What is Isosorbide mono and how is it used?
Isosorbide mono is a prescription medicine used to treat the symptoms of chest pain. Isosorbide mono may be used alone or with other medications.
Isosorbide mono belongs to a class of drugs called Nitrates, Angina.
It is not known if Isosorbide mono is safe and effective in children.
What are side effects of Isosorbide mono?
Side effects of Isosorbide mono include:
- worsening chest pain,
- fast or slow heart rate, and
- pounding heartbeats or fluttering in your chest
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Isosorbide mono include:
- headache, and
- flushing (warmth, redness or tingly feeling)
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Isosorbide mono. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Isosorbide mono (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.
DOSAGE AND ADMINISTRATION
(SEE INDICATIONS AND USAGE)
The recommended regimen of Isosorbide mono (isosorbide mononitrate) 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. As noted above , multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The dosing regimen for Isosorbide mono (isosorbide mononitrate) tablets provides a daily nitrate-free interval to avoid the development of this tolerance. Well-controlled studies have shown that tolerance to Isosorbide mono (isosorbide mononitrate) 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, Isosorbide mono (isosorbide mononitrate) 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.
Store at 20 – 25° C (68 -77° F) [See USP Controlled Room Temperature]. Dispense in tight container.