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Overview

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This medicine contains an important and useful components, as it consists of
Hydrocortisone, Coal taris available in the market in concentration

Name

Isosorbide Mononitrate

Precaution

Before using Isosorbide Mononitrate, patients should discuss their medical history and current health conditions with a healthcare provider to ensure its safe use. Isosorbide Mononitrate is a nitrate that helps in managing angina and heart failure by dilating blood vessels and reducing the heart's workload. - **Pregnancy and Breastfeeding**: - Isosorbide Mononitrate is classified as Category C for pregnancy, which means it can cause harm to a developing fetus, but it may be used when the benefits outweigh the risks. Its use during pregnancy should be carefully considered and prescribed only if necessary. - It is excreted into breast milk, but the effects on a nursing infant are not well established. Breastfeeding mothers should consult their healthcare provider before using this medication. - **Pre-existing Conditions**: - **Hypotension**: Isosorbide Mononitrate can cause significant drops in blood pressure, leading to dizziness or fainting. Caution is required for patients with low blood pressure or those on antihypertensive medications. - **Volume depletion**: Dehydration or low blood volume may increase the risk of hypotension with Isosorbide Mononitrate. - **Glaucoma**: Since nitrates can potentially raise intraocular pressure, patients with glaucoma should be monitored closely. - **Liver or Kidney Impairment**: Patients with liver or kidney problems should use Isosorbide Mononitrate with caution, as these organs are involved in the drug’s metabolism and elimination. Reduced doses may be necessary. - **Monitoring**: - Blood pressure should be monitored regularly, especially when initiating therapy or adjusting the dose. - Liver and kidney function should be assessed periodically in patients with known impairments.

Indication

Isosorbide Mononitrate is primarily indicated for the prevention and treatment of angina pectoris and in some cases for heart failure. It works by dilating blood vessels, easing the heart's workload, and improving oxygen delivery to the heart. - **Primary Indication**: - **Angina Pectoris**: Isosorbide Mononitrate is used to prevent chest pain (angina) associated with coronary artery disease. By relaxing and widening blood vessels, it reduces the strain on the heart and improves blood flow to the myocardium (heart muscle). - **Heart Failure**: In combination with other treatments, Isosorbide Mononitrate can help in managing heart failure by reducing preload and afterload, thus decreasing the heart’s workload. - **Off-label Uses**: - Isosorbide Mononitrate may be used in the treatment of pulmonary hypertension, though it is not its primary approved indication. - It may also be used in specific cases of esophageal spasm or as part of therapy for other vascular diseases, though these uses are less common and are based on clinical judgment.

Contra indication

Certain conditions should preclude the use of Isosorbide Mononitrate due to safety concerns. - **Absolute Contraindications**: - **Hypersensitivity**: Patients with known hypersensitivity or allergy to nitrates should avoid using Isosorbide Mononitrate. - **Severe Hypotension**: Isosorbide Mononitrate can significantly lower blood pressure. It should not be used in patients with severe hypotension or shock. - **Concurrent Use with PDE5 Inhibitors**: Using nitrates with phosphodiesterase type 5 (PDE5) inhibitors (such as sildenafil, tadalafil) can cause a dangerous, potentially life-threatening drop in blood pressure. These medications should not be taken together. - **Other Contraindications**: - **Right ventricular infarction**: Patients who have suffered a right-sided heart attack may experience worsened hemodynamics with the use of nitrates. - **Severe Anemia**: In cases of severe anemia, Isosorbide Mononitrate could exacerbate symptoms, as it reduces oxygen delivery to tissues.

Side Effect

Common side effects of Isosorbide Mononitrate are typically related to its vasodilatory effects, but more serious effects can occur, especially if the medication is not used properly. - **Common Side Effects**: - **Headaches**: One of the most common side effects due to the vasodilation of blood vessels, particularly in the head. - **Dizziness or lightheadedness**: Especially when standing up (orthostatic hypotension), this can lead to falls or fainting. - **Flushing**: A reddening of the skin, especially on the face, is a frequent vasodilatory side effect. - **Nausea or vomiting**: Gastrointestinal discomfort may occur, although this is less common. - **Serious Side Effects**: - **Severe hypotension**: This can lead to dizziness, syncope (fainting), or even shock. - **Reflex tachycardia**: The heart may respond to the lowered blood pressure by increasing the heart rate, which could worsen symptoms. - **Methemoglobinemia**: A rare but serious side effect where oxygen delivery to tissues is impaired. Symptoms include cyanosis (blue skin or lips) and difficulty breathing. - **Angina paradoxica**: A rare complication where chest pain becomes worse, indicating potential worsening of ischemia. - **Elevated intracranial pressure**: In patients with pre-existing conditions like head trauma or brain injury, nitrates may exacerbate pressure increases. - **Management of Side Effects**: - For headaches, over-the-counter analgesics like acetaminophen may provide relief. - Orthostatic hypotension can be managed by standing up slowly from a sitting or lying position. - Severe symptoms like methemoglobinemia or paradoxical angina require immediate medical attention.

Pregnancy Category ID

3

Mode of Action

Isosorbide Mononitrate is a nitrate that exerts its therapeutic effects primarily through the release of nitric oxide (NO), which leads to the relaxation of vascular smooth muscle and vasodilation. - **Mechanism of Action**: - After administration, Isosorbide Mononitrate is converted into nitric oxide, which stimulates the production of cyclic GMP (cGMP). This cascade of events causes smooth muscle relaxation and vasodilation. - **Primary Effects**: The primary effect is the dilation of the coronary arteries, improving blood flow to the heart, thereby reducing angina. - **Secondary Effects**: Isosorbide Mononitrate also causes the dilation of peripheral veins, which decreases venous return to the heart (preload) and reduces the heart’s workload. This is especially beneficial in patients with heart failure, as it decreases afterload and helps the heart pump more efficiently.

Interaction

Isosorbide Mononitrate may interact with a variety of other medications, foods, and substances, affecting its effectiveness and safety. - **Drug-Drug Interactions**: - **PDE5 Inhibitors**: Concomitant use with PDE5 inhibitors (e.g., sildenafil, tadalafil) can cause severe hypotension, dizziness, and fainting. These drugs should not be taken together under any circumstances. - **Other Antihypertensive Agents**: Isosorbide Mononitrate can enhance the blood pressure-lowering effects of other antihypertensive medications, including beta-blockers, calcium channel blockers, and ACE inhibitors. Close monitoring of blood pressure is required to avoid excessive hypotension. - **Alcohol**: Alcohol can potentiate the blood pressure-lowering effects of Isosorbide Mononitrate, increasing the risk of dizziness and fainting. Alcohol should be consumed with caution or avoided. - **Anticholinergics and Antipsychotics**: These may increase the risk of hypotension or exacerbate side effects when used in conjunction with Isosorbide Mononitrate. - **Ergotamines**: Used for migraine treatment, ergotamines can lead to severe vasoconstriction and should not be combined with nitrates like Isosorbide Mononitrate. - **Food Interactions**: - There are no significant food interactions with Isosorbide Mononitrate. However, taking it on an empty stomach may optimize its absorption.

Pregnancy Category Note

Information not available

Adult Dose

The dosing of Isosorbide Mononitrate depends on the condition being treated and the individual patient’s response. - **Angina Pectoris**: - **Immediate-release form**: Typically, 5-20 mg taken 2-3 times daily, with a maximum dose of 40 mg per dose. - **Extended-release form**: Starting at 30-60 mg once daily, with a maximum dose of 120 mg daily, depending on the patient's response. - The dose should be titrated upwards carefully to avoid excessive blood pressure drops. - **Heart Failure**: - It is usually combined with other medications, such as hydralazine, and dosed at 20-30 mg, 2-3 times per day, but the dose can be adjusted based on response. - **Titration and Maximum Doses**: - Dosing should be gradually adjusted, starting at lower doses and increasing as needed to minimize side effects. The maximum dose depends on the formulation and the individual’s tolerance to the drug.

Child Dose

Isosorbide Mononitrate is not typically used in pediatric populations, and its safety and efficacy in children have not been well established. - **Pediatric Use**: - The drug is generally not prescribed for children unless under strict medical supervision for specific conditions, such as congenital heart defects or pulmonary hypertension. - If used in children, dosing would be highly individualized, based on weight and response, and pediatric patients would require close monitoring for adverse effects like hypotension.

Renal Dose

Isosorbide Mononitrate is minimally cleared by the kidneys; however, caution should be exercised in patients with renal impairment, and dose adjustments may be needed. - **Renal Impairment Considerations**: - In patients with mild to moderate renal dysfunction, no significant dose adjustments are typically necessary. However, for patients with severe renal impairment (creatinine clearance <30 mL/min), reduced doses or close monitoring may be required. - Careful observation for hypotension and other side effects is essential in these patients.

Administration

Information not available