Isosorbide Dinitrate (Page 3 of 3)

DOSAGE AND ADMINISTRATION

As noted under CLINICAL PHARMACOLOGY, multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for isosorbide dinitrate tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long.

As also noted under CLINICAL PHARMACOLOGY, the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.

Large controlled studies with other nitrates suggest that no dosing regimen with isosorbide dinitrate tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.

As with all titratable drugs, it is important to administer the minimum dose which produces the desired clinical effect. The usual starting dose of isosorbide dinitrate is 5 mg to 20 mg, two or three times daily. For maintenance therapy, 10 mg to 40 mg, two or three times daily is recommended. Some patients may require higher doses. A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.

HOW SUPPLIED

Isosorbide dinitrate tablets, USP are supplied as:

5 mg: Round, pink, scored tablets, debossed GG 259 on one side and plain on the reverse side, and supplied as:

NDC 0781-1635-01 bottles of 100

NDC 0781-1635-10 bottles of 1000

10 mg: Round, white, scored tablets, debossed GG 26 on one side and plain on the reverse side, and supplied as:

NDC 0781-1556-01 bottles of 100

NDC 0781-1556-10 bottles of 1000

20 mg: Round, green, scored tablets, debossed GG 227 on one side and plain on the reverse side, and supplied as:

NDC 0781-1695-01 bottles of 100

NDC 0781-1695-10 bottles of 1000

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Distributed by

Sandoz Inc.

Princeton, NJ 08540

46299656

MF42026487REV11/21

Rev. November 2021

5 mg Label

NDC 0781-1635-01

Isosorbide

Dinitrate

Tablets, USP

5 mg ORAL

Rx only

100 Tablets

SANDOZ

5mg-100Tablets
(click image for full-size original)

10 mg Label

NDC 0781-1556-01

Isosorbide

Dinitrate

Tablets, USP

10 mg ORAL

Rx only

100 Tablets

SANDOZ

10mg-100Tablets
(click image for full-size original)

20 mg Label

NDC 0781-1695-01

Isosorbide

Dinitrate

Tablets, USP

20 mg ORAL

Rx only

100 Tablets

SANDOZ

20mg-100Tablets
(click image for full-size original)

10 mg Carton Label

NDC 0781-8011-13

Isosorbide

Dinitrate

Tablets, USP

10 mg ORAL

Rx only

100 Tablets

SANDOZ

10mg-100TabletsCarton
(click image for full-size original)

20 mg Carton Label

NDC 0781-8026-13

Isosorbide

Dinitrate

Tablets, USP

20 mg ORAL

Rx only

100 Tablets

SANDOZ

20mg-100TabletsCarton
(click image for full-size original)
ISOSORBIDE DINITRATE
isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1635
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
FD&C RED NO. 40
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code GG259
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-1635-10 1000 TABLET in 1 BOTTLE None
2 NDC:0781-1635-01 100 TABLET in 1 BOTTLE None
3 NDC:0781-1635-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0781-1635-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086221 01/07/1988 03/22/2027
ISOSORBIDE DINITRATE
isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1556
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code GG26
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-1556-01 100 TABLET in 1 BOTTLE None
2 NDC:0781-1556-05 500 TABLET in 1 BOTTLE None
3 NDC:0781-1556-10 1000 TABLET in 1 BOTTLE None
4 NDC:0781-1556-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0781-1556-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086223 01/07/1988 03/22/2027
ISOSORBIDE DINITRATE
isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1695
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code GG227
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-1695-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0781-1695-13)
2 NDC:0781-1695-10 1000 TABLET in 1 BOTTLE None
3 NDC:0781-1695-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089367 01/07/1988 03/22/2027
Labeler — Sandoz Inc. (005387188)

Revised: 08/2022 Sandoz Inc.

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