Isosorbide Dinitrate: Package Insert and Label Information (Page 2 of 2)

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:

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

NDC: 70518-0063-00

NDC: 70518-0063-01

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

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.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Isosorbide Dinitrate

GENERIC: Isosorbide Dinitrate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0063-0

NDC: 70518-0063-1

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: GG26

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • ISOSORBIDE DINITRATE 10mg in 1

INACTIVE INGREDIENT(S):

  • MICROCRYSTALLINE CELLULOSE
  • MAGNESIUM STEARATE
  • LACTOSE MONOHYDRATE
MM1
(click image for full-size original)
MM2
(click image for full-size original)
ISOSORBIDE DINITRATE
isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0063(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:70518-0063-0 30 TABLET in 1 BLISTER PACK None
2 NDC:70518-0063-1 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086223 12/14/2016
Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2022 REMEDYREPACK INC.

Page 2 of 2 1 2

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.