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Disopyramide Phosphate (Disopyramide Phosphate)

Trade Name : Disopyramide Phosphate

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 100 mg/1

DISOPYRAMIDE PHOSPHATE Antiarrhythmic [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Disopyramide Phosphate (Disopyramide Phosphate) which is also known as Disopyramide Phosphate and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 100 mg/1 per ml. Read more

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Disopyramide Phosphate is an antiarrhythmic drug available for oral administration in capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Disopyramide Phosphate is:
  • CHNOu2022HPO M.W. 437.47
  • u03b1-[2-(diisopropylamino) ethyl]-u03b1-phenyl-2-pyridineacetamide phosphate
  • Disopyramide Phosphate is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/mL. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2.
  • Disopyramide Phosphate is a racemic mixture of - and -isomers. This drug is not chemically related to other antiarrhythmic drugs.
  • Inactive Ingredients:n- Capsules:
  • Capsule Print and Shell Constituents:
  • Mechanisms of Action
  • Disopyramide Phosphate is a Type 1 antiarrhythmic drug (i.e., similar to procainamide and quinidine). Disopyramide Phosphate decreases the rate of diastolic depolarization (phase 4) in cells with augmented automaticity, decreases the upstroke velocity (phase 0) and increases the action potential duration of normal cardiac cells, decreases the disparity in refractoriness between infarcted and adjacent normally perfused myocardium, and has no effect on alpha- or beta-adrenergic receptors.
  • Electrophysiology
  • In man, Disopyramide Phosphate at therapeutic plasma levels shortens the sinus node recovery time, lengthens the effective refractory period of the atrium, and has a minimal effect on the effective refractory period of the AV node. Little effect has been shown on AV-nodal and His-Purkinje conduction times or QRS duration. However, prolongation of conduction in accessory pathways occurs.
  • Hemodynamics
  • At recommended oral doses, Disopyramide Phosphate rarely produces significant alterations of blood pressure in patients without congestive heart failure (see ). With intravenous Disopyramide Phosphate, either increases in systolic/diastolic or decreases in systolic blood pressure have been reported, depending on the infusion rate and the patient population. Intravenous Disopyramide Phosphate may cause cardiac depression with an approximate mean 10% reduction of cardiac output, which is more pronounced in patients with cardiac dysfunction.
  • Anticholinergic Activity
  • The anticholinergic activity of Disopyramide Phosphate is approximately 0.06% that of atropine; however, the usual dose for Disopyramide Phosphate is 150 mg every 6 hours compared to 0.4 to 0.6 mg for atropine (see and for anticholinergic side effects).
  • Pharmacokinetics
  • Following oral administration of Disopyramide Phosphate, disopyramide phosphate is rapidly and almost completely absorbed, and peak plasma levels are usually attained within 2 hours. The usual therapeutic plasma levels of disopyramide base are 2 to 4 mcg/mL, and at these concentrations protein binding varies from 50% to 65%. Because of concentration-dependent protein binding, it is difficult to predict the concentration of the free drug when total drug is measured.
  • The mean plasma half-life of disopyramide in healthy humans is 6.7 hours (range of 4 to 10 hours). In six patients with impaired renal function (creatinine clearance less than 40 mL/min), disopyramide half-life values were 8 to 18 hours.
  • After the oral administration of 200 mg of disopyramide to 10 cardiac patients with borderline to moderate heart failure, the time to peak serum concentration of 2.3 u00b1 1.5 hours (mean u00b1 SD) was increased, and the mean peak serum concentration of 4.8 u00b1 1.6 mcg/mL was higher than in healthy volunteers. After intravenous administration in these same patients, the mean elimination half-life was 9.7 u00b1 4.2 hours (range in healthy volunteers of 4.4 to 7.8 hours). In a second study of the oral administration of disopyramide to 7 patients with heart disease, including left ventricular dysfunction, the mean plasma half-life was slightly prolonged to 7.8 u00b1 1.9 hours (range of 5 to 9.5 hours).
  • In healthy men, about 50% of a given dose of disopyramide is excreted in the urine as the unchanged drug, about 20% as the mono-N-dealkylated metabolite, and 10% as the other metabolites. The plasma concentration of the major metabolite is approximately one tenth that of disopyramide. Altering the urinary pH in man does not affect the plasma half-life of disopyramide.
  • Drug Interactions
  • Effects of other drugs on disopyramide pharmacokinetics: metabolic studies indicated that disopyramide is metabolized by cytochrome P450 3A4 and that inhibitors of this enzyme may result in elevation of plasma levels of disopyramide. Although specific drug interaction studies have not been done, cases of life-threatening interactions have been reported for disopyramide when given with clarithromycin and erythromycin.
  • Disopyramide Phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Disopyramide Phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
  • Initiation of Disopyramide Phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
  • Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
  • Disopyramide Phosphate is contraindicated in the presence of cardiogenic shock, preexisting second- or third-degree AV block (if no pacemaker is present), congenital Q-T prolongation, or known hypersensitivity to the drug.
  • Negative Inotropic Properties
  • Heart Failure/Hypotension
  • Disopyramide Phosphate may cause or worsen congestive heart failure or produce severe hypotension as a consequence of its negative inotropic properties. Hypotension has been observed primarily in patients with primary cardiomyopathy or inadequately compensated congestive heart failure. Disopyramide Phosphate should not be used in patients with uncompensated or marginally compensated congestive heart failure or hypotension unless the congestive heart failure or hypotension is secondary to cardiac arrhythmia. Patients with a history of heart failure may be treated with Disopyramide Phosphate, but careful attention must be given to the maintenance of cardiac function, including optimal digitalization. If hypotension occurs or congestive heart failure worsens, Disopyramide Phosphate should be discontinued and, if necessary, restarted at a lower dosage only after adequate cardiac compensation has been established.
  • QRS Widening
  • Although it is unusual, significant widening (greater than 25%) of the QRS complex may occur during Disopyramide Phosphate administration; in such cases Disopyramide Phosphate should be discontinued.
  • Q-T Prolongation
  • As with other Type 1 antiarrhythmic drugs, prolongation of the Q-T interval (corrected) and worsening of the arrhythmia, including ventricular tachycardia and ventricular fibrillation, may occur. Patients who have evidenced prolongation of the Q-T interval in response to quinidine may be at particular risk. As with other Type 1A antiarrhythmics, disopyramide phosphate has been associated with torsade de pointes.
  • If a Q-T prolongation of greater than 25% is observed and if ectopy continues, the patient should be monitored closely, and consideration given to discontinuing Disopyramide Phosphate.
  • Hypoglycemia
  • In rare instances significant lowering of blood-glucose values has been reported during Disopyramide Phosphate administration.
  • Concomitant Antiarrhythmic Therapy
  • The concomitant use of Disopyramide Phosphate with other Type 1A antiarrhythmic agents (such as quinidine or procainamide), Type 1C antiarrhythmics (such as encainide, flecainide or propafenone), and/or propranolol should be reserved for patients with life-threatening arrhythmias who are demonstrably unresponsive to single-agent antiarrhythmic therapy. Such use may produce serious negative inotropic effects, or may excessively prolong conduction.
  • Heart Block
  • If first-degree heart block develops in a patient receiving Disopyramide Phosphate, the dosage should be reduced.
  • Anticholinergic Activity
  • Because of its anticholinergic activity, disopyramide phosphate should not be used in patients with glaucoma, myasthenia gravis or urinary retention unless adequate overriding measures are taken;
  • No data
  • The adverse reactions which were reported in Disopyramide Phosphate clinical trials encompass observations in 1,500 patients, including 90 patients studied for at least 4 years. The most serious adverse reactions are hypotension and congestive heart failure. The most common adverse reactions, which are dose dependent, are associated with the anticholinergic properties of the drug. These may be transitory, but may be persistent or can be severe. Urinary retention is the most serious anticholinergic effect.
  • The following reactions were reported in 10% to 40% of patients:
  • Anticholinergic: dry mouth (32%), urinary hesitancy (14%), constipation (11%)
  • The following reactions were reported in 3% to 9% of patients:
  • Anticholinergic: blurred vision, dry nose/eyes/throat
  • Genitourinary: urinary retention, urinary frequency and urgency
  • Gastrointestinal: nausea, pain/bloating/gas
  • General: dizziness, general fatigue/muscle weakness, headache, malaise, aches/pains
  • The following reactions were reported in 1% to 3% of patients:
  • Genitourinary: impotence
  • Cardiovascular: hypotension with or without congestive heart failure, increased congestive heart failure (see ), cardiac conduction disturbances (see ), edema/weight gain, shortness of breath, syncope, chest pain
  • Gastrointestinal: anorexia, diarrhea, vomiting
  • Dermatologic: generalized rash/dermatoses, itching
  • Central nervous system: nervousness
  • Other: hypokalemia, elevated cholesterol/triglycerides
  • The following reactions were reported in less than 1%:
  • Depression, insomnia, dysuria, numbness/tingling, elevated liver enzymes, AV block, elevated BUN, elevated creatinine, decreased hemoglobin/hematocrit
  • Hypoglycemia has been reported in association with Disopyramide Phosphate administration (see ).
  • Infrequent occurrences of reversible cholestatic jaundice, fever, and respiratory difficulty have been reported in association with disopyramide therapy, as have rare instances of thrombocytopenia, reversible agranulocytosis, and gynecomastia. Some cases of LE (lupus erythematosus) symptoms have been reported; most cases occurred in patients who had been switched to disopyramide from procainamide following the development of LE symptoms. Rarely, acute psychosis has been reported following Disopyramide Phosphate therapy, with prompt return to normal mental status when therapy was stopped. The physician should be aware of these possible reactions and should discontinue Disopyramide Phosphate therapy promptly if they occur.
  • Symptoms
  • Deliberate or accidental overdosage of oral disopyramide may be followed by apnea, loss of consciousness, cardiac arrhythmias, and loss of spontaneous respiration. Death has occurred following overdosage.
  • Toxic plasma levels of disopyramide produce excessive widening of the QRS complex and Q-T interval, worsening of congestive heart failure, hypotension, varying kinds and degrees of conduction disturbance, bradycardia, and finally asystole. Obvious anticholinergic effects are also observed.
  • The approximate oral LD of disopyramide phosphate is 580 and 700 mg/kg for rats and mice, respectively.
  • Treatment
  • Experience indicates that prompt and vigorous treatment of overdosage is necessary, even in the absence of symptoms. Such treatment may be life-saving. No specific antidote for disopyramide phosphate has been identified. Treatment should be symptomatic and may include induction of emesis or gastric lavage, administration of a cathartic followed by activated charcoal by mouth or stomach tube, intravenous administration of isoproterenol and dopamine, insertion of an intra-aortic balloon for counterpulsation, and mechanically assisted ventilation. Hemodialysis or, preferably, hemoperfusion with charcoal may be employed to lower serum concentration of the drug.
  • The electrocardiogram should be monitored, and supportive therapy with cardiac glycosides and diuretics should be given as required.
  • If progressive AV block should develop, endocardial pacing should be implemented. In case of any impaired renal function, measures to increase the glomerular filtration rate may reduce the toxicity (disopyramide is excreted primarily by the kidney).
  • The anticholinergic effects can be reversed with neostigmine at the discretion of the physician.
  • Altering the urinary pH in humans does not affect the plasma half-life or the amount of disopyramide excreted in the urine.
  • The dosage of Disopyramide Phosphate must be individualized for each patient on the basis of response and tolerance. The usual adult dosage of Disopyramide Phosphate is 400 to 800 mg per day given in divided doses. The recommended dosage for most adults is 600 mg/day given in divided doses (150 mg every 6 hours). For patients whose body weight is less than 110 pounds (50 kg), the recommended dosage is 400 mg/day given in divided doses (100 mg every 6 hours). In the event of increased anticholinergic side effects, plasma levels of disopyramide should be monitored and the dose of the drug adjusted accordingly. A reduction of the dose by one third, from the recommended 600 mg/day to 400 mg/day, would be reasonable, without changing the dosing interval.
  • For patients with cardiomyopathy or possible cardiac decompensation, a loading dose, as discussed below, should not be given, and initial dosage should be limited to 100 mg every 6 to 8 hours.n- WARNINGS
  • For patients with moderate renal insufficiency (creatinine clearance greater than 40 mL/min) or hepatic insufficiency, the recommended dosage is 400 mg/day given in divided doses (100 mg every 6 hours).
  • For patients with severe renal insufficiency (C 40 mL/min or less), the recommended dosage regimen is 100 mg at intervals shown in the table below, with or without an initial loading dose of 150 mg.
  • For patients in whom rapid control of ventricular arrhythmia is essential, an initial loading dose of 300 mg of Disopyramide Phosphate (200 mg for patients whose body weight is less than 110 pounds) is recommended, followed by the appropriate maintenance dosage. Therapeutic effects are usually attained 30 minutes to 3 hours after administration of a 300 mg loading dose. If there is no response or evidence of toxicity within 6 hours of the loading dose, 200 mg of Disopyramide Phosphate every 6 hours may be prescribed instead of the usual 150 mg. If there is no response to this dosage within 48 hours, either Disopyramide Phosphate should then be discontinued or the physician should consider hospitalizing the patient for careful monitoring while subsequent Disopyramide Phosphate doses of 250 mg or 300 mg every 6 hours are given. A limited number of patients with severe refractory ventricular tachycardia have tolerated daily doses of Disopyramide Phosphate up to 1600 mg per day (400 mg every 6 hours), resulting in disopyramide plasma levels up to 9 mcg/mL. If such treatment is warranted, it is essential that patients be hospitalized for close evaluation and continuous monitoring.
  • Transferring to Disopyramide Phosphate
  • The following dosage schedule based on theoretical considerations rather than experimental data is suggested for transferring patients with normal renal function from either quinidine sulfate or procainamide therapy (Type 1 antiarrhythmic agents) to Disopyramide Phosphate therapy:
  • Disopyramide Phosphate should be started using the regular maintenance schedule 6 to 12 hours after the last dose of quinidine sulfate or 3 to 6 hours after the last dose of procainamide.
  • In patients in whom withdrawal of quinidine sulfate or procainamide is likely to produce life-threatening arrhythmias, the physician should consider hospitalization of the patient.
  • Pediatric Dosage
  • Controlled clinical studies have not been conducted in pediatric patients; however, the following suggested dosage table is based on published clinical experience.
  • Total daily dosage should be divided and equal doses administered orally every 6 hours or at intervals according to individual patient needs. Disopyramide plasma levels and therapeutic response must be monitored closely. Patients should be hospitalized during the initial treatment period, and dose titration should start at the lower end of the ranges provided below.
  • Disopyramide Phosphate is supplied as:
  • 100 mg - hard gelatin capsule with a light-blue body imprinted u201c93-3127u201d and a scarlet cap imprinted u201c93-3127u201d, containing 100 mg of disopyramide base present as the phosphate, in bottles of 100 (NDC 0093-3127-01).
  • 150 mg - hard gelatin capsule with a scarlet body imprinted u201c93-3129u201d and a buff cap imprinted u201c93-3129u201d, containing 150 mg of disopyramide base present as the phosphate, in bottles of 100 (NDC 0093-3129-01).
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to77u00b0F) [See USP Controlled Room Temperature].
  • Distributed By:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. J 8/2015
  • No data
  • No data

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