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SECTRAL

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Overview

What is SECTRAL?

Sectral (acebutolol HCl) is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration. Sectral capsules are provided in two dosage strengths which contain 200 or 400 mg of acebutolol as the hydrochloride salt. The inactive ingredients present are D&C Red 22, FD&C Blue 1, FD&C Yellow 6, gelatin, povidone, starch, stearic acid, and titanium dioxide. The 200 mg dosage strength also contains D&C Red 28 and the 400 mg dosage strength also contains FD&C Red 40.

Acebutolol HCl has the following structural formula:

Acebutolol HCl is a white or slightly off-white powder freely soluble in water, and less soluble in alcohol. Chemically it is defined as the hydrochloride salt of (±)N-[3-Acetyl-4-[2- hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl] butanamide.



What does SECTRAL look like?



What are the available doses of SECTRAL?

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What should I talk to my health care provider before I take SECTRAL?

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How should I use SECTRAL?

Sectral is indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.


What interacts with SECTRAL?

Sectral is contraindicated in: 1) persistently severe bradycardia; 2) second- and third-degree heart block; 3) overt cardiac failure; and 4) cardiogenic shock. (See .)



What are the warnings of SECTRAL?

Cardiac Failure

Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by β-adrenergic receptor blockade may precipitate more severe failure. Although β-blockers should be avoided in overt cardiac failure, Sectral can be used with caution in patients with a history of heart failure who are controlled with digitalis and/or diuretics. Both digitalis and Sectral impair AV conduction. If cardiac failure persists, therapy with Sectral should be withdrawn.

In Patients Without a History of Cardiac Failure

In patients with aortic or mitral valve disease or compromised left ventricular function, continued depression of the myocardium with β-blocking agents over a period of time may lead to cardiac failure. At the first signs of failure, patients should be digitalized and/or be given a diuretic and the response observed closely. If cardiac failure continues despite adequate digitalization and/or diuretic, Sectral therapy should be withdrawn.

Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal

Following abrupt cessation of therapy with certain β-blocking agents in patients with coronary artery disease, exacerbation of angina pectoris and, in some cases, myocardial infarction and death have been reported. Therefore, such patients should be cautioned against interruption of therapy without a physician’s advice. Even in the absence of overt ischemic heart disease, when discontinuation of Sectral is planned, the patient should be carefully observed, and should be advised to limit physical activity to a minimum while Sectral is gradually withdrawn over a period of about two weeks. (If therapy with an alternative β-blocker is desired, the patient may be transferred directly to comparable doses of another agent without interruption of β-blocking therapy.) If an exacerbation of angina pectoris occurs, antianginal therapy should be restarted immediately in full doses and the patient hospitalized until his condition stabilizes.

Peripheral Vascular Disease

Treatment with β-antagonists reduces cardiac output and can precipitate or aggravate the symptoms of arterial insufficiency in patients with peripheral or mesenteric vascular disease. Caution should be exercised with such patients, and they should be observed closely for evidence of progression of arterial obstruction.

Bronchospastic Disease

PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE A β-BLOCKER. Because of its relative β-selectivity, however, low doses of Sectral may be used with caution in patients with bronchospastic disease who do not respond to, or who cannot tolerate, alternative treatment. Since β-selectivity is not absolute and is dose-dependent, the lowest possible dose of Sectral should be used initially, preferably in divided doses to avoid the higher plasma levels associated with the longer dose-interval. A bronchodilator, such as theophylline or a β- stimulant, should be made available in advance with instructions concerning its use.

Anesthesia and Major Surgery

The necessity, or desirability, of withdrawal of a - blocking therapy prior to major surgery is controversial. -adrenergic receptor blockade impairs the ability of the heart to respond to -adrenergically mediated reflex stimuli. While this might be of benefit in preventing arrhythmic response, the risk of excessive myocardial depression during general anesthesia may be enhanced and difficulty in restarting and maintaining the heart beat has been reported with beta-blockers. If treatment is continued, particular care should be taken when using anesthetic agents which depress the myocardium, such as ether, cyclopropane, and trichlorethylene, and it is prudent to use the lowest possible dose of Sectral. Sectral, like other -blockers, is a competitive inhibitor of -receptor agonists, and its effect on the heart can be reversed by cautious administration of such agents (e.g., dobutamine or isoproterenol—see ). Manifestations of excessive vagal tone (e.g., profound bradycardia, hypotension) may be corrected

Diabetes and Hypoglycemia

β-blockers may potentiate insulin-induced hypoglycemia and mask some of its manifestations such as tachycardia; however, dizziness and sweating are usually not significantly affected. Diabetic patients should be warned of the possibility of masked hypoglycemia.

Thyrotoxicosis

β-adrenergic blockade may mask certain clinical signs (tachycardia) of hyperthyroidism. Abrupt withdrawal of β-blockade may precipitate a thyroid storm; therefore, patients suspected of developing thyrotoxicosis from whom Sectral therapy is to be withdrawn should be monitored closely.

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What are the precautions of SECTRAL?

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What are the side effects of SECTRAL?

Sectral is well tolerated in properly selected patients. Most adverse reactions have been mild, not required discontinuation of therapy, and tended to decrease as duration of treatment increases.

The following table shows the frequency of treatment-related side effects derived from controlled clinical trials in patients with hypertension, angina pectoris, and arrhythmia. These patients received Sectral, propranolol, or hydrochlorothiazide as monotherapy, or placebo.

The following selected (potentially important) side effects were seen in up to 2% of Sectral patients:

Cardiovascular:

Central Nervous System:

Dermatological:

Gastrointestinal:

Genitourinary:

Liver and Biliary System:

Musculoskeletal:

Respiratory:

Special Senses:

Autoimmune:

The incidence of drug-related adverse effects (volunteered and solicited) according to Sectral dose is shown below. (Data from 266 hypertensive patients treated for 3 months on a constant dose.)

Body System/Adverse ReactionSECTRAL(N=1002)%Propranolol(N=424)%Hydrochloro-thiazide(N=178)%Placebo(N=314)%
  Chest Pain2441
  Edema2241
  Depression2131
  Dizziness67122
  Fatigue1117104
  Headache69134
  Insomnia3651
  Abnormal dreams2301
  Rash2241
  Constipation4270
  Diarrhea4551
  Dyspepsia4631
  Flatulence3471
  Nausea4630
  Micturition(frequency)319
  Arthralgia2132
  Myalgia2140
  Cough1120
  Dyspnea4642
  Rhinitis214
  Abnormal Vision2230
Body System400 mg/day(N=132)800 mg/day(N=63)1200 mg/day(N=71)
Cardiovascular5%2%1%
Gastrointestinal3%3%7%
Musculoskeletal2%3%4%
Central Nervous System9%13%17%
Respiratory1%5%6%
Skin1%2%1%
Special Senses2%2%6%
Genitourinary2%3%1%


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In addition, certain adverse effects not listed above have been reported with other β-blocking agents and should also be considered as potential adverse effects of Sectral.

Central Nervous System

Cardiovascula

Allergic:

Hematologic:

Gastrointestinal:

Miscellaneous:


What should I look out for while using SECTRAL?

Sectral is contraindicated in: 1) persistently severe bradycardia; 2) second- and third-degree heart block; 3) overt cardiac failure; and 4) cardiogenic shock. (See .)


What might happen if I take too much SECTRAL?

No specific information on emergency treatment of overdosage is available for Sectral. However, overdosage with other β-blocking agents has been accompanied by extreme bradycardia, advanced atrioventricular block, intraventricular conduction defects, hypotension, severe congestive heart failure, seizures, and in susceptible patients, bronchospasm and hypoglycemia. Although specific information on the emergency treatment of Sectral overdose is not available, on the basis of the pharmacological actions and the observations in treating overdoses with other β-blockers, the following general measures should be considered:

Sectral is dialyzable.


How should I store and handle SECTRAL?

Sorry No Records found


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Clinical Information

Chemical Structure

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Clinical Pharmacology

β-cardioselectivity has been demonstrated in experimental animal studies. In anesthetized dogs and cats, Sectral is more potent in antagonizing isoproterenol-induced tachycardia (β) than in antagonizing isoproterenol-induced vasodilatation (β).In guinea pigs and cats, it is more potent in antagonizing this tachycardia than in antagonizing isoproterenol- induced bronchodilatation (β). ISA of Sectral has been demonstrated in catecholamine-depleted rats by tachycardia induced by intravenous administration of this agent. A membrane-stabilizing effect has been detected in animals, but only with high concentrations of Sectral.

Clinical studies have demonstrated β-blocking activity at the recommended doses by: a) reduction in the resting heart rate and decrease in exercise-induced tachycardia; b) reduction in cardiac output at rest and after exercise; c) reduction of systolic and diastolic blood pressures at rest and postexercise; d) inhibition of isoproterenol-induced tachycardia.

The β-selectivity of Sectral has also been demonstrated on the basis of the following vascular and bronchial effects:

Vascular Effects: Sectral has less antagonistic effects on peripheral vascular β-receptors at rest and after epinephrine stimulation than nonselective β-antagonists.

Bronchial Effects: In single-dose studies in asthmatics examining effects of various beta-blockers on pulmonary function, low doses of acebutolol produce less evidence of bronchoconstriction and less reduction of beta agonist, bronchodilating effects, than nonselective agents like propranolol but more than atenolol.

ISA has been observed with Sectral in man, as shown by a slightly smaller (about 3 beats per minute) decrease in resting heart rate when compared to equivalent β-blocking doses of propranolol, metoprolol or atenolol. Chronic therapy with Sectral induced no significant alteration in the blood lipid profile.

Sectral has been shown to delay AV conduction time and to increase the refractoriness of the AV node without significantly affecting sinus node recovery time, atrial refractory period, or the HV conduction time. The membrane-stabilizing effect of Sectral is not manifest at the doses used clinically.

Significant reductions in resting and exercise heart rates and systolic blood pressures have been observed 1.5 hours after Sectral administration with maximal effects occurring between 3 and 8 hours postdosing in normal volunteers. Sectral has demonstrated a significant effect on exercise-induced tachycardia 24 to 30 hours after drug administration.

There are significant correlations between plasma levels of acebutolol and both the reduction in resting heart rate and the percent of β-blockade of exercise-induced tachycardia.

The antihypertensive effect of Sectral has been shown in double-blind controlled studies to be superior to placebo and similar to propranolol and hydrochlorothiazide. In addition, patients responding to Sectral administered twice daily had a similar response whether the dosage regimen was changed to once daily administration or continued on a b.i.d. regimen. Most patients responded to 400 to 800 mg per day in divided doses.

The antiarrhythmic effect of Sectral was compared with placebo, propranolol, and quinidine. Compared with placebo, Sectral significantly reduced mean total ventricular ectopic beats (VEB), paired VEB, multiform VEB, R-on-T beats, and ventricular tachycardia (VT). Both Sectral and propranolol significantly reduced mean total and paired VEB and VT. Sectral and quinidine significantly reduced resting total and complex VEB; the antiarrhythmic efficacy of Sectral was also observed during exercise.

Non-Clinical Toxicology
Sectral is contraindicated in: 1) persistently severe bradycardia; 2) second- and third-degree heart block; 3) overt cardiac failure; and 4) cardiogenic shock. (See .)

Ritalin should not be used in patients being treated (currently or within the proceeding two weeks) with MAO Inhibitors (see CONTRAINDICATIONS, Monoamine Oxidase Inhibitors). Because of possible effects on blood pressure, Ritalin should be used cautiously with pressor agents.

Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Methylphenidate is metabolized primarily to ritalinic acid by de-esterification and not through oxidative pathways.

Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine, clomipramine, desipramine). Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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