Phosphate Novartis (Sodium Acid Phosphate)

PHOSPHATE-NOVARTIS

Novartis Pharmaceuticals

Sodium Acid Phosphate

Hypercalciuria – Electrolyte Replenisher

Indications And Clinical Uses: Hypercalciuria, electrolyte replenisher.

Contra-Indications: Do not use this medication if hyperphosphatemia is present or in the presence of severe impairment of renal function (less than 30% of normal).

Manufacturers’ Warnings In Clinical States: Use carefully in patients with cardiac disease treated with digitalis and in conditions where high potassium concentration may be encountered such as: adrenal insufficiency, acute dehydration, severe renal insufficiency, in conditions such as in severe burns, where high tissue breakdown is expected.

Because of the sodium content of this product, use carefully in the presence of cardiac failure, liver cirrhosis or severe hepatic disease, edema, hypernatremia, hypertension and toxemia of pregnancy.

Precautions: High phosphate intake may result in high serum concentrations which may be associated with an increase in extraskeletal calcification. If long-term therapy is prescribed, the following patient monitoring may be warranted: evaluation of renal function, and serum determination of the following ions: calcium, phosphorus, potassium, sodium.

Pregnancy: No well-controlled studies have been conducted in humans or in animals to determine the effect of phosphate during pregnancy. Nevertheless, the benefit of treatment should be considered in relation to the risks before instituting treatment in a pregnant woman.

Lactation: It is not known if phosphates are excreted in breast milk. However, problems in nursing infants have not been documented.

Drug Interactions: Concurrent use of sodium phosphates with glucocorticoids and related compounds may result in hypernatremia.

Androgens and anabolic steroids may increase the risk of edema.

Oxalates and phytates in food, and aluminum and/or magnesium antacids may bind phosphates and prevent absorption.

Calcium containing drugs (e.g. dietary supplement and antacids) may increase the risk of calcium deposition in soft tissues.

Drugs containing potassium and ACE inhibitors may produce hyperkalemia.

Thiazide diuretics taken with phosphates may cause or worsen renal damage.

Iron supplements will form insoluble complex with phosphates resulting in a decreased absorption of iron.

Phosphates by producing marked acidification of urine may accelerate excretion of mexiletine and decrease salicylate excretion. Potassium content in this drug may enhance quinidine’s effects.

Vitamin D enhances phosphate absorption and may increase potential for hyperphosphatemia if taken with high doses of phosphate.

Adverse Reactions: The following reactions have been reported: nausea, vomiting, stomach pain, laxative effect or diarrhea, and less frequently: fluid retention associated with swelling of feet and/or weight gain, hyperkalemia associated with confusion; tiredness or weakness; irregular or slow heartbeat; numbness or tingling around lips, hands or feet; unexplained anxiety; breathing problems, hypernatremia associated with confusion; convulsions; decrease in urine volume or in frequency of urination; fast heartbeat; headache or dizziness; increased thirst; hyperphosphatemia or hypocalcemic tetany associated with muscle cramps; numbness, tingling, pain, or weakness in hands or feet; shortness of breath or troubled breathing.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Withhold further administration of phosphates. Correct deficient serum electrolyte concentrations (such as that of calcium). Implement general supportive measures.

Dosage And Administration: Adults: Usual dosage for hypercalciuria and as an electrolyte replenisher: 1 tablet 2 times a day with meals. Adjust dose according to patient response.

Children: Half of the adult dose.

Take tablets only when dissolved in water. Use preferably 250 mL of diluent. Use only on the advice of a physician.

Do not take if renal function is impaired or if sodium (table salt) restriction has been prescribed.

Availability And Storage: Each white, round, flat tablet, approximately 25 mm in diameter with a coarse surface, contains: phosphorus 500 mg from anhydrous sodium acid phosphate 1 936 mg. Also contains potassium 123 mg (3.1 mmol), sodium 469 mg (20.4 mmol), sucrose and calcium cyclamate. Energy: 9.9 kJ (2.38 kcal). Lactose-, paraben-, starch-, sulfite- and tartrazine-free. Tubes of 20. Store at 15 to 30°C, protect from heat and humidity.

PHOSPHATE-NOVARTIS Novartis Pharmaceuticals Sodium Acid Phosphate Hypercalciuria – Electrolyte Replenisher

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