Propranolol Hydrochloride 20mg Information
Propranolol hydrochloride 20mg (Propranolol hydrochloride) Description
Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are:
Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80.
Each tablet for oral administration contains 10 mg, 20 mg, 40 mg, 60 mg or 80 mg of propranolol hydrochloride and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The coloring agents are:
10 mg: FD&C Yellow No. 6 Aluminum Lake
20 mg: FD&C Blue No. 1 Aluminum Lake
40 mg: FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake
60 mg: FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake
80 mg: FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake
Propranolol hydrochloride 20mg (Propranolol hydrochloride) Clinical Pharmacology
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. Although total peripheral resistance may increase initially, it readjusts to or below the pretreatment level with chronic use of propranolol. Effects of propranolol on plasma volume appear to be minor and somewhat variable.
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 may increase oxygen requirements by increasing left ventricular fiber length, end diastolic pressure, and systolic ejection period. The net physiologic effect of beta-adrenergic blockade is usually advantageous and is manifested during exercise by delayed onset of pain and increased work capacity.
Propranolol exerts its antiarrhythmic effects in concentrations associated with beta-adrenergic blockade, and this appears to be its principal antiarrhythmic mechanism of action. In dosages greater than required for beta-blockade, propranolol also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential. The significance of the membrane action in the treatment of arrhythmias is uncertain.
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. Clinical studies have demonstrated that propranolol is of benefit in exaggerated physiological and essential (familial) tremor.
Propranolol hydrochloride 20mg (Propranolol hydrochloride) Contraindications
Propranolol hydrochloride tablets are contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.
Propranolol hydrochloride 20mg (Propranolol hydrochloride) Warnings
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. If propranolol therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute propranolol therapy and take other measures appropriate for the management of angina pectoris. Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease who are given propranolol for other indications.
Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol (see ).
Cutaneous reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria, have been reported with use of propranolol (see ).
Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, some have been shown to be highly beneficial when used with close follow-up in patients with a history of failure who are well compensated and are receiving additional therapies, including diuretics as needed. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.
In Patients without a History of Heart Failure,
The necessity or desirability of withdrawal of beta-blocking therapy prior to major surgery is controversial. It should be noted, however, that the impaired ability of the heart to respond to reflex adrenergic stimuli in propranolol-treated patients may augment the risks of general anesthesia and surgical procedures.
Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension.
Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia, especially in labile insulin-dependent diabetics. In these patients, it may be more difficult to adjust the dosage of insulin.
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 hydrochloride 20mg (Propranolol hydrochloride) Precautions
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. Withdrawal may lead to a return of increased intraocular pressure.
While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Safety and effectiveness of propranolol in pediatric patients have not been established.
Bronchospasm and congestive heart failure have been reported coincident with the administration of propranolol therapy in pediatric patients.
Propranolol hydrochloride 20mg (Propranolol hydrochloride) Adverse Reactions
The following adverse events were observed and have been reported in patients using propranolol.
Propranolol hydrochloride 20mg (Propranolol hydrochloride) Overdosage
Propranolol is not significantly dialyzable. In the event of overdosage or exaggerated response, the following measures should be employed:
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 to 150 mcg/kg intravenously followed by continuous drip of 1 to 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.
The electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance must be monitored. Isoproterenol and aminophylline may be used for bronchospasm.
Propranolol hydrochloride 20mg (Propranolol hydrochloride) Dosage And Administration
The usual initial dosage is 40 mg propranolol hydrochloride tablets 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.
Propranolol hydrochloride 20mg (Propranolol hydrochloride) How Supplied
Propranolol hydrochloride tablets, USP are available containing 10 mg, 20 mg, 40 mg, 60 mg and 80 mg of propranolol hydrochloride, USP.
The 10 mg tablets are orange, round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows:
NDC 0378-0182-01bottles of 100 tablets
NDC 0378-0182-10bottles of 1000 tablets
The 20 mg tablets are blue, round, scored tablets debossed with above the score andbelow the score on one side of the tablet and on the other side. They are available as follows:
NDC 0378-0183-01bottles of 100 tablets
NDC 0378-0183-10bottles of 1000 tablets
The 40 mg tablets are green, round, scored tablets debossed with above the score andbelow the score on one side of the tablet and on the other side. They are available as follows:
NDC 0378-0184-01bottles of 100 tablets
NDC 0378-0184-10bottles of 1000 tablets
The 60 mg tablets are light purple, round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows:
NDC 0378-0187-01bottles of 100 tablets
NDC 0378-0187-05bottles of 500 tablets
The 80 mg tablets are yellow, round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows:
NDC 0378-0185-01bottles of 100 tablets
NDC 0378-0185-05bottles of 500 tablets
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Mylan Pharmaceuticals Inc.Morgantown, WV 26505
REVISED OCTOBER 2009PRAN:R26
Propranolol hydrochloride 20mg (Propranolol hydrochloride)
Propranolol hydrochloride 20mg (Propranolol hydrochloride)
Propranolol hydrochloride 20mg (Propranolol hydrochloride)
Propranolol hydrochloride 20mg (Propranolol hydrochloride)
Propranolol hydrochloride 20mg (Propranolol hydrochloride)
