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Disopyramide Phosphate (Norpace Cr)

Trade Name : Norpace CR

G.D. Searle LLC Division of Pfizer Inc

CAPSULE, EXTENDED RELEASE

Strength 100 mg/1

DISOPYRAMIDE PHOSPHATE Antiarrhythmic [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Disopyramide Phosphate (Norpace Cr) which is also known as Norpace CR and Manufactured by G.D. Searle LLC Division of Pfizer Inc. It is available in strength of 100 mg/1 per ml. Read more

Disopyramide Phosphate (Norpace Cr) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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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.

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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.

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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
  • Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release 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 Norpace is:
  • Norpace 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.
  • Norpace is a racemic mixture of and isomers. This drug is not chemically related to other antiarrhythmic drugs.
  • Norpace CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Norpace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace capsules.
  • Inactive ingredients of Norpace include corn starch, edible ink, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Blue No. 1.
  • Inactive ingredients of Norpace CR include corn starch, D&C Yellow No. 10, edible ink, ethylcellulose, FD&C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Red No. 3 and FD&C Yellow No. 6.
  • No data
  • Norpace and Norpace CR are 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 Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
  • Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired.
  • Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
  • Norpace and Norpace CR are 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.
  • No data
  • No data
  • The adverse reactions which were reported in Norpace 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 Norpace 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 Norpace therapy, with prompt return to normal mental status when therapy was stopped. The physician should be aware of these possible reactions and should discontinue Norpace or Norpace CR therapy promptly if they occur.
  • No data
  • The dosage of Norpace or Norpace CR must be individualized for each patient on the basis of response and tolerance. The usual adult dosage of Norpace or Norpace CR 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 (either 150 mg every 6 hours for immediate-release Norpace or 300 mg every 12 hours for Norpace CR). For patients whose body weight is less than 110 pounds (50 kg), the recommended dosage is 400 mg/day given in divided doses (either 100 mg every 6 hours for immediate-release Norpace or 200 mg every 12 hours for Norpace CR). 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 of immediate-release Norpace every 6 to 8 hours.n- Array
  • 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 (either 100 mg every 6 hours for immediate-release Norpace or 200 mg every 12 hours for Norpace CR).
  • For patients with severe renal insufficiency (C 40 ml/min or less), the recommended dosage regimen of immediate-release Norpace is 100 mg at intervals shown in the table below, with or without an initial loading dose of 150 mg.
  • The above dosing schedules are for Norpace immediate-release capsules; Norpace CR is not recommended for patients with severe renal insufficiency.
  • For patients in whom rapid control of ventricular arrhythmia is essential, an initial loading dose of 300 mg of immediate-release Norpace (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 immediate-release Norpace every 6 hours may be prescribed instead of the usual 150 mg. If there is no response to this dosage within 48 hours, either Norpace should then be discontinued or the physician should consider hospitalizing the patient for careful monitoring while subsequent immediate-release Norpace 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 Norpace 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.
  • Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired.
  • Norpace (disopyramide phosphate) is supplied in hard gelatin capsules containing either 100 mg or 150 mg of disopyramide base, present as the phosphate.
  • Norpace 100-mg capsules are white and orange, with markings SEARLE, 2752, NORPACE, and 100 MG.
  • Norpace 150-mg capsules are brown and orange, with markings SEARLE, 2762, NORPACE, and 150 MG.
  • Norpace CR (disopyramide phosphate) Controlled-Release is supplied as specially prepared controlled-release beads in hard gelatin capsules containing either 100 mg or 150 mg of disopyramide base, present as the phosphate.
  • Norpace CR 100-mg capsules are white and light green, with markings SEARLE, 2732, NORPACE CR, and 100 mg.
  • Norpace CR 150-mg capsules are brown and light green, with markings SEARLE, 2742, NORPACE CR, and 150 mg.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u201330u00b0C (59u201386u00b0F). [See USP Controlled Room Temperature.]
  • Rx only
  • LAB-0066-5.0
  • Revised September 2019
  • NDC 0025-2752-31
  • 100 CapsulesRx only
  • Norpacen
  • 100 mg*
  • Pfizern- Distributed byn- G.D. Searle LLC
  • NDC 0025-2762-31
  • 100 CapsulesRx only
  • Norpacen
  • 150 mg*
  • Pfizern- Distributed byn- G.D. Searle LLC
  • NDC 0025-2732-31
  • 100 CapsulesRx only
  • Norpace CR
  • 100 mg*
  • Pfizern- Distributed byn- G.D. Searle LLC
  • NDC 0025-2742-31
  • 100 CapsulesRx only
  • Norpace CR
  • 150 mg*
  • Pfizern- Distributed byn- G.D. Searle LLC

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