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Rx only
Inderal (propranolol hydrochloride) is a synthetic beta-adrenergic receptor blocking agent chemically described as 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is
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Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.81.
Inderal is available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration and as a 1 mg/mL sterile injectable solution for intravenous administration.
The inactive ingredients contained in Inderal Tablets are: lactose, magnesium stearate, microcrystalline cellulose, and stearic acid. In addition, Inderal 10 mg and 80 mg Tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10; Inderal 20 mg Tablets contain FD&C Blue No. 1; Inderal 40 mg Tablets contain FD&C Blue No. 1, FD&C Yellow No. 6, and D&C Yellow No. 10; Inderal 60 mg Tablets contain D&C Red No. 30.
Inderal is a nonselective beta-adrenergic receptor blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor stimulating agents for available receptor sites. When access to beta-receptor sites is blocked by Inderal, the chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately.
Propranolol is almost completely absorbed from the gastrointestinal tract, but a portion is immediately bound by the liver. Peak effect occurs in one to one- and one-half hours. The biologic half-life is approximately four hours.
There is no simple correlation between dose or plasma level and therapeutic effect, and the dose-sensitivity range as observed in clinical practice is wide. The principal reason for this is that sympathetic tone varies widely between individuals. Since there is no reliable test to estimate sympathetic tone or to determine whether total beta blockade has been achieved, proper dosage requires titration.
The mechanism of the antihypertensive effect of Inderal has not been established. Among the factors that may be involved in contributing to the antihypertensive action are (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. Effects on plasma volume appear to be minor and somewhat variable. Inderal has been shown to cause a small increase in serum potassium concentration when used in the treatment of hypertensive patients.
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, Inderal 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 Inderal'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 Inderal is of benefit in exaggerated physiological and essential (familial) tremor.
Beta-receptor blockade can be useful in conditions in which, because of pathologic or functional changes, sympathetic activity is detrimental to the patient. But there are also situations in which sympathetic stimulation is vital. For example, in patients with severely damaged hearts, adequate ventricular function is maintained by virtue of sympathetic drive, which should be preserved. In the presence of AV block greater than first degree, beta blockade may prevent the necessary facilitating effect of sympathetic activity on conduction. Beta blockade results in bronchial constriction by interfering with adrenergic bronchodilator activity, which should be preserved in patients subject to bronchospasm.
Propranolol is not significantly dialyzable.
The Beta-Blocker Heart Attack Trial (BHAT) was a National Heart, Lung and Blood Institute-sponsored multicenter, randomized, double-blind, placebo-controlled trial conducted in 31 U.S. centers (plus one in Canada) in 3,837 persons without history of severe congestive heart failure or presence of recent heart failure; certain conduction defects; angina since infarction, who had survived the acute phase of myocardial infarction. Propranolol was administered at either 60 or 80 mg t.i.d. based on blood levels achieved during an initial trial of 40 mg t.i.d. Therapy with Inderal, begun 5 to 21 days following infarction, was shown to reduce overall mortality up to 39 months, the longest period of follow-up. This was primarily attributable to a reduction in cardiovascular mortality. The protective effect of Inderal was consistent regardless of age, sex, or site of infarction. Compared with placebo, total mortality was reduced 39% at 12 months and 26% over an average follow-up period of 25 months. The Norwegian Multicenter Trial in which propranolol was administered at 40 mg q.i.d. gave overall results which support the findings in the BHAT.
Although the clinical trials used either t.i.d. or q.i.d. dosing, clinical, pharmacologic, and pharmacokinetic data provide a reasonable basis for concluding that b.i.d. dosing with propranolol should be adequate in the treatment of postinfarction patients.
In the BHAT, patients on Inderal were prescribed either 180 mg/day (82% of patients) or 240 mg/day (18% of patients). Patients were instructed to take the medication 3 times a day at mealtimes. This dosing schedule would result in an overnight dosing interval of 12 to 14 hours which is similar to the dosing interval for a b.i.d regimen. In addition, blood samples were drawn at various times and analyzed for propranolol. When the patients were grouped into tertiles based on the blood levels observed and the mortality in the upper and lower tertiles was compared, there was no evidence that blood levels affected mortality.
Pharmacologic
Studies in normal volunteers have shown that a 90 mg b.i.d. regimen maintains beta blockade at, or above, the minimum for 60 mg t.i.d. dosing for 24 hours even though differences occurred at two time intervals. At 10 to 12 hours after the first dose of the day, t.i.d. dosing gave more beta blockade than b.i.d. dosing; at 20 to 24 hours the trend of the relationship was reversed. These relationships were similar in direction to those observed for plasma propranolol levels. (See " Pharmacokinetic .")
A bioavailability study in normal volunteers showed that the blood levels produced by 180 mg/day given b.i.d. are below those provided by the same daily dosage given t.i.d. at 10 to 12 hours after the first dose of the day, but above those of a t.i.d. regimen at 20 to 24 hours. However, the blood levels produced by b.i.d. dosing were always equivalent to or above the minimum for t.i.d. dosing throughout the 24 hours. In addition, the mean AUC on the fourth day for the b.i.d. regimen was about 17% greater than for the t.i.d. regimen (1,194 vs. 1,024 ng/mL·hr).
Hypertension
Inderal 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 is not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Inderal is indicated for the long-term management of patients with angina pectoris.
Cardiac Arrhythmias
Inderal is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
Migraine
Inderal 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.
Inderal 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. Inderal causes a reduction in the tremor amplitude but not in the tremor frequency. Inderal is not indicated for the treatment of tremor associated with Parkinsonism.
Hypertrophic Subaortic Stenosis
Inderal is useful in the management of hypertrophic subaortic stenosis, especially for treatment of exertional or other stress-induced angina, palpitations, and syncope. Inderal also improves exercise performance. The effectiveness of propranolol hydrochloride in this disease appears to be due to a reduction of the elevated outflow pressure gradient, which is exacerbated by beta-receptor stimulation. Clinical improvement may be temporary.
After primary treatment with an alpha-adrenergic blocking agent has been instituted, Inderal may be useful as adjunctive therapy if the control of tachycardia becomes necessary before or during surgery. It is hazardous to use Inderal unless alpha-adrenergic blocking drugs are already in use, since this would predispose to serious blood pressure elevation. Blocking only the peripheral dilator (beta) action of epinephrine leaves its constrictor (alpha) action unopposed. In the event of hemorrhage or shock, there is a disadvantage in having both beta and alpha blockade since the combination prevents the increase in heart rate and peripheral vasoconstriction needed to maintain blood pressure.
With inoperable or metastatic pheochromocytoma, Inderal may be useful as an adjunct to the management of symptoms due to excessive beta-receptor stimulation.
Inderal is contraindicated in 1) cardiogenic shock, 2) sinus bradycardia and greater than first degree block, 3) bronchial asthma, 4) congestive heart failure (see " ") unless the failure is secondary to a tachyarrhythmia treatable with Inderal.
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, if necessary, they can be used with close follow-up in patients with a history of failure who are well compensated and are receiving digitalis and diuretics. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.
In Patients Without a History of Heart Failure , continued use of beta blockers can, in some cases, lead to cardiac failure. Therefore, at the first sign or symptom of heart failure, the patient should be digitalized and/or treated with diuretics, and the response observed closely, or Inderal should be discontinued (gradually, if possible).
| In Patients with Angina Pectoris , there have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of Inderal therapy. Therefore, when discontinuance of Inderal 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' advice. If Inderal therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute Inderal therapy and take other measures appropriate for the management of unstable 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. |
PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA BLOCKERS. Inderal should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta receptors.
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 may augment the risks of general anesthesia and surgical procedures.
Inderal, like other beta blockers, 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. Difficulty in starting and maintaining the heartbeat has also been reported with beta blockers.
Diabetes and Hypoglycemia
Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia in labile insulin-dependent diabetes. In these patients, it may be more difficult to adjust the dosage of insulin. Hypoglycemic attacks may be accompanied by a precipitous elevation of blood pressure in patients on propranolol.
Propranolol therapy, particularly in infants and children, diabetic or not, has been associated with hypoglycemia especially during fasting as in preparation for surgery. Hypoglycemia also has been found after this type of drug therapy and prolonged physical exertion and has occurred in renal insufficiency, both during dialysis and sporadically, in subjects on propranolol.
Beta blockade may mask certain clinical signs of hyperthyroidism. Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid-function tests, increasing T 4 and reverse T 3 and decreasing T 3 .
In Patients With Wolff-Parkinson-White Syndrome , several cases have been reported in which, after propranolol, the tachycardia was replaced by a severe bradycardia requiring a demand pacemaker. In one case this resulted after an initial dose of 5 mg propranolol.
General
Propranolol should be used with caution in patients with impaired hepatic or renal function. Inderal is not indicated for the treatment of hypertensive emergencies.
Beta-adrenoreceptor blockade can cause reduction of intraocular pressure. Patients should be told that Inderal may interfere with the glaucoma screening test. Withdrawal may lead to a return of increased intraocular pressure.
Risk of anaphylactic reaction. 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.
Clinical Laboratory Tests
Elevated blood urea levels in patients with severe heart disease, elevated serum transaminase, alkaline phosphatase, lactate dehydrogenase.
Patients receiving catecholamine-depleting drugs such as reserpine should be closely observed if Inderal is administered. The added catecholamine-blocking action may produce an excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.
Caution should be exercised when patients receiving a beta blocker are administered a calcium-channel blocking drug, especially intravenous verapamil, for both agents may depress myocardial contractility or atrioventricular conduction. On rare occasions, the concomitant intravenous use of a beta blocker and verapamil has resulted in serious adverse reactions, especially in patients with severe cardiomyopathy, congestive heart failure or recent myocardial infarction.
Blunting of the antihypertensive effect of beta-adrenoceptor blocking agents by nonsteroidal anti-inflammatory drugs has been reported.
Hypotension and cardiac arrest have been reported with the concomitant use of propranolol and haloperidol.
Aluminum hydroxide gel greatly reduces intestinal absorption of propranolol.
Ethanol slows the rate of absorption of propranolol.
Phenytoin, phenobarbitone, and rifampin accelerate propranolol clearance.
Chlorpromazine, when used concomitantly with propranolol, results in increased plasma levels of both drugs.
Antipyrine and lidocaine have reduced clearance when used concomitantly with propranolol.
Thyroxine may result in a lower than expected T 3 concentration when used concomitantly with propranolol.
Cimetidine decreases the hepatic metabolism of propranolol, delaying elimination and increasing blood levels.
Theophylline clearance is reduced when used concomitantly with propranolol.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In dietary administration studies in which mice and rats were treated with propranolol for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis. In a study in which both male and female rats were exposed to propranolol in their diets at concentrations of up to 0.05%, from 60 days prior to mating and throughout pregnancy and lactation for two generations, there were no effects on fertility. Based on differing results from Ames Tests performed by different laboratories, there is equivocal evidence for a genotoxic effect of propranolol in bacteria ( S. typhimurium strain TA 1538).
Pregnancy: Pregnancy Category C
In a series of reproductive and developmental toxicology studies, propranolol was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day (> 10 times the maximum recommended human daily dose of propranolol on a body weight basis), but not at doses of 80 mg/kg/day, treatment was associated with embryotoxicity (reduced litter size and increased resorption sites) as well as neonatal toxicity (deaths). Propranolol also was administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (> 15 times the maximum recommended daily human dose). No evidence of embryo or neonatal toxicity was noted.
There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation has been reported in neonates whose mothers received propranolol during pregnancy. Neonates whose mothers are receiving propranolol at parturition have exhibited bradycardia, hypoglycemia and respiratory depression. Adequate facilities for monitoring these infants at birth should be available. Inderal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Inderal is excreted in human milk. Caution should be exercised when Inderal is administered to a nursing woman.
Pediatric Use
High serum propranolol levels have been noted in patients with Down' syndrome (trisomy 21), suggesting that the bioavailability of propranolol may be increased in patients with this condition.
Evaluation of the effects of propranolol in pediatric patients, relative to the drug' efficacy and safety, has not been as systematically performed as in adults. Information is available in the medical literature to allow fair estimates, and specific dosing information has been reasonably studied.
Cardiovascular diseases that are common to adults and children are generally as responsive to propranolol intervention in children as they are in adults.
Adverse reactions are also similar: for example, bronchospasm and congestive heart failure related to propranolol therapy have been reported in pediatric patients and occur through the same mechanisms as previously described in adults.
The normal echocardiogram evolves through a series of changes as the heart matures during growth and development in pediatric patients. Should echocardiography be used to monitor propranolol therapy in pediatric patients, the age-related changes in the echocardiogram need to be borne in mind.
Geriatric Use
Clinical studies of propranolol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of the decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Most adverse effects have been mild and transient and have rarely required the withdrawal of therapy.
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; reversible mental depression progressing to 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. Total daily doses above 160 mg (when administered as divided doses of greater than 80 mg each) may be associated with an increased incidence of fatigue, lethargy, and vivid dreams.
Gastrointestinal : Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.
Allergic : Pharyngitis and agranulocytosis, erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.
Respiratory: Bronchospasm.
Hematologic : Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.
Autoimmune : In extremely rare instances, systemic lupus erythematosus has been reported.
Miscellaneous : Alopecia, LE-like reactions, psoriasiform rashes, dry eyes, male impotence, and Peyronie' disease have been reported rarely. Oculomucocutaneous reactions involving the skin, serous membranes and conjunctivae reported for a beta blocker (practolol) have not been associated with propranolol.
Hypertension -- Dosage must be individualized.
The usual initial dosage is 40 mg Inderal 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 -- Dosage must be individualized.
Total daily doses of 80 mg to 320 mg, 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 " .")
Arrhythmias --10 mg to 30 mg three or four times daily, before meals and at bedtime.
Myocardial Infarction --The recommended daily dosage is 180 mg to 240 mg per day in divided doses. Although a t.i.d. regimen was used in the Beta-Blocker Heart Attack Trial 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 b.i.d. regimen (see " CLINICAL PHARMACOLOGY "). 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 -- Dosage must be individualized.
The initial oral dose is 80 mg Inderal 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, Inderal therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks.
Essential Tremor -- Dosage must be individualized.
The initial dosage is 40 mg Inderal 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 --20 mg to 40 mg three or four times daily, before meals and at bedtime.
Pheochromocytoma -- Preoperatively-- 60 mg daily in divided doses for three days prior to surgery, concomitantly with an alpha-adrenergic blocking agent.
-- Management of inoperable tumor --30 mg daily in divided doses.
Use in Pediatric Patients : Intravenous administration of Inderal is not recommended in pediatric patients. Oral dosage for treating hypertension requires individual titration, beginning with a 1.0 mg per kg (body weight) per day dosage regimen (i.e., 0.5 mg per kg b.i.d.).
The usual pediatric dosage range is 2 mg to 4 mg per kg per day in two equally divided doses (i.e., 1.0 mg per kg b.i.d. to 2.0 mg per kg b.i.d.). Pediatric dosage calculated by weight (recommended) generally produces propranolol plasma levels in a therapeutic range similar to that in adults. On the other hand, pediatric doses calculated on the basis of body surface area ( not recommended) usually result in plasma levels above the mean adult therapeutic range. Doses above 16 mg per kg per day should not be used in pediatric patients. If treatment with Inderal is to be discontinued, a gradually decreasing dose titration over a 7- to 14-day period is necessary.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Intravenous administration is reserved for life-threatening arrhythmias or those occurring under anesthesia. The usual dose is from 1 mg to 3 mg administered under careful monitoring, e.g., electrocardiographic, central venous pressure. The rate of administration should not exceed 1 mg (1 mL) per minute to diminish the possibility of lowering blood pressure and causing cardiac standstill. Sufficient time should be allowed for the drug to reach the site of action even when a slow circulation is present. If necessary, a second dose may be given after two minutes. Thereafter, additional drug should not be given in less than four hours. Additional Inderal should not be given when the desired alteration in rate and/or rhythm is achieved.
Transference to oral therapy should be made as soon as possible.
The intravenous administration of Inderal has not been evaluated adequately in the management of hypertensive emergencies.
Overdosage
Inderal is not significantly dialyzable. In the event of overdosage or exaggerated response, the following measures should be employed:
General --If ingestion is or may have been recent, evacuate gastric contents, taking care to prevent pulmonary aspiration.
Bradycardia --ADMINISTER ATROPINE (0.25 mg to 1.0 mg); IF THERE IS NO RESPONSE TO VAGAL BLOCKADE, ADMINISTER ISOPROTERENOL CAUTIOUSLY.
Cardiac Failure --DIGITALIZATION AND DIURETICS.
Hypotension -- VASOPRESSORS, e.g., LEVARTERENOL OR EPINEPHRINE (THERE IS EVIDENCE THAT EPINEPHRINE IS THE DRUG OF CHOICE).
Bronchospasm -- ADMINISTER ISOPROTERENOL AND AMINOPHYLLINE.
Inderal®
(propranolol hydrochloride)
Tablets
INDERAL 10 --Each hexagonal-shaped, orange, scored tablet, embossed with an "I" and imprinted with "INDERAL 10", contains 10 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0421-81); 1,000 (NDC 0046-0421-91); and 5,000 (NDC 0046-0421-95). Also in Unit Dose packages of 100 (NDC 0046-0421-99).
Dispense in a well-closed container as defined in the USP.
INDERAL 20 --Each hexagonal-shaped, blue, scored tablet, embossed with an "I" and imprinted with "INDERAL 20", contains 20 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0422-81); 1,000 (NDC 0046-0422-91); and 5,000 (NDC 0046-0422-95).
Dispense in a well-closed, light-resistant container as defined in the USP.
Protect from light.
Use carton to protect contents from light.
INDERAL 40 --Each hexagonal-shaped, green, scored tablet, embossed with an "I" and imprinted with "INDERAL 40", contains 40 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0424-81); 1,000 (NDC 0046-0424-91); and 5,000 (NDC 0046-0424-95).
Dispense in a well-closed, light-resistant container as defined in the USP.
Protect from light.
Use carton to protect contents from light.
INDERAL 60 --Each hexagonal-shaped, pink, scored tablet, embossed with an "I" and imprinted with "INDERAL 60", contains 60 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0426-81).
Dispense in a well-closed container as defined in the USP.
INDERAL 80 --Each hexagonal-shaped, yellow, scored tablet, embossed with an "I" and imprinted with "INDERAL 80", contains 80 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0428-81); 1,000 (NDC 0046-0428-91); and 5,000 (NDC 0046-0428-95).
Dispense in a well-closed container as defined in the USP.
The appearance of these tablets is a registered trademark of Wyeth-Ayerst Laboratories.
--Each mL contains 1 mg of propranolol hydrochloride in Water for Injection. The pH is adjusted with citric acid. Supplied as: 1 mL ampuls in boxes of 10 (NDC 0046-3265-10).
Protect from freezing or excessive heat.
Manufactured by:
Ayerst Laboratories Inc.
A Wyeth-Ayerst Company
Philadelphia, PA 19101
CI 3791-9 Revised April 13, 1999
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