Monofast
Generic Name
Isosorbide Mononitrate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
monofast 5 mg tablet | ৳ 7.00 | ৳ 70.00 |
Description
Overview of the medicine
Monofast 5 mg tablet contains Isosorbide Mononitrate, a nitrate used for the prevention and long-term treatment of angina pectoris (chest pain) caused by coronary artery disease. It helps to widen blood vessels, allowing more blood and oxygen to reach the heart.
Uses & Indications
Dosage
Adults
Usually 5-20 mg twice daily, with the first dose in the morning and the second dose 7 hours later. This allows for a nitrate-free interval to prevent tolerance. Doses up to 40 mg twice daily may be used.
Elderly
No specific dose adjustment is usually required, but caution is advised due to potential for increased sensitivity.
Renal_impairment
No specific dose adjustment is generally needed, but monitor patients with severe renal impairment carefully.
How to Take
Take orally with or without food. Swallow the tablet whole with a glass of water. Do not chew or crush.
Mechanism of Action
Isosorbide Mononitrate is an organic nitrate that acts as a vasodilator. It is metabolized to nitric oxide (NO) which activates guanylyl cyclase, increasing cyclic GMP (cGMP) in smooth muscle cells. This leads to dephosphorylation of the myosin light chain and subsequent relaxation of vascular smooth muscle, resulting in venodilation and arterial dilation. Venodilation reduces preload (end-diastolic volume), and arterial dilation reduces afterload (systemic vascular resistance), both of which decrease myocardial oxygen demand. It also redistributes coronary blood flow to ischemic areas of the myocardium.
Pharmacokinetics
Onset
Onset of action typically within 20-60 minutes.
Excretion
Excreted mainly via the kidneys as metabolites, with less than 2% unchanged drug.
Half life
Approximately 4-5 hours.
Absorption
Rapid and complete oral absorption; bioavailability is nearly 100%.
Metabolism
Primarily hepatic metabolism via denitration and glucuronidation. No significant first-pass metabolism.
Side Effects
Contraindications
- Hypersensitivity to isosorbide mononitrate or any other nitrates
- Acute circulatory failure (shock, vascular collapse)
- Severe hypotension (systolic blood pressure less than 90 mmHg)
- Cardiogenic shock
- Hypertrophic obstructive cardiomyopathy
- Constrictive pericarditis
- Cardiac tamponade
- Severe anaemia
- Closed-angle glaucoma
- Concomitant use with phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil)
Drug Interactions
Dihydroergotamine
Nitrates may potentiate the hypertensive effects of dihydroergotamine.
PDE5 inhibitors (sildenafil, tadalafil)
Profound potentiation of the hypotensive effects of nitrates, leading to severe hypotension, syncope, or myocardial ischemia. Concomitant use is absolutely contraindicated.
Antihypertensives, beta-blockers, calcium channel blockers, diuretics, tricyclic antidepressants, major tranquilizers
May potentiate the hypotensive effects of isosorbide mononitrate.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension, persistent throbbing headache, flushing, palpitations, visual disturbances, dizziness, syncope, nausea, vomiting, diarrhoea, and methaemoglobinaemia (rare). Management involves supportive care, elevation of legs, intravenous fluids, and if necessary, alpha-adrenergic agonists (e.g., phenylephrine) to reverse hypotension. For severe methaemoglobinaemia, methylene blue may be administered.
Pregnancy & Lactation
Pregnancy Category C. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. It is unknown whether isosorbide mononitrate is excreted in human milk. Exercise caution when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to isosorbide mononitrate or any other nitrates
- Acute circulatory failure (shock, vascular collapse)
- Severe hypotension (systolic blood pressure less than 90 mmHg)
- Cardiogenic shock
- Hypertrophic obstructive cardiomyopathy
- Constrictive pericarditis
- Cardiac tamponade
- Severe anaemia
- Closed-angle glaucoma
- Concomitant use with phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil)
Drug Interactions
Dihydroergotamine
Nitrates may potentiate the hypertensive effects of dihydroergotamine.
PDE5 inhibitors (sildenafil, tadalafil)
Profound potentiation of the hypotensive effects of nitrates, leading to severe hypotension, syncope, or myocardial ischemia. Concomitant use is absolutely contraindicated.
Antihypertensives, beta-blockers, calcium channel blockers, diuretics, tricyclic antidepressants, major tranquilizers
May potentiate the hypotensive effects of isosorbide mononitrate.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension, persistent throbbing headache, flushing, palpitations, visual disturbances, dizziness, syncope, nausea, vomiting, diarrhoea, and methaemoglobinaemia (rare). Management involves supportive care, elevation of legs, intravenous fluids, and if necessary, alpha-adrenergic agonists (e.g., phenylephrine) to reverse hypotension. For severe methaemoglobinaemia, methylene blue may be administered.
Pregnancy & Lactation
Pregnancy Category C. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. It is unknown whether isosorbide mononitrate is excreted in human milk. Exercise caution when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Isosorbide mononitrate has been extensively studied in clinical trials demonstrating its efficacy and safety in the prophylaxis and long-term treatment of angina pectoris. Trials typically focus on dose-response, once-daily vs. twice-daily dosing to manage nitrate tolerance, and comparison with other anti-anginal agents.
Lab Monitoring
- Blood pressure monitoring (especially during initiation and dose titration)
- Heart rate monitoring
Doctor Notes
- Counsel patients on the importance of the nitrate-free interval to prevent tolerance.
- Emphasize the absolute contraindication with PDE5 inhibitors.
- Advise patients about potential headaches and how they usually subside with continued treatment.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking this medicine suddenly without consulting your doctor, as it may worsen your angina.
- Avoid alcohol while on this medication.
- Stand up slowly from a sitting or lying position to avoid dizziness.
- This medicine is for preventing angina attacks, not for treating acute attacks (use sublingual nitroglycerin for acute attacks).
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness or lightheadedness, especially at the start of treatment or after a dose increase. Avoid driving or operating machinery until you know how this medicine affects you.
Lifestyle Advice
- Adopt a heart-healthy diet low in saturated fats and cholesterol.
- Engage in regular physical activity as advised by your doctor.
- Quit smoking.
- Manage stress levels.
- Maintain a healthy weight.
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