Healthy Inc > Blog > Isosorbide Mononitrate BP/USP/IP
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What is isosorbide mononitrate 10mg used for?

In the pharmaceutical industry, Isosorbide Mononitrate 10 mg is a standard-strength organic nitrate vasodilator. As a pharmacist and manufacturer, I characterize the 10 mg tablet as a critical “starting dose.” Because nitrates can cause significant initial headaches (due to rapid vasodilation), this lower strength is used to titrate the patient upward, allowing their vascular system to adapt before moving to the 20 mg or 40 mg maintenance doses.

Primary Clinical Uses

  • Prophylaxis of Angina Pectoris: Its primary role is the long-term prevention of chest pain caused by coronary artery disease.

  • Chronic Heart Failure: Used as an adjunctive treatment to reduce the workload on the heart, often in combination with other cardiovascular medications.

  • Maintenance Therapy: Unlike nitroglycerin, which is for acute attacks, the 10 mg mononitrate is taken on a regular schedule to provide a consistent “nitrate-rich” environment in the bloodstream.

Mechanism of Action: Vascular Relaxation

Isosorbide Mononitrate is the active metabolite of Isosorbide Dinitrate. It works by relaxing the smooth muscles of the blood vessels.

Nitric Oxide (NO) Release: The drug acts as a donor of nitric oxide.

cGMP Activation: NO stimulates the enzyme guanylate cyclase, increasing levels of cyclic guanosine monophosphate (cGMP).

Dilation: This biochemical cascade triggers the relaxation of veins and, to a lesser extent, arteries.

Preload Reduction: By dilating the veins, it reduces the volume of blood returning to the heart (preload), lowering the oxygen demand of the heart muscle and preventing the onset of angina.

The Manufacturer’s Perspective: Formulation & Export

From a production and global trade standpoint, Isosorbide Mononitrate 10 mg is a high-demand cardiovascular staple:

  • Avoidance of Nitrate Tolerance: As a pharmacist, you know that 24-hour nitrate exposure leads to “tolerance” (the drug stops working). As a manufacturer, we provide clinical dosing guidelines (the “asymmetric dosing” schedule) to ensure a 7-8 hour nitrate-free interval each day.

  • API Purity & Stability: We strictly follow BP/USP/IP monographs. Because nitrates are moisture-sensitive, we utilize Alu-Alu blister packaging to ensure a 36-month shelf life for export to Zone IVb regions (Africa, Southeast Asia).

  • B2B & Institutional Supply: This is a core product for cardiovascular clinics and government health tenders. Our Mumbai-based facility provides full CTD/eCTD Dossiers to support international registration against the innovator (Monoket or Ismo).

Isosorbide 5 mg Mononitrate 20 mg Tablets

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What is isosorbide 5 mononitrate 20 mg used for?

In the pharmaceutical industry, Isosorbide-5-Mononitrate (ISMN) 20 mg is a potent organic nitrate and the active metabolite of Isosorbide Dinitrate. As a pharmacist, I classify this as a “long-acting vasodilator.” Unlike nitroglycerin, which is used for emergency relief of a heart attack (acute angina), ISMN is used for daily maintenance to prevent chest pain from occurring.

Primary Clinical Uses

  • Prophylaxis of Angina Pectoris: It is primarily indicated for the long-term prevention of angina pectoris (chest pain) due to coronary artery disease.

  • Chronic Heart Failure: Often used as an adjunctive therapy (frequently in combination with hydralazine) to reduce the workload on the heart.

  • Vasodilation in Portal Hypertension: Occasionally used in specialized settings to reduce pressure in the portal vein.

Mechanism of Action: The Nitric Oxide Pathway

ISMN works by relaxing the smooth muscles of the blood vessels, particularly the veins.

Nitric Oxide Release: Once in the body, the nitrate group is converted into nitric oxide (NO).

cGMP Activation: NO stimulates the enzyme guanylate cyclase, which increases the levels of cyclic guanosine monophosphate (cGMP).

Vasodilation: Increased cGMP leads to the dephosphorylation of myosin light chains, causing the smooth muscle in blood vessels to relax.

Reduced Preload: By dilating the veins, it reduces the amount of blood returning to the heart (preload), which lowers the heart’s oxygen demand and prevents angina.

The Manufacturer’s Perspective: Formulation & Export

From a production and global trade standpoint, ISMN 20 mg is a high-demand cardiovascular product:

  • Avoidance of “Nitrate Tolerance”: A key technical challenge with nitrates is that the body can become “immune” to them if they are in the system 24/7. As a manufacturer, we design the dosing schedule (often “twice daily, 7 hours apart”) to allow for a “nitrate-free interval” to maintain efficacy.

    Sustained Release (SR) vs. Immediate Release: While 20 mg is often an immediate-release strength, we also manufacture SR/ER versions (30mg, 60mg). For your B2B marketplace, offering both formats is essential for capturing different international clinical preferences.

  • Stability for Global Trade: ISMN is relatively stable but sensitive to moisture. We utilize Alu-Alu blister packaging to ensure a 36-month shelf life for export to Zone IVb regions (Africa, SE Asia)

  • B2B & Dossier Support: Our Mumbai facility provides the necessary CTD/eCTD Dossiers to support international registration against the innovator (Imdur/Ismo).

Isosorbide 5 mg Mononitrate 20 mg Tablets

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