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
10 mg Label
NDC 0781-1556-01
Isosorbide
Dinitrate
Tablets, USP
10 mg ORAL
Rx only
100 Tablets
SANDOZ
20 mg Label
NDC 0781-1695-01
Isosorbide
Dinitrate
Tablets, USP
20 mg ORAL
Rx only
100 Tablets
SANDOZ
10 mg Carton Label
NDC 0781-8011-13
Isosorbide
Dinitrate
Tablets, USP
10 mg ORAL
Rx only
100 Tablets
SANDOZ
20 mg Carton Label
NDC 0781-8026-13
Isosorbide
Dinitrate
Tablets, USP
20 mg ORAL
Rx only
100 Tablets
SANDOZ
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ISOSORBIDE DINITRATE isosorbide dinitrate tablet | |||||||||||||||||||||||||
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Labeler — Sandoz Inc. (005387188) |
Revised: 08/2022 Sandoz Inc.
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