DIPYRIDAMOLE Oral Suspension Ref.[7997] Active ingredients: Dipyridamole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Syri Limited t/a Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Therapeutic indications

An adjunct to oral anti-coagulation for prophylaxis of thrombo-embolism associated with prosthetic heart valves.

Posology and method of administration

Adults: 300-600mg (7.5-15ml) daily in three or four doses.

Children: Dipyridamole is not recommended for children.

Dipyridamole should usually be taken before meals.

Method of administration

For oral use only.

Shake well before use.

Overdose

Symptoms

Due to the low number of observations, experience with dipyridamole overdose is limited. Symptoms such as a warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness and anginal complaints can be expected. A drop in blood pressure and tachycardia might be observed.

Therapy

Symptomatic therapy is recommended. Administration of xanthine derivatives (e.g. aminophylline) may reverse the haemodynamic effects of dipyridamole overdose. Due to its wide distribution to tissues and its predominantly hepatic elimination, dipyridamole is not likely to be accessible to enhanced removal procedures.

Shelf life

21 months.

Discard after 60 days of first opening.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

*ottle: Ph.Eur Type III Amber glass

Closure: Tamper evident, child resistant, plastic (Polypropylene/Polyethylene) cap with an EPE liner.

Dosing Device: Double ended white polypropylene plastic spoon with 2.5ml and 5ml measuring ends.

Pack size: 150ml and 300ml.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

This product may settle during storage. Shake the bottle well before use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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