Isosorbide Dinitrate (Page 3 of 3)

HOW SUPPLIED

Isosorbide dinitrate tablets, USP are available as follows:

5 mg oral, white, round, bisected tablets, debossed with “PAR 020” on one side and plain on the other side.

10 mg oral, white, round, bisected tablets, debossed with “PAR 021” on one side and plain on the other side.

20 mg oral, green, round, bisected tablets, debossed with “PAR 022” on one side and plain on the other side.

30 mg oral, blue, round, bisected tablets, debossed with “PAR 009” on one side and plain on the other side.

Bottles of 100 NDC 42291-350-01

Store at room temperature, approximately 25°C (77°F). Protect from light. Keep bottles tightly closed.

Dispense in a light-resistant, tight container.

CLINICAL STUDIES

In clinical trials, immediate-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 30 mg to 480 mg. Controlled trials of single oral doses of isosorbide dinitrate have demonstrated effective reductions in exercise-related angina for up to 8 hours. Anti-anginal activity is present about 1 hour after dosing.

Most controlled trials of multiple-dose oral isosorbide dinitrate taken every 12 hours (or more frequently) for several weeks have shown statistically significant anti-anginal efficacy for only 2 hours after dosing. Once-daily regimens, and regimens with one daily dose-free interval of at least 14 hours ( e.g. , a regimen providing doses at 0800, 1400 and 1800 hours), have shown efficacy after the first dose of each day that was similar to that shown in the single-dose studies cited above. The effects of the second and later doses have been smaller and shorter-lasting than the effect of the first.

From large, well-controlled studies of other nitrates, it is reasonable to believe that the maximal achievable daily duration of anti-anginal effect from isosorbide dinitrate is about 12 hours. No dosing regimen for isosorbide dinitrate, however, has ever actually been shown to achieve this duration of effect. One study of 8 patients, who were administered a pretitrated dose (average 27.5 mg) of immediate-release isosorbide dinitrate at 0800, 1300, and 1800 hours for 2 weeks, revealed that significant anti-anginal effectiveness was discontinuous and totaled about 6 hours in a 24 hour period.

Manufactured for:

AvKARE, Inc.

Mfg. Rev. 03/2015

AV 05/16 (P)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE, Inc.
NDC 42291-350-01
Isosorbide Dinitrate Tablets, USP Oral
30 mg
100 Tablets Rx Only

Each tablet contains:
Isosorbide Dinitrate ……. 30 mg
USUAL DOSAGE:
Read Accompanying Literature.
Dispense in a light-resistant, tight container.

Store at room temperature, approximately 25°C (77°F).
Protect from light.
Keep bottle tightly closed.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478 Mfg. Rev. R03/09 AV 05/16 (P)

N3 42291 35001 4

ISOSORBIDE DINITRATE isosorbide dinitrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-350(NDC:49884-009) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE 30 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE

Product Characteristics Color blue Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code Par;009 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-350-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA087946 06/07/2016

Labeler — AvKARE (796560394)

Revised: 01/2022 AvKARE