Propranolol, Oral for Hemangioma

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat infantile hemangioma. Give it exactly as directed.
• This medicine may increase the risk of stroke in certain children who have severe problems with the blood vessels in their brain. This medicine may also cause other unwanted side effects. Tell your healthcare provider if your child has any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat your child about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: beta blocker

Generic and brand names: propranolol, oral for hemangioma; Hemangeol

What is this medicine used for?

This medicine is taken by mouth to treat infantile hemangioma, a growth in babies from 5 weeks to 5 months of age.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before my child takes this medicine?

Before your child takes this medicine, be sure to tell your healthcare provider if your child has ever had:

• An allergic reaction to any other medicine
• A lung disease such as asthma or COPD that causes shortness of breath, coughing, wheezing, or other breathing problems. (This medicine may make these problems worse.)
• Diabetes
• Slow heartbeat or any other heart problems
• Low blood pressure
• Pheochromocytoma (a tumor of the adrenal gland)

Also, tell your healthcare provider if your child was born prematurely, or if your child is vomiting or not able to take feedings.

Females of childbearing age: If you are breastfeeding your child, it is important to tell your child's healthcare provider about all the medicines you take. Certain medicines may pass to your child through your breast-milk and interact with this medicine. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when your child starts taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your child’s specific dose. Be sure you know when to give the medicine and how much medicine you should give. Your healthcare provider may change the dose of this medicine as your child's weight changes.

Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Always give this medicine with a feeding or right after a feeding. This medicine is usually given 2 times each day, at least 9 hours apart.

Do NOT shake the bottle before use.

Use only the oral dosing syringe in the medicine package to measure each dose. The average household teaspoon may not hold the right amount of liquid. It is best to give your child the medicine directly into his or her mouth. If needed, you can mix the dose in a small amount of milk or fruit juice and give it to your child in a baby bottle.

Check with your healthcare provider before using this medicine in children over age 1 year.

What if I miss a dose?

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.

If you miss a dose, give it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and give the next one as directed. Do not give double doses. If you are not sure about what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If your child or anyone else has taken too much of this medicine, call 911 or go to the emergency room right away. If your child passes out, has seizures, weakness or confusion, or has trouble breathing, call 911. If you think that your child may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: slow or irregular heartbeat, trouble breathing, wheezing, weakness, fainting, seizures, sweating, tremors.

What should I watch out for?

Your child's heart rate and blood pressure should be checked for 2 hours after the first dose of this medicine, and after dose increases. Talk with your healthcare provider about this.

This medicine may lower your child’s blood sugar, especially if your child is vomiting or not eating well. It may be harder to tell if your child’s blood sugar level is too low. To help reduce the risk of low blood sugar:

• Give this medicine during or shortly after feeding your child.
• Feed your child regularly during treatment. Tell your healthcare provider if your child has a poor appetite.
• If your child is not taking feedings due to an illness or vomiting, ask your healthcare provider if you should stop giving the medicine until your child is eating normally again.

This medicine may increase the risk of stroke in certain children who have severe problems with the blood vessels in their brain, especially if your child has a large hemangioma that affects the face or head. Talk with your healthcare provider about this.

If your child needs emergency care, surgery, or lab tests, tell the healthcare provider that your child is taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; tightness in your chest; trouble breathing; swelling of your face, throat, or tongue).

Serious (Report these to your healthcare provider right away.): Pale, blue, or purple skin color; sweating; irritability; crying for no reason; poor feeding; severe or ongoing vomiting; low body temperature (arms or legs feel cold); unusual sleepiness or grogginess; seizures; breathing stops for short periods of time; slow, fast, or irregular heartbeat; fainting; wheezing or trouble breathing.

Other: Trouble sleeping, diarrhea.

What products might interact with this medicine?

When your child takes this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you or your child are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and ramipril (Altace)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Anesthetics such as bupivacaine (Exparel, Marcaine, Sensorcaine), lidocaine (Lidoderm, Xylocaine), and mepivacaine
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antacids (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antibiotics such as ciprofloxacin (Cipro), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin, and rifampin (Rifadin)
• Antidepressants such as amitriptyline, amoxapine, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, trimipramine (Surmontil), venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), terbinafine (Lamisil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), prochlorperazine (Compro), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as abiraterone (Zytiga), axitinib (Inlyta), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), dasatinib (Sprycel), erlotinib (Tarceva), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), obinutuzumab (Gazyva), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), teniposide, vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colestipol (Colestid), fluvastatin (Lescol), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Clobazam (Onfi)
• Clonidine (Catapres, Kapvay)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cough, cold, or allergy medicines such as diphenhydramine (Benadryl), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Diabetes medicines such as acarbose (Precose), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and tolbutamide
• Diazepam (Valium)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, eplerenone (Inspra), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen)
• Heart or blood pressure medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), felodipine, flecainide, hydralazine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), procainamide, propafenone (Rythmol), quinidine, reserpine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as albuterol (ProAir, Proventil, Ventolin), arformoterol (Brovana), formoterol (Perforomist), metaproterenol, theophylline, and zileuton (Zyflo)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), dipyridamole (Persantine), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Methoxsalen (8-MOP, Oxsoralen Ultra, Uvadex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), methylergonovine, naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Natural remedies such as bayberry, black cohosh, blue cohosh, California poppy, cayenne, coleus, dog quai, ephedra, garlic, ginger, ginseng, goldenseal, hawthorn, kola, licorice, ma huang, mistletoe, periwinkle, shepherd's purse, St. John's wort, and yohimbe
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen (Advil, Motrin), indomethacin (Indocin), ketorolac, naproxen (Aleve, Anaprox, Naprelan), and sulindac (Clinoril)
• Paroxetine (Brisdelle, Paxil, Pexeva)

Do not drink alcohol if you are breast-feeding while your child is taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Throw away the bottle 2 months after you open it, even if there is medicine left in the bottle.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.