Adult: As 0.5 mg/mL or 0.05% solution: To facilitate prolonged balloon inflation and to prevent or relieve coronary spasm: 1 mg via bolus inj before balloon inflation; may give additional doses up to a Max of 5 mg within a 30-minute period. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Intravenous Left ventricular failure
Adult: For the treatment of unresponsive cases secondary to acute MI or of various aetiology: 2-12 mg per hour, may be titrated up to 20 mg per hour according to patient response.
Intravenous Angina pectoris
Adult: For the treatment of severe or unstable angina pectoris: 2-12 mg per hour, may be titrated up to 20 mg per hour according to patient response.
Oral Congestive heart failure
Adult: As conventional tab: 40-160 mg daily in divided doses, adjust dose according to patient response. Max: 240 mg daily in divided doses. Dosage recommendations may vary among countries and between individual products (refer to specific product guidelines).
Oral Angina pectoris
Adult: As prophylaxis and treatment: As conventional tab: 20-120 mg daily in divided doses, adjust dose according to patient response. Max: 240 mg daily in divided doses. Alternative dosage regimen for prophylaxis: Initially, 5-20 mg bid or tid. Maintenance: 10-40 mg bid or tid. Daily dose-free interval of at least 14 hours is recommended after the evening and morning doses to minimise the risk of tolerance. Dosage recommendations may vary among countries and between individual products (refer to specific product guidelines).
Sublingual Congestive heart failure
Adult: For acute and chronic cases: 5-10 mg every 2 hours or as required. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Sublingual Angina pectoris
Adult: As prophylaxis and treatment: 5-10 mg every 2-3 hours. Supplemental doses of 5-10 mg may be given before activities that may provoke an angina attack. Dosage and recommendations may vary among countries and between individual products (refer to specific product guidelines).
What are the brands available for Isosorbide dinitrate in Malaysia?
Isosorbide dinitrate Should be taken on an empty stomach. SL tab: Do not chew/crush.
Reconstitution
IV/Intracoronary: Concentrated solution containing 1 mg/mL must be diluted with a compatible solution to make a concentration of 0.5 mg/mL prior to administration.
Incompatibility
IV inj: Avoid use of polyvinyl chloride (PVC) and polyurethane (PU) sets and containers.
Contraindications
Hypertrophic obstructive cardiomyopathy, severe hypotension, low cardiac filling pressures, cardiac tamponade, constrictive pericarditis, aortic or mitral valve stenosis, acute circulatory failure (e.g. shock, vascular collapse), diseases associated with raised intracranial pressure (e.g. following a head trauma, cerebral haemorrhage), marked anaemia, hypovolaemia. Concomitant use with phosphodiesterase 5 (PDE5) inhibitors (e.g. sildenafil, vardenafil, tadalafil) and riociguat.
Special Precautions
Patient with hypothyroidism, hypothermia, angle closure glaucoma, malnutrition, hypoxaemia, ventilation or perfusion imbalance due to lung disease or ischaemic heart failure, orthostatic syndrome. Avoid abrupt withdrawal. Severe renal and hepatic impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Severe hypotension or hypotension accompanied by paradoxical bradycardia and increased angina; postural or orthostatic hypotension, syncope; precipitate or aggravate increased intracranial pressure; tolerance and cross-tolerance to other nitrates. Cardiac disorders: Palpitations, tachycardia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea. General disorders and administration site conditions: Fatigue, asthenia. Nervous system disorders: Headache, dizziness, drowsiness. Vascular disorders: Flushing.
This drug may cause headache, dizziness or tiredness, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor blood pressure and heart rate.
Overdosage
Symptoms: Headache, dizziness hypotension (≤90 mmHg), syncope, nausea, vomiting, diarrhoea pallor, sweating, tachycardia, weak pulse, asthenia, increased intracranial pressure; methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness, and cardiac arrest may also occur. Management: Symptomatic and supportive treatment. Perform gastric lavage and supply oxygen with assisted respiration as necessary. In case of hypotension, the patient must be kept in a horizontal position with raised legs or lowered head, and plasma volume expanders (e.g. IV fluids) may be administered. In patients who do not respond to adequate fluid resuscitation, vasopressors may be used. For the treatment of methaemoglobinaemia, initiate artificial ventilation and administration of oxygen and reduction therapy with vitamin C, methythioninium chloride, or tolunium chloride. Initiate immediate resuscitation measures in case of respiratory and circulatory arrest.
Drug Interactions
Increased hypotensive effects with blood pressure lowering drugs (e.g. β-blockers, calcium channel blockers, vasodilators, alprostadil, aldesleukin, ACE inhibitors, ARBs), neuroleptics or TCAs. Concurrent administration with ACE inhibitors may cause symptoms of circulatory collapse. May act as a physiological antagonist to norepinephrine, acetylcholine, histamine, and other agents. Potentially Fatal: Increased risk of severe hypotension, syncope, or myocardial ischaemia with phosphodiesterase type-5 inhibitors (e.g. sildenafil, tadalafil, vardenafil). Increased risk of hypotension with riociguat.
Food Interaction
Increased hypotensive effects with alcohol.
Action
Description: Mechanism of Action: Isosorbide dinitrate is an organic nitrate vasodilator. It forms the free radical nitric oxide, which stimulates guanylate cyclase, increasing guanosine 3'5' monophosphate (cGMP), thus relaxing the vascular smooth muscles and consequently causing dilatation of peripheral arteries and veins. Dilatation of the veins promotes peripheral pooling of blood and reduces venous return to the heart, thereby decreasing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload), while arteriolar relaxation decreases systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Onset: Anti-anginal: Approx 2-5 minutes (sublingual); approx 1 hour (oral). Duration: Anti-anginal: 1-2 hours (sublingual); 4-6 hours (oral). Pharmacokinetics: Absorption: Readily absorbed from the oral mucosa (sublingual) and the gastrointestinal tract (oral). Bioavailability: 10-90% (highly variable; increases with chronic therapy). Distribution: Widely distributed. Volume of distribution: 2-4 L/kg. Metabolism: Rapidly metabolised in the liver into isosorbide 2-mononitrate and isosorbide 5-mononitrate (major active metabolites); undergoes extensive first-pass metabolism. Excretion: Elimination half-life: Approx 1 hour (isosorbide dinitrate); 5 hours (isosorbide 5-mononitrate); 2 hours (isosorbide 2-mononitrate).
Chemical Structure
Isosorbide dinitrate Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6883, Isosorbide Dinitrate. https://pubchem.ncbi.nlm.nih.gov/compound/Isosorbide-Dinitrate. Accessed Aug. 26, 2025.
Storage
Tab: Store between 15-30°C. IV inj: Store below 30°C. Once opened or diluted, use immediately or may store between 2-8°C for 24 hours. Storage recommendations may vary among countries and individual products. Refer to detailed product guidelines.
C01DA08 - isosorbide dinitrate ; Belongs to the class of organic nitrate vasodilators. Used in the treatment of cardiac disease. C05AE02 - isosorbide dinitrate ; Belongs to the class of muscle relaxants. Used in the topical treatment for the treatment of hemorrhoids and anal fissures.
References
AA-ISDN Tablet 10 mg (Pharmaforte [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/08/2025.Brayfield A, Cadart C (eds). Isosorbide Dinitrate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/08/2025.Isoket Ampoule 10 mg/10 mL (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/08/2025.Isordil 5 mg Sublingual Tablet and 10 mg Oral Tablet (Pfizer, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 19/08/2025.Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion (Torbay Pharmaceuticals Limited). MHRA. https://products.mhra.gov.uk. Accessed 07/08/2025.Isosorbide Dinitrate Tablet (Northstar Rx LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/08/2025.Isosorbide Dinitrate Tablets 20 mg (Chemidex Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 07/08/2025.Isosorbide Dinitrate Tablets BP 20 mg (Accord-UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 07/08/2025.Isosorbide Dinitrate, Isosorbide Mononitrate. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 07/08/2025.Isosorbide Dinitrate. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 07/08/2025.Joint Formulary Committee. Isosorbide Dinitrate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/08/2025.Solbid 10 mg Tablet (SM Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/08/2025.
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