STERILE POTASSIUM ACID PHOSPHATE Solution for injection Ref.[27509] Active ingredients: Potassium phosphate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 1999  Publisher: Macarthys Laboratories Limited, T/A Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford, RM3 8UG

4.3. Contraindications

Hyperphosphataemia

Renal function impairment severe – less than 30% of normal

Urolithiasis

Risk – Benefit should be considered when the following medical problems exist

(reasons given when appropriate):

Conditions in which high phosphate concentrations may be encountered, such as

Hypoparathyroidism

Chronic Renal Disease.

Conditions in which low calcium concentrations may be encountered, such as:

Hypoparathyroidism

Osteomalacia

Acute Pancreatitis.

Chronic Renal disease.

Rickets

Sensitivity 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 disease

Acute dehydration.

Severe renal insufficiency.

Extensive tissue breakdown, such as severe burns.

Myotonia congenita

4.4. 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 stated.

4.8. 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).

6.2. Incompatibilities

A precipitate may form when phosphates are added to a solution containing calcium or magnesium.

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