Pyridantin Bp 100mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PYRIDANTIN / Dipyridamole BP 100 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dipyridamole BP 100 mg
3 PHARMACEUTICAL FORM
Sugar-coated tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
1. As an adjunct to oral anti-coagulation for prophylaxis of thromboembolism associated with prosthetic heart valves.
2. In combination with aspirin for:
a. Prophylaxis of deep venous thrombosis as an alternative to subcutaneous heparin, other than in hip surgery.
b. Prophylaxis of recurrent venous thrombosis resistant to oral anticoagulation.
c. Prophylaxis of occlusion following prosthetic arterial grafts and coronary artery bypass grafts.
4.2 Posology and method of administration
Adults: 300-600 mg daily in three or four doses.
Children: The normal total oral daily dose is 5 mg/kg bodyweight in
divided doses.
Elderly: As for adults.
PYRIDANTIN is taken by mouth, and should usually be taken before meals.
4.3 Contraindications
Patients with a known hypersensitivity to Dipyridamole. Patients with known cardiac conduction difficulties or dysrhythmias.
4.4 Special warnings and precautions for use
PYRIDANTIN should be used with caution in patients with coagulation disorders. PYRIDANTIN is a potent vasodilator and should be used with caution in patients with rapidly worsening angina, sub-valvular aortic stenosis or haemodynamic instability associated with a recently sustained myocardial infarction.
4.5 Interaction with other medicinal products and other forms of interaction
The effect of adenosine is enhanced and extended by dipyridamole. The concurrent use of antacids may reduce the efficacy of PYRIDANTIN. PYRIDANTIN may enhance the effects of oral anticoagulants.
4.6 Pregnancy and lactation
PYRIDANTIN should not be used in pregnancy, especially for the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
If these occur it is usually during the early part of treatment and they are often dose-related. The vasodilating properties of PYRIDANTIN may occasionally produce a vascular headache which normally disappears with dosage reduction. Dizziness, faintness, dyspepsia, mild diarrhoea, myalgia, hypotension, hot flushes and tachycardia have also been reported occasionally.
In rare cases worsening symptoms of coronary heart disease; hypersensitivity reactions such as rash, urticaria, severe bronchospasm and angioedema; increased bleeding during or after surgery and thrombocytopenia have been reported.
4.9 Overdose
Overdosage may lead to headache, gastro-intestinal symptoms and hypotension. Coronary vasodilation may cause chest pain in patients with ischaemic heart disease. General supportive measures should be employed. Coronary vasodilation may be reversed by administering aminophylline by slow IV injection.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The antithrombotic activity of phosphodiesterase inhibitors, such as Dipyridamole, depend upon the activation of platelet adenylcyclase by potentiation of endogenous prostacyclin. Dipyridamole inhibits platelet function through its effect on prostacyclin metabolism in platelets.
5.2 Pharmacokinetic properties
Dipyridamole is readily absorbed from the gastro-intestinal tract. It is concentrated in the liver and is mainly excreted in the faeces. Excretion may be delayed by reabsorption. A small amount is excreted in the urine as glucuronide.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
lactose maize starch povidone
pregelatinised starch magnesium stearate bleached shellac sucrose talc
titanium dioxide beeswax carnauba wax orange colour
6.2 Incompatibilities
Sensitivity to Dipyridamole or any of the other ingredients of PYRIDANTIN. The concurrent use of antacids may reduce the efficacy of PYRIDANTIN.
6.3 Shelf life
36 Months (all pack sizes).
6.4 Special precautions for storage
Store below 25°C in well closed containers. Protect from light.
6.5 Nature and contents of container
Polypropylene or high density polystyrene with polythene closure and polyurethane wads or polythene inserts.
Packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000 tablets.
PVC/Aluminium foil blister packs 250 micron PVC glass-clear bluish rigid PVC (Pharmaceutical grade). 20 micron hard-tempered aluminium foil coated on the dull side with 6-7 gsm heat-seal lacquer and printed on the bright side.
Packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000 tablets.
6.6 Special precautions for disposal
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street,
3rd floor, 1060 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0042
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/12/2004
10 DATE OF REVISION OF THE TEXT
17/02/2009