Consumer medicine information

Persantin Ampoules

Dipyridamole

BRAND INFORMATION

Brand name

Persantin Ampoules

Active ingredient

Dipyridamole

Schedule

SUMMARY CMI

Persantin^® Ampoules

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Persantin Ampoules?

Persantin Ampoules contain the active ingredient dipyridamole. Persantin Ampoules are used as a tool in detecting potential problems on how the heart functions in times of stress.

For more information, see Section 1. Why am I using Persantin Ampoules? in the full CMI.

2. What should I know before I use Persantin Ampoules?

Do not use if you have ever had an allergic reaction to dipyridamole or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Persantin Ampoules? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Persantin Ampoules and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Persantin Ampoules?

Your doctor will decide what dose you will receive, based on your body weight.
Persantin Ampoules are given as an infusion (drip) into your veins, over several minutes.

More instructions can be found in Section 4. How do I use Persantin Ampoules? in the full CMI.

5. What should I know while using Persantin Ampoules?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using Persantin. Tell your doctor if you are pregnant or if you think you may be pregnant or are breast-feeding. Tell your doctor if you have or have had any of the following medical conditions: any heart condition or heart disease asthma, high or low blood pressure unexplained fainting or mini-stroke severe muscle disease (myasthenia gravis).
Things you should not do	You should not be given this medicine in states of shock or collapse. You should not be given this medicine if you have any serious heart conditions You should not be given this medicine if you are pregnant or are breast-feeding
Looking after your medicine	Persantin Ampoules will be stored in the pharmacy or ward below 25°C. Each ampoule can only be used once and unused contents of opened ampoules must be discarded.

For more information, see Section 5. What should I know while using Persantin Ampoules? in the full CMI.

6. Are there any side effects?

Tell your doctor or nurse as soon as possible if you experience any side effects during or after treatment with Persantin Ampoules, so that these may be properly treated. These side effects include:

angina
heart attack, heart failure
stroke or mini-stroke
changes in heart beat (faster, slower or irregular).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Persantin^® Ampoules

Active ingredient: dipyridamole

Consumer Medicine Information (CMI)

This leaflet provides important information about using Persantin Ampoules. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Persantin Ampoules.

Where to find information in this leaflet:

1. Why am I using Persantin Ampoules?
2. What should I know before I use Persantin Ampoules?
3. What if I am taking other medicines?
4. How do I use Persantin Ampoules?
5. What should I know while using Persantin Ampoules?
6. Are there any side effects?
7. Product details

1. Why am I using Persantin Ampoules?

Persantin Ampoules contains the active ingredient dipyridamole. Persantin is a heart medicine. Persantin increases blood flow to the heart by causing the blood-supplying arteries to widen.

Persantin Ampoules are used as a tool in detecting potential problems on how the heart functions in times of stress. It is therefore useful in predicting the likelihood of the risks of heart disease.

2. What should I know before I am given Persantin Ampoules?

Warnings

You should not be given Persantin Ampoules if:

you are allergic to dipyridamole, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
you are in states of shock or collapse.
you have any serious heart conditions such as:
- heart attack or failure
- angina
- abnormal changes in rhythm or rate of the heart beat (irregular, fast or slow)
- heart valve problems
- blockage of the lung artery
- inflammation of the heart muscle (myocarditis), inner lining of the heart (endocarditis) or membrane enclosing the heart (pericarditis)
- tear in the wall of the aorta (major artery in the body).

Check with your doctor if you:

have or have had any of the following medical conditions:
- any heart condition or heart disease
- asthma
- high or low blood pressure
- unexplained fainting or mini-stroke
- severe muscle disease (myasthenia gravis).
- take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

You should not be given this medicine if you are pregnant or are breast-feeding.

It may affect your developing baby if you have it during pregnancy.

The active ingredient in Persantin passes into breast milk.

Children and adolescents

This medicine should not be given to a child.

There is limited information about the use of Persantin Ampoules in children.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Persantin and affect how it works.

In particular tell your doctor if you are taking:

aspirin
any medicine containing dipyridamole (e.g. Persantin^® SR or Asasantin^® SR capsules)
medicines used to thin your blood such as warfarin
medicines used to treat asthma, bronchitis and emphysema such as theophylline
medicines used to treat high blood pressure
neostigmine, distigmine and related medicines (used, for example, in the treatment of myasthenia gravis)
medicines used to treat rapid heart rhythm such as adenosine

You may need different amounts of your medicines, or you may need to take different medicines.

Avoid drinks such as tea, coffee and cola (which contain caffeine) for 24 hours before treatment with Persantin Ampoules.

This is because the caffeine in these drinks can decrease the effects of the medicine..

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Persantin Ampoules.

4. How am I given Persantin Ampoules?

How much is given

Persantin Ampoules are given as an infusion (drip) into your veins, over several minutes.
Your doctor will decide what dose you will receive, based on your body weight.

PERFUSION IMAGING:

The recommended dose is 0.14 mg/kg/min (0.56 mg/kg total) infused over 4 minutes.

STRESS ECHO TESTING:

The recommended dose is 0.56 mg/kg over a 4 minute period, followed by 4 minutes of no dose, and if echo monitoring shows no changes, by an additional 0.28 mg/kg over 2 minutes. The cumulative dosage is 0.84 mg/kg over 10 minutes. The protocol may also be given in 6 minutes.

If you are given too much Persantin Ampoules

As Persantin Ampoules are given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

Symptoms of an overdose may include feeling warm, flushing, sweating, restlessness, weakness and dizziness. There may be effects on the heart and circulation causing chest pain, an increase in pulse rate and a drop in blood pressure.

Tell your doctor or nurse immediately if you experience any signs of overdose, or, if you are not in hospital, go to the Emergency department at your nearest hospital.

You may need urgent medical attention.

5. What should I know while using Persantin Ampoules?

Things you must do

Tell your doctor if you are pregnant or if you think you may be pregnant or are breast-feeding

Call your doctor straight away if you:

do not feel well while you are being given Persantin Ampoules.

Remind any doctor, dentist or pharmacist you visit that you are using Persantin Ampoules.

Looking after your medicine

Persantin Ampoules will be stored in the pharmacy or ward below 25°C. Each ampoule can only be used once and unused contents of opened ampoules must be discarded.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Persantin must not be used after the expiry date printed on the pack or ampoule or if the packaging is torn or shows signs of tampering..

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Some of the side effects of Persantin are related to the way the medicine works on the heart and circulation. Persantin causes widening of the arteries and if these widen too much there may be a fall in blood pressure which may cause problems with the blood circulation.

Less serious side effects

Less serious side effects	What to do
headache vomiting, nausea, diarrhoea muscle aches and pains dizziness stomach pain tingling or numbness of the hands or feet hot flushes	Speak to your doctor or nurse if you have any of these side effects during or after treatment with Persantin Ampoules, so that these may be properly treated.

Serious side effects

Serious side effects	What to do
angina heart attack heart failure stroke or mini-stroke changes in heart beat (faster, slower or irregular). Allergic reaction. Symptoms are rash, hives, difficulty in breathing, and swelling of the face, lips, mouth, etc fits/convulsions sudden collapse	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is only available with a doctor's prescription.

What Persantin Ampoules contain

Active ingredient (main ingredient)	Dipyridamole 10 mg
Other ingredients (inactive ingredients)	Tartaric acid Macrogol 600 Hydrochloric acid Water for injections
Potential allergens	-

Do not take this medicine if you are allergic to any of these ingredients.

What Persantin Ampoules looks like

Persantin Ampoules are a clear, yellow solution. It comes in a glass ampoules. (AUST R 17934).

Who distributes Persantin Ampoules

Persantin Ampoules are supplied in Australia by:

Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough VIC 3173
Australia
Telephone: 1800 899 005

This leaflet was prepared in January 2021.

Published by MIMS April 2021

BRAND INFORMATION

Brand name

Persantin Ampoules

Active ingredient

Dipyridamole

Schedule

1 Name of Medicine

Dipyridamole.

2 Qualitative and Quantitative Composition

Persantin Ampoules contain dipyridamole 10 mg in 2 mL and are intended for intravenous administration.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Persantin 10 mg/2 mL solution for injection is a clear, yellow solution practically free from suspended particles.

4 Clinical Particulars

4.1 Therapeutic Indications

Persantin Ampoules are indicated as an alternative to exercise in myocardial imaging.

4.2 Dose and Method of Administration

Perfusion imaging.

The dose of intravenous Persantin as an adjunct to myocardial perfusion imaging should be adjusted according to the weight of the patient. The recommended dose is 0.14 mg/kg/min (0.56 mg/kg total) infused over 4 minutes. Although the maximum tolerated dose has not been determined, clinical experience suggests that a total dose beyond 60 mg is not needed for any patient.

Stress echo.

The recommended protocol for intravenous dosing is 0.56 mg/kg over a 4 minute period, followed by 4 minutes of no dose and, if echo monitoring performed and analysed in real time shows no changes, by an additional 0.28 mg/kg over 2 minutes, yielding a cumulative dosage of 0.84 mg/kg over 10 minutes. This 'high dose' protocol may also be given in 6 minutes. Most experience has been gained using a total dose of 0.84 mg/kg over 10 minutes or 6 minutes, therefore it is not recommended to exceed this dose for diagnostic testing.
Prior to intravenous administration, Persantin should be diluted in at least a 1:2 ratio with sodium chloride 0.45% or 0.9% or glucose 5% to a total volume of approximately 20 to 50 mL. Infusion of undiluted Persantin may cause local irritation. The imaging agent should be injected within 5 minutes following administration of intravenous Persantin.
Persantin for intravenous administration should not be mixed with other drugs in the same syringe or infusion container.

4.3 Contraindications

Hypersensitivity to any of the components of the product.
Acute myocardial infarction. Unstable angina. Uncontrolled cardiac arrhythmias causing symptoms or haemodynamic compromise. Symptomatic severe aortic stenosis. Uncontrolled symptomatic heart failure. Acute pulmonary embolus or pulmonary infarction. Acute myocarditis or pericarditis. Active endocarditis. Acute aortic dissection.
Patients already receiving treatment with regular oral dipyridamole should not receive additional intravenous Persantin.

4.4 Special Warnings and Precautions for Use

The potential clinical information to be gained through use of intravenous Persantin as an adjunct in myocardial imaging must be weighed against the risk to the patient. Comparable reactions to exercise-induced stress may occur, and therefore appropriate monitoring is indicated. Patients with a history of severe coronary heart disease may be at a greater risk.
Patients with asthma, baseline hypotension (systolic pressure < 90 mmHg), recent unexplained syncope or transient ischaemic attacks should not be treated with intravenous dipyridamole.
Caution should be taken in patients with left main coronary stenosis, moderate stenotic valvular heart disease, electrolytic abnormalities, severe arterial hypertension (systolic pressure > 200 mmHg and/or diastolic pressure > 110 mmHg), tachyarrhythmias or bradyarrhythmias, hypertrophic cardiomyopathy and other forms of outflow tract obstruction, or high-degree atrioventricular block.
Patients using dipyridamole, theophylline or caffeine chronically should not undergo testing for at least 24 hours after withdrawal of therapy because adenosine blood levels could be unpredictably high. If pharmacological stress testing with intravenous dipyridamole is considered necessary, drugs containing oral dipyridamole (e.g. Asasantin SR, Persantin) should be discontinued for twenty-four hours prior to the stress testing. Failure to do so may impair the sensitivity of the test.
In patients with myasthenia gravis, the possibility of an interaction between dipyridamole and cholinesterase inhibitors should be considered (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Serious adverse reactions associated with the intravenous administration of Persantin for myocardial imaging have been reported (see Section 4.8 Adverse Effects (Undesirable Effects)).
Most of the adverse effects of dipyridamole may be reversed with intravenous aminophylline, but it is not recommended that this be given routinely. If variant angina (elevated ST segments) is induced by dipyridamole, then it may be worsened by aminophylline and alternative vasodilators such as nitrates should be given.

Use in the elderly.

No data available.

Paediatric use.

Safety and efficacy in children have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Xanthine derivatives (e.g. caffeine and theophylline) can weaken the vasodilating effect of dipyridamole and should therefore be avoided 24 hours before myocardial imaging with intravenous Persantin.
Dipyridamole increases the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage should be considered.
Dipyridamole may increase the hypotensive effect of blood pressure lowering drugs and may counteract the anticholinesterase effect of cholinesterase inhibitors thereby potentially aggravating myasthenia gravis.
When dipyridamole is used in combination with anticoagulants or aspirin, the statements on intolerance and risks for these preparations must be observed. Addition of dipyridamole to aspirin does not increase the incidence of bleeding events. When dipyridamole was administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies on the effect on human fertility have been conducted with intravenous Persantin.
(Category B1)
Drugs in this category have been taken by only a limited number of pregnant women and women of child-bearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the foetus having been observed. Studies in animals have not shown evidence of an increased occurrence of foetal damage.
However, the usual precautions regarding the use of medication at this time, especially during the first trimester, should be observed.
Dipyridamole has been reported to distribute into breast milk. Caution should therefore be used when the drug is administered to nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that they may experience undesirable effects such as dizziness during treatment with intravenous Persantin. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

When intravenous Persantin is used as an adjunct to myocardial perfusion imaging, the following adverse effects have been reported:

Immune system disorders.

Hypersensitivity, anaphylactoid reactions, angioedema.

Nervous system disorders.

Headache, dizziness, paraesthesia, transient ischaemic attacks, cerebrovascular accident, convulsion.

Cardiac disorders.

Chest pain/ angina pectoris, arrhythmia, tachycardia, myocardial infarction, bradycardia, cardiac arrest, ventricular fibrillation, syncope, sinus arrest, atrioventricular block.

Vascular disorders.

Hypotension, hot flush.

Respiratory, thoracic and mediastinal disorders.

Bronchospasm, laryngospasm.

Gastrointestinal disorders.

Nausea, abdominal pain, diarrhoea, vomiting.

Skin and subcutaneous tissue disorders.

Urticaria, rash.

Musculoskeletal, connective tissue and bone disorders.

Myalgia.

General disorders and administration site conditions.

Cardiac death, oedema.

Investigations.

Electrocardiogram ST-T change, electrocardiogram change.
There have also been rare reports of cerebral seizure/ grand mal seizure. For high doses of intravenous dipyridamole, as used in cardiac imaging, more frequent and severe adverse reactions have been reported than those reported during oral administration of dipyridamole at the recommended doses in therapeutic indications. Nevertheless, all available data suggest that the benefit-risk ratio is at least as favourable as the benefit-risk ratio of conventional exercise testing.
When intravenous Persantin was used as an adjunct to myocardial perfusion imaging in a study of 3911 patients, the adverse events occurring at a frequency of 1% or greater in patients are shown in Table 1.

Safety data were obtained from a review of 7 published studies (n = 89,482) and serious adverse events are reported in Table 2.

Monitoring of patients.

When myocardial imaging is performed with intravenous Persantin, parenteral aminophylline should be readily available for relieving adverse effects such as bronchospasm or chest pain. Vital signs should be monitored during and for 10-15 minutes following the intravenous infusion of Persantin and an electrocardiographic tracing should be obtained using at least one chest lead. Should severe chest pain or bronchospasm occur, aminophylline may be administered by slow intravenous injection (50-100 mg over 30 to 60 seconds) in doses ranging from 50 to 250 mg. Nitroglycerin (sublingual or intravenous) may be administered if aminophylline fails to completely eliminate ischaemia. If chest pain continues despite use of aminophylline and nitroglycerin, the possibility of myocardial infarction should be considered.
In the case of severe hypotension, the patient should be placed in a supine position with the head tilted down if necessary, before administration of parenteral aminophylline.
If 250 mg aminophylline does not relieve chest pain symptoms within a few minutes, sublingual nitroglycerin may be administered.
If the clinical condition of a patient with an adverse effect permits a one minute delay in the administration of parenteral aminophylline, the imaging agent may be injected and allowed to circulate for one minute before the injection of aminophylline. This will allow initial perfusion imaging to be performed before reversal of the pharmacological effects of intravenous Persantin on the coronary circulation.

Reporting of suspected adverse reactions.

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

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

Symptoms.

No cases of overdosage in humans have been reported in this indication. It is unlikely that overdosage will occur because of the nature of use (i.e. single intravenous administration in controlled settings).
Signs and symptoms as described, see Section 4.8 Adverse Effects (Undesirable Effects) would be expected to occur. These could be severe in certain individuals.

Treatment.

Symptomatic therapy is recommended.
Should severe chest pain or bronchospasm occur, parenteral aminophylline may be administered by slow intravenous injection (50-100 mg over 30 to 60 seconds) in doses ranging from 50 to 250 mg. Nitroglycerin (sublingual or intravenous) may be administered if aminophylline fails to completely eliminate ischaemia.
Due to its wide distribution to tissues and its predominantly hepatic elimination, dipyridamole is not likely to be accessible to enhanced removal procedures.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Dipyridamole is a coronary vasodilator. It produces vasodilation indirectly via two mechanisms, namely the inhibition of adenosine uptake which leads to an increase in the circulating adenosine, and the inhibition of cGMP-phosphodiesterase.
Vasodilation induced by intravenous Persantin leads to regional redistribution of coronary blood flow and may lead to abnormalities in the distribution of imaging agent and ventricular function in patients with coronary artery disease. The normal vessels dilate with enhanced flow, leaving relatively reduced pressure and flow across areas of haemodynamically important coronary stenoses.
Dipyridamole also has an antithrombotic action.

Clinical trials.

In a review of published literature dipyridamole perfusion imaging was examined in 32 studies. With the exception of one study, dipyridamole perfusion imaging was compared with coronary arteriography. A single study compared exercise and dipyridamole in patients undergoing thallium-201 myocardial imaging. A total of 2240 patients were assessed in these studies. Information on the total number of patients with coronary artery disease was not available. With the exception of one study where sensitivity was only 37%, sensitivity ranged from 67% to 100%. There was one study with a specificity of 28%, specificity in remaining studies ranged from 50% to 96%. Pooling these studies gave a combined sensitivity of 86% and specificity of 74%.
Dipyridamole stress echocardiography was compared with coronary arteriography in 28 studies. A total of 2137 patients were assessed with 1296 (61%) diagnosed as having coronary artery disease. Sensitivity of dipyridamole stress echocardiography ranged from 32% to 100% and specificity from 72% to 100%. The combined results from these studies gave a sensitivity of 73% and specificity of 91%.
The prognosis following dipyridamole stress testing was examined in 59 studies where patients had undergone dipyridamole perfusion imaging. All but 3 studies confirmed that an abnormal dipyridamole stress study was associated with more subsequent cardiac events than a normal study. Prognosis following dipyridamole stress echocardiography was examined in 21 studies. An abnormal test was predictive of more subsequent cardiac events than a normal study. Typically, with either technique in a group of patients with intermediate risk of coronary artery disease, an abnormal study suggested a cardiac event post-operatively in 20% and a normal study in only 2%.

5.2 Pharmacokinetic Properties

(Most pharmacokinetic data refer to healthy volunteers.)
Adequate curve fitting is achieved by a 3 compartment model.
(a) A rapid alpha phase, with a half-life of about 3 minutes, presumably reflecting distribution of the drug from the central compartment to peripheral compartments.
(b) A beta phase, with a half-life of about 40 minutes, which represents the elimination of most of the administered drug and, together with the alpha phase, accounts for about 70% of the total area under the plasma concentration time curve (AUC).
(c) A final, prolonged terminal elimination phase (gamma) with a half-life of about 15 hours. This represents about 30% of the total AUC and probably represents the rediffusion of a smaller proportion of the administered dose from remotely accessible tissues of low capacity back into the central compartment. This may also reflect some enterohepatic recycling (which is evident from smaller secondary peaks several hours after the end of the infusion at time points which are related to food intake).
At the end of a 4 minute infusion of 0.5 mg/kg, mean dipyridamole plasma concentration was 6.30 ± 0.32 microgram/mL, while at 1 hour afterwards the mean plasma concentration was 1.13 ± 0.36 microgram/mL.

Distribution.

On account of its high lipophilicity, log P 3.92 (n-octanol/0.1 N NaOH), dipyridamole distributes to many organs. In animals, dipyridamole is distributed preferentially to the liver, then to the lungs, kidneys, spleen and heart. Dipyridamole does not cross the blood-brain barrier.
The apparent volume of distribution of the central compartment (V_c) is about 5 L (similar to plasma volume). The apparent volume of distribution at steady state is about 100-140 L, reflecting distribution to various compartments. Total clearance is approximately 200 mL/min and mean residence time is about 7 hours.
Placental transfer of dipyridamole is very low. It is known to be excreted into breast milk.
Protein binding of dipyridamole is about 97-99%. It is primarily bound to alpha-1-acid glycoprotein and albumin.

Metabolism and excretion.

Dipyridamole is metabolised in the liver predominantly to form a monoglucuronide and only small amounts of diglucuronide, desalkyl dipyridamole and a hydroxy compound. After intravenous treatment, the amount of glucuronides is about 10%. Renal excretion is about 5%.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The inactive ingredients are: tartaric acid, macrogol 600, hydrochloric acid (to adjust pH) and water for injections.

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

Store below 25°C.

6.5 Nature and Contents of Container

Persantin Ampoules 10 mg/2 mL are supplied in glass ampoules.
Boxes of 5 ampoules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Dipyridamole is an odourless, yellow crystalline powder with a bitter taste. It has a melting point in the range of 164-168°C, and is soluble in dilute acids, methanol, ethanol and chloroform.
Approved Name: Dipyridamole.

Chemical structure.

Chemical Name: 2,6-bis(diethanolamino)- 4,8-dipiperidino- pyrimido(5,4-d)pyrimidine.
Laboratory Code: R-A 8-BS.
Molecular Formula: C₂₄H₄₀N₈O₄.
Molecular Weight: 504.6.
Structural Formula:

Log in

Consumer medicine information

Persantin Ampoules

Dipyridamole

Keep track of your medicines

BRAND INFORMATION