What is Hemangeol?

Following abrupt cessation of therapy with beta-blockers, exacerbations of angina pectoris and myocardial infarction have occurred. Warn patients against interruption or discontinuation of therapy without physician advice .

Propranolol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure may reduce the risk of stroke and heart attacks.

Propranolol is also used to treat severe chest pain (angina), migraine headaches, or hypertrophic subaortic stenosis (thickened heart muscle).

This medicine may also be used to treat irregular heartbeats, tremors, or pheochromocytoma (adrenal gland tumor). It may also be used to reduce the risk of death in patients who have heart attacks.

Propranolol oral solution is used to treat proliferating infantile hemangioma.

This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Your dose may need to be changed several times in order to find out what works best for you.

This medicine should come with a Medication Guide and patient directions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the long-acting oral capsules whole. Do not chew, crush, or open them.

Propranolol extended-release capsules should be taken at bedtime (10 p.m.). This medicine may be taken with or without food. However, you should take it the same way each time.

Measure the concentrated oral solution, Intensol™ with the dropper that comes with the package. You may mix the concentrated solution with water, juice, soda, applesauce, or pudding to make it easier to swallow, then take the mixture right away.

Measure the oral liquid with the dosing syringe that comes with the package. It should be given directly into the child's mouth, during or right after eating or breastfeeding. It may also be mixed with a small amount of milk or fruit juice and given with a baby's bottle. Do not shake before use.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For acute heart attack:
  • For oral dosage form (solution):
    • Adults—180 to 240 milligrams (mg) per day, given in divided doses.
    • Children—Dose is based on body weight and must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—At first, 40 milligrams (mg) three times a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.
• For adrenal gland tumor (pheochromocytoma):
  • For oral dosage form (solution):
    • Adults—60 milligrams (mg) per day, given in divided doses for 3 days before having surgery. In patients who cannot have surgery, the usual dose is 30 mg per day, given in divided doses.
    • Children—Dose is based on body weight and must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—60 milligrams (mg) per day, given in divided doses for 3 days before having surgery. In patients who cannot have surgery, the usual dose is 30 mg per day, given in divided doses.
    • Children—Use and dose must be determined by your doctor.
• For chest pain (angina):
  • For oral dosage form (long-acting oral capsules):
    • Adults—At first, 80 milligrams (mg) once a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—80 to 320 milligrams (mg) per day, given in divided doses.
    • Children—Dose is based on body weight and must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—80 to 320 milligrams (mg) per day, given in divided doses.
    • Children—Use and dose must be determined by your doctor.
• For high blood pressure (hypertension):
  • For oral dosage form (extended-release capsules):
    • Adults—At first, 80 milligrams (mg) once a day, given at bedtime. Your doctor may increase your dose if needed. However, the dose is usually not more than 120 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (long-acting oral capsules):
    • Adults—At first, 80 milligrams (mg) once a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.
• For hypertrophic subaortic stenosis (thickened heart muscle):
  • For oral dosage form (long-acting oral capsules):
    • Adults—80 to 160 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—20 to 40 milligrams (mg) three or four times a day, given before meals and at bedtime.
    • Children—Dose is based on body weight and must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—20 to 40 milligrams (mg) three or four times a day, given before meals and at bedtime.
    • Children—Use and dose must be determined by your doctor.
• For irregular heartbeats:
  • For oral dosage form (solution):
    • Adults—10 to 30 milligrams (mg) three or four times a day, given before meals and at bedtime.
    • Children—Dose is based on body weight and must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—10 to 30 milligrams (mg) three or four times a day, given before meals and at bedtime.
    • Children—Use and dose must be determined by your doctor.
• For migraine headaches:
  • For oral dosage form (long-acting oral capsules):
    • Adults—At first, 80 milligrams (mg) once a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—At first, 80 milligrams (mg) per day, given in divided doses. Your doctor may increase your dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—At first, 80 milligrams (mg) per day, given in divided doses. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.
• For proliferating infantile hemangioma:
  • For oral dosage form (solution):
    • Children 5 weeks to 5 months of age—Dose is based on your child's body weight and must be determined by the doctor. The starting dose is usually 0.6 milligram (mg) per kilogram (kg) of your child's body weight two times a day, taken at least 9 hours apart. Give the dose during or immediately after a feeding. Do not administer the dose if the infant is vomiting or not eating. After 1 week, the doctor will increase the dose to 1.1 mg per kg of body weight two times a day. After 2 weeks, the doctor will increase the dose to 1.7 mg per kg of body weight two times a day, taken for 6 months.
    • Children under 5 weeks of age—Use is not recommended.
• For tremors:
  • For oral dosage form (solution):
    • Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
    • Children—Dose is based on body weight and must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused Hemangeol™ after 2 months.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of propranolol capsules, extended-release capsules, and tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of propranolol oral solution in children.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of propranolol oral solution to treat proliferating infantile hemangioma in children 5 weeks to 5 months of age. However, safety and efficacy have not been established in children older than 1 year of age.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of propranolol in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving propranolol.

No information is available on the relationship of age to the effects of propranolol oral solution in geriatric patients.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupivacaine
• Bupivacaine Liposome
• Bupropion
• Clonidine
• Crizotinib
• Darunavir
• Diatrizoate
• Diltiazem
• Dronedarone
• Epinephrine
• Eslicarbazepine Acetate
• Fenoldopam
• Fingolimod
• Fluoxetine
• Haloperidol
• Indacaterol
• Iobenguane I 131
• Iohexol
• Lacosamide
• Lercanidipine
• Lidocaine
• Mefloquine
• Mepivacaine
• Oxymetazoline
• Peginterferon Alfa-2b
• Pixantrone
• Prilocaine
• Rivastigmine
• Simeprevir
• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Alfuzosin
• Alogliptin
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amiodarone
• Amtolmetin Guacil
• Arbutamine
• Aspirin
• Bromfenac
• Bufexamac
• Bunazosin
• Calcium Carbonate
• Canagliflozin
• Celecoxib
• Chlorpromazine
• Chlorpropamide
• Cholestyramine
• Choline Salicylate
• Cimetidine
• Clonixin
• Dapagliflozin
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitoxin
• Digoxin
• Dihydroergotamine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Dipyrone
• Disopyramide
• Doxazosin
• Droxicam
• Dulaglutide
• Empagliflozin
• Ergotamine
• Ertugliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fluvoxamine
• Glimepiride
• Glipizide
• Glyburide
• Guggul
• Ibuprofen
• Indomethacin
• Insulin Aspart, Recombinant
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Human Inhaled
• Insulin Human Isophane (NPH)
• Insulin Human Regular
• Insulin Lispro, Recombinant
• Ketoprofen
• Ketorolac
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magaldrate
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Metildigoxin
• Mibefradil
• Miglitol
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Phenylephrine
• Piketoprofen
• Pioglitazone
• Piperine
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propoxyphene
• Propyphenazone
• Proquazone
• Quinidine
• Repaglinide
• Rifapentine
• Rizatriptan
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sertraline
• Sitagliptin
• Sodium Salicylate
• St John's Wort
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Trimazosin
• Tubocurarine
• Urapidil
• Valdecoxib
• Vildagliptin
• Zileuton

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anaphylactic reaction (severe), history of—May increase risk for repeated anaphylactic reactions.

• Angina (severe chest pain) or
• Glaucoma or
• Heart attack, recent or
• Muscle problems (eg, myopathy, myotonia)—Use with caution. May make these conditions worse.

• Asthma or
• Bradycardia (slow heartbeat), without a pacemaker or
• Cardiogenic shock (shock caused by heart attack) or
• Heart block, without a pacemaker or
• Heart failure, decompensated or
• Sick sinus syndrome (type of abnormal heart rhythm), without a pacemaker or
• Tremors due to Parkinson's disease—Should not be used in patients with these conditions.

• Asthma, or history of or
• Bradycardia (slow heartbeat), severe or
• Bronchospasm, history of or
• Hypotension (low blood pressure) or
• Infants weighing less than 2 kilograms or
• Pheochromocytoma (an adrenal problem) or
• Premature infants with corrected age younger than 5 weeks of age—Hemangeol™ should not be given to patients with these conditions.

• Diabetes or
• Hyperthyroidism (overactive thyroid) or
• Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal from the body.

• Lung disease (eg, bronchitis, emphysema)—Use with caution. May cause difficulty with breathing in patients with this condition.

• Tachycardia (fast heartbeat) or
• Wolff-Parkinson-White syndrome (rare heart condition)—May cause very slow heartbeat in patients with these conditions.

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. .

Propranolol may cause heart failure in some patients. Check with your doctor right away if you or your child are having chest pain or discomfort, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, shortness of breath, swelling of the face, fingers, feet, or lower legs, weight gain, or wheezing.

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you or your child have these problems or if you notice a change in the results of your blood or urine sugar tests.

Make sure any doctor or dentist who treats you knows that you are using this medicine. Do not stop taking this medicine before surgery without your doctor's approval.

This medicine may cause some people to become less alert than they are normally. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while taking propranolol.

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth or lips, or unusual tiredness or weakness.

Propranolol will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system and may cause drowsiness. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may increase risk of stroke in PHACE syndrome patients with severe blood vessel problems in the brain. Talk to your child's doctor about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.