Isosorbide Mononitrate

Name: Isosorbide Mononitrate

How supplied

Ismo (isosorbide mononitrate) tablets, 20 mg, are available in bottles of 100 (NDC 67857-702-01). Each orange, round, film-coated tablet is engraved "ISMO (isosorbide mononitrate) 20" on one side and scored on the reverse side.

Store at 20 - 25° C (68 -77° F) [See USP Controlled Room Temperature]. Dispense in tight container.

Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Manufactured for: Reddy Pharmaceuticals, LLC. Bridgewater, NJ 08807

Isosorbide Mononitrate Dosage

Take isosorbide mononitrate exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Isosorbide Mononitrate dose your doctor recommends will be based on the following (use any or all that apply):

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

Isosorbide Mononitrate is available in the following doses:

  • Isosorbide Mononitrate 10 Mg Oral Tablet
  • Isosorbide Mononitrate 120 Mg Oral Tablet, Extended Release
  • Isosorbide Mononitrate 20 Mg Oral Tablet
  • Isosorbide Mononitrate 30 Mg Oral Tablet, Extended Release
  • Isosorbide Mononitrate 60 Mg Oral Tablet, Extended Release

Side effects

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.

Frequency of Adverse Reactions (Discontinuations)*
  6 Controlled Studies 92 Clinical Studies
Dose Placebo 20 mg (varied)
Patients 204 219 3344
Headache 9% (0%) 38% (9%) 19% (4.3%)
Dizziness 1% (0%) 5% (1%) 3% (0.2%)
Nausea, Vomiting < 1% (0%) 4% (3%) 2% (0.2%)
*Some individuals discontinued for multiple reasons.

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.

Read the entire FDA prescribing information for Ismo (Isosorbide Mononitrate)

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Commonly used brand name(s)

In the U.S.

  • Imdur
  • Imdur ER
  • Ismo
  • Monoket

Available Dosage Forms:

  • Tablet, Extended Release
  • Tablet

Therapeutic Class: Antianginal

Chemical Class: Nitrate

isosorbide mononitrate Side Effects

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:

Less common
  • 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
Rare
  • 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:

Symptoms of overdose
  • 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:

Less common
  • 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.

Principal Display Panel - Bottle Label 30 mg 500 count

ZyGenerics

NDC 68382-650-05

Isosorbide Mononitrate

Extended-Release Tablets

30 mg

Rx only

500 Tablets

P10233

Rev: 02/15

Each tablet contains: Isosorbide Mononitrate ....30 mg

USUAL DOSAGE: See accompanying package outsert for full prescribing information.

Dispense in a tight container as defined in the USP/NF.

Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].

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

Manufactured by:

Nesher Pharmaceuticals USA LLC.

St. Louis, MO 63044

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Bottle Label 30 mg 500 count

Principal Display Panel - Bottle Label 60 mg 100 count

ZyGenerics

NDC 68382-651-01

Isosorbide Mononitrate

Extended-Release Tablets

60 mg

Rx only

100 Tablets

P10234

Rev: 02/15

Each tablet contains: Isosorbide Mononitrate ....60 mg

USUAL DOSAGE: See accompanying package outsert for full prescribing information.

Dispense in a tight container as defined in the USP/NF.

Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].

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

Manufactured by:

Nesher Pharmaceuticals USA LLC.

St. Louis, MO 63044

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Bottle Label 60 mg 100 count

Principal Display Panel - Bottle Label 60 mg 500 count

ZyGenerics

NDC 68382-651-05

Isosorbide Mononitrate

Extended-Release Tablets

60 mg

Rx only

500 Tablets

P10235

Rev: 02/15

Each tablet contains: Isosorbide Mononitrate ....60 mg

USUAL DOSAGE: See accompanying package outsert for full prescribing information.

Dispense in a tight container as defined in the USP/NF.

Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].

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

Manufactured by:

Nesher Pharmaceuticals USA LLC.

St. Louis, MO 63044

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Bottle Label 60 mg 500 count

Pharmacologic Category

  • Antianginal Agent
  • Vasodilator

Pharmacology

Nitroglycerin and other nitrates form free radical nitric oxide. In smooth muscle, nitric oxide activates guanylate cyclase which increases guanosine 3’5’ monophosphate (cGMP) leading to dephosphorylation of myosin light chains and smooth muscle relaxation. Produces a vasodilator effect on the peripheral veins and arteries with more prominent effects on the veins. Primarily reduces cardiac oxygen demand by decreasing preload (left ventricular end-diastolic pressure); may modestly reduce afterload; dilates coronary arteries and improves collateral flow to ischemic regions.

Absorption

Rapid and complete

Distribution

Vd: ~0.6 L/kg

Metabolism

Hepatic

Excretion

Predominantly urine (2% as unchanged drug); feces (1%)

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache. Have patient report immediately to prescriber angina, severe dizziness, passing out, bradycardia, or tachycardia (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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