Isosorbide mononitrate tablet

Home >> Products >> Taj Generics >>Metformin

Isosorbide mononitrate 20 mg oral tablet

GENERIC NAME: isosorbide mononitrate

Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

DRUG CLASS AND MECHANISM: Isosorbide mononitrate is in the class of drugs called nitrates that are used for treating and preventing angina. Other nitrates include nitroglycerin (Nitrostat, NitroQuick, Nitrolingual, Nitro-Dur and others) and isosorbide dinitrate (Isordil Titradose, Dilatrate-SR, Isochron). Nitrates are vasodilators (dilators of blood vessels). Blood returning from the body in the veins must be pumped by the heart through the lungs and into the body's arteries against the high pressure in the arteries. In order to accomplish this work, the heart's muscle must produce and use energy ("fuel") which requires oxygen brought to the heart by the blood.

Angina pectoris (angina) or "heart pain" is due to an inadequate flow of blood (and oxygen) to the muscle of the heart. Nitrates, including isosorbide mononitrate, correct the imbalance between the flow of blood and oxygen to the heart and the work that the heart must do by dilating the arteries and veins in the body. Dilation of the veins reduces the amount of blood that returns to the heart that must be pumped. Dilation of the arteries lowers the pressure in the arteries against which the heart must pump. As a consequence of both effects, the heart works less and requires less blood and oxygen.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Tablets (immediate release): 10, 20 mg. Tablets (extended release): 30, 60, 120 mg.

STORAGE: Isosorbide mononitrate should be stored at room temperature, 15-30 C (59-86 F) in a tight, moisture- proof container.

PRESCRIBED FOR: Isosorbide mononitrate is used for the treatment and prevention of angina. It can be used to decrease the frequency and severity of anginal (chest pain) episodes and to reduce the need for sublingual (under the tongue) nitroglycerin.

DOSING: The recommended dose of isosorbide mononitrate is 20 mg of immediate release tablets twice daily. The two doses should be administered 7 hours apart in order to avoid tolerance (decreased effect after several doses). The dose for extended release tablets is 30-240 mg once daily.

DRUG INTERACTIONS: Sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra) increase the blood pressure lowering effects of isosorbide mononitrate and may cause excessive reductions in blood pressure. Therefore, patients taking isosorbide mononitrate should not receive sildenafil, tadalafil or vardenafil.

Severe reductions in blood pressure, especially when changing posture (orthostatic hypotension), may occur when isosorbide mononitrate is combined with calcium channel blockers [for example, diltiazem (Cardizem, Dilacor, Tiazac and several others), verapamil (Calan, Verelan, Verelan PM, Isoptin, Isoptin SR, Covera-HS)], which also reduce blood pressure.

PREGNANCY: There are no adequate studies of isosorbide mononitrate in pregnant women.

NURSING MOTHERS: It is not known if isosorbide mononitrate is excreted in human breast-milk.

SIDE EFFECTS: Headaches are the most common side effect of isosorbide mononitrate and usually are dose related (increase with higher doses). Flushing may occur because isosorbide mononitrate dilates (enlarges) blood vessels. Isosorbide mononitrate may cause a severe drop in blood pressure when rising from a sitting position, causing dizziness, palpitations, and weakness. To reduce the risk of low blood pressure, patients should rise slowly from a sitting position.

USES: Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart.This medication will not relieve chest pain once it occurs. It is also not intended to be taken just before physical activities (such as exercise, sexual activity) to prevent chest pain. Other medications may be needed in these situations. Consult your doctor for more details.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This medication may also be used with other drugs to improve the symptoms of heart failure (such as trouble breathing).

HOW TO USE: Take this medication by mouth, usually twice daily or as directed by your doctor. Take the first dose of the day when you wake up, then take the second dose 7 hours later. It is important to take the drug at the same times each day. Do not change the dosing times unless directed by your doctor.Use this medication regularly to get the most benefit from it. Do not stop taking it without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Although unlikely, when this medication is used for a long time, it may not work as well and may require different dosing. Tell your doctor if this medication stops working well (for example, you have worsening chest pain or it occurs more often).

DOSAGE AND ADMINISTRATION: The recommended starting dose of Isosorbide mononitrate Tablets is 30 mg (given as a single 30-mg tablet or as ½ of a 60-mg tablet) or 60 mg (given as a single tablet) once daily. After several days, the dosage may be increased to 120 mg (given as a single 120-mg tablet or as two 60-mg tablets) once daily. Rarely, 240 mg may be required. The daily dose of IMDUR Tablets should be taken in the morning on arising. IMDUR Extended Release Tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid.

HOW SUPPLIED: Isosorbide mononitrate Extended Release Tablets
30 mg: rose-colored tablets, scored on both sides and branded with the tradename ("Isosorbide mononitrate ") on one side and the strength on the other.

Bottles of 100                                          NDC 0085-3306-03
Unit Dose 100 (10 × 10 blister strips)      NDC 0085-3306-01

60 mg: yellow-colored tablets, scored on both sides and branded with the tradename ("Isosorbide mononitrate ") on one side and the strength on the other.

Bottles of 100                                          NDC 0085-4110-03
Unit Dose 100 (10 × 10 blister strips)      NDC 0085-4110-01

120 mg: white-colored tablets, branded with the tradename ("Isosorbide mononitrate ") on one side and the strength on the other.

Bottles of 100                                          NDC 0085-1153-03
Unit Dose 100 (10 × 10 blister strips)      NDC 0085-1153-04

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]
***Protect unit dose from excessive moisture.