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propranolol


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.

Important information

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.

Before taking this medicine

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 propranolol.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

How should I take propranolol?

Take propranolol exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Adults may take propranolol with or without food, but take it the same way each time.

Take propranolol at the same time each day.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

Hemangeol must be given to an infant during or just after a feeding. Doses should be spaced at least 9 hours apart. Make sure your child gets fed regularly while taking this medicine. Tell your doctor when the child has any changes in weight. Hemangeol doses are based on weight in children, and any changes may affect your child"s dose.

Call your doctor if a child taking Hemangeol is sick with vomiting, or has any loss of appetite.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not shake Hemangeol liquid.

Your blood pressure will need to be checked often.

If you need surgery, tell the surgeon ahead of time that you are using propranolol. You may need to stop using the medicine for a short time.

Do not skip doses or stop using propranolol suddenly. Stopping suddenly may make your condition worse. Follow your doctor"s instructions about tapering your dose.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using propranolol.

If you are being treated for high blood pressure, keep using propranolol even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Propranolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze. Throw away any unused Hemangeol 2 months after you first opened the bottle.

What happens if I miss a dose?

For regular (short-acting) propranolol: Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 4 hours away.

For extended-release propranolol (Inderal LA, InnoPran XL and others): Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 8 hours away.

Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include slow or uneven heartbeats, dizziness, weakness, or fainting.

What should I avoid while taking propranolol?

Avoid drinking alcohol. It may increase your blood levels of propranolol.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Propranolol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to propranolol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • slow or uneven heartbeats;

  • a light-headed feeling, like you might pass out;

  • wheezing or trouble breathing;

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • sudden weakness, vision problems, or loss of coordination (especially in a child with hemangioma that affects the face or head);

  • cold feeling in your hands and feet;

  • depression, confusion, hallucinations;

  • liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • low blood sugar - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;

  • low blood sugar in a baby - pale skin, blue or purple skin, sweating, fussiness, crying, not wanting to eat, feeling cold, drowsiness, weak or shallow breathing (breathing may stop for short periods), seizure (convulsions), or loss of consciousness; or

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common propranolol side effects may include:

  • nausea, vomiting, diarrhea, constipation, stomach cramps;

  • decreased sex drive, impotence, or difficulty having an orgasm;

  • sleep problems (insomnia); or

  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Propranolol dosing information

Usual Adult Dose of Propranolol for Hypertension:

Initial dose:
Immediate-release: 40 mg propranolol orally 2 times a day
Sustained-release: 80 mg orally once a day
XL sustained-release: 80 mg orally once a day at bedtime
Maintenance dose:
Immediate-release: 120 to 240 mg orally per day
Sustained-release: 120 to 160 mg orally per day
XL sustained-release: 80 to 120 mg orally once a day at bedtime
Maximum dose:
IR/SR: 640 mg orally per day
XR: 120 mg orally per day

Comments:
-The XL sustained-release formulation should be administered once daily at bedtime (approximately 10 PM) and should be taken consistently either on an empty stomach or with food.
-Dose titration should be done gradually until adequate blood pressure control is achieved.
-The recommended dosing is the same whether used alone or added to a diuretic.
-The time needed for full hypertensive response to a given dosage is variable and may range from a few days to several weeks.
-While twice daily dosing of the immediate release formulation is effective and can maintain a reduction in blood pressure throughout the day, some patients, especially when lower doses are used, may experience a modest rise in blood pressure toward the end of the 12 hour dosing interval. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. If control is not adequate, a larger dose, or 3 times daily therapy may achieve better control.

Usual Adult Dose of Propranolol for Angina Pectoris:

Immediate-release: Total daily doses of 80 to 320 mg orally 2 to 4 times a day have been shown to increase exercise tolerance and to reduce ischemic changes in the ECG.
Sustained-release: Initial dose: 80 mg orally once a day. Dosage should be gradually increased at 3 to 7 day intervals. The average optimal dosage appears to be 160 mg once a day.
Maximum dose: 320 mg per day

Comments:
-If treatment is to be discontinued, dosage should be reduced gradually over a period of a few weeks.

Usual Adult Dose for Arrhythmias:

Immediate-release: 10 to 30 mg propranolol orally 3 to 4 times a day, before meals and at bedtime
IV: 1 to 3 mg at a rate not exceeding 1 mg/min. Sufficient time should be allowed for the drug to reach the site of action even when a slow circulation is present. A second dose may be given after 2 minutes. Thereafter, additional drug should not be given in less than 4 hours.

Comments:
-IV administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia.
-IV doses should be administered under careful monitoring, such as electrocardiography, and central venous pressure.
-The rate of IV administration should not exceed 1 mg (1 mL) per minute to decrease the possibility of lowering blood pressure and causing cardiac standstill.
-Transfer from IV to oral therapy should be considered as soon as possible.

Usual Adult Dose of Propranolol for Myocardial Infarction:

Immediate-release:
Initial dose: 40 mg orally 3 times a day for 1 month, then increase to 60 to 80 mg orally 3 times a day as tolerated.
Maintenance dose: 180 mg to 240 mg orally per day in divided doses (2 to 4 times daily)
Maximum dose: 240 mg orally per day

Usual Adult Dose for Migraine Prophylaxis:

Immediate-release:
Initial dose: 80 mg orally per day in divided doses
Maintenance dose: 160 to 240 mg orally per day in divided doses
Sustained-release:
Initial dose: 80 mg orally once a day
Maintenance dose: 160 to 240 mg once a day

Comments:
-The dosage should be increased gradually to achieve optimum migraine prophylaxis. If a satisfactory response is not obtained within 4 to 6 weeks after reaching the maximum dose, therapy should be discontinued.
-Withdrawal of therapy should be accomplished over a period of several weeks.

Usual Adult Dose of Propranolol for Benign Essential Tremor:

Immediate-release:
Initial dose: 40 mg propranolol orally 2 times a day
Maintenance dose: 120 to 320 mg orally per day

Comments:
-OptiPropranolol um reduction of essential tremor is usually achieved with a dose of 120 mg orally per day.
-Occasionally, it may be necessary to administer 240 to 320 mg orally per day.

Usual Adult Dose for Aortic Stenosis:

Immediate-release: 20 to 40 mg orally 3 to 4 times a day, before meals and at bedtime
Sustained-release: 80 to 160 mg orally once a day

Use: Hypertrophic Subaortic Stenosis

Usual Adult Dose of Propranolol for Pheochromocytoma:

Immediate-release:
Preoperatively: 60 mg orally daily in divided doses for 3 days prior to surgery as adjunctive therapy to alpha-adrenergic blockade
Management of Inoperable Tumor: 30 mg propranolol orally daily in divided doses as adjunctive therapy to alpha-adrenergic blockade

Usual Adult Dose for Atrial Fibrillation:

Immediate-release: 10 mg to 30 mg orally 3 or 4 times a day before meals and at bedtime

Usual Pediatric Dose for Arrhythmias:

Oral: Children: Initial: 0.5 to 1 mg/kg/day in divided doses every 6 to 8 hours; titrate dosage upward every 3 to 5 days; usual dose: 2 to 4 mg/kg/day; higher doses may be needed; do not exceed 16 mg/kg/day

IV: Children: 0.01 to 0.1 mg/kg slow IV over 10 minutes; maximum dose: 1 mg (infants); 3 mg (children)

Usual Pediatric Dose of Propranolol for Hypertension:

Children:
Immediate release formulations:
Initial: 0.5 to 1 mg/kg/day in divided doses every 6 to 12 hours; increase gradually every 5 to 7 days
Usual dose: 1 to 5 mg/kg/day
Maximum dose: 8 mg/kg/day

Children and Adolescents 1 to 17 years:
Immediate release formulations:
Initial: 1 to 2 mg/kg/day divided in 2 to 3 doses/day; titrate dose to effect
Maximum dose: 4 mg/kg/day up to 640 mg/day; sustained release formulation may be dosed once daily (National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents).

Usual Pediatric Dose for Thyrotoxicosis:

Neonates: Oral: 2 mg/kg/day in divided doses every 6 to 12 hours; occasionally higher doses may be required

Adolescents: Oral: 10 to 40 mg/dose every 6 hours

Usual Pediatric Dose for Hemangioma:

Propranolol oral solution 4.28 mg/mL:
Initiate treatment at ages 5 weeks to 5 months:
Initial dose: 0.15 mL/kg (0.6 mg/kg) orally 2 times a day (at least 9 hours apart)
-After 1 week: Increase the daily dose to 0.3 mL/kg (1.1 mg/kg) orally 2 times a day (at least 9 hours apart)
-After 2 weeks: Increase the dose to 0.4 mL/kg (1.7 mg/kg) orally 2 times a day (at least 9 hours apart) maintain for 6 months

Comments:
-Dose should be periodically adjusted as the weight of the child increases.
-Administration directly into the mouth of the child is recommended; however, the product may be diluted in a small quantity of milk or fruit juice, given in a bottle.
-This drug should be administered during or right after a feeding to reduce the risk of hypoglycemia.
-The dose should be skipped if the child is not eating or is vomiting.
-Heart rate and blood pressure should be monitored for 2 hours after drug initiation or dose increases.
-If hemangiomas recur, treatment may be reinitiated.

Uses: For the treatment of proliferating infantile hemangioma requiring systemic therapy.

What other drugs will affect propranolol?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with propranolol, especially:

  • a blood thinner - warfarin, Coumadin, Jantoven;

  • an antidepressant - amitriptyline, clomipramine, desipramine, imipramine, and others;

  • drugs to treat high blood pressure or a prostate disorder - doxazosin, prazosin, terazosin;

  • heart or blood pressure medicine - amiodarone, diltiazem, propafenone, quinidine, verapamil, and others;

  • NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

  • steroid medicine-prednisone and others.

This list is not complete. Other drugs may interact with propranolol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.


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