your doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart conditions: Propranolol may cause symptoms of certain heart conditions to become worse. It may decrease the heart rate or blood pressure or may cause heart block. If your child has heart problems, discus with your child's doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: The safety and effectiveness of this using this medication have not been determined for children with kidney problems. Propranolol oral solution should not be used by children with decreased kidney function.

Liver function: The safety and effectiveness of this using this medication have not been determined for children with liver problems. Propranolol oral solution should not be used by children with decreased liver function.

Low blood sugar: This medication may cause low blood sugar or make low blood sugar worse in children. The early signs of low blood sugar, such as shakiness, hunger or rapid heartbeat, may not be as noticeable when taking propranolol. In children, unusual irritability, sleepiness, nightmares, or crying out during sleep may be signs of low blood sugar. Providing a sugary drink such as fruit juice can help relieve these symptoms. Talk to your doctor about the best way to treat these symptoms if they occur. Episodes of severe low blood sugar can cause seizures or be life-threatening.

It is recommended that this medication be given during or right after a feed to reduce the risk of low blood sugar developing.

Pheochromocytoma: This medication can worsen the symptoms of pheochromocytoma (a tumour of the adrenal gland) if it is taken alone. If your child has a pheochromocytoma, discuss with your doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Severe allergies: People with allergies severe enough to cause anaphylaxis (a severe allergic reaction where swelling of the face, lips, and throat make it difficult to breathe) should talk to their doctor about what to do if they have an allergic reaction. Propranolol may make it more difficult to treat their allergic reaction with epinephrine.

Sleep and mood disturbances: People taking propranolol may experience increased sleepiness, difficulty sleeping, or nightmares, as well as unusual irritability or anxiety. If you notice any behaviour in your child that seems unexpected or unusual, contact your doctor.

Surgery: This medication may interfere with other medications used for surgery and contribute to dangerously low blood pressure or rapid heartbeat. If your child is scheduled for surgery, inform all doctors involved in caring for your child that your child is taking propranolol.

Pregnancy: This medication is not intended to be used by women who are pregnant.

Breast-feeding: Propranolol oral solution is intended for infants and children and is not intended to be used by women who are breast-feeding. For breastfed babies, other medications that the mother takes may pass into breast milk and may interact with propranolol. Your doctor may change your medications to prevent these interactions.

Children: The safety and effectiveness of this medication has not been determined for children less than 5 weeks of age. It should not be given to premature children who have not reached the corrected age of 5 weeks.

What other drugs could interact with this medication?

There may be an interaction between propranolol oral solution and any of the following:

  • abiraterone
  • alcohol
  • alpha-agonists (e.g., clonidine, methyldopa)
  • alpha-blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • anti-malarial medications (e.g., chloroquine, hydroxychloroquine, primaquine)
  • anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • asunaprevir
  • baclofen
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • beta-2 agonists (e.g., formoterol, indacaterol, salmeterol, terbutaline, vilanterol)
  • other beta blockers (e.g., atenolol, carvedilol, timolol)
  • brimonidine
  • bromocriptine
  • bupropion
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cannabis
  • celecoxib
  • cholestyramine
  • cinacalcet
  • ciprofloxacin
  • cobicistat
  • colesevelam
  • colestipol
  • conivaptan
  • darifenacin
  • deferasirox
  • dexmethylphenidate
  • digoxin
  • dipyridamole
  • disopyramide
  • donepezil
  • dronedarone
  • duloxetine
  • ergot alkaloids (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine)
  • epinephrine
  • fentanyl
  • fingolimod
  • galantamine
  • grass pollen allergen extract
  • guanfacine
  • HIV protease inhibitors (e.g., darunavir, tipranavir)
  • insulin
  • ivabradine
  • lacosamide
  • lanreotide
  • leflunomide
  • levodopa
  • lidocaine
  • methadone
  • methylphenidate
  • mexiletine
  • midodrine
  • mirabegron
  • morphine
  • nabilone
  • nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
  • non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
  • obinutuzumab
  • octreotide
  • ozanimod
  • pasireotide
  • pentoxifylline
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • pramipexole
  • propafenone
  • protein kinase inhibitors (e.g., bortezomib, ceritinib, imatinib, tofacitinib)
  • quinidine
  • quinine
  • rasagiline
  • rifampin
  • riociguat
  • rivastigmine
  • rizatriptan
  • ropinirole
  • sacubitril
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)
  • selegiline
  • siponimod
  • sulfonylureas (e.g., gliclazide, glyburide, tolbutamide)
  • terbinafine
  • teriflunomide
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • tipranavir
  • tizanidine
  • tranylcypromine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Hemangiol

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