Inderal XL

Propranolol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Propranolol is used to treat tremors, angina (chest pain), hypertension (high blood pressure), heart rhythm disorders, and other heart or circulatory conditions. It is also used to treat or prevent heart attack, and to reduce the severity and frequency of migraine headaches.

Hemangeol (propranolol oral liquid 4.28 milligrams) is given to infants who are at least 5 weeks old to treat a genetic condition called infantile hemangiomas. Hemangiomas are caused by blood vessels grouping together in an abnormal way. These blood vessels form benign (non-cancerous) growths that can develop into ulcers or red marks on the skin. Hemangiomas can also cause more serious complications inside the body (in the liver, brain, or digestive system).

Propranolol may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to propranolol, if you have asthma, very slow heart beats, or a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker).

Babies who weigh less than 4.5 pounds should not be given Hemangeol oral liquid.

You should not use propranolol if you are allergic to it, or if you have:

• asthma;
• very slow heart beats that have caused you to faint; or
• a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker).

Babies who weigh less than 4.5 pounds should not be given Hemangeol oral liquid.

To make sure propranolol is safe for you, tell your doctor if you have:

• a muscle disorder;
• bronchitis, emphysema, or other breathing disorders;
• low blood sugar, or diabetes (propranolol can make it harder for you to tell when you have low blood sugar);
• slow heartbeats, low blood pressure;
• congestive heart failure;
• depression;
• liver or kidney disease;
• a thyroid disorder;
• pheochromocytoma (tumor of the adrenal gland); or
• problems with circulation (such as Raynaud's syndrome).

FDA pregnancy category C. It is not known whether propranolol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Propranolol can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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:

Allergies

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.

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 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.

Geriatric

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.

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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
• 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
• 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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Feeling sleepy.
• Feeling tired or weak.
• Upset stomach or throwing up.
• Not able to sleep.
• Stomach cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Inderal XL or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Inderal XL. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Inderal XL is contraindicated in patients with:

• Cardiogenic shock or decompensated heart failure
  
• Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place
  
• Bronchial asthma
  
• Known hypersensitivity (e.g., anaphylactic reaction) to propranolol hydrochloride or any of the components of Inderal XL

5.1 Cardiac Ischemia after Abrupt Discontinuation

Following abrupt discontinuation of therapy with beta-blockers, exacerbations of angina pectoris and myocardial infarction have occurred.

When discontinuing chronically administered Inderal XL, particularly in patients with ischemic heart disease, gradually reduce the dose over a period of 1-2 weeks and monitor the patients. If angina markedly worsens or acute coronary insufficiency develops, promptly resume therapy, at least temporarily and take other measures appropriate for the management of unstable angina. Warn patients against interruption or discontinuation of therapy without physician’s advice.

Because coronary artery disease is common and may be unrecognized, avoid abrupt discontinuation of Inderal XL therapy even in patients treated only for hypertension.

5.2 Cardiac Failure

Beta-blockers, like Inderal XL, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of Inderal XL or to discontinue it.

5.3 Maintain During Major Surgery

Chronically administered beta-blocking therapy, including Inderal XL, should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

5.4 Masked Signs of Hypoglycemia

Beta-blockers, like Inderal XL, may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.

5.5 Thyrotoxicosis

Inderal XL may mask clinical signs of hyperthyroidism, such as tachycardia. Avoid abrupt withdrawal of beta-blockade, which may precipitate a thyroid storm.

5.6 Bradycardia 

Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Inderal XL. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders (including Wolff-Parkinson-White) may be at increased risk. The concomitant use of beta adrenergic blockers and non-dihydropyridine calcium channel blockers (e.g., verapamil and diltiazem), digoxin or clonidine increases the risk of significant bradycardia. Monitor heart rate and rhythm in patients receiving Inderal XL. If severe bradycardia develops, reduce or stop Inderal XL.

5.7 Reduced Effectiveness of Epinephrine in Treating Anaphylaxis

Beta adrenergic blocker- treated patients treated with epinephrine for a severe anaphylactic reaction may be less responsive to the typical doses of epinephrine. In these patients, consider other medications (e.g., intravenous fluids, glucagon).

Most overdoses of propranolol are mild and respond to supportive care.

Propranolol is not significantly dialyzable.

Hypotension and bradycardia have been reported following propranolol overdose and should be treated appropriately. Glucagon can exert potent inotropic and chronotropic effects and may be particularly useful for the treatment of hypotension or depressed myocardial function after a propranolol overdose.

Glucagon should be administered as 50-150 mcg/kg intravenously followed by continuous drip of 1-5 mg/hour for positive chronotropic effect. Isoproterenol, dopamine or phosphodiesterase inhibitors may also be useful. Epinephrine, however, may provoke uncontrolled hypertension. Bradycardia can be treated with atropine or isoproterenol. Serious bradycardia may require temporary cardiac pacing.

Monitor the electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance. Isoproterenol and aminophylline may be used for bronchospasm.

Inderal XL (propranolol hydrochloride) Extended-Release Capsules are supplied as capsules containing either 80 mg, or 120 mg propranolol hydrochloride imprinted with “Inderal XL”.

Storage: Store at 25ºC (77ºF); excursions permitted to 15º and 30ºC (59º and 86ºF) [see USP Controlled Room Temperature] in a tightly closed container.

Applies to propranolol: oral capsule extended release, oral solution, oral tablet

Other dosage forms:

• intravenous solution

Along with its needed effects, propranolol (the active ingredient contained in Inderal XL) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

• Cough producing mucus
• difficulty with breathing
• tightness in the chest

• Abdominal or stomach pain and tenderness
• 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
• extreme fatigue
• 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
• reddening of the skin, especially around the ears
• runny nose
• scaly skin
• seeing, hearing, or feeling things that are not there
• severe sleepiness
• short-term memory loss
• shortness of breath
• skin irritation or rash, including rash that looks like psoriasis
• skin rash, hives, or itching
• 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
• tightness in the chest
• 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 of propranolol 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:

• Anxiety
• dry mouth
• hyperventilation
• irritability
• restlessness
• shaking
• sleepiness or unusual drowsiness
• trouble sleeping
• unusual dreams

• Decreased appetite

• 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