Isosorbide Mononitrate Extended-Release Tablets, Rx only

/Isosorbide Mononitrate Extended-Release Tablets, Rx only
Isosorbide Mononitrate Extended-Release Tablets, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

Isosorbide Mononitrate Extended-Release Tablets, Rx only

ID:

6c45880d-9da2-12c8-e053-2991aa0a9e47

Code:

34391-3

DESCRIPTION


id: 6c45a5cc-33b4-4d7c-e053-2991aa0a55a9
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C
6H
9NO
6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula:
ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane.

INDICATIONS AND USAGE


id: 6c45a5cc-33bb-4d7c-e053-2991aa0a55a9
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention 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: 6c45a5cc-33bc-4d7c-e053-2991aa0a55a9
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Isosorbide Mononitrate Extended-Release Tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

WARNINGS


id: 6c45a5cc-33bd-4d7c-e053-2991aa0a55a9
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 ISMN 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: 6c45a5cc-33cb-4d7c-e053-2991aa0a55a9
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The table below shows the frequencies of the adverse events that occurred in >5% of the subjects in three placebo-controlled North American studies, in which patients in the active treatment arm received 30 mg, 60 mg, 120 mg, or 240 mg of Isosorbide Mononitrate Extended-Release Tablets once daily. In parentheses, the same table shows the frequencies with which these adverse events were associated with the discontinuation of treatment. Overall, 8% of the patients who received 30 mg, 60 mg, 120 mg, or 240 mg of isosorbide mononitrate in the three placebo-controlled North American studies discontinued treatment because of adverse events. Most of these discontinued because of headache. Dizziness was rarely associated with withdrawal from these studies. Since headache appears to be a dose-related adverse effect and tends to disappear with continued treatment, it is recommended that ISMN treatment be initiated at low doses for several days before being increased to desired levels.

FREQUENCY AND ADVERSE EVENTS (DISCONTINUED)
a
Three Controlled North American Studies
Dose Placebo 30 mg 60 mg 120 mg
Patients were started on 60 mg and titrated to their final dose.
240 mg
Patients 96 60 102 65 65
Headache 15% (0%) 38% (5%) 51% (8%) 42% (5%) 57% (8%)
Dizziness 4% (0%) 8% (0%) 11% (1%) 9% (2%) 9% (2%)
In addition, the three North American trials were pooled with 11 controlled trials conducted in Europe. Among the 14 controlled trials, a total of 711 patients were randomized to Isosorbide Mononitrate Extended-Release Tablets. When the pooled data were reviewed, headache and dizziness were the only adverse events that were reported by >5% of patients. Other adverse events, each reported by ≤5% of exposed patients, and in many cases of uncertain relation to drug treatment, were: Autonomic Nervous System Disorders: Dry mouth, hot flushes. Body as a Whole: Asthenia, back pain, chest pain, edema, fatigue, fever, flu-like symptoms, malaise, rigors. Cardiovascular Disorders, General: Cardiac failure, hypertension, hypotension. Central and Peripheral Nervous System Disorders: Dizziness, headache, hypoesthesia, migraine, neuritis, paresis, paresthesia, ptosis, tremor, vertigo. Gastrointestinal System Disorders: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gastric ulcer, gastritis, glossitis, hemorrhagic gastric ulcer, hemorrhoids, loose stools, melena, nausea, vomiting. Hearing and Vestibular Disorders: Earache, tinnitus, tympanic membrane perforation. Heart Rate and Rhythm Disorders: Arrhythmia, arrhythmia atrial, atrial fibrillation, bradycardia, bundle branch block, extrasystole, palpitation, tachycardia, ventricular tachycardia. Liver and Biliary System Disorders: SGOT increase, SGPT increase. Metabolic and Nutritional Disorders: Hyperuricemia, hypokalemia. Musculoskeletal System Disorders: Arthralgia, frozen shoulder, muscle weakness, musculoskeletal pain, myalgia, myositis, tendon disorder, torticollis. Myo-, Endo-, Pericardial and Valve Disorders: Angina pectoris aggravated, heart murmur, heart sound abnormal, myocardial infarction, Q wave abnormality. Platelet, Bleeding and Clotting Disorders: Purpura, thrombocytopenia. Psychiatric Disorders: Anxiety, concentration impaired, confusion, decreased libido, depression, impotence, insomnia, nervousness, paroniria, somnolence. Red Blood Cell Disorder: Hypochromic anemia. Reproductive Disorders, Female: Atrophic vaginitis, breast pain. Resistance Mechanism Disorders: Bacterial infection, moniliasis, viral infection. Respiratory System Disorders: Bronchitis, bronchospasm, coughing, dyspnea, increased sputum, nasal congestion, pharyngitis, pneumonia, pulmonary infiltration, rales, rhinitis, sinusitis. Skin and Appendages Disorders: Acne, hair texture abnormal, increased sweating, pruritus, rash, skin nodule. Urinary System Disorders: Polyuria, renal calculus, urinary tract infection. Vascular (Extracardiac) Disorders: Flushing, intermittent claudication, leg ulcer, varicose vein. Vision Disorders: Conjunctivitis, photophobia, vision abnormal. In addition, the following spontaneous adverse event has been reported during the marketing of isosorbide mononitrate: syncope.

DOSAGE AND ADMINISTRATION


id: 6c45a5cc-33cf-4d7c-e053-2991aa0a55a9
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

The recommended starting dose of Isosorbide Mononitrate Extended-Release Tablets is 30 mg (given as a single 30 mg tablet or as 1/2 of a 60 mg tablet) or 60 mg (given as a single tablet) once daily. After several days, the dosage may be increased to 120 mg (given as a single 120 mg tablet or as two 60 mg tablets) once daily. Rarely, 240 mg may be required. The daily dose of Isosorbide Mononitrate Extended-Release Tablets should be taken in the morning on arising. Isosorbide Mononitrate Extended-Release Tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid. Do not break the 30 mg tablet.

HOW SUPPLIED


id: 6c45a5cc-33d0-4d7c-e053-2991aa0a55a9
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Isosorbide Mononitrate Extended-Release Tablets, USP 30 mg are white, capsule-shaped tablets scored on one side and engraved “KU 128” on the unscored side. NDC 50268-451-15

10 Tablets per card, 5 cards per carton. Isosorbide Mononitrate Extended-Release Tablets, USP 60 mg are white, capsule-shaped tablets scored on one side and engraved “KU 119” on the unscored side. NDC 50268-452-15

10 Tablets per card, 5 cards per carton. Isosorbide Mononitrate Extended-Release Tablets, USP 120 mg are white, capsule-shaped tablets engraved “KU 129” on one side.

NDC 50268-453-15

10 Tablets per card, 5 cards per carton.

Dispensed in Blister Punch Material.  For Institutional Use Only.

Store at 20°-30°C (68°-86°F) [See USP]. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 Mfg. Rev. 4E 01/11 AV Rev. 04/14 (P)

AvPAK

Principal Display Panel


id: 6c45a5cc-33d1-4d7c-e053-2991aa0a55a9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 50268-451-15

Isosorbide Mononitrate Extended-Release Tablets, USP

30 mg

Rx Only

50 Tablets (5 X 10) Unit Dose

5026845115 NDC 50268-451-15

Isosorbide Mononitrate Extended-Release Tablets, USP

30 mg

Rx Only

50 Tablets (5 X 10) Unit Dose

5026845115 Each scored, capsule-shaped tablet contains 30 mg isosorbide mononitrate.

USUAL DOSAGE: See package insert for full prescribing information.

Store at 20
o – 30
oC (68- 86
oF) [See USP].

Dispense in tight containers as described in USP-NF.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 AvPAK

A PRODUCT OF AvKARE

Mfg. Rev. 4E L3771F          AV Rev. 02/14 (P) NDC 50268-452-15

Isosorbide Mononitrate Extended-Release Tablets, USP

60 mg

Rx Only

50 Tablets (5 X 10) Unit Dose

5026845215 NDC 50268-452-15

Isosorbide Mononitrate Extended-Release Tablets, USP

60 mg

Rx Only

50 Tablets (5 X 10) Unit Dose

5026845215 Each scored, capsule-shaped tablet contains 60 mg isosorbide mononitrate.

USUAL DOSAGE: See package insert for full prescribing information.

Store at 20
o – 30
oC (68 – 86
oF) [See USP].

Dispense in tight containers as described in USP-NF.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 AvPAK

A PRODUCT OF AvKARE

Mfg. Rev. 3E L3062D         AV Rev. 02/14 (P) NDC 50268-453-15

Isosorbide Mononitrate Extended-Release Tablets, USP

120 mg

Rx Only

50 Tablets (5 X 10) Unit Dose

5026845315

NDC 50268-453-15

Isosorbide Mononitrate Extended-Release Tablets, USP

120 mg

Rx Only

50 Tablets (5 X 10) Unit Dose

5026845315

Each capsule-shaped tablet contains 120 mg isosorbide mononitrate.

USUAL DOSAGE: See package insert for full prescribing information.

Store at 20- 30
oC (68
o– 86
oF) [See USP].

Dispense in tight containers as described in USP-NF.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

AvPAK

A PRODUCT OF AvKARE

Mfg. Rev. 4E L3772E         AV 04/14 (P)