Inderal LA

The following adverse events were observed and have been reported in patients using propranolol.

Cardiovascular

Bradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type.

Central Nervous System

Light-headedness; mental depression manifested by insomnia, lassitude, weakness, fatigue; catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics. For immediate release formulations, fatigue, lethargy, and vivid dreams appear dose related.

Gastrointestinal

Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.

Allergic

Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress.

Respiratory

Bronchospasm.

Hematologic

Agranulocytosis, nonthrombocytopenic purpura, and thrombocytopenic purpura.

Autoimmune

Systemic lupus erythematosus (SLE).

Skin And Mucous Membranes

Stevens-Johnson Syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis, erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasisiform rashes. Oculomucocutaneous syndrome involving the skin, serous membranes, and conjunctivae reported for a beta-blocker (practolol) have not been associated with propranolol.

Genitourinary

Male impotence; Peyronie's disease.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Your pharmacist can provide more information about propranolol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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In the U.S.

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

Available Dosage Forms:

• Tablet
• Capsule, Extended Release
• Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

• It is used to treat high blood pressure.
• It is used to treat chest pain or pressure.
• It is used to help certain heart problems.
• It is used to prevent migraine headaches.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
• Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Very bad dizziness or passing out.
• Chest pain that is new or worse.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Mood changes.
• A burning, numbness, or tingling feeling that is not normal.
• Change in eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Any unexplained bruising or bleeding.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Feeling cold.
• Change in sex ability.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

• 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 Inderal LA, 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 this medicine 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 Inderal LA. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 Inderal LA.

Review Date: October 4, 2017

Hypertension

In a retrospective, uncontrolled study, 107 patients with diastolic blood pressure 110 to 150 mmHg received propranolol 120 mg t.i.d. for at least 6 months, in addition to diuretics and potassium, but with no other hypertensive agent. Propranolol contributed to control of diastolic blood pressure, but the magnitude of the effect of propranolol on blood pressure cannot be ascertained.

Four double-blind, randomized, crossover studies were conducted in a total of 74 patients with mild or moderately severe hypertension treated with Inderal LA 160 mg once daily or propranolol 160 mg given either once daily or in two 80 mg doses. Three of these studies were conducted over a 4-week treatment period. One study was assessed after a 24-hour period. Inderal LA was as effective as propranolol in controlling hypertension (pulse rate, systolic and diastolic blood pressure) in each of these trials.

Angina Pectoris

In a double-blind, placebo-controlled study of 32 patients of both sexes, aged 32 to 69 years, with stable angina, propranolol 100 mg t.i.d. was administered for 4 weeks and shown to be more effective than placebo in reducing the rate of angina episodes and in prolonging total exercise time.

Twelve male patients with moderately severe angina pectoris were studied in a double-blind, crossover study. Patients were randomized to either Inderal LA 160 mg daily or conventional propranolol 40 mg four times a day for 2 weeks. Nitroglycerine tablets were allowed during the study. Blood pressure, heart rate and ECG's were recorded during serial exercise treadmill testing. Inderal LA was as effective as conventional propranolol for exercise heart rate, systolic and diastolic blood pressure, duration of anginal pain and ST-segment depression before or after exercise, exercise duration, angina attack rate and nitroglycerine consumption.

In another double-blind, randomized, crossover trial, the effectiveness of propranolol LA 160 mg daily and conventional propranolol 40 mg four times a day were evaluated in 13 patients with angina. ECG's were recorded while patients exercised until angina developed. Inderal LA was as effective as conventional propranolol for amount of exercise performed, ST-segment depression, number of anginal attacks, amount of nitroglycerine consumed, systolic and diastolic blood pressures and heart rate at rest and after exercise.

Migraine

In a 34-week, placebo-controlled, 4-period, dose-finding crossover study with a double-blind randomized treatment sequence, 62 patients with migraine received propranolol 20 to 80 mg 3 or 4 times daily. The headache unit index, a composite of the number of days with headache and the associated severity of the headache, was significantly reduced for patients receiving propranolol as compared to those on placebo.

Hypertrophic Subaortic Stenosis

In an uncontrolled series of 13 patients with New York Heart Association (NYHA) class 2 or 3 symptoms and hypertrophic subaortic stenosis diagnosed at cardiac catheterization, oral propranolol 40 to 80 mg t.i.d. was administered and patients were followed for up to 17 months. Propranolol was associated with improved NYHA class for most patients.

Hypertension

Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.

Angina Pectoris Due to Coronary Atherosclerosis

Inderal LA is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.

Migraine

Inderal LA is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.

Hypertrophic Subaortic Stenosis

Inderal LA improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.

Applies to propranolol: intravenous solution, oral capsule extended release, oral concentrate, oral liquid, oral solution, oral tablet

Cardiovascular

Use of a nonselective beta-blocker like propranolol (the active ingredient contained in Inderal LA) may at least blunt cardiac output in some patients, especially those with preexisting left ventricular systolic dysfunction and during exertion. Data have shown that cardiac conditioning can delay or attenuate this side effect of propranolol.

Abrupt cessation of propranolol therapy may result in hypertension, myocardial infarction, and angina pectoris in some patients.

Paradoxical hypertension may occur in patients with pheochromocytoma, unless alpha-adrenergic blockade is already instituted.

At least two cases of electrical alternans associated with propranolol are reported from pediatric cases. In one case, electrical alternans was clearly not rate-related (since it occurred during propranolol therapy at a slower rate than the patient's "native" ventricular tachycardia) and was associated with echocardiographically-demonstrated mechanical alternans.[Ref]

Common (1% to 10%): Hypotension, cold extremities, Raynaud's phenomenon
Uncommon (0.1% to 1%): Heart failure, precipitation of heart block
Rare (less than 0.1%): Exacerbation of claudication, postural hypotension (which may be associated with syncope)
Frequency not reported: Bradycardia, congestive heart failure[Ref]

Nervous system

Rare cases of paresthesias and myasthenia gravis have been associated with propranolol (the active ingredient contained in Inderal LA) [Ref]

Common (1% to 10%): Fatigue and/or lassitude (often transient), sleep disturbances, nightmares, sleep disorder, agitation, somnolence, irritability
Rare (less than 0.1%): Dizziness, paresthesia (especially of the hands)
Very rare (less than 0.01%): Seizure (linked to hypoglycemia)
Frequency not reported: Reduction or loss of libido, lightheadedness, mental depression (manifested by insomnia), weakness, catatonia, hallucinations, an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium[Ref]

Renal

There are reports of patients who experienced reversible renal insufficiency with no decline in systemic blood pressure, but these patients had preexisting renal disease. This may be important in patients with preexisting renal insufficiency. New or worsened renal dysfunction has been reported in patients with underlying renal disease and no decline in systemic blood pressure.[Ref]

Uncommon (0.1% to 1%): Renal insufficiency (related to lowering of systemic blood pressure)[Ref]

Respiratory

Rare (less than 0.1%): Dyspnea, worsening of reactive airways diseases, bronchospasm in patients with bronchial asthma or a history of asthmatic complaints (sometimes fatal)[Ref]

Limited data have shown a mean fall in maximal midexpiratory flow rate (MMFR) during propranolol therapy relative to placebo in nine of ten patients whose lung function was assessed. Interestingly, the fall was not related to smoking or to atopic status, suggestive of resting beta-adrenergic bronchodilator activity in nonasthmatic subjects.

Non-selective beta-blockers, such as propranolol, are used with caution in patients with asthma and chronic obstructive pulmonary disease due to inhibition of bronchodilation.[Ref]

Endocrine

Beta-blockers, such as propranolol (the active ingredient contained in Inderal LA) are used with caution in patients with diabetes due to masking of the catecholamine response to hypoglycemia. Propranolol may also mask the signs of hyperthyroidism by the same mechanism.

Propranolol has been associated with significant increases in serum triglycerides, fasting blood glucose, and LDL and VLDL cholesterol, and significant decreases in HDL cholesterol.[Ref]

Very rare (less than 0.01%): Hypoglycemia (particularly in neonates, infants, children, elderly patients, patients on hemodialysis, patients on concomitant antidiabetic therapy, patients with prolonged fasting and patients with chronic liver disease), hypertriglyceridemia[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Anorexia, nausea, vomiting, diarrhea, abdominal pain, flatulence, decreased appetite[Ref]

Psychiatric

One study of 34 hypertensive patients who were taking propranolol (the active ingredient contained in Inderal LA) found the incidence of depressive symptoms in this population to be 50% to 74% (depending on the criteria used). Propranolol-induced depression may be more likely in patients with a personal or family history of depression. Of the 34 patients, 12 had a history of depression and 8 had a history of substance abuse, alcoholism, or a family history of psychiatric disorders. Since none of the 12 patients with a history of depression were clinically depressed at the start of propranolol therapy and were comparable by age, diagnosis, and propranolol dosage to the other 22 patients, a comparison was made. Patients with a personal or family history of depression had significantly higher scores on depression scales than those without such histories.

A 72-year-old retired college professor with no history of affective disorders developed progressive sadness, tearfulness, hopelessness, decreased energy, social withdrawal, anhedonia, insomnia, and decreased memory and concentration within two weeks after beginning propranolol monotherapy for hypertension. The signs and symptoms of depression resolved upon substitution with a thiazide diuretic. Interestingly, the patient later was treated for recurrent depression while not receiving propranolol.

Rare cases of psychoses associated with propranolol have been reported.[Ref]

Rare (less than 0.1%): Depression (dose dependent), hallucinations, psychoses, mood changes, confusion, memory loss[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis, contact dermatitis[Ref]

Hematologic

Uncommon (0.1% to 1%): Reduction of platelet adhesiveness, thrombocytopenic purpura, nonthrombocytopenic purpura, agranulocytosis, eosinophilia[Ref]

Dermatologic

Rare (less than 0.1%): Psoriatic flares
Frequency not reported: Stevens - Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, urticaria, purpura, alopecia, skin rashes, SLE-like reactions[Ref]

Immunologic

Postmarketing reports: Enhanced immune system[Ref]

Propranolol can enhance the immune system by causing an increase in the number of circulating T cells, increased interleukin-2 (IL-2) secretion, increased expression of IL-2 receptors, and increased lymphocyte production in response to the T cell mitogen Con A. Interestingly, NK (natural killer) cell activity may be decreased during propranolol therapy, although the number of circulating NK cells may remain unchanged. These results are consistent with previous data showing decreased immunologic function during periods of elevated sympathetic activity, such as congestive heart failure, uremia, or life-threatening events.[Ref]

Genitourinary

Frequency not reported: Male impotence, Peyronie's disease[Ref]

Metabolic

Frequency not reported: Weight gain[Ref]

The mechanism by which propranolol induces weight gain is unknown. Some investigators have reported a 4% to 9% reduction in total energy expenditure and a 25% reduction in thermogenic response to food during beta-blocker treatment.[Ref]

Musculoskeletal

Very rare (less than 0.01%): Myasthenia gravis like syndrome or exacerbation of myasthenia gravis
Frequency not reported: Myopathy, myotonia[Ref]

Hepatic

Very rare (less than 0.01%): Elevated liver function tests[Ref]

Ocular

Rare (less than 0.1%): Dry eyes, visual disturbances[Ref]

Some side effects of Inderal LA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.