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POTASSIUM CITRATE

acalkaź





FORMULATION:
Each tablet contains:
Potassium Citrate .............................................................(10mEq) 1,080 mg

INDICATIONS:
- Treatment of patients with renal lithiasis and hypocitraturia, chronic
Formers of calcium oxalate, phosphate calculia
- Uric acid lithiasis alone or accompanied by calcium lithiasis
- Tubular acidosis with calcium nephrolithiasis

DOSAGE:
The aim of the treatment is to restore the level of the urinary citrate and to increase the pH of urine to 6-7, and to this end, the dosage pattern are:
- In patients with severe hypocitraturia start the treatment with a dose of 60mEq (6 tablets) daily, divided into 3 takings daily.
- In patients with mild hypocitraturia start the treatment with a dose of 30mEq (3 tablets) daily, divided into 3 takings daily.

It is recommended to take the tablets 30 minutes after meals. Approximately 24 hours after having started the treatment, make determination of urinary citrate and pH, and adjust the dose in accordance with the needs of the patient. If necessary, the dose can be increased, though it is not advisable to exceed the dose of 100 mEq (10 tablets) /day.

IMPORTANT NOTE:
THE TABLETS MUST NOT BE MASTICATED OR DILUTED.
The active component of Acalka (potassium citrate) is contained within a porous wax matrix. As this WAX MATRIX IS INSOLUBLE, IT CAN BE ELIMINATED IN VISIBLE FORM IN THE FECES. The active component, however, has been released in the gastrointestinal tract.

CONTRAINDICATION:
  • Renal Insufficiency
  • Persistent alkaline urinary infections
  • Obstruction of the Urinary tract
  • Hyperpotassemia
  • Adrenal insufficiency
  • Respiratory or metabolic alkalosis
  • Active peptic ulcer
  • Intestinal obstruction
  • Patients submitted to anticholinergic therapy
  • Patients with slow gastric emptying
INTERACTIONS:
Must not be administered to patients receiving potassium-sparing diuretics (triamtrene, spirolactone or amyloride)

ADVERSE REACTIONS:
Slight gastrointestinal disorders may appear which can be palliated by means of the joint administration of food.

PRECAUTIONS AND WARNINGS:
In patients with altered potassium excretion mechanism, hyperpotassemia may appear.

In patients with renal insufficiency there is an increased risk of appearance of hyperpotassemia, and, for this reason, it is advised not to exceed the recommended doses.

It is advisable to carry out an evaluation of electrolytes (Na-K-Cl) and CO2, createnine and hemogram every 4 hours.

It is recommended that during pregnancy and lactation, the product is administered upon strict medical control.

It is recommended that patients in treatment with ACALKA follow a diet without salt and increase intake of liquids.

Once the active principle is released, the porous wax matrix, in which it was contained for its gradual release, can be eliminated in a still visible way in the feces.

CAUTION:
Food, drugs, Devices and Cosmetics Act prohibits the dispensing without prescription.

OVERDOSAGE AND ITS TREATMENT:
The long-term administration in patients having a trend to retain potassium may produce hyperpotassemia. In advanced phase, muscular paralysis and cardiovascular collapse may be produced.

The recommended treatment in case of hyperpotassemia is: IV administration of 10% dextrose solution, containing 10-12 units of insulin/1000ml. Correction of the possible acidosis with IV sodium bicarbonate and hemodialysis or peritoneal dialysis.

AVAILABILITY: Bottles of 30's

STORE AT TEMPERATURE NOT EXCEEDING 30°C
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