Monotrate 12 HR TABLET (Isosorbide Mononitrate 12 HR TABLET)20mg – 200 tablet

Isosorbide Mononitrate Information

What is this drug used for?

• It is used to prevent chest pain.
• It may be given to you for other reasons. Talk with the doctor.

Possible side effects

Isosorbide Mononitrate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Dizziness.
• You may have headaches when you start taking this drug. Most of the time it gets better with time. Do not change how you use this drug to avoid these headaches. Talk with your doctor for ways to lessen this side effect.

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Fast or slow heartbeat.
• Chest pain that is new or worse.

Medication Safety Issues

Sound-alike/look-alike issues:

Storage and Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.

Adverse Reactions

>10%: Central nervous system: Headache (≤57%), dizziness (≤11%)

1% to 10%:

Cardiovascular: Abnormal heart sounds (≤5%), atrial arrhythmia (≤5%), atrial fibrillation (≤5%), bradycardia (≤5%), bundle branch block (≤5%), cardiac arrhythmia (≤5%), cardiac failure (≤5%), chest pain (≤5%), ECG abnormality (Q wave: ≤5%), edema (≤5%), exacerbation of angina pectoris (≤5%), extrasystoles (≤5%), flushing (≤5%), heart murmur (≤5%), hypertension (≤5%), hypotension (≤5%), intermittent claudication (≤5%), myocardial infarction (≤5%), palpitations (≤5%), tachycardia (≤5%), varicose veins (≤5%), ventricular tachycardia (≤5%), cardiovascular toxicity (2%)

Central nervous system: Anxiety (≤5%), confusion (≤5%), depression (≤5%), drowsiness (≤5%), fatigue (≤5%), hypoesthesia (≤5%), insomnia (≤5%), lack of concentration (≤5%), malaise (≤5%), migraine (≤5%), myasthenia (≤5%), nervousness (≤5%), neuritis (≤5%), nightmares (≤5%), paresis (≤5%), paresthesia (≤5%), rigors (≤5%), vertigo (≤5%), pain (4%), emotional lability (2%)

Dermatologic: Abnormal hair texture (≤5%), acne vulgaris (≤5%), diaphoresis (≤5%), leg ulcer (≤5%), pruritus (≤5%), skin rash (≤5%)

Endocrine & metabolic: Decreased libido (≤5%), hot flash (≤5%), hyperuricemia (≤5%), hypokalemia (≤5%)

Gastrointestinal: Abdominal pain (≤5%), constipation (≤5%), diarrhea (≤5%), dyspepsia (≤5%), flatulence (≤5%), gastric ulcer (≤5%), gastric ulcer with hemorrhage (≤5%), gastritis (≤5%), glossitis (≤5%), hemorrhoids (≤5%), loose stools (≤5%), melena (≤5%), nausea (≤5%), vomiting (≤5%), xerostomia (≤5%)

Genitourinary: Atrophic vaginitis (≤5%), impotence (≤5%), mastalgia (≤5%), urinary tract infection (≤5%)

Hematologic & oncologic: Hypochromic anemia (≤5%), nonthrombocytopenic purpura (≤5%), thrombocytopenia (≤5%)

Hepatic: Increased serum alanine aminotransferase (≤5%), increased serum aspartate aminotransferase (≤5%)

Hypersensitivity: Hypersensitivity reaction (2%)

Infection: Bacterial infection (≤5%), candidiasis (≤5%), viral infection (≤5%)

Neuromuscular & skeletal: Arthralgia (≤5%), asthenia (≤5%), back pain (≤5%), musculoskeletal pain (≤5%), myalgia (≤5%), myositis (≤5%), shoulder stiffness (frozen shoulder: ≤5%), tendon disease (≤5%), torticollis (≤5%), tremor (≤5%)

Ophthalmic: Blepharoptosis (≤5%), conjunctivitis (≤5%), photophobia (≤5%), visual disturbance (≤5%)

Otic: Otalgia (≤5%), perforated tympanic membrane (≤5%), tinnitus (≤5%)

Renal: Nephrolithiasis (≤5%), polyuria (≤5%)

Respiratory: Bronchitis (≤5%), bronchospasm (≤5%), cough (≤5%), dyspnea (≤5%), flu-like symptoms (≤5%), increased bronchial secretions (≤5%), nasal congestion (≤5%), pharyngitis (≤5%), pneumonia (≤5%), pulmonary infiltrates (≤5%), rales (≤5%), rhinitis (≤5%), sinusitis (≤5%), upper respiratory infection (1% to 4%), increased cough (2%)

Miscellaneous: Fever (≤5%), nodule (≤5%)

<1%, postmarketing, and/or case reports: Acute myocardial infarction, amblyopia, anorexia, asthma, bitter taste, cerebrovascular accident, increased thirst, muscle cramps, neck pain, pallor, prostatic disease, restlessness, syncope, weight loss