Isosorbide Mononitrate

Isosorbide mononitrate is a prescription drug 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.
• Isosorbide mononitrate is available under the following different brand names: Imdur, Monoket, and ISMO.

Adult and Pediatric Dosages:

Tablets

• 10 mg
• 20 mg

Tablets, extended-release

• 30 mg
• 60 mg
• 120 mg

Dosage Considerations – Should be Given as Follows:

Angina Pectoris

Adult Dosage:

• Prevention of angina pectoris caused by coronary artery disease
• Immediate release: 5-10 mg orally twice daily initially (5 mg in small patients) given each dose 7 hours apart; increased to 10 mg orally every 12 hours by day 2 or 3; maintenance: 20 mg orally every 12 hours
• Extended-release: 30-60 mg orally once daily in the morning initially; may be increased to 120 mg orally once daily; wait at least 3 days between increases; if warranted may increase up to 240 mg orally once daily (rare)
• Geriatric:
  • Start with the lowest recommended adult dosage

Dosing considerations

• Take on an empty stomach, 30 minutes before meals or 1 hour after a meal
• Take on an empty stomach, 30 minutes before or 1 hour after a meal
• Extended-release tablet should be swallowed whole; must not be chewed, crushed, or split

Pediatric

• Safety and efficacy not established

Common side effects of isosorbide include:

• abdominal pain
• abnormal hair texture
• abnormal heart rhythm
• the abnormal large volume of urine
• abnormal neck position
• abnormal vision
• acne
• aggravated chest pain
• anxiety
• back pain
• bacterial infection
• blood disorder (methemoglobinemia)
• breast pain
• bronchitis
• bundle branch block
• cardiac failure
• chest pain
• confusion
• constipation
• coughing
• dark stools containing blood
• decreased sex drive
• depression
• diarrhea
• dizziness
• dizziness upon standing
• drooping eyelid
• dry mouth
• earache
• morbid dreams or nightmares
• excess uric acid
• fainting
• fast heart rate
• fatigue
• feeling unwell
• fever
• flu-like symptoms
• flushing
• frozen shoulder
• gas (flatulence)
• headache
• heart attack (myocardial infarction)
• heart murmur
• heart sound abnormal
• hemorrhoids
• high blood pressure (hypertension)
• impaired concentration
• inability to have an erection or orgasm
• increased sputum
• increased sweating
• infection of the lungs
• inflammation of nerves
• inflammation of the stomach
• inflammation of the throat
• insomnia
• intermittent claudication
• irregular, rapid heart rate
• joint pain
• kidney stones
• leg wound
• loose stools
• low blood potassium levels
• low blood pressure (hypotension)
• migraine
• muscle inflammation
• muscle weakness
• musculoskeletal pain
• nasal congestion
• nausea
• nervousness
• numbness and tingling
• pale red blood cells
• palpitations
• pink eye
• platelet deficiency in the blood
• pneumonia
• Q wave abnormality
• rash
• rattling sound when you breathe
• red or purple spots on the skin
• reduced sense of touch
• restlessness
• ringing in the ears
• ruptured eardrum
• sensitivity to light
• severe itching
• SGOT increase
• SGPT increase
• shaking
• shaking or shivering
• shortness of breath
• sinus infection
• skin nodule
• sleepiness
• spinning sensation (vertigo)
• stomach ulcer
• stuffy or runny nose
• sudden difficulty breathing
• swelling
• swollen tongue
• tendon disorder
• urinary tract infection
• vaginal inflammation
• varicose veins
• viral infection
• vomiting
• weakness
• yeast infection

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe interactions of isosorbide mononitrate include:
  • avanafil
  • riociguat
  • sildenafil
  • tadalafil
  • vardenafil
• Serious interactions of isosorbide mononitrate include:
  • cabergoline
  • ergoloid mesylates
  • ergonovine
  • ergotamine
  • idelalisib
  • ivacaftor
  • methylergonovine
• Moderate interactions of isosorbide mononitrate include:
  • arginine
  • captopril
  • crofelemer
  • dabrafenib
  • dapsone topical
  • dichlorphenamide
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • iloperidone
  • maraviroc
  • mitotane
  • nitroglycerin (rectal)
  • tetracaine
• Mild interactions of isosorbide mononitrate include:
  • acetylcysteine
  • acetylcysteine (antidote

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

This medication contains isosorbide mononitrate. Do not take Imdur, Monoket, or ISMO if you are allergic to isosorbide mononitrate or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to organic nitrates
• PDE-5 inhibitors (avanafil, sildenafil, tadalafil, or vardenafil); concomitant use can cause severe hypotension, syncope, or myocardial ischemia
• Concomitant administration with guanylate stimulator riociguat (may cause hypotension)

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Isosorbide?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Isosorbide?"

Cautions

• Use caution in acute myocardial infarction, alcohol use, hyperthyroidism, hypertrophic cardiomyopathy, increased intracranial pressure (from head trauma or cerebral hemorrhage; potential contraindication), increased intraocular pressure, postural hypotension, volume depletion, congestive heart failure, and low systolic blood pressure
• Do not change brands unintentionally; formulations are not all bioequivalent
• Treat drug-induced headache with aspirin or acetaminophen
• Provide nitrate-free intervals (10-12 hours or overnight) to prevent the development of tolerance
• Avoid excessive, prolonged hypotension
• Withdraw gradually to prevent acute angina
• Discontinue if blurred vision develops
• Use supportive treatment to manage overdose
• Narrow-angle glaucoma (controversial: may not be clinically significant)

Pregnancy and Lactation

• Use isosorbide mononitrate during pregnancy with caution if benefits outweigh risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• Use isosorbide mononitrate with caution when breastfeeding, as it is unknown if isosorbide mononitrate crosses into breast milk.