Propranolol hydrochloride

What is Propranolol hydrochloride?

• Propranolol hydrochloride (Inderal) is a synthetic beta-adrenergic receptor blocking agent used to treat high blood pressure, a number of types of irregular heart rate, thyrotoxicosis, capillary hemangiomas, performance anxiety, and essential tremors, as well to prevent migraine headaches, and to prevent further heart problems in those with angina or previous heart attacks.
• Propranolol hydrochloride used under the brand name Hemangeol to treat infantile hemangioma (a benign blood vessel tumor).

Propranolol

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Propranolol-3D-balls

Propranolol Enantiomers

What are the uses of this medicine?

Propranolol hydrochloride (Inderal) is used in the treatment:

• hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic.
• Angina Pectoris Due to Coronary Atherosclerosis
• Atrial Fibrillation
• Myocardial Infarction
• Migraine
• Essential Tremor
• Hypertrophic Subaortic Stenosis
• Pheochromocytoma

How does this medicine work?

• The mechanism of the antihypertensive effect of propranolol has not been established. Factors that may contribute to the antihypertensive action include: (1) decreased cardiac output, (2) inhibition of renin release by the kidneys, and (3) diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain.
• In angina pectoris, propranolol generally reduces the oxygen requirement of the heart at any given level of effort by blocking the catecholamine-induced increases in the heart rate, systolic blood pressure, and the velocity and extent of myocardial contraction.
• Propranolol exerts its antiarrhythmic effects in concentrations associated with beta-adrenergic blockade, and this appears to be its principal antiarrhythmic mechanism of action.
• The mechanism of the antimigraine effect of propranolol has not been established. Beta-adrenergic receptors have been demonstrated in the pial vessels of the brain.
• The specific mechanism of propranolol’s antitremor effects has not been established, but beta-2 (noncardiac) receptors may be involved. A central effect is also possible.

Who Should Not Use this medicine ?

This medicine cannot be used with:

• cardiogenic shock
• sinus bradycardia and greater than first degree block
• bronchial asthma
• with known hypersensitivity to propranolol hydrochloride.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• ACE inhibitors
• antacids containing aluminum (Maalox, Mylanta, others)
• anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven)
• calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac, others), nicardipine (Cardene), nifedipine (Adalat, Procardia XL), and nisoldipine (Sular)
• cholestyramine (Prevalite)
• cimetidine
• ciprofloxacin (Cipro)
• chlorpromazine
• colestipol (Colestid)
• diazepam (Diastat, Valium)
• digoxin (Lanoxin)
• fluvoxamine (Luvox)
• haloperidol (Haldol)
• HMG-CoA reductase inhibitors (cholesterol-lowering agents) such as lovastatin (Altoprev, Mevacor, in Advicor) and pravastatin (Pravachol)
• isoniazid (in Rifamate, in Rifater)
• medications for depression such as bupropion (Aplenzin, Forfivo XL, Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem, Selfemra), imipramine (Tofranil), and paroxetine (Brisdelle, Paxil, Pexeva)
• fluconazole (Diflucan)
• medications for migraine headaches such as rizatriptan (Maxalt) and zolmitriptan (Zomig)
• medications for high blood pressure such as clonidine (Catapres, Kapvay, in Clorpres), doxazosin (Cardura), prazosin (Minipress), and terazosin
• medications for seizures such as phenytoin (Dilantin, Phenytek) and phenobarbital
• certain medications for irregular heartbeats such as amiodarone (Cordarone, Nexterone, Pacerone), propafenone (Rythmol), and quinidine (in Nuedexta)
• monoamine oxidase (MAO) inhibitors such as phenelzine (Nardil)
• montelukast (Singulair)
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as indomethacin (Indocin, Tivorbex)
• theophylline (Theo-24, Theochron, Uniphyl)
• reserpine
• rifampin (Rifadin, Rimactane, in Rifater, in Rifamate)
• ritonavir (Norvir, in Kaletra, in Viekira Pak)
• teniposide (Vumon)
• thioridazine
• ticlopidine
• tolbutamide
• tricyclic antidepressants
• zileuton (Zyflo)

Is this medicine FDA approved?

• Propranolol was approved for use in the United States in 1967 and is still commonly used, with several million prescriptions filled yearly.

How should this medicine be used?

Recommended dosage: Hypertension:

• The usual initial dosage is 40 mg propranolol hydrochloride twice daily, whether used alone or added to a diuretic.
• Dosage may be increased gradually until adequate blood pressure control is achieved.
• The usual maintenance dosage is 120 mg to 240 mg per day.
• In some instances a dosage of 640 mg a day may be required.

Angina Pectoris:

• Total daily doses of 80 mg to 320 mg propranolol hydrochloride, when administered orally, twice a day, three times a day, or four times a day, have been shown to increase exercise tolerance and to reduce ischemic changes in the ECG.

Atrial Fibrillation: The recommended dose is 10 mg to 30 mg propranolol hydrochloride three or four times daily before meals and at bedtime.

Myocardial Infarction:

• The initial dose was 40 mg t.i.d., with titration after 1 month to 60 mg to 80 mg t.i.d. as tolerated.
• The recommended daily dosage is 180 mg to 240 mg propranolol hydrochloride per day in divided doses.

Migraine:

• The initial dose is 80 mg propranolol hydrochloride daily in divided doses.
• The usual effective dose range is 160 mg to 240 mg per day.

Essential Tremor:

• The initial dosage is 40 mg propranolol hydrochloride twice daily.
• Optimum reduction of essential tremor is usually achieved with a dose of 120 mg per day. Occasionally, it may be necessary to administer 240 mg to 320 mg per day.

Hypertrophic Subaortic Stenosis:

• The usual dosage is 20 mg to 40 mg propranolol hydrochloride three or four times daily before meals and at bedtime.

Pheochromocytoma:

• The usual dosage is 60 mg propranolol hydrochloride daily in divided doses for three days prior to surgery as adjunctive therapy to alpha-adrenergic blockade.

Administration:

• Propranolol comes as a tablet, solution (liquid),and as an extended-release (long-acting) capsule to take by mouth.
• The extended-release propranolol capsule (Inderal LA) usually is taken once a day.
• The extended-release capsule (Innopran XL, Inderal XL) is usually taken at bedtime and should consistently be taken either always with or always without food each time.
• Immediate-acting propranolol tablets or solution may be taken two, three, or four times a day.
• Take propranolol at around the same time(s) every day.
• Swallow the extended-release capsules whole; do not split, chew, or crush them.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet, solution (liquid),and as an extended-release (long-acting) capsule

This medicine is available in fallowing brand namesː

• Inderal
• Inderal XL
• Inderal LA
• InnoPran
• InnoPran XL
• Pronol

What side effects can this medication cause?

The most common side effects of this medicine include:

• bradycardia, hypotension, fatigue, dizziness, depression, memory loss, incontinence, cold limbs, tiredness, diarrhea, constipation

• Less commonly severe hypotension, heart failure and bronchospasm. Sudden withdrawal can trigger rebound hypertension.

What special precautions should I follow?

• There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced over at least a few weeks and the patient should be cautioned against interruption or cessation of therapy without the physician’s advice.
• Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol.
• In general, patients with bronchospastic lung disease should not receive beta blockers. Propranolol should be administered with caution.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking propranolol.
• Propranolol should be used with caution in patients with impaired hepatic or renal function. Propranolol is not indicated for the treatment of hypertensive emergencies.
• Beta-adrenergic receptor blockade can cause reduction of intraocular pressure. Patients should be told that propranolol may interfere with the glaucoma screening test.
• In patients with hypertension, use of propranolol has been associated with elevated levels of serum potassium, serum transaminases and alkaline phosphatase.
• The necessity or desirability of withdrawal of beta-blocking therapy prior to major surgery is controversial.
• Propranolol therapy, particularly when given to infants and children, diabetic or not, has been associated with hypoglycemia especially during fasting as in preparation for surgery. Hypoglycemia has been reported in patients taking propranolol after prolonged physical exertion and in patients with renal insufficiency.
• Propranolol may change thyroid-function tests, increasing T4 and reverse T3 and decreasing T3.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Hypotension
• bradycardia

Management of overdosage:

• Propranolol is not significantly dialyzable.
• If ingestion is or may have been recent, evacuate gastric contents, taking care to prevent pulmonary aspiration.
• Hypotension and bradycardia have been reported following propranolol overdose and should be treated appropriately.
• Glucagon is useful for the treatment of hypotension or depressed myocardial function after a propranolol overdose.
• 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.
• The electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance must be monitored.
• Isoproterenol and aminophylline may be used for bronchospasm.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies in pregnant women.
• Propranolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness of propranolol in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PROPRANOLOL HYDROCHLORIDE

Inactive ingredients:

• ANHYDROUS LACTOSE
• SILICON DIOXIDE
• CROSCARMELLOSE SODIUM
• D&C YELLOW NO. 10
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• STEARIC ACID
• FD&C BLUE NO. 1

Who manufactures and distributes this medicine?

Manufactured By:

• Watson Pharma Private Limited
• Verna, Salcette Goa INDIA

Distributed By:

• Watson Pharma, Inc.
• Corona, CA USA

What should I know about storage and disposal of this medication?

• Store at 20°-25°C (68°-77°F).
• Dispense in a well-closed, light-resistant container with child-resistant closure.

• Dailymed label info on Propranolol hydrochloride
• FDA Propranolol hydrochloride

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