Consumer medicine information

Isordil Sublingual Tablets

Isosorbide dinitrate

BRAND INFORMATION

Brand name

Isordil

Active ingredient

Isosorbide dinitrate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Isordil Sublingual Tablets.

What Isordil is used for

Isordil Sublingual tablets are for the prevention and treatment of attacks of angina. It will not reduce the pain of an angina attack, but when taken regularly may prevent an attack from occurring

Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms, neck and sometimes to the shoulders and back. The pain may be caused by too little blood and oxygen getting to the heart.

Isordil belongs to a group of medicines called nitrates. Isordil works by opening up blood vessels which allows more blood and oxygen to reach the heart.

Isordil may also be helpful in the treatment of some types of heart failure.

Your doctor may have prescribed Isordil for another purpose.

Ask your doctor if you have any questions why Isordil has been prescribed for you.

There is no evidence that Isordil is addictive.

Before you use it

When you must not use it

  1. If you have allergies to:
  • Isordil
  • any medication or food containing nitrates or nitrites
  • any ingredients listed at the end of this leaflet
Symptoms of an allergic reaction may include skin rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing, hay fever, and feeling faint.
  1. If you have any of the following medical conditions:
  • you suffer from certain types of heart or vascular disease (your doctor will advise you if this applies)
  • you have very low blood pressure
  • you have anaemia
  • you are pregnant or breastfeeding, unless your doctor advised that you can use Isordil. Ask your doctor about the risks or benefits involved
  1. Do not use Isordil after the expiry date (Exp) printed on the pack.
  2. Do not take it if the package shows any sign of tampering.
  3. Isordil is not recommended for use in children (your doctor will advise you if this applies).

Before you start to use Isordil

See your doctor for a check-up before you start to use Isordil. You must tell your doctor if you are taking any other medicines, including any medicines that you have bought from a pharmacy or supermarket

Tell your doctor if you have any of the following conditions

  • heart, liver or kidney disease
  • blood disorders or hardening of the arteries
  • low blood pressure
  • if you have recently had a heart attack, stroke or head injury
  • hypothyroidism, hypothermia, malnutrition or angle closure glaucoma
  • other medical conditions

Tell your doctor or pharmacist if you take any other medicines, including any of the following:

  • medications for high blood pressure and other heart medications
  • tranquillisers/sedatives
  • medications for arthritis
  • medications for depression

These medicines may affect the way Isordil works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

Do not start to take any other medicine unless prescribed or approved by your doctor.

This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.

How to use it

Isordil Sublingual tablets are for the relief of an anginal attack.

How to take Isordil

At the first signs of an anginal attack, place one or two tablets under your tongue. If your angina is not relieved after taking these tablets you should call your doctor or nearest hospital immediately.

Your may doctor may recommend a different dose for you.

Follow your doctor’s instructions if they are different from these.

Swallow the tablets with a glass of water.

Take this medicine exactly as directed by your doctor.

Elderly patients may need a lower dose.

If you forget to take Isordil

If you should be taking your next dose within 2 hours, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take Isordil as soon as you remember, and then go back to take it as you would normally.

Do not try to make up for the dose that you missed by taking more than one dose at a time.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

Overdose

Immediately telephone your doctor or Poisons Information Centre (Phone 13 11 26) for advice or go to Casualty of your nearest hospital if you think that you or anyone else may have taken too much Isordil, even if there are no signs of discomfort or poisoning. Keep the telephone number for these places handy whilst taking any medications.

If you take too many Isordil tablets, you may experience a headache, become flushed, experience cold sweats, nausea, vomiting, very low blood pressure and a fast heartbeat.

While you are using Isordil tablets

Things you must do

Visit your doctor regularly for a check up and always discuss with your doctor any problems you have with Isordil tablets.

Tell your doctor immediately if your angina attacks are getting worse or more frequent whilst using Isordil.

Take Isordil as your doctor has prescribed.

Keep enough tablets to last weekends and holidays. If you do happen to run out, Isordil can be purchased from a pharmacy without a prescription.

Before having any type of surgery, tell your doctor or anaesthetist you are taking Isordil.

If a headache occurs after taking Isordil, pain relievers are recommended. The headache usually disappears on continual therapy with Isordil. If the headache persists, contact your doctor.

Things to be careful of

You may feel light-headed or dizzy or faint when you begin to take Isordil. This is because your blood pressure is falling suddenly.

Get up slowly when getting out of bed or standing up from a sitting position if you feel light-headed, dizzy or faint.

If you drink alcohol, dizziness or faintness may be worse.

Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. The problem usually goes away after the first few doses.

Be careful driving or operating machinery until you know how Isordil affects you.

Even though you may feel better when you start taking Isordil, be careful to avoid excessive physical activities.

Things you must not do

Do not chew or crush the tablets.

If you have been taking Isordil regularly for some time, do not suddenly stop taking it as this may bring on an angina attack.

Check with your doctor for the best way to slowly reduce the amount of Isordil you are taking before stopping completely.

Do not give this medicine to anyone else.

Do not take any other medicines unless you have discussed this with your doctor or pharmacist. This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Isordil.

Isordil helps most people with angina, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get any of the following side effects.

More common effects

  • headache (temporary or persistent)
  • dizziness, light-headedness, or feeling faint, especially when getting up from sitting or lying down

Less common

  • nausea and vomiting
  • flushing
  • swollen hands and feet
  • skin rash and flaking of the skin
  • anaemia
  • increase in your heart rate
  • hypoxaemia (low blood oxygen levels)

Serious side effects

  • severe drops in blood pressure and an increase in your heart rate
  • sensitive patients may experience a decrease in blood flow, which could damage your heart or result in heart failure.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. Some people may get other side effects while taking Isordil.

Ask your doctor or pharmacist to answer any questions you may have.

After using it

Storage

Keep your Isordil tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they will not keep well.

Keep your medicine in a cool dry place where the temperature stays below 30°C.

Do not store Isordil or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep your medication where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave Isordil in the car on hot days.

Disposal

Return any unused medicine to your pharmacist.

Product Description

What Isordil looks like

Isordil 5 mg Sublingual tablets - pink round tablet, supplied in a bottle containing 100 tablets.

Ingredients

Isordil 5 mg Sublingual

Active ingredient: 5 mg isosorbide dinitrate

Inactive ingredients:

  • lactose monohydrate
  • starch
  • magnesium stearate
  • microcrystalline cellulose
  • Erythrosine Lake CI 45430 colouring agent

Contains sugars as lactose.

Distributor

Arrow Pharma Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

This leaflet was last revised in June 2022.

Australian Registration Numbers:

Isordil 5 mg:
AUST R 12957

Published by MIMS August 2022

BRAND INFORMATION

Brand name

Isordil

Active ingredient

Isosorbide dinitrate

Schedule

S3

 

1 Name of Medicine

Isosorbide dinitrate.

2 Qualitative and Quantitative Composition

Isordil sublingual tablets contain 5 mg of isosorbide dinitrate.
Isordil oral tablets come in three strengths and contain 10 mg, 30 mg or 40 mg of isosorbide dinitrate.

Excipients with known effect.

Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Isordil sublingual tablets.

5 mg.

Round, flat, pink, unmarked tablet.

Isordil oral tablets.

10 mg*.

Round, white, bi-convex tablet impressed with the company logo with a break bar on other side.

30 mg*.

Round, blue, bi-convex tablet, impressed with the company logo and a break bar on other side.

40 mg*.

Round, green, bi-convex tablet, impressed with the company logo and a break bar on other side.
* Currently not marketed.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of angina pectoris (classic effort associated angina, chronic stable angina, vasospastic angina, variant angina, unstable angina and angina decubitus) and myocardial ischaemia due to ischaemic heart disease, and an aid in the management of left ventricular failure, either alone or as part of the syndrome of congestive heart failure.

Sublingual.

Prevention and treatment of angina pectoris and myocardial ischaemia due to ischaemic heart disease. Acute and chronic left ventricular failure, either alone or as part of the syndrome of congestive heart failure, to improve cardiac performance and stabilise the patient's condition.

Oral.

Relief of angina pectoris. It is not intended to abort the acute anginal episode, but is useful in the prophylactic treatment of angina pectoris and myocardial ischaemia due to ischaemic heart disease. An aid in the management of left ventricular failure, either alone or as part of the syndrome of congestive heart failure.

4.2 Dose and Method of Administration

Tolerance to the antianginal effects (measured by exercise stress testing) and effects in heart failure of nitrates has been shown to be a major factor limiting efficacy and blunting the effect of sublingual nitroglycerin when nitrates are used either continuously (i.e. infusion, transdermal) or with any regular schedule of oral administration where dosing occurs every 8 hours or more often during a day. The development of tolerance can be altered (prevented or attenuated) by a noncontinuous (intermittent or asymmetric) dosing schedule. In general, a nitrate free interval of at least 8 hours every 24 hours is recommended to prevent tolerance.

Adult.

Angina pectoris and myocardial ischaemia due to ischaemic heart disease. The usual dose of sublingual isosorbide dinitrate for this indication is 5 to 10 mg every two to three hours, for treatment of an angina pectoris attack, or prophylactically in situations likely to provoke such attacks. The sublingual tablets may also be swallowed in doses of 5 to 10 mg for prevention of angina pectoris or to supplement the oral dosage form.
Oral tablets should be taken in doses of 5 to 30 mg four times daily, the average patient requiring 10 mg four times daily.
Left ventricular failure either alone or as part of the syndrome of congestive heart failure. In order to obtain full therapeutic effect, it is important that the dosage of sublingual and oral forms be individualised in accordance with each patient's needs, clinical response and haemodynamic monitoring. Isordil therapy should begin with the lowest effective dose and further adjusted as necessary, based on left ventricular performance. For treatment of acute left ventricular failure, the sublingual form of Isordil should be preferred. For the treatment of chronic left ventricular failure, initially the rapid acting sublingual form of Isordil should be administered to stabilise the patient's symptoms or to determine the magnitude of haemodynamic response; then it should be followed by the oral form for maintenance therapy.
The average recommended doses for acute and chronic left ventricular failure are the following:

Acute left ventricular failure.

Sublingual tablet: 5 to 10 mg every two hours or as needed.

Chronic left ventricular failure.

Initial dosage, sublingual tablet: 5 to 10 mg every two hours or as needed. Maintenance dosage, oral tablet: 20 to 40 mg four times daily or as needed.

4.3 Contraindications

In patients with a confirmed diagnosis of isolated right ventricular failure, particularly in the setting of acute myocardial infarction and due to dominant right ventricular infarction.
Known hypersensitivity to isosorbide dinitrate or a known idiosyncratic reaction to organic nitrate drugs.
Hypotension or uncorrected hypovolaemia, as the use of isosorbide dinitrate in such states could produce severe hypotension or shock.
Constrictive pericarditis and pericardial tamponade.
Severe anaemia or arterial hypoxaemia.
Intracranial hypertension.
Do not use isosorbide dinitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil or vardenafil. Concomitant use can cause severe hypotension, syncope or myocardial ischemia.
Acute circulatory failure (shock, vascular collapse).
Aortic/mitral valve stenosis and disease associated with a raised intra-cranial pressure e.g. following a head trauma and including cerebral haemorrhage.

4.4 Special Warnings and Precautions for Use

As with other vasodilators, Isordil may cause paradoxical side effects in sensitive patients, which may increase ischaemia and may even lead to extension of myocardial damage and advanced congestive heart failure.

Acute myocardial infarction.

Data supporting the use of nitrates during the acute phase of myocardial infarction (the period during which clinical and laboratory findings are unstable) are insufficient to establish safety. Management of acute left ventricular failure secondary to acute myocardial infarction depends on accurate diagnosis, and may require flow directed cardiac catheterisation before institution of appropriate drug therapy.

Hypotension.

Care must be taken to avoid the significant risk of a precipitous fall in blood pressure, particularly in patients with severe coronary or cerebral atherosclerosis or renal insufficiency. Isosorbide dinitrate may cause faintness if taken while standing or sitting, and this hazard is of particular importance in patients not previously treated with the drug.

Withdrawal.

Nitrate dependence is a potentially serious problem. In terminating treatment of patients with angina who are receiving isosorbide dinitrate, both the dosage and frequency of administration should be gradually reduced over a period of two weeks to prevent potential withdrawal reactions such as increased frequency of angina attacks.

Tolerance.

During sustained therapy with isosorbide dinitrate, partial tolerance to the antianginal and circulatory effects may develop. Cross tolerance to other organic nitrates or nitrites may occur.
In the treatment of acute or chronic cardiac failure, pulmonary capillary pressure should not be allowed to fall below 15 mmHg or systolic blood pressure below the physiological range in normal or hypertensive patients. Systolic pressure should be preserved in patients with pre-existing hypotension in the range of 90-100 mmHg.
Marked symptomatic, orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustment of either class of agents may be necessary.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
Tolerance to this drug and cross tolerance to other nitrates and nitrites may occur.

Hypoxaemia.

Arterial oxygen tension decreases after administration of glyceryl trinitrate in normal subjects and in patients with coronary artery disease, and therefore it is advised that isosorbide dinitrate should be used cautiously in hypoxic patients because a decrease in available oxygen may oppose the antianginal effect of isosorbide dinitrate.

Haemolytic anaemia.

Isosorbide dinitrate has been reported to induce haemolytic anaemia in glucose-6-phosphate dehydrogenase deficient patients.

Relief of acute episodes of angina.

Oral isosorbide dinitrate tablets should not be administered for rapid relief of the pain of angina. Sublingual administration of isosorbide dinitrate tablets offers relatively fast relief.

Relief of left ventricular failure.

If left ventricular filling pressures are not elevated at the time isosorbide dinitrate is administered, the drug may cause severe hypotension due to a reduction in cardiac output.

Use in hepatic impairment.

Isosorbide dinitrate is, in part, metabolised by the liver and therefore impairment of liver function may necessitate a reduction in dosage.

Use in renal impairment.

In patients with renal failure, the plasma concentrations of isosorbide dinitrate and its active metabolites after single oral doses of the drug are not different from those seen in subjects with normal renal function. Although only 5% of a single dose of isosorbide dinitrate is excreted in the urine as the mononitrate metabolites, it is possible that with chronic dosing of isosorbide dinitrate, renal impairment could cause clinically significant accumulation of the active mononitrate metabolites (see Section 5.2 Pharmacokinetic Properties).

Use in the elderly.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Paediatric use.

As safety and efficacy have not been demonstrated for this age group, isosorbide dinitrate is not recommended for use in children.
These tablets should be used with caution in patients who are suffering from hypothyroidism, hypothermia, malnutrition, angle closure glaucoma.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent use of sildenafil can result in significant potentiation of the hypotensive effects of organic nitrates, such as isosorbide dinitrate, and is therefore contraindicated. Concomitant use of isosorbide dinitrate with phosphodiesterase inhibitors is contraindicated (see Section 4.3 Contraindications).
Patients receiving antihypertensive drugs or phenothiazines with nitrates should be observed for possible additive hypotensive effects.
Concomitant use with alcohol may cause hypotension due to an enhanced vasodilatory effect of isosorbide dinitrate.
Caution should be observed when giving tricyclic antidepressants and anticholinergic agents concomitantly with isosorbide dinitrate because these agents may potentiate the hypotensive effects of isosorbide dinitrate. Nonsteroidal anti-inflammatory drugs may attenuate the effects of isosorbide dinitrate, considering similar reports for glyceryl trinitrate.
The use of beta-adrenergic blocking agents may require a reduction in isosorbide dinitrate dosage if excessive hypotension is to be avoided.
Nitrate preparations can act as physiological antagonists to noradrenaline, acetylcholine, histamine and other agents.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
The safety of isosorbide dinitrate in pregnancy has not been established. The drug should not be administered to pregnant women unless, in the opinion of the physician, the probable clinical benefits outweigh the possible hazards.
 It is not known whether isosorbide dinitrate or its metabolites are excreted in milk, or whether it has a harmful effect on the newborn. Therefore, it is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Occasionally individuals may exhibit marked sensitivity to the hypotensive effects of nitrates, even with the usual therapeutic dosage.
Headache, dizziness, fatigue, palpitations, orthostatic hypotension, and flushing may occur at the beginning of treatment. These reactions are usually controlled by lowering the dose; and tend to decline with time.

More common reactions.

Nervous system.

Headache, which may be temporary or persistent, is the most common adverse reaction in patients treated with isosorbide dinitrate. Dizziness, especially postural.

Less common reactions.

Cardiovascular system.

Cutaneous dilatation with flushing; peripheral oedema, hypoxaemia. During treatment with these tablets, a temporary hypoxaemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease this may lead to a myocardial hypoxia, collapse may occur (sometimes accompanied by bradyarrhythmia and syncope).

Dermatological.

Rash, exfoliative dermatitis, Stevens-Johnson syndrome.

Gastrointestinal.

Nausea, vomiting, pallor and excessive perspiration.

Haematological.

Haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase deficient syndrome (see Section 4.4 Special Warnings and Precautions for Use).

Severe or life threatening reactions.

Severe hypotension and bradycardia may be hazardous, particularly in patients with cerebral or coronary atherosclerosis. Severe hypotension may lead to enhanced angina symptoms. Reflex tachycardia may exacerbate ischaemic injury in patients with acute myocardial infarction.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Clinical features.

Overdosage of isosorbide dinitrate may result in severe hypotension and reflex tachycardia. Headache may be an indication of excessive dosage.

Management.

Following recent ingestion of large numbers of isosorbide dinitrate tablets, gastric lavage and administration of oxygen with assisted respiration may be necessary.
Hypotension and reflex tachycardia caused by overdosage can be treated by elevating the legs until the patient's condition stabilises. Since the duration of the haemodynamic effects following isosorbide dinitrate administration may be prolonged, additional corrective measures may be required. In that event, cautious administration of intravenous fluids or an alpha-adrenergic agonist (e.g. metaraminol) should be considered.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Antianginal, vasodilator.
Isosorbide dinitrate is an organic nitrate ester. It has a slower time to onset of action but longer duration of action than glyceryl trinitrate. The longer duration of action is due, in part, to the drug having a longer elimination half-life than glyceryl trinitrate and to the fact that its mononitrated metabolites are pharmacologically active and have long elimination half-lives (see Section 5.2 Pharmacokinetic Properties).
Like other organic nitrate ester drugs, the principal action of isosorbide dinitrate is to relax vascular smooth muscle. Venodilation causes venous pooling which reduces venous return, left ventricular filling pressure and pulmonary artery and capillary pressures. Myocardial oxygen requirements are also reduced. Arteriolar dilatation can result in a reduction in afterload. The clinical implication of these haemodynamic changes in patients with congestive heart failure can be an increase in cardiac output and a reduction in symptoms of pulmonary vascular congestion. Patients with angina pectoris attain relief through a reduction in myocardial oxygen requirements.
Nitrates may cause a redistribution of coronary blood flow to ischaemic areas by selectively dilating large coronary vessels or collateral vessels which may develop secondary to myocardial ischaemia.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Isosorbide dinitrate is absorbed faster after sublingual administration than after oral administration.
An oral availability of at least 20% means that the oral route is effective in providing significant amounts of isosorbide dinitrate for systemic pharmacological effects.
After chronic oral dosing at 6 hourly intervals, plasma levels of isosorbide dinitrate are greater than after single doses of the drug. This is associated with a reduced clearance of isosorbide dinitrate after chronic dosing.

Half-life.

An apparent terminal half-life of 1.1 to 1.3 hours has been reported for single oral and sublingual doses, and IV doses of isosorbide dinitrate. However, on monitoring plasma isosorbide dinitrate concentrations for up to 24 hours after chronic doses at 6 hourly intervals, a biexponential decay profile was reported with the first phase having a half-life of 1.1 hours and a second phase having a half-life of 7.7 hours. The first and faster half-life probably represents elimination of isosorbide dinitrate, while the second and slower half-life represents either protracted oral absorption or a redistribution of isosorbide dinitrate back from the peripheral tissues to the systemic circulation.
The apparent disappearance half-lives of the 2- and 5-mononitrate metabolites are about 3 hours and 4-6 hours respectively.
There are no differences in plasma levels of isosorbide dinitrate after single oral doses of the drug in normal subjects and renal failure patients, but because isosorbide dinitrate and its mononitrate metabolites accumulate with chronic dosing, significant accumulation of the drug and its metabolites may occur, particularly in patients with hepatic and/or renal failure.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The 5 mg tablets also contain the following excipients: cellulose-microcrystalline, erythrosine, lactose monohydrate, magnesium stearate, starch-maize.
The 10 mg, 30 mg and 40 mg tablets also contain the following excipients: ammonium phosphate-monobasic, cellulose-microcrystalline, lactose monohydrate, magnesium stearate, brilliant blue FCF (30 mg and 40 mg only), quinoline yellow (40 mg only), sunset yellow FCF (40 mg only).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Isordil sublingual tablets.

5 mg: store below 30°C.

Isordil oral tablets.

10, 30 and 40 mg: store below 25°C.

6.5 Nature and Contents of Container

Isordil sublingual tablets 5 mg.

20s* and 100s in bottles.

Isordil oral tablets 10 mg, 30 mg and 40 mg.

20s and 100's in bottles* and blister packs*.
* Currently not marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Isosorbide dinitrate is fine, white or almost white, crystalline powder. It is very slightly soluble in water, very soluble in acetone, sparingly soluble in ethanol (96 percent).
Isosorbide dinitrate; also known as sorbide nitrate. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-2,5-di-O-nitro-D-glucitol.

Chemical structure.

Its structural formula is:
C6H8N2O8. Molecular weight: 236.1.

CAS number.

87-33-2.

7 Medicine Schedule (Poisons Standard)

Isordil Sublingual Tablets, 5 mg - S3 Pharmacist only Medicine.
Isordil Oral Tablets, 10 mg - S2 Pharmacy Medicine.
Isordil Oral Tablets, 30 mg - S4 Prescription only Medicine.
Isordil Oral Tablets, 40 mg - S4 Prescription only Medicine.

Summary Table of Changes