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Indications

Adult Dosage

The recommended dose is one capsule twice daily, usually one in the morning and one in the evening preferably with meals.

The capsules should be swallowed whole without chewing together with a glass of water.

Alternative regimen in case of intolerable headaches

In the event of intolerable headaches during treatment initiation, switch to one capsule at bedtime and low-dose acetylsalicylic acid (ASA) in the morning. Because there are no outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen as soon as possible, usually within one week.

Child Dosage

ASASANTIN Retard is not indicated for use in children and young people. Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki's disease)

Contra Indications

Hypersensitivity to any component of the product or salicylates.

Patients with active gastric or duodenal ulcers or with bleeding disorders.

Patients in the last trimester of pregnancy.

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “special warnings and precautions”) the use of the product is contraindicated.

Special Precautions

Among other properties dipyridamole acts as a vasodilator. It should be used with caution in patients with severe coronary artery disease, including unstable angina and/or recent myocardial infarction, left ventricular outflow obstruction, or haemodynamic instability (e.g. decompensated heart failure).

Patients being treated with regular oral doses of ASASANTIN Retard should not receive additional intravenous dipyridamole. Clinical experience suggests that patients being treated with oral dipyridamole who also require pharmacological stress testing with intravenous dipyridamole, should discontinue drugs containing oral dipyridamole twenty-four hours prior to stress testing.

ASASANTIN Retard should be used in caution in patients with coagulation disorders.

In patients with myasthenia gravis readjustment of therapy may be necessary after changes in dipyridamole dosage.

Due to the aspirin component, ASASANTIN Retard should be used in caution in patients with asthma, allergic rhinitis, nasal polyps, chronic or recurring gastric or duodenal complaints, impaired renal (avoid if severe) or hepatic function or glucose-6-phosphate dehydrogenase deficiency.

In addition, caution is advised in patients hypersensitive to other non-steroidal anti-inflammatory drugs.

ASASANTIN Retard is not indicated for use in children and young people. There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason aspirin should not be given to children aged under 16 years unless specifically indicated (e.g. for Kawasaki's disease).

The dose of aspirin in ASASANTIN Retard has not been studied in secondary prevention of myocardial infarction.

Caution should be advised in patients receiving concomitant medication which may increase the risk of bleeding, such as anti-platelet agents (e.g. clopidogrel, ticlopidine) or selective serotonin reuptake inhibitors (SSRIs).

The product contains 106 mg of lactose and 22.64 mg sucrose per maximum recommended daily dose. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Interactions

When dipyridamole is used in combination with aspirin or with warfarin, the statements regarding precautions, warnings and tolerance for these preparations must be observed.

Aspirin has been shown to enhance the effect of anticoagulants (e.g. coumarin derivatives and heparin), antiplatelet drugs (e.g. clopidogrel, ticlopidine) and selective serotonin reuptake inhibitors (SSRIs) and may increase the risk of bleeding.

Aspirin may enhance the effect of valproic acid with possible increased risk of hepatotoxicity.

Gastrointestinal side effects may increase when aspirin is administered concomitantly with NSAIDs, corticosteroids or chronic alcohol use. The 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.

Dipyridamole increases the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage should therefore be considered if use with dipyridamole is unavoidable.

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.

The effect of hypoglycaemic agents and the toxicity of methotrexate may be increased by the concomitant administration of aspirin.

Aspirin may decrease the natriuretic effect of spironolactone and inhibit the effect of uricosuric agents (e.g. probenecid, sulphinpyrazone).

There is some experimental evidence that ibuprofen interferes with aspirin induced inhibition of platelet cyclo-oxygenase. This interaction could reduce the beneficial cardiovascular effects of aspirin, however the evidence for this is not conclusive. Further, in view of the known increased risk of gastrointestinal toxicity associated with NSAID and aspirin co-medication, this combination should be avoided wherever possible. When such a combination is necessary the balance of gastrointestinal and cardiovascular risks should be considered

Adverse Reactions

Adverse reactions at therapeutic doses are usually mild. Vomiting, diarrhoea and symptoms such as dizziness, nausea, dyspepsia, headache, also migraine-like (especially at the beginning of treatment) and myalgia have been observed following treatment with dipyridamole. These tend to occur early after initiating treatment and may disappear with continued treatment.

As a result of its vasodilating properties, dipyridamole may cause hypotension, hot flushes and tachycardia. Worsening of the symptoms of coronary heart disease such as angina and arrhythmias has been observed.

Aspirin produces a prolongation of the bleeding time and in very rare cases increased bleeding during or after surgery has been observed following administration of dipyridamole.

Aspirin may produce epigastric distress, nausea and vomiting, gastro or duodenal ulcers and erosive gastritis which may lead to serious gastrointestinal bleeding. These side effects are more likely to occur when higher doses are administered although they may also occur when low doses are used.

Iron deficiency anaemia may develop as a result of occult gastrointestinal bleeding when aspirin is used for long periods of time.

Hypersensitivity reactions including rash, urticaria, severe bronchospasm and angio-oedema have been reported for both dipyridamole and for aspirin. In addition rhinitis, and severe cutaneous skin eruptions have been observed with aspirin. Very rarely, a reduction in platelet count (thrombocytopenia) may occur following administration of aspirin and isolated cases have been reported in conjunction with treatment with dipyridamole. Skin haemorrhages such as contusion, ecchymosis and haematoma may occur with ASASANTIN Retard. Dizziness and tinnitus can, particularly in elderly patients, be symptoms of aspirin overdosage.

Dipyridamole has been shown to be incorporated into gallstones.

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