Sytron

1. Name Of The Medicinal Product

Sytron

2. Qualitative And Quantitative Composition

Sodium feredetate 190mg (equivalent to 27.5mg of iron/5ml)

3. Pharmaceutical Form

Oral solution

4. Clinical Particulars

4.1 Therapeutic Indications

Iron deficiency anaemia, notably in paediatrics.

In pregnancy when other forms of oral iron may not be well tolerated.

Anaemias secondary to rheumatoid arthritis.

4.2 Posology And Method Of Administration

For oral administration:

Adults: 5ml increasing gradually to 10ml three times daily.

Elderly (over 65 years): As for adults.

Infants (including premature infants) up to 1 year: 2.5ml twice daily; somewhat smaller doses should be used initially.

1 to 5 years: 2.5ml three times daily.

6 to 12 years: 5ml three times daily.

4.3 Contraindications

None known

4.4 Special Warnings And Precautions For Use

None known

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

No adverse effects have been reported.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

Patients have occasionally complained of nausea or mild diarrhoea in the early stages of treatment. In such cases it has been found that if treatment is withdrawn for a short time, these symptoms quickly disappear and subsequently the patient will tolerate further doses, which should be on a somewhat reduced scale. Normal individuals have taken Sytron at twice the recommended dosage and some of these have experienced mild diarrhoea. This should be taken into account if dosage is increased much higher than the recommended scale.

4.9 Overdose

Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may occur.

Treatment of overdosage

1. Administer an emetic.

2. Emesis should be followed by gastric lavage with desferrioxamine solution (2g/l). Desferrioxamine 5g in 50ml to 100ml water should be introduced into the stomach following gastric emptying.

3. Keep the patient under constant surveillance to detect possible aspiration of vomitus. Maintain suction apparatus and standby emergency oxygen in case of need.

4. In adults, a drink of mannitol or sorbitol should be given to induce small bowel emptying. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children.

5. Severe poisoning: in the presence of shock and/or coma with high serum iron levels (adults >142µmol/l, children >90µmol/l), immediate supportive measures should be introduced. Desferrioxamine should be given by slow iv infusion (adults 5mg/kg/h, children 15mg/kg/h). The maximum dose is 80mg/kg/24h. Warning: hypotension may occur if the infusion rate is too rapid.

6. Less severe poisoning: im desferrioxamine should be administered (adults 50mg/kg to a maximum of 4g, children 1g 4 to 6 hourly).

7. Serum iron levels should be monitored throughout.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Iron preparations

ATC classification: B03A

After absorption, elemental iron is available for haemoglobin regeneration and reversal of anaemia associated with iron-deficient states.

5.2 Pharmacokinetic Properties

Sodium feredetate is not an iron salt as it contains iron in an un-ionised form. In this compound the iron is “insulated” or “sequestered” with the sodium salt of ethylenediamine tetra-acetic acid (EDTA) to form a chelate. This accounts for the fact that Sytron is not astringent and does not discolour teeth. Studies using radioactive tracers have shown that the iron chelate is split within the gastro-intestinal tract, releasing elemental iron which is absorbed and rendered available for haemoglobin regeneration.

Iron absorption is enhanced in iron-deficiency states. Post-absorption distribution of elemental iron is as follows: 60% to 70% is incorporated into haemoglobin and most of the remainder is present in storage forms, either as ferritin or haemosiderin, in the reticulo-endothelial system and to a lesser extent, hepatocytes. A further 4% is present in myoglobin and haeme-containing enzymes, or bound to transferrin in plasma. Excretion is mainly in the faeces.

EDTA passes through the body unchanged. The compound is poorly absorbed, and that which reaches the bloodstream is eliminated by both glomerular filtration and tubular excretion.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Methyl hydroxybenzoate

Propyl hydroxybenzoate

Citric acid monohydrate

Saccharin sodium

Glycerol

Sorbitol solution

Ethanol 96%

Black cherry flavour 51-779A

Ponceau 4R (E124)

Potable water

6.2 Incompatibilities

None known

6.3 Shelf Life

Unopened: 60 months

Opened: 3 months from date of opening

If this product has been diluted with water use within 14 days of preparation.

6.4 Special Precautions For Storage

Store below 30°C

6.5 Nature And Contents Of Container

Sytron is supplied in round amber glass bottles with a CRC cap. Each bottle contains either 125ml or 500ml or 2250ml of Sytron.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Water is the recommended diluent for this product.

7. Marketing Authorisation Holder

Archimedes Pharma Limited

250 South Oak Way

Green Park

Reading

Berkshire

RG2 6UG

UK

8. Marketing Authorisation Number(S)

PL 12406/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

13 October 1993/11 November 1998

10. Date Of Revision Of The Text

November 2007

® Sytron is a registered trade mark

SYTL500-SPC06