Ismo

Patients should be told that the antianginal efficacy of Ismo (isosorbide mononitrate) tablets can be maintained by carefully following the prescribed schedule of dosing (two doses taken 7 hours apart). For most patients, this can be accomplished by taking the first dose on awakening and the second dose 7 hours later. As with other nitrates, daily headaches sometimes accompany treatment with isosorbide mononitrate. In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with isosorbide mononitrate, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Aspirin and/or acetaminophen, on the other hand, often successfully relieve isosorbide mononitrate-induced headaches with no deleterious effect on isosorbide mononitrate's antianginal efficacy. Treatment with isosorbide mononitrate may be associated with lightheadedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.

Do not use isosorbide mononitrate if you are taking sildenafil (Viagra, Revatio). Serious, life-threatening side effects can occur if you take isosorbide mononitrate while you are using sildenafil.

You should not use this medication if you are allergic to isosorbide mononitrate, isosorbide dinitrate, (Isordil, Dilatrate, Isochron), or nitroglycerin, or if you have early signs of a heart attack (chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling).

Before taking isosorbide mononitrate, tell your doctor if you have congestive heart failure, low blood pressure, or kidney disease.

Isosorbide mononitrate can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use the medication. Do not stop taking isosorbide mononitrate. Ask your doctor before using any headache pain medication.

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

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

Do not stop taking isosorbide mononitrate suddenly. Stopping suddenly could cause a severe angina attack.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abnormal heart sound
• absence of or decrease in body movement
• arm, back, or jaw pain
• black, tarry stools
• bladder pain
• bleeding after defecation
• bleeding gums
• blood in the urine or stools
• blurred vision
• body aches or pain
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• chest tightness or heaviness
• chills
• cold sweats
• colds
• confusion
• convulsions
• cough or hoarseness
• decreased urine
• diarrhea
• difficult or labored breathing
• difficult, burning, or painful urination
• dilated neck veins
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• ear congestion
• extra heartbeats
• fainting
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• fever or chills
• flu-like symptoms
• frequent urge to urinate
• frequent urination
• general feeling of discomfort or illness
• headache
• headache, severe and throbbing
• heart murmur
• increased need to urinate
• increased sweating
• increased thirst
• increased volume of pale, dilute urine
• irregular breathing
• itching, pain, redness, or swelling on the leg
• joint pain, stiffness, or swelling
• lightheadedness
• loss of appetite
• loss of voice
• lower back, side, or stomach pain
• muscle aches and pains
• muscle cramps
• nasal congestion
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, back, or neck
• pain, tension, and weakness upon walking that subsides during periods of rest
• partial or slight paralysis
• passing urine more often
• pinpoint red or purple spots on the skin
• pounding in the ears
• runny nose
• shakiness in the legs, arms, hands, or feet
• shivering
• sneezing
• sore on the leg
• sore throat
• sudden decrease in the amount of urine
• sweating
• swelling
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• trembling or shaking of the hands or feet
• trouble sleeping
• troubled breathing
• uncomfortable swelling around the anus
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weakness
• weight gain

• Bluish-colored lips, fingernails, or palms
• dark urine
• pale skin
• rapid heart rate

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred or loss of vision
• bulging soft spot on the head of an infant
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• cold, clammy skin
• disturbed color perception
• double vision
• feeling of constant movement of self or surroundings
• halos around lights
• headache, severe and throbbing
• loss of consciousness
• night blindness
• overbright appearance of lights
• paralysis
• sensation of spinning
• tunnel vision

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• anxiety
• back pain
• belching
• blemishes on the skin
• bloated
• breast pain
• burning feeling in the chest or stomach
• burning, dry, or itching eyes
• change in color vision
• changes in vision
• cold sweats
• congestion
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• cough producing mucus
• decreased interest in sexual intercourse
• difficulty seeing at night
• difficulty with moving
• discharge, excessive tearing
• double vision
• drooping upper eyelids
• dull ache or feeling of pressure or heaviness in the legs
• earache
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• feeling of warmth
• feeling unusually cold
• frequent urge to defecate
• frozen shoulder
• full feeling
• hearing loss
• heartburn
• hyperventilation
• inability to have or keep an erection
• increased appetite
• increased sensitivity of the eyes to sunlight
• increased sputum
• indigestion
• irritability
• itching skin near damaged veins
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• muscle or bone pain
• muscle stiffness or weakness
• nightmares
• noisy breathing
• pain or tenderness around the eyes and cheekbones
• passing gas
• pimples
• poor concentration
• rash
• redness of the face, neck, arms, and occasionally, upper chest
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• redness, swelling, or soreness of the tongue
• restlessness
• seeing double
• sensation of spinning
• sleepiness or unusual drowsiness
• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
• small lumps under the skin
• sore mouth or tongue
• stiff neck
• stomach bloating, burning, cramping, or pain
• stomach discomfort or upset
• straining while passing stool
• stuffy nose
• sudden sweating
• swollen feet and ankles
• tender, swollen glands in the neck
• tenderness in the stomach area
• terrifying dreams causing sleep disturbances
• tooth disorder
• trouble swallowing
• uncontrolled twisting movements of the neck
• voice changes
• weight loss
• white patches in the mouth, tongue, or throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to isosorbide mononitrate or any other part of ISMO (isosorbide mononitrate tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking any of these drugs: Avanafil, riociguat, sildenafil, tadalafil, or vardenafil.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ISMO with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not stop taking ISMO all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ISMO, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ISMO. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using ISMO.

Review Date: October 4, 2017

Isosorbide mononitrate is 1,4:3,6-dianhydro-D-glucitol, 5-nitrate, an organic nitrate whose structural formula is:

and whose molecular weight is 191.14. The organic nitrates are vasodilators, active on both arteries and veins. Each Ismo® tablet contains 20 mg of isosorbide mononitrate. The inactive ingredients in each tablet are colloidal silicon dioxide, D&C Yellow 10 Aluminum Lake, FD&C Yellow 6 Aluminum Lake, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 20, povidone, sodium starch glycolate, titanium dioxide and hydroxypropyl cellulose.

The table below shows the frequencies of the adverse reactions observed in more than 1% of the subjects (a) in 6 placebo-controlled domestic studies in which patients in the active-treatment arm received 20 mg of isosorbide mononitrate twice daily, and (b) in all studies in which patients received isosorbide mononitrate in a variety of regimens. In parentheses, the same table shows the frequencies with which these adverse reactions led to discontinuation of treatment. Overall, 11% of the patients who received isosorbide mononitrate in the six controlled U.S. studies discontinued treatment because of adverse reactions. Most of these discontinued because of headache. “Dizziness” and nausea were also frequently associated with withdrawal from these studies.

Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were::

Cardiovascular: angina pectoris, arrhythmias, atrial fibrillation, hypotension, palpitations, postural hypotension, premature ventricular contractions, supraventricular tachycardia, syncope.

Dermatologic: pruritus, rash.

Gastrointestinal: abdominal pain, diarrhea, dyspepsia, tenesmus, tooth disorder, vomiting.

Genitourinary: dysuria, impotence, urinary frequency.

Miscellaneous: asthenia, blurred vision, cold sweat, diplopia, edema, malaise, neck stiffness, rigors.

Musculoskeletal: arthralgia.

Neurological: agitation, anxiey, confusion, dyscoordination, hypoesthesia, hypokinesia, increased appetite, insomnia, nervousness, nightmares.

Respiratory: bronchitis, pneumonia, upper-respiratory tract infection.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for futher discussion of its diagnosis and treatment see under OVERDOSAGE.

Applies to isosorbide mononitrate: oral tablet, oral tablet extended release

Along with its needed effects, isosorbide mononitrate (the active ingredient contained in Ismo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking isosorbide mononitrate:

• Abnormal heart sound
• absence of or decrease in body movement
• arm, back, or jaw pain
• black, tarry stools
• bladder pain
• bleeding after defecation
• bleeding gums
• blood in the urine or stools
• blurred vision
• body aches or pain
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• chest tightness or heaviness
• chills
• cold sweats
• colds
• confusion
• convulsions
• cough or hoarseness
• decreased urine
• diarrhea
• difficult or labored breathing
• difficult, burning, or painful urination
• dilated neck veins
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• ear congestion
• extra heartbeats
• fainting
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• fever or chills
• flu-like symptoms
• frequent urge to urinate
• frequent urination
• general feeling of discomfort or illness
• headache
• headache, severe and throbbing
• heart murmur
• increased need to urinate
• increased sweating
• increased thirst
• increased volume of pale, dilute urine
• irregular breathing
• itching, pain, redness, or swelling on the leg
• joint pain, stiffness, or swelling
• lightheadedness
• loss of appetite
• loss of voice
• lower back, side, or stomach pain
• muscle aches and pains
• muscle cramps
• nasal congestion
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, back, or neck
• pain, tension, and weakness upon walking that subsides during periods of rest
• partial or slight paralysis
• passing urine more often
• pinpoint red or purple spots on the skin
• pounding in the ears
• runny nose
• shakiness in the legs, arms, hands, or feet
• shivering
• sneezing
• sore on the leg
• sore throat
• sudden decrease in the amount of urine
• sweating
• swelling
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• trembling or shaking of the hands or feet
• trouble sleeping
• troubled breathing
• uncomfortable swelling around the anus
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weakness
• weight gain

• Bluish-colored lips, fingernails, or palms
• dark urine
• pale skin
• rapid heart rate

Get emergency help immediately if any of the following symptoms of overdose occur while taking isosorbide mononitrate:

• Blurred or loss of vision
• bulging soft spot on the head of an infant
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• cold, clammy skin
• disturbed color perception
• double vision
• feeling of constant movement of self or surroundings
• halos around lights
• headache, severe and throbbing
• loss of consciousness
• night blindness
• overbright appearance of lights
• paralysis
• sensation of spinning
• tunnel vision

Some side effects of isosorbide mononitrate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• anxiety
• back pain
• belching
• blemishes on the skin
• bloated
• breast pain
• burning feeling in the chest or stomach
• burning, dry, or itching eyes
• change in color vision
• changes in vision
• cold sweats
• congestion
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• cough producing mucus
• decreased interest in sexual intercourse
• difficulty seeing at night
• difficulty with moving
• discharge, excessive tearing
• double vision
• drooping upper eyelids
• dull ache or feeling of pressure or heaviness in the legs
• earache
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• feeling of warmth
• feeling unusually cold
• frequent urge to defecate
• frozen shoulder
• full feeling
• hearing loss
• heartburn
• hyperventilation
• inability to have or keep an erection
• increased appetite
• increased sensitivity of the eyes to sunlight
• increased sputum
• indigestion
• irritability
• itching skin near damaged veins
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• muscle or bone pain
• muscle stiffness or weakness
• nightmares
• noisy breathing
• pain or tenderness around the eyes and cheekbones
• passing gas
• pimples
• poor concentration
• rash
• redness of the face, neck, arms, and occasionally, upper chest
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• redness, swelling, or soreness of the tongue
• restlessness
• seeing double
• sensation of spinning
• sleepiness or unusual drowsiness
• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
• small lumps under the skin
• sore mouth or tongue
• stiff neck
• stomach bloating, burning, cramping, or pain
• stomach discomfort or upset
• straining while passing stool
• stuffy nose
• sudden sweating
• swollen feet and ankles
• tender, swollen glands in the neck
• tenderness in the stomach area
• terrifying dreams causing sleep disturbances
• tooth disorder
• trouble swallowing
• uncontrolled twisting movements of the neck
• voice changes
• weight loss
• white patches in the mouth, tongue, or throat

Applies to isosorbide mononitrate: oral tablet, oral tablet extended release

General

The most common adverse effects are headache and dizziness.[Ref]

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[Ref]

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[Ref]

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[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction[Ref]

Hematologic

Frequency not reported: Methemoglobinemia, thrombocytopenia, hypochromic anemia[Ref]

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[Ref]

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[Ref]

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[Ref]

Psychiatric

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

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[Ref]

Metabolic

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

Genitourinary

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

Ocular

Frequency not reported: Amblyopia, ptosis, conjunctivitis, photophobia, vision abnormal[Ref]

Immunologic

Frequency not reported: Bacterial infection, moniliasis, viral infection[Ref]

Hepatic

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

Endocrine

Frequency not reported: Pituitary hemorrhage[Ref]

Renal

Frequency not reported: Renal calculus[Ref]

Some side effects of Ismo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.