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Isopen-20

Isopen-20

isosorbide mononitrate

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Isosorbide 5-mononitrate
Indications/Uses
Long-term treatment of CHD. Pulmonary HTN. Chronic heart failure concomitantly treated w/ glycosides &/or diuretics. Prophylaxis of angina pectoris.
Dosage/Direction for Use
Initially ¼ (5 mg)-½ (10 mg) tab bid for 1st & 2nd day, then 1 tab bid for the next 2 days. Standard dose: 1 tab bid, if necessary, up to 1 tab tid. Prevent or minimize possible occurrence of headaches by slowly increasing dose at beginning of treatment.
Administration
May be taken with or without food: Swallow unchewed w/ plenty of fluid after meals. If required, take 1 tab before bedtime.
Contraindications
Hypersensitivity to isosorbide-5-mononitrate, other nitrates or nitrites. Concomitant use w/ phosphodiesterase-5 (PDE-5) inhibitors (sildenafil, tadalafil or vardenafil) or riociguat. Marked hypotension (systolic BP <90 mmHg), circulatory collapse, shock, MI w/ low ventricular filling pressure or cardiogenic shock unless sufficient end-diastolic pressure is maintained eg, use of +ve inotropic drugs or intraaortic balloon counterpulsation.
Special Precautions
Avoid use in hypertrophic cardiomyopathy w/ outflow tract obstruction; patients w/ marked bradycardia or tachycardia & right ventricular MI. Not recommended in patients w/ acute MI or heart failure. Hypotension or syncope &/or worsening of heart failure. Severe hypotension w/ paradoxical bradycardia & increased angina pectoris may occur. Severe postural hypotension w/ light-headedness & dizziness after alcohol consumption. Tolerance development & cross-tolerance w/ other nitrate compd. Methemoglobinemia w/ cyanosis, dyspnea & tachypnea in high doses; increased ICP w/ cerebral symptoms in very high doses. Avoid abrupt discontinuation. Observe primary symptoms of intoxication (headache, fall in BP w/ orthostatic hypotension & reflex tachycardia). Allow vol substitution in case of severe hypotension; sympathomimetics (eg, norepinephrine, dopamine) may be used in exceptional cases of severe intoxication. Pregnancy & lactation.
Adverse Reactions
Possible methemoglobin formation. Transient nitrate headache, nausea, vomiting, dizziness, orthostatic hypotension.
Drug Interactions
May enhance hypotensive effect of other vasodilators, antihypertensives (eg, ACE inhibitors, AIIA, β-blockers, Ca channel blockers, diuretics), neuroleptics, TCAs & alcohol. May enhance hypertensive effect (eg, increase standing systolic BP) of ergot derivatives. May enhance vasodilatory effect w/ phosphodiesterase-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil).
MIMS Class
Anti-Anginal Drugs
ATC Classification
C01DA14 - isosorbide mononitrate ; Belongs to the class of organic nitrate vasodilators. Used in the treatment of cardiac disease.
Presentation/Packing
Form
Isopen-20 tab 20 mg
Packing/Price
10 × 10's
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