Isosorbide Mononitrate (Nitrofix SR) 30mg Prolonged Release Tablet 100's

Product Description:

Isosorbide Mononitrate (Nitrofix SR) 30mg Prolonged Release Tablet is a medication used primarily in the management of heart conditions. The active ingredient, Isosorbide Mononitrate, is a type of nitrate that helps to dilate blood vessels, thus improving blood flow and reducing the heart's workload. This prolonged-release formulation ensures a slow and steady release of the active ingredient over time, offering prolonged action for effective management of angina (chest pain) and heart failure.

Each Nitrofix SR tablet contains 30 mg of Isosorbide Mononitrate and is designed for gradual absorption to maintain therapeutic levels in the body. The tablet is available in 100-tablet bottles.

Indications:

Isosorbide Mononitrate (Nitrofix SR) is primarily used in the treatment of conditions related to insufficient blood flow to the heart, including:

1. Angina Pectoris:

   • Used in the prevention and treatment of angina, a condition characterized by chest pain or discomfort caused by inadequate blood supply to the heart muscle.

2. Chronic Stable Angina:

   • Effective in controlling chronic, stable angina, particularly for patients who require a long-term treatment strategy to prevent episodes of chest pain.

3. Congestive Heart Failure (CHF):

   • Sometimes used as part of combination therapy to reduce the symptoms of heart failure by improving circulation and lowering the heart’s workload.

4. Hypertension (Off-label use):

   • In some cases, Isosorbide Mononitrate may be used as part of a regimen to lower blood pressure, though it is more commonly indicated for angina and heart failure.

Dosage:

The typical dosage for Isosorbide Mononitrate (Nitrofix SR) depends on the condition being treated and individual patient needs. It is important to follow the prescribed dosage and not adjust the dose without consulting a healthcare provider.

For Angina Pectoris:

• Initial dose: 30 mg once daily in the morning.

• The dosage may be increased based on the patient's response, typically up to 60 mg or 120 mg per day, taken once daily.

For Chronic Stable Angina:

• Initial dose: 30 mg once daily in the morning.

• Dosage may be adjusted depending on patient response and tolerance.

For Congestive Heart Failure:

• The dose can start at 30 mg daily and may be increased based on the patient's response, under the supervision of a healthcare provider.

Dosage Adjustments:

• Elderly patients or those with renal or hepatic impairment may require a reduced dose.

Tablets should be taken whole, not crushed or chewed, to maintain the prolonged-release effect.

Side Effects:

Common side effects associated with Isosorbide Mononitrate (Nitrofix SR) may include:

Common Side Effects:

• Headache (often the most common side effect due to vasodilation).

• Dizziness or light-headedness.

• Flushing (redness or warmth in the face).

• Nausea or vomiting.

• Fatigue or weakness.

• Low blood pressure (hypotension), especially after the first dose.

• Palpitations (feeling of a racing heart or irregular heartbeat).

Serious Side Effects:

• Severe hypotension (very low blood pressure), leading to dizziness, fainting, or shock.

• Severe allergic reactions, including rash, itching, or swelling of the face, lips, tongue, or throat (anaphylaxis).

• Chest pain or worsening of angina after taking the medication.

• Shortness of breath or swelling (signs of worsening heart failure).

• Blurring of vision or other visual disturbances.

Other Possible Side Effects:

• Tachycardia (rapid heartbeat).

• Dysphoria (feeling of unease or dissatisfaction).

• Gastrointestinal issues, including constipation or diarrhea.

• Sleep disturbances.

Contraindications:

Isosorbide Mononitrate (Nitrofix SR) is contraindicated in certain conditions. It should not be used in:

1. Hypersensitivity:

   • Known allergy to Isosorbide Mononitrate, nitrates, or any of the excipients in the formulation.

2. Severe Hypotension:

   • Should not be used in patients with severely low blood pressure (hypotension) or those who are at risk of experiencing shock.

3. Concurrent Use with Phosphodiesterase Type 5 Inhibitors (e.g., Sildenafil):

   • Isosorbide Mononitrate should not be used in combination with PDE-5 inhibitors (like Sildenafil, Vardenafil, Tadalafil) used for erectile dysfunction, as this can lead to severe hypotension.

4. Severe Anemia:

   • Contraindicated in patients with severe anemia or increased intracranial pressure due to the risk of worsening blood flow issues.

5. Acute Myocardial Infarction (MI):

   • Not recommended for acute MI, as it may cause an unstable blood pressure and inadequate perfusion.

6. Glaucoma (closed-angle):

   • Should be used with caution or avoided in patients with closed-angle glaucoma.

7. Severe Liver or Kidney Impairment:

   • Contraindicated in patients with severe liver or renal impairment due to reduced clearance of the drug.

Precautions:

• Tolerance: Prolonged use of nitrates like Isosorbide Mononitrate can lead to the development of nitrate tolerance. A nitrate-free interval (such as overnight) is recommended to reduce the risk of tolerance.

• Hypotension: Use cautiously in patients who may be at risk of low blood pressure (e.g., those with dehydration, heart failure, or on antihypertensive therapy). Monitor blood pressure regularly.

• Headache: Headaches are common, especially at the start of therapy. This is often a result of vasodilation and usually diminishes with continued use.

• Alcohol: Patients should avoid alcohol while taking Isosorbide Mononitrate, as it can enhance the blood pressure-lowering effects and increase the risk of hypotension.

• Pregnancy and Breastfeeding:

  • Pregnancy Category C: Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

  • Breastfeeding: Isosorbide Mononitrate is excreted in breast milk, so it should only be used during breastfeeding if absolutely necessary, and the potential risks should be discussed with a healthcare provider.

Drug Interactions:

Isosorbide Mononitrate (Nitrofix SR) may interact with several drugs:

1. Phosphodiesterase-5 inhibitors (PDE5 inhibitors):

   • Co-administration with Sildenafil, Tadalafil, or Vardenafil can cause severe hypotension due to the additive vasodilatory effects.

2. Antihypertensives:

   • Isosorbide Mononitrate may potentiate the blood-pressure-lowering effects of other antihypertensive drugs, leading to an increased risk of hypotension.

3. Alcohol:

   • Alcohol can enhance the blood pressure-lowering effect of Isosorbide Mononitrate, leading to an increased risk of hypotension.

4. Other Nitrates:

   • Should not be used concurrently with other nitrate medications due to the risk of excessive vasodilation and hypotension.

5. CYP450 Enzyme Inhibitors:

   • Drugs that inhibit CYP3A4, such as ketoconazole and itraconazole, may increase Isosorbide Mononitrate levels, increasing the risk of side effects.

Conclusion:

Isosorbide Mononitrate (Nitrofix SR) is an effective prolonged-release nitrate for the management of angina and heart failure. It works by relaxing blood vessels to improve blood flow and reduce the heart’s workload. While it is generally well-tolerated, patients should be cautious of potential side effects, especially headaches and hypotension. It is contraindicated in certain conditions such as severe hypotension, acute myocardial infarction, and concurrent use with PDE5 inhibitors. Always follow the prescribed dosage and consult a healthcare provider before starting therapy with Isosorbide Mononitrate.