Inderal XL (Oral)

Propranolol is used by itself or with other medicines to treat high blood pressure (hypertension). High blood pressure increases the workload on the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Lowering blood pressure may lower 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 lower the risk of death in patients who have had heart attacks.

Propranolol oral solution is used to treat proliferating infantile hemangioma.

This medicine is a beta-blocker. It works by changing how the body responds to nerve impulses in certain areas, like the heart. As a result, the heart beats slower and blood pressure decreases. When blood pressure goes down, more blood and oxygen are delivered to the heart.

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

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Hemangeol® may increase the risk of heart or blood vessel problems (for example, bradycardia, hypotension). Check with your doctor right away if your child has blurred vision, chest pain or discomfort, confusion, lightheadedness, dizziness, fainting, slow or uneven heartbeat, sweating, trouble breathing, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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 with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

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

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, including rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests. Call your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.

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 normally are. 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 suddenly 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.

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 these medicines while you are using this medicine.

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

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Some men who use this medicine may experience erectile dysfunction. Check with your doctor right away if you have decreased interest in sexual intercourse, inability to have or keep an erection, or loss in sexual ability, drive, or performance. If you have questions about this, talk to your doctor.

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.

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

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other medications. Additionally inform 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.

Pediatric

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 issues 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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of propranolol in the elderly. Nevertheless, 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 guidance is available on the relationship of age to the effects of propranolol oral solution in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks prior to using this drug while breastfeeding.

Interactions with Medicines

Although certain drugs 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 drugs 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 clinician may decide not to treat you with this drug or change some of the other medicines you take.

• Rizatriptan
• Thioridazine

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

• Abametapir
• Albuterol
• Bupivacaine
• Bupivacaine Liposome
• Bupropion
• Capmatinib
• Ceritinib
• Clonidine
• Crizotinib
• Darunavir
• Desvenlafaxine
• Diatrizoate
• Diltiazem
• Dronedarone
• Epinephrine
• Escitalopram
• Eslicarbazepine Acetate
• Fedratinib
• Fenoldopam
• Fexinidazole
• Fingolimod
• Fluoxetine
• Formoterol
• Haloperidol
• Indacaterol
• Iobenguane I 131
• Iohexol
• Lacosamide
• Lercanidipine
• Levalbuterol
• Lidocaine
• Mefloquine
• Mepivacaine
• Olodaterol
• Oxymetazoline
• Pixantrone
• Ponesimod
• Prilocaine
• Rivastigmine
• Salmeterol
• Simeprevir
• Siponimod
• Sparsentan
• Terbutaline
• Venlafaxine
• Verapamil
• Vilanterol
• Zileuton

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 therapy for you. If both drugs are prescribed together, your doctor may change the dose or how frequently you use one or both of the drugs.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Alfuzosin
• Alogliptin
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amtolmetin Guacil
• 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
• Doxazosin
• Droxicam
• Dulaglutide
• Empagliflozin
• Ergotamine
• Ertugliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fluvoxamine
• Glimepiride
• Glipizide
• Glyburide
• 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
• Miglitol
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propyphenazone
• Proquazone
• Quinidine
• Repaglinide
• Rifapentine
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• St John's Wort
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Trimazosin
• Urapidil
• Valdecoxib
• Vildagliptin

Interactions with Food/Tobacco/Alcohol

Certain medications 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 drugs 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 typically not advised, but may be unavoidable in some cases. If used together, your clinician 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

Other Medical Issues

The presence of other medical issues may affect the use of this medication. Make sure you inform your clinician if you have any other medical issues, especially:

• Anaphylactic reaction (serious), history of—May raise chance for repeated anaphylactic reactions.

• Angina (serious 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 issue) or
• Premature infants with corrected age younger than 5 weeks of age—Hemangeol® should not be given to patients with these conditions.

• Colds or
• Infection or
• Poor oral food intake (eg, not eating, vomiting) or
• Stress—Hemangeol® may raise the chance of low blood sugar in 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 since 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 extremely slow heartbeat in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

in children

• Chest tightness
• Cough producing mucus
• Difficulty with breathing

Incidence not known

• Black, tarry stools
• Blistering, peeling, or loosening of the skin
• Blood in the urine
• Bloody nose
• Bloody stools
• Blurred or loss of vision
• Body aches or pain
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Chest pain or discomfort
• Confusion about identity, place, and time
• Congestion
• Constipation
• Cough
• Cracks in the skin
• Crying
• Decreased awareness or responsiveness
• Decreased urine output
• Depersonalization
• Diarrhea
• Difficulty with swallowing
• Dilated neck veins
• Disturbed color perception
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Double vision
• Dryness or soreness of the throat
• Dysphoria
• Euphoria
• Fast, pounding, slow, or irregular heartbeat
• Fever and chills
• General feeling of discomfort, illness, or weakness
• Hair loss
• Halos around lights
• Headaches
• Heavier menstrual periods
• Hoarseness
• Irregular breathing
• Lightheadedness, dizziness, or fainting
• Loss of heat from the body
• Mental depression
• Mimicry of speech or movements
• Muscle or joint pain
• Mutism
• Nausea
• Negativism
• Night blindness
• Noisy breathing
• Overbright appearance of lights
• Paleness or cold feeling in the fingertips and toes
• Paranoia
• Peculiar postures or movements, mannerisms, or grimacing
• Pinpoint red or purple spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Quick to react or overreact emotionally
• Rapidly changing moods
• Rectal bleeding
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Red, swollen skin
• Reddish skin, especially around the ears
• Runny nose
• Scaly skin
• Seeing, hearing, or feeling things that are not there
• Severe sleepiness
• Short-term memory loss
• Skin irritation or rash, including rash that looks like psoriasis
• Skin rash, hives, or itching
• Stomach pain and tenderness
• Sores, ulcers, or white spots in the mouth or on the lips
• Sweating
• Swelling of the eyes, face, fingers, feet, or lower legs
• Swollen glands
• Tender, swollen glands in the neck
• Tingling or pain in fingers or toes when exposed to cold
• Tunnel vision
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Voice changes
• Vomiting
• Weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

in children

• Anxiety
• Dry mouth
• Hyperventilation
• Irritability
• Restlessness
• Shaking
• Sleepiness or unusual drowsiness
• Trouble sleeping
• Unusual dreams

Less common

in children

• Decreased appetite

Incidence not known

• Dry eyes
• Heartburn
• Loss of strength or energy
• Muscle weakness
• Pain or discomfort in the chest, upper stomach, or throat
• Stomach cramps
• Unusual drowsiness, dullness, or feeling of sluggishness
• Vivid dreams

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Hemangeol
• Inderal
• Inderal LA
• Inderal XL
• InnoPran XL
• Propranolol HCl Intensol

Available Dosage Forms:

• Capsule, Extended Release
• Solution
• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

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 and tablets whole. Do not break, chew, crush, or open them.

Propranolol extended-release capsules should be taken at bedtime (10 pm). 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.

Dosing

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 as 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 as needed. The dose is usually not more than 320 mg per day. 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 as 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 as 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 as 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 as 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 as needed. The dose is usually not more than 240 mg per day. 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 as 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 as 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) (0.15 milliliters [mL]) per kilogram (kg) of your child's body weight 2 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 (0.3 mL) per kg of body weight two times a day. After 2 weeks, the doctor will increase the dose to 1.7 mg (0.4 mL) per kg of body weight 2 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 as 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 as needed. Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Storage

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.

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