Isosorbide Mononitrate Tablets, USP

/Isosorbide Mononitrate Tablets, USP
Isosorbide Mononitrate Tablets, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Isosorbide Mononitrate Tablets, USP

ID:

b141986d-5629-48d6-bf20-802ae2fc2dcb

Code:

34391-3

DESCRIPTION


id: 244c9709-5b40-4316-94f9-ca2d966dcd03
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula: Isosorbide Mononitrate Tablets, USP are available as 10 mg and 20 mg tablets. Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate.

CLINICAL PHARMACOLOGY


id: af6352be-f8f7-4d52-9197-2e19a5ee4f57
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Isosorbide mononitrate is the major active metabolite of isosorbide dinitrate (ISDN), and most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of isosorbide mononitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction and coronary dilatation remains undefined.

INDICATIONS AND USAGE


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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Isosorbide Mononitrate Tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

CONTRAINDICATIONS


id: bc129e3e-d794-4dc8-8f74-45597e537a45
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Allergic reactions to organic nitrates are extremely rare, but they do occur. Isosorbide mononitrate is contraindicated in patients who are allergic to it.

WARNINGS


id: 0998914d-29e9-4deb-87ab-330f9d75a3c6
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Amplification of the vasodilatory effects of isosorbide mononitrate by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. The benefits of isosorbide mononitrate in patients with acute myocardial infarction or congestive heart failure have not been established. Because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings. If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.

ADVERSE REACTIONS


id: 0cf0774c-be91-4d7f-b6b3-8008650053ac
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy. The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad. The same table shows the frequency of withdrawal for these adverse reactions. In many cases the adverse reactions were of uncertain relation to drug treatment.

Frequency of Adverse Reactions (Discontinuations)Some individuals discontinued for multiple reasons.
6 Placebo-Controlled Studies
Dose Placebo 5 mg 10 mg 20 mg
Patients 160 54 52 159
Headache 6% (0%) 17% (0%) 13% (0%) 35% (5%)
Fatigue 2% (0%) 0% (0%) 4% (0%) 1% (0%)
Upper Respiratory Infection <1% (0%) 0% (0%) 4% (0%) 1% (0%)
Pain <1% (0%) 4% (0%) 0% (0%) <1% (0%)
Dizziness 1% (0%) 0% (0%) 0% (0%) 4% (0%)
Nausea <1% (0%) 0% (0%) 0% (0%) 3% (2%)
Increased Cough <1% (0%) 0% (0%) 2% (0%) <1% (0%)
Rash 0% (0%) 2% (2%) 0% (0%) <1% (0%)
Abdominal Pain <1% (0%) 0% (0%) 2% (0%) 0% (0%)
Allergic Reaction 0% (0%) 0% (0%) 2% (0%) 0% (0%)
Cardiovascular Disorder 0% (0%) 2% (0%) 0% (0%) 0% (0%)
Chest Pain <1% (0%) 0% (0%) 2% (0%) <1% (0%)
Diarrhea 0% (0%) 0% (0%) 2% (0%) 0% (0%)
Flushing 0% (0%) 0% (0%) 2% (0%) 0% (0%)
Emotional Lability 0% (0%) 2% (0%) 0% (0%) 0% (0%)
Pruritus 1% (0%) 2% (2%) 0% (0%) 0% (0%)
Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were:
Cardiovascular: acute myocardial infarction, apoplexy, arrhythmias, bradycardia, edema, hypertension, hypotension, pallor, palpitations, tachycardia.
 
Dermatologic: sweating.
 
Gastrointestinal: anorexia, dry mouth, dyspepsia, thirst, vomiting, decreased weight.
 
Geritourinary: prostatic disorder.
 
Miscellaneous: amblyopia, back pain, bitter taste, muscle cramps, neck pain, paresthesia, susurrus aurium.
 
Neurologic: anxiety, impaired concentration, depression, insomnia, nervousness, nightmares, restlessness, tremor, vertigo.
 
Respiratory: asthma, dyspnea, sinusitis.
Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see under Overdosage.

DOSAGE AND ADMINISTRATION


id: 70f784df-0f8a-43f0-9b6a-56e16d83056c
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

The recommended regimen of Isosorbide Mononitrate Tablets is 20 mg twice daily, with the doses seven hours apart. A starting dose of 5 mg (½ tablet of the 10 mg dosing strength) might be appropriate for persons of particularly small stature but should be increased to at least 10 mg by the second or third day of therapy. Dosage adjustments are not necessary for elderly patients or patients with altered hepatic or renal function. As noted above (Clinical Pharmacology), multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The asymmetric (2 doses, 7 hours apart) dosing regimen for Isosorbide Mononitrate Tablets provides a daily nitrate-free interval to minimize the development of tolerance. As also noted under Clinical Pharmacology, well-controlled studies have shown that tolerance to Isosorbide Mononitrate Tablets occurs to some extent when using the twice-daily regimen in which the two doses are given seven hours apart. This regimen has been shown to have antianginal efficacy beginning one hour after the first dose and lasting at least seven hours after the second dose. The duration (if any) of antianginal activity beyond fourteen hours has not been studied. In clinical trials, isosorbide mononitrate has been administered in a variety of regimens and doses. Doses above 20 mg twice a day (with the doses seven hours apart) have not been adequately studied. Doses of 5 mg twice a day are clearly effective (effectiveness based on exercise tolerance) for only the first day of a twice-a-day (with doses 7 hours apart) regimen.

HOW SUPPLIED


id: 0dfb949e-0bb1-4723-b2d7-051170223a1d
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Isosorbide Mononitrate 10 mg Tablets, USP are white, round, scored and engraved “10” on one side and engraved “KU 106” on the other. They are supplied as follows:

Bottles of 10 NDC 54868-4478-1
Bottles of 60 NDC 54868-4478-0

PRINCIPAL DISPLAY PANEL – 10 mg Tablet Bottle Label


id: a52547fc-def7-4a9c-8a2c-087b904eccd3
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Isosorbide
Mononitrate
Tablets, USP
10 mg Rx Only