ISOSORBIDE MONONITRATE, EXTENDED-RELEASE TABLETS USP, 30 mg, 60 mg, and 120 mg

/ISOSORBIDE MONONITRATE, EXTENDED-RELEASE TABLETS USP, 30 mg, 60 mg, and 120 mg
ISOSORBIDE MONONITRATE, EXTENDED-RELEASE TABLETS USP, 30 mg, 60 mg, and 120 mg2018-09-06T09:12:40+00:00

Prescription Drug Name:

ISOSORBIDE MONONITRATE, EXTENDED-RELEASE TABLETS USP, 30 mg, 60 mg, and 120 mg

ID:

48d78a2b-146d-4bf1-bbf0-924497fc09c5

Code:

34391-3

DESCRIPTION


id: a1c0e533-9733-417f-b78b-e59fcf57a360
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. Isosorbide Mononitrate Extended-Release Tablets, for oral administration, contain 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 and microcrystalline cellulose. The molecular formula of ISMN is C6H9NO6 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. USP dissolution test pending.

INDICATIONS AND USAGE


id: ffcdf7cd-cada-4e4b-af81-5b3758d51917
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: 6da871f6-3104-4134-b745-cd2a796734d4
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: 314a5cee-c804-480f-8772-df3434912de4
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Amplification of the vasodilatory effects of isosorbide mononitrate extended-release tablets 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: 73d45722-9dad-4e36-aba0-e804aa0b0d66
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 as 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 isosorbide mononitrate extended-release tablet treatment be initiated at low doses for several days before being increased to desired levels.

FREQUENCY AND ADVERSE EVENTS (DISCONTINUED)Some individuals discontinued for multiple reasons. 
 Three Controlled North American Studies
   Dose  Placebo  30 mg  60 mg  120 mgPatients were started on 60 mg and titrated to their final dose.   240 mg 
   Patients  96  60  102  65  65
   Headaches  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: eac2c7c0-c866-404b-9828-b9c018c9d636
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 ½ 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.

HOW SUPPLIED


id: a7a1fbcb-76eb-4175-8b5a-d80a107c428a
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Product: 63629-7477 NDC: 63629-7477-1 30 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-7477-2 18 TABLET, EXTENDED RELEASE in a BOTTLE

Isosorbide Mono. ER 120mg Tablet


id: a67bb138-cc5a-46ee-aad1-1955f1d57c81
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4