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SECTRAL
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?
Sorry No records found
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withdrawn.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.
Array
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 Reaction | SECTRAL(N=1002)% | Propranolol(N=424)% | Hydrochloro-thiazide(N=178)% | Placebo(N=314)% |
|---|---|---|---|---|
| Chest Pain | 2 | 4 | 4 | 1 |
| Edema | 2 | 2 | 4 | 1 |
| Depression | 2 | 1 | 3 | 1 |
| Dizziness | 6 | 7 | 12 | 2 |
| Fatigue | 11 | 17 | 10 | 4 |
| Headache | 6 | 9 | 13 | 4 |
| Insomnia | 3 | 6 | 5 | 1 |
| Abnormal dreams | 2 | 3 | 0 | 1 |
| Rash | 2 | 2 | 4 | 1 |
| Constipation | 4 | 2 | 7 | 0 |
| Diarrhea | 4 | 5 | 5 | 1 |
| Dyspepsia | 4 | 6 | 3 | 1 |
| Flatulence | 3 | 4 | 7 | 1 |
| Nausea | 4 | 6 | 3 | 0 |
| Micturition(frequency) | 3 | 1 | 9 | <1 |
| Arthralgia | 2 | 1 | 3 | 2 |
| Myalgia | 2 | 1 | 4 | 0 |
| Cough | 1 | 1 | 2 | 0 |
| Dyspnea | 4 | 6 | 4 | 2 |
| Rhinitis | 2 | 1 | 4 | <1 |
| Abnormal Vision | 2 | 2 | 3 | 0 | Body System | 400 mg/day(N=132) | 800 mg/day(N=63) | 1200 mg/day(N=71) |
| Cardiovascular | 5% | 2% | 1% | |
| Gastrointestinal | 3% | 3% | 7% | |
| Musculoskeletal | 2% | 3% | 4% | |
| Central Nervous System | 9% | 13% | 17% | |
| Respiratory | 1% | 5% | 6% | |
| Skin | 1% | 2% | 1% | |
| Special Senses | 2% | 2% | 6% | |
| Genitourinary | 2% | 3% | 1% |
Array
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
Clinical Information
Chemical Structure
No Image foundClinical 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.
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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