Global Pharm Distribution, LLC
Description
What is Propranolo and how is it used?
Propranolo is a prescription medicine used to treat the symptoms high blood pressure (hypertension), migraine, chest pain (angina), heart rhythm disorders, and other circulatory conditions, as a preventative of heart attacks and to reduce migraines. Propranolo may be used alone or with other medications.
Propranolo belongs to a class of drugs called Antidysrhythmics, II, Beta-Blockers, Nonselective, Antianginal Agents, Antimigraine Agents.
What are the possible side effects of Propranolo?
Propranolo may cause serious side effects including:
- slow or uneven heartbeats,
- lightheadedness,
- wheezing,
- trouble breathing,
- shortness of breath,
- swelling,
- rapid weight gain,
- sudden weakness,
- vision problems,
- loss of coordination (especially in a child with hemangioma in the face or head),
- cold feeling in your hands and feet,
- depression,
- confusion,
- hallucinations,
- nausea,
- upper stomach pain,
- itching,
- tired feeling,
- loss of appetite,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- headache,
- hunger,
- weakness,
- sweating,
- irritability,
- dizziness,
- fast heart rate,
- feeling jittery,
- pale skin,
- blue or purple skin,
- fussiness,
- crying,
- not wanting to eat,
- feeling cold,
- drowsiness,
- weak or shallow breathing,
- seizures (convulsions),
- loss of consciousness,
- fever,
- sore throat,
- swelling in your face or tongue,
- burning in your eyes, and
- skin pain followed by a red or purple skin rash that spreads and causes blistering and peeling
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Propranolo include:
- nausea,
- vomiting,
- diarrhea,
- constipation,
- stomach cramps,
- decreased sex drive,
- impotence,
- difficulty having an orgasm,
- sleep problems (insomnia), and
- feeling tired
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Propranolo. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
INDICATIONS
Hypertension
Propranolo is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolo is not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Propranolo is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Atrial Fibrillation
Propranolo is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
Myocardial Infarction
Propranolo is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
Migraine
Propranolo 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.
Essential Tremor
Propranolo is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolo causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolo is not indicated for the treatment of tremor associated with Parkinsonism.
Hypertrophic Subaortic Stenosis
Propranolo improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Pheochromocytoma
Propranolo is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
DOSAGE AND ADMINISTRATION
General
Because of the variable bioavailability of propranolol, the dose should be individualized based on response.
Hypertension
The usual initial dosage is 40 mg Propranolo 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. The time needed for full antihypertensive response to a given dosage is variable and may range from a few days to several weeks.
While twice-daily dosing 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.
Angina Pectoris
Total daily doses of 80 mg to 320 mg Propranolo, 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. If treatment is to be discontinued, reduce dosage gradually over a period of several weeks. (See WARNINGS.)
Atrial Fibrillation
The recommended dose is 10 mg to 30 mg Propranolo three or four times daily before meals and at bedtime.
Myocardial Infarction
In the Beta-Blocker Heart Attack Trial (BHAT), 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 Propranolo per day in divided doses. Although a t.i.d. regimen was used in the BHAT and a q.i.d. regimen in the Norwegian Multicenter Trial, there is a reasonable basis for the use of either a t.i.d. or bid. regimen (see Pharmacodynamics And Clinical Effects). The effectiveness and safety of daily dosages greater than 240 mg for prevention of cardiac mortality have not been established. However, higher dosages may be needed to effectively treat coexisting diseases such as angina or hypertension (see above).
Migraine
The initial dose is 80 mg Propranolo daily in divided doses. The usual effective dose range is 160 mg to 240 mg per day. The dosage may be increased gradually to achieve optimum migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximum dose, Propranolo therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks.
Essential Tremor
The initial dosage is 40 mg Propranolo 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 Propranolo three or four times daily before meals and at bedtime.
Pheochromocytoma
The usual dosage is 60 mg Propranolo daily in divided doses for three days prior to surgery as adjunctive therapy to alpha-adrenergic blockade. For the management of inoperable tumors, the usual dosage is 30 mg daily in divided doses as adjunctive therapy to alpha-adrenergic blockade.
Store at controlled room temperature 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F).
Dispense in a well-closed, light-resistant container as defined in the USP.
Protect from light.
Use carton to protect contents from light.