Angifix 20 Tablet

Isosorbide-5-mononitrate is an active metabolite of isosorbide dinitrate. It is a vasodilator with effects on both arteries and vein and also coronary vessels. It causes reduction of preload and afterload and redistributes coronary flow to ischemic regions.

Isosorbide mononitrate relaxes vascular smooth muscles by stimulating cyclic-GMP. It decreases left ventricular pressure (preload) and arterial resistance (afterload).

Uses

Isosorbide mononitrate tablets are used 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.
  • Long-term treatment of blood-flow disorders of the coronary vessels (coronary heart disease)
  • Long-term treatment and prophylaxis of angina pectoris (chest pain due to coronary blood-flow disorders of the coronary vessels).
  • Treatment of severe myocardial insufficiency (chronic heart failure)

Angifix 20 is also used to associated treatment for these conditions: Angina Pectoris

Trade Name Angifix 20
Generic Isosorbide Mononitrate
Other Names ISMN, Isosorbide 5-mononitrate, Isosorbide 5-nitrate, Isosorbide mononitrate, Isosorbidi mononitras, Mononitrate d'isosorbide, Mononitrato de isosorbida, Monosorbitrate
Weight 20mg
Type Tablet
Formula C6H9NO6
Weight Average: 191.1388
Monoisotopic: 191.042987025
Protein binding

Isosorbide mononitrate is about 5% bound to plasma proteins.

Therapeutic Class Nitrates: Coronary vasodilators
Manufacturer Incepta Pharmaceuticals Limited
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:21 am

Dosage

Angifix 20 dosage

The recommended regimen of Angifix 20 tablets is 20 mg (one tablet) twice daily, with the two doses given 7 hours apart. For most patients, this can be accomplished by taking the first dose on awakening and the second dose 7 hours later. Dosage adjustments are not necessary for elderly patients or patients with altered renal or hepatic function.

Multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The dosing regimen for Angifix 20 tablets provides a daily nitrate-free interval to avoid the development of this tolerance. Well-controlled studies have shown that tolerance to Angifix 20 tablets is avoided when using the twice-daily regimen in which the two doses are given 7 hours apart. This regimen has been shown to have antianginal efficacy beginning 1 hour after the first dose and lasting at least 5 hours after the second dose. The duration (if any) of antianginal activity beyond 12 hours has not been studied; large controlled studies with other nitrates suggest that no dosing regimen should be expected to provide more than about 12 hours of continuous antianginal efficacy per day.

In clinical trials, Angifix 20 tablets have been administered in a variety of regimens. Single doses less than 20 mg have not been adequately studied, while single doses greater than 20 mg have demonstrated no greater efficacy than doses of 20 mg.

Side Effects

Hypotension, tachycardia, flushing, headache, dizziness, palpitation, syncope, confusion. Nausea, vomiting, abdominal pain. Restlessness, weakness and vertigo. Dry mouth, chest pain, back pain, oedema, fatigue, abdominal pain, constipation, diarrhoea, dyspepsia and flatulence.

Precaution

Severe renal or severe hepatic impairment, hypothyroidism, malnutrition, or hypothermia. Caution in patients who are already hypotensive. May aggravate angina caused by hypertrophic cardiomyopathy. Tolerance may develop after long-term treatment. Lactation.

Interaction

Hypotensive effects may be increased when used with alcohol or vasodilators. Concurrent use with calcium channel blockers may lead to marked orthostatic hypotension.

Food Interaction

  • Take with or without food. The absorption is unaffected by food.

Volume of Distribution

The volume of distribution is approximately 0.6 L/kg, which is approximately the volume of total body water.

Half Life

The elimination half-life of isosorbide mononitrate is about 5 hours. The elimination half-life of its metabolites, isosorbide and 2-glucuronide of mononitrate, are 8 hours and 6 hours, respectively.

Clearance

The total body clearance is 115-120 mL/min.

Pregnancy & Breastfeeding use

There are no adequate and controlled studies to date with Isosorbide-5-mononitrate in pregnant women, and the drug should be used during pregnancy only when the potential benefit justified possible risks to the fetus. Execration of Isosorbide-5-mononitrate into human milk is unknown, so precaution should be taken when it is administered to a nursing mother.

Contraindication

It is contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

Acute Overdose

Symptoms : Most common symptoms are hypotension, throbbing headache, tachycardia, and flushing. Methemoglobinemia may occur with massive doses. 

Treatment: Treatment consists of placing patients in recumbent position and administering fluids; alpha-adrenergic vasopressors may be required. Methemoglobinemia should be treated with methyline blue at a dose of 1-2 mg/kg IV slowly.

Storage Condition

Store at 20-25° C.

Angifix 20 contains Isosorbide Mononitrate see full prescribing information from innovator Monograph