This information is intended for use by health professionals
1. Name of the medicinal product
PHOSPHATE SANDOZ® Effervescent Tablets
2. Qualitative and quantitative composition
PHOSPHATE SANDOZ Effervescent Tablets containing 1.936g of sodium acid phosphate anhydrous.
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
Hypercalcaemia associated with such conditions as hyperparathyroidism, multiple myelomatosis and malignancy.Hypophosphataemia associated with vitamin D resistant rickets and vitamin D resistant hypophosphataemic osteomalacia.
4.2 Posology and method of administration
PHOSPHATE SANDOZ Effervescent should be dissolved in 1/3 to 1/2 a tumblerful of water and taken orally.Dosage should be adjusted to suit the requirements of individual patients. Excessive dosage has been reported to produce hypocalcaemia in isolated cases. Particular care should therefore be taken to ensure appropriate dosage in the elderly. Adults Hypercalcaemia: up to 6 tablets daily (adjustment being made according to requirements). Vitamin D resistant hypophosphateaemic osteomalacia: 4-6 tablets daily.Children under 5 yearsHypercalcaemia: up to 3 tablets daily (adjustment being made according to requirements). Vitamin D resistant rickets: 2-3 tablets daily.
4.4 Special warnings and precautions for use
In cases of impaired renal function associated with hypercalcaemia and in cases where restricted sodium intake is required, e.g. congestive cardiac failure, hypertension or pre-eclamptic toxaemia, the sodium (20.4mmol per tablet) and potassium (3.1mmol per tablet) content of PHOSPHATE SANDOZ should be taken into consideration. In cases of hypercalcaemia associated with impaired renal function and hyperphosphataemia, the main effect of oral phosphate is to bind calcium in the gut and thus reduce calcium absorption.The effect of oral phosphate on serum phosphate is likely to be minimal, but close monitoring of serum levels is recommended.Soft tissue calcification and nephrocalcinosis have been reported in isolated cases following intravenous therapy with phosphate.This is thought to be a function of dosage and rapidity of phosphate administration. While such effects appear less likely to occur with oral phosphates, careful surveillance of patients is recommended, especially if on long term therapy.
4.5 Interaction with other medicinal products and other forms of interaction
Concurrent administrations of antacids, containing agents such as aluminium hydroxide, may result in displacement of calcium from binding to oral phosphate, thus reducing efficacy.
4.6 Pregnancy and lactation
The safety of PHOSPHATE SANDOZ in human pregnancy has not been formally studied, but the drug has been widely used for many years without ill-consequence.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Apart from gastro-intestinal upsets, nausea and diarrhoea, very few side effects have been reported.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation 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 via the national reporting system in the United Kingdom: Yellow Card SchemeWebsite: www.mhra.gov.uk/yellowcard
Excessive dosage has been reported to produce hypocalcaemia in isolated cases. This has proved reversible when dosage has been adjusted.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Oral administration of inorganic phosphates produces a fall in serum calcium in patients with hypercalcaemia. PHOSPHATE SANDOZ Effervescent Tablets also contain sodium ions which aid the correction of the dehydration and sodium depletion seen in hypercalcaemia.
5.2 Pharmacokinetic properties
Approximately two thirds of ingested phosphate is absorbed from the gastro-intestinal tract; most of the absorbed phosphate is then filtered by the glomeruli and subsequently undergoes reabsorption. Parathyroid hormone and vitamin D stimulate absorption of phosphate from the small intestine and its reabsorption from the proximal tubule. Virtually all absorbed phosphate is eventually excreted in the urine, the remainder being excreted in the faeces.
5.3 Preclinical safety data
PHOSPHATE SANDOZ Effervescent Tablets contain sodium acid phosphate, anhydrous, sodium bicarbonate and potassium bicarbonate (all of which are subject to pharmacopoeial monographs). The physiological, pharmacological and clinical toxicity of potassium salts are well documented and limited animal data are therefore available.
6. Pharmaceutical particulars
6.1 List of excipients
Potassium bicarbonate, sodium bicarbonate, sodium saccharin, orange flavour 52.570 TP, polyethylene glycol 4000, sugar icing CP, citric acid anhydrous, water.
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container. Keep the container tightly closed
6.5 Nature and contents of container
Polypropylene tubes of 20 effervescent tablets in boxes of 5 tubes (100 tablets).
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Alturix Limited287 Upper Fourth StreetMilton KeynesMK9 1EH
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
28th April 1998
10. Date of revision of the text