Isorey

Isorey

isosorbide dinitrate

Manufacturer:

Kwality Pharma

Distributor:

Pharma-Surrey

Marketer:

Pharma-Surrey
Concise Prescribing Info
Contents
Isosorbide dinitrate
Indications/Uses
Management & treatment of severe or unstable angina pectoris; left ventricular failure unresponsive to conventional therapy secondary to acute MI; left ventricular failure of various etiologies unresponsive to standard treatment; adjunctive use during percutaneous transluminal coronary angioplasty to facilitate prolonged balloon inflation & to prevent or relieve coronary spasm.
Dosage/Direction for Use
IV 2-12 mg/hr. Doses up to 20 mg/hr may be given & should be adjusted based on response. Intracoronary 1 mg as bolus inj before balloon inflation. Additional doses may be given if needed, but total should not exceed 5 mg w/in 30 min.
Contraindications
Hypersensitivity to isosorbide dinitrate, or other nitrates or nitrites. Must not be used in conditions associated w/ low filling pressure, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, or cardiogenic shock, unless measures are in place to maintain adequate diastolic pressure. Circulatory collapse, severe aortic or mitral valve stenosis, severe hypotension (systolic BP <90 mmHg), head trauma, cerebral hemorrhage, or diseases associated w/ increased ICP. Patients w/ marked anemia, hypovolemia, or closed-angle glaucoma. Concomitant use w/ phosphodiesterase-5 inhibitors (eg, sildenafil, tadalafil, vardenafil) or the soluble guanylate cyclase stimulator riociguat.
Special Precautions
Should not be given as a direct bolus inj, except via intracoronary route before balloon inflation. Caution in patients w/ hypothyroidism, hypothermia, malnutrition, severe liver or renal disease, & in those w/ orthostatic hypotension; hypoxemia or ventilation/perfusion imbalance due to lung disease or ischemic heart failure. Reports of development of tolerance (reduced efficacy) & cross-tolerance to other nitrate-type drugs; avoid continuously high doses to prevent decrease or loss of effect. Regularly monitor BP & pulse, & adjust dose according to clinical response. Avoid alcohol during treatment. Patients receiving maintenance therapy on isosorbide dinitrate must not use phosphodiesterase inhibitors (eg, sildenafil, tadalafil, vardenafil); do not interrupt therapy to take these products. Acute therapy w/ isosorbide dinitrate must not be administered to patients who have recently taken phosphodiesterase inhibitors (w/in 24 hr of sildenafil or vardenafil intake, or 48 hr of tadalafil intake). Use during pregnancy only if clearly necessary. Caution when administering to lactating women. Safety & efficacy have not yet been established in childn.
Adverse Reactions
Headache. Dizziness, somnolence; tachycardia; orthostatic hypotension; asthenia.
Drug Interactions
May lead to pronounced hypotension & potentially life-threatening CV events w/ phosphodiesterase-5 inhibitors (eg, sildenafil, tadalafil, vardenafil). Hypotensive effect may be potentiated by other BP-lowering drugs eg, β-blockers, Ca channel blockers, ACE inhibitors, vasodilators, MAOIs, neuroleptics, TCAs, or alcohol. May increase plasma conc of dihydroergotamine, potentially enhancing its hypertensive effects. Risk of pronounced hypotension w/ riociguat. Caution w/ agents that induce vasodilation via nitric oxide pathways, including classical NO donors eg, glycerol trinitrate, isosorbide dinitrate, or isosorbide 5-mononitrate.
MIMS Class
Anti-Anginal Drugs
ATC Classification
C01DA08 - isosorbide dinitrate ; Belongs to the class of organic nitrate vasodilators. Used in the treatment of cardiac disease.
Presentation/Packing
Form
Isorey 1 mg/mL (10 mg/10 mL) soln for IV infusion
Packing/Price
10 mL x 5 × 1's;10 mL x 10 × 1's