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04-17-2015, 12:30 AM
ISOSORBIDE-5-NITRATE 100 MG


What is isosorbide mononitrate?

Isosorbide mononitrate is in a group of drugs called nitrates. It dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Isosorbide mononitrate is used to prevent angina attacks (chest pain).

Isosorbide mononitrate will not treat an angina attack that has already begun.

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Before taking this medicine

Do not use isosorbide mononitrate if you are taking medicine to treat erectile dysfunction or pulmonary arterial hypertension (PAH). This includes sildenafil (Viagra, Revatio), avanafil (Stendra), tadalafil (Cialis, Adcirca), vardenafil (Levitra, Staxyn), and riociguat (Adempas). Serious, life-threatening side effects may occur.

You should not use this medicine if:

you are allergic to isosorbide mononitrate, isosorbide dinitrate, or nitroglycerin; or
you have early signs of a heart attack (chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating).
To make sure this medicine is safe for you, tell your doctor if you have:

congestive heart failure;
low blood pressure; or
kidney disease (or if you are on dialysis);
if you take a diuretic or "water pill"; or
if you are on a low salt diet.
FDA pregnancy category C. It is not known whether isosorbide mononitrate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.


It is not known whether isosorbide mononitrate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take isosorbide mononitrate?

Take isosorbide mononitrate exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Not all brands and forms of isosorbide mononitrate are taken the same number of times per day. You may need to take the medicine only once daily, in the morning after getting out of bed. Or you may need a second dose later in the day. Follow your doctor's dosing instructions very carefully.

If possible, try to rest or stay seated when you use this medicine. Isosorbide mononitrate can cause dizziness or fainting.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. Prolonged illness can lead to a serious electrolyte imbalance, making it dangerous for you to use isosorbide mononitrate.

Use isosorbide mononitrate regularly to prevent an angina attack. Get your prescription refilled before you run out of medicine completely.

You should not stop using this medicine suddenly if you take this medicine to prevent angina. Stopping suddenly may cause you to have a severe attack of angina.

Do not change brands of isosorbide mononitrate without the approval of your doctor.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.


Side Effects:

General

The most common adverse effects are headache and dizziness.

Nervous system

Very common (10% or more): Headache (up to 57%), dizziness (up to 11%)
Common (1% to 10%): Light-headedness
Frequency not reported: Bitter taste, paresthesia, impaired concentration, tremor, hypoesthesia, migraine, neuritis, paresis, somnolence, fainting, drowsiness
Postmarketing reports: Syncope

Cardiovascular

Common (1% to 10%): Cardiovascular disorder, flushing, hypotension
Frequency not reported: Acute myocardial infarction, apoplexy, arrhythmias, bradycardia, edema, hypertension, pallor, palpitations, tachycardia, hot flushes, cardiac failure, arrhythmia, arrhythmia atrial, atrial fibrillation, bundle branch block, extrasystole, ventricular tachycardia, angina pectoris aggravated, heart murmur, heart sound abnormal, myocardial infarction, Q wave abnormality, intermittent claudication, varicose vein, reflex tachycardia, collapse, bradyarrhythmia, paroxysmal bradycardia, orthostatic hypotension

Gastrointestinal

Common (1% to 10%): Nausea, abdominal pain, diarrhea, gastrointestinal disturbances
Frequency not reported: Dry mouth, dyspepsia, vomiting, constipation, flatulence, gastric ulcer, gastritis, glossitis, hemorrhagic gastric ulcer, hemorrhoids, loose stools, melena, heartburn

Hypersensitivity

Common (1% to 10%): Allergic reaction

Hematologic

Frequency not reported: Methemoglobinemia, thrombocytopenia, hypochromic anemia

Other

Common (1% to 10%): Fatigue, pain, chest pain, tiredness
Frequency not reported: Susurrus aurium, vertigo, asthenia, fever, flu-like symptoms, malaise, rigors, earache, tinnitus, tympanic membrane perforation, breast pain, feeling of weakness

Respiratory

Common (1% to 10%): Upper respiratory infection, increased cough
Frequency not reported: Asthma, dyspnea, sinusitis, bronchitis, bronchospasm, coughing, increased sputum, nasal congestion, pharyngitis, pneumonia, pulmonary infiltration, rales, rhinitis, hypoxia

Dermatologic

Common (1% to 10%): Rash, pruritus
Frequency not reported: Sweating, purpura, acne, hair texture abnormal, increased sweating, skin nodule, leg ulcer, exfoliative dermatitis, excessive perspiration, allergic dermatitis, hyperhidrosis

Psychiatric

Common (1% to 10%): Emotional lability, sleep disturbances
Frequency not reported: Anxiety, depression, insomnia, nervousness, nightmares, restlessness, confusion, decreased libido, paroniria

Musculoskeletal

Very rare (less than 0.01%): Myalgia
Frequency not reported: Back pain, muscle cramps, neck pain, arthralgia, frozen shoulder, muscle weakness, musculoskeletal pain, myositis, tendon disorder, torticollis

Metabolic

Frequency not reported: Anorexia, thirst, decreased weight, hyperuricemia, hypokalemia, poor appetite

Genitourinary

Frequency not reported: Prostatic disorder, impotence, atrophic vaginitis, polyuria, urinary tract infection

Ocular

Frequency not reported: Amblyopia, ptosis, conjunctivitis, photophobia, vision abnormal

Immunologic

Frequency not reported: Bacterial infection, moniliasis, viral infection

Hepatic

Frequency not reported: Serum glutamic oxaloacetic transaminase (SGOT) increased, serum glutamate-pyruvate transaminase (SGPT) increased

Endocrine

Frequency not reported: Pituitary hemorrhage

Renal

Frequency not reported: Renal calculus