KLOR-CON Extended-release tablet Ref.[10576] Active ingredients: Potassium chloride

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

Klor-Con is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

2. Dosage and Administration

2.1 Administration and Monitoring

If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation.

Monitoring

Monitor serum potassium and adjust dosages accordingly. Monitor serum potassium periodically during maintenance therapy to ensure potassium remains in desired range.

The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms, and the clinical status of the patient. Correct volume status, acid-base balance, and electrolyte deficits as appropriate.

Administration

Take Klor-Con with meals and with a glass of water or other liquid. Do not take Klor-Con on an empty stomach because of its potential for gastric irritation [see Warnings and Precautions (5.1)].

Swallow tablets whole without crushing, chewing or sucking.

2.2 Dosing

Dosage must be adjusted to the individual needs of each patient. Dosages greater than 40 mEq per day should be divided such that no more than 40 mEq is given in a single dose.

Treatment of Hypokalemia: Typical dose range is 40 to 100 mEq per day.

Maintenance or Prophylaxis: Typical dose range is 20 mEq per day.

10. Overdosage

10.1 Symptoms

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, potentially fatal hyperkalemia can result [see Contraindications and Warnings].

It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5 mEq/L to 8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 to 12 mEq/L).

10.2 Treatment

Treatment measures for hyperkalemia include the following:

  • Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties.
  • Intravenous administration of 300 mL/hr to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.
  • Correction of acidosis, if present, with intravenous sodium bicarbonate.
  • Use of exchange resins, hemodialysis or peritoneal dialysis.

In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.

The extended-release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Dispense in a tight container with a child-resistant closure.

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