Sterile Potassium Acid Phosphate Solution

Sterile Aqueous Solution - Injection.

4.1 Therapeutic indications As a source of potassium ions and phosphate ions in electrolyte replacement therapy.4.2 Posology and method of administration The normal concentration of serum inorganic phosphate is 3 to 4.5mg (0.03 to 0.045mmol) per 100ml in adults and 4 to 7 mg (0.04 to 0.07mmol) per 100ml in children.Before administration, the concentrated phosphate injection must be diluted and thoroughly mixed with a larger volume of fluid.The dose and rate of administration must be individualised.When used as an electrolyte replenisher, a dose of the equivalent of 10 to 15mmol (310mg to 465mg) of phosphorus a day is usually sufficient to maintain normal serum phosphate, although larger amounts may be required in hypermetabolic states.The solution should be infused slowly to avoid phosphate intoxication. **Usual adult and adolescent dose** As an electrolyte replenisherThe equivalent of 10mmol (310mg) of phosphorus a day by intravenous infusion **Usual Paediatric use** As an electrolyte replenisherThe equivalent of 1.5 to 2 mmol (46.5 to 62mg) of phosphorus a day by intravenous infusion.4.3 Contraindications HyperphosphataemiaRenal function impairment severe - less than 30% of normalUrolithiasisRisk - Benefit should be considered when the following medical problems exist(reasons given when appropriate):Conditions in which high phosphate concentrations may be encountered, such asHypoparathyroidismChronic Renal Disease.Conditions in which low calcium concentrations may be encountered, such as:HypoparathyroidismOsteomalaciaAcute Pancreatitis.Chronic Renal disease.RicketsSensitivity to Potassium or Phosphates.Cardiac disease, particularly in digitalised patients.Conditions in which high potassium concentrations may be encountered, such as:Severe adrenal insufficiency - Addison's diseaseAcute dehydration.Severe renal insufficiency.Extensive tissue breakdown, such as severe burns.Myotonia congenita4.4 Special warnings and precautions for use The product must be diluted before use.Electrocardiogram (may be required at regular intervals during intravenous therapy)4.5 Interaction with other medicinal products and other forms of interaction Interactions with other medications include Captopril, Potassium - Sparing Diuretics, Enalapril, Lisinopril, Adrenocorticoids, Glucocorticoids (especially those with significant mineralocorticoid activity), Mineralocorticoids, Corticotropin (ACTH), Anabolic Steroids or Androgens.Interaction with potassium containing medications (concurrent use with potassium phosphate may result in hyperkalaemia; patient should have serum potassium concentration determinations at periodic intervals). **Interaction with Digitalis Glycosides** Use of potassium phosphate injection in digitalised patients with severe or complete heart block is not recommended because of possible hyperkalaemia. **Interaction with Diuretics or Thiazides** Concurrent use with phosphate may cause or worsen renal damage. **Interaction with Mexiletine** May lead to marked acidification of urine by monobasic potassium phosphate and potassium and sodium phosphates combination may accelerate excretion of Mexiletine. **Interaction with Quinidine** Concurrent use with potassium phosphate usually enhances effects of the Quinidine. **Interaction with Salicylates** Concurrent use with potassium and sodium phosphates combination or monobasic potassium phosphate may increase plasma concentrations of salicylates since salicylate excretion is decreased in acidified urine; addition of these phosphates to patients stabilised on a salicylate may lead to toxic salicylate concentrations.4.6. Pregnancy and lactation There has been no adequate and well controlled studies carried out in this area in either humans or animals.It is not known if phosphates are excreted in breast milk. However problems in nursing infants have not been documented.4.7 Effects on ability to drive and use machines None stated4.8 Undesirable effects Undesirable effects include:Fluid retention (swelling of feet or lower legs and weight gain).Hyperkalemia (confusion, tiredness or weakness, irregular or slow heartbeat, numbness or tingling around lips, hands or feet, unexplained anxiety, weakness or heaviness of legs, shortness of breath or troubled breathing).Hypernatremia (confusion, tiredness or weakness, convulsions, decrease in amount of urine or in frequency of urination, fast heartbeat, headache or dizziness, increased thirst).Hyperphosphataemia.Hypocalcemic tetany (muscle cramps, numbness, tingling, pain or weakness in hands or feet, shortness of breath or troubled breathing).4.9 Overdose May result in hyperkalaemia and hyperphosphataemia.Recommended treatment consists of the following:-Withholding administration of phosphatesCorrecting deficient serum electrolyte concentrations (such as that of calcium)

5.1 Pharmacodynamic properties Potassium is the principle cation in intracellular fluid. It is involved with carbohydrate metabolism, glycogen storage and protein synthesis.It is involved with transmembrane potential and profound effects on muscle.Phosphorus has many important biochemical functions in the body and is involved in many significant metabolic and enzyme reactions in almost all organs and tissues.5.2 Pharmacokinetic properties The normal levels of potassium in intracellular fluid and plasma are 160mmol/l and 3.5 - 5.0mmol/l respectively.The normal level of phosphate in plasma is 0.8 - 1.5mmol/l.5.3 Preclinical safety data No data available.

6.1 List of excipients Disodium Edetate BPWater for Injection BP6.2 Incompatibilities A precipitate may form when phosphates are added to a solution containing calcium or magnesium.6.3 Shelf life 36 Months.6.4 Special precautions for storage None noted.6.5 Nature and contents of container Product is filled into clear colourless 10ml ampoules of Ph.Eur. type I glass.Packed into cartons of 10 ampoules.6.6 Special precautions for disposal and other handling None