Disopyramide Phosphate (Page 4 of 4)

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.

SUGGESTED TOTAL DAILY DOSAGE *
Age
(years)
Disopyramide
(mg/kg body weight/day)
*
Dosage is expressed in milligrams of disopyramide base. Since disopyramide phosphate 100-mg capsules contain 100 mg of disopyramide base, the pharmacist can readily prepare a 1-mg/ml to 10-mg/ml liquid suspension by adding the entire contents of disopyramide phosphate capsules to cherry syrup. (Prepare cherry syrup as follows: cherry juice, 475 ml; sucrose 800 g; alcohol, 20 ml; purified water, a sufficient quantity to make 1000 ml.) The resulting suspension, when refrigerated, is stable for one month and should be thoroughly shaken before the measurement of each dose. The suspension should be dispensed in an amber glass bottle with a child-resistant closure.

Under 1

10 to 30

1 to 4

10 to 20

4 to 12

10 to 15

12 to 18

6 to 15

HOW SUPPLIED

Disopyramide phosphate is supplied in hard gelatin capsules containing either 100 mg or 150 mg of disopyramide base, present as the phosphate.

Disopyramide phosphate 100-mg capsules are white and orange, with markings SEARLE, 2752, NORPACE, and 100 MG.

NDC Number Size

59762-0386-1

bottle of 100

Disopyramide phosphate 150-mg capsules are brown and orange, with markings SEARLE, 2762, NORPACE, and 150 MG.

NDC Number Size

59762-0400-1

bottle of 100

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.]

This product’s label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

Rx only

logo

LAB-1270-1.0
Revised March 2018

PRINCIPAL DISPLAY PANEL — 100 mg Capsule Bottle Label

NDC 59762-0386-1
100 Capsules

GREENSTONE® BRAND

disopyramide
phosphate
capsules USP

100 mg*

Rx only

PRINCIPAL DISPLAY PANEL -- 100 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg Capsule Bottle Label

NDC 59762-0400-1
100 Capsules

GREENSTONE® BRAND

disopyramide
phosphate
capsules USP

150 mg*

Rx only

PRINCIPAL DISPLAY PANEL -- 150 mg Capsule Bottle Label
(click image for full-size original)
DISOPYRAMIDE PHOSPHATE
disopyramide phosphate capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-0386
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE) DISOPYRAMIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FD&C RED NO. 3
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE, ORANGE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code SEARLE;2752;NORPACE;100;MG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-0386-1 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA017447 04/23/2019
DISOPYRAMIDE PHOSPHATE
disopyramide phosphate capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-0400
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE) DISOPYRAMIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FD&C RED NO. 3
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 1
Product Characteristics
Color BROWN, ORANGE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code SEARLE;2762;NORPACE;150;MG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-0400-1 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA017447 04/23/2019
Labeler — Greenstone LLC (825560733)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Viatris Pharmaceuticals LLC 829084552 ANALYSIS (59762-0386), ANALYSIS (59762-0400), MANUFACTURE (59762-0386), MANUFACTURE (59762-0400), PACK (59762-0386), PACK (59762-0400), LABEL (59762-0386), LABEL (59762-0400)

Revised: 09/2023 Greenstone LLC

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.