Potrelease TR Tablet

Potrelease TR Tablet

potassium chloride

Manufacturer:

SM Pharmaceuticals

Distributor:

SM Pharmaceuticals
Full Prescribing Info
Contents
Potassium chloride.
Description
Each tablet contains potassium chloride 600 mg.
Action
Pharmacology: Pharmacodynamics: Mode or Mechanisms of Action: Potassium is the predomination cation of (150 mEq per liter) within cells. Intracellular sodium content is relatively low. In extracellular fluid, sodium predominates and the potassium content is low (4 to 5 mEq per liter). A membrane-bound enzyme, sodium-potassium-activated adenosine triphosphatase (Na+ -K+ ATPase), actively transports or pumps sodium out of and potassium into cells in order to maintain these concentration gradients. The gradients are necessary for the conduction of nerve impulses in such specialized tissues as the heart, brain, and skeletal muscle, and to maintain normal renal function and acid-base balance. High intracellular potassium concentrations are necessary for numerous cellular metabolic processes.
Pharmacokinetics: Onset and Duration: Peak elevation of serum potassium levels following SR preparations is highly delayed (2hours) compared to liquid form (1hour).
Effect on serum potassium is generally confined to the first 3 hours after dosing.
Plasma Levels: (May vary depending on laboratory) 3.5 - 5 mEq/L (adult and child); 5 - 7.5 mEq/L (newborn); total body stores are approximately 50 mEq/kg or 3500 mEq. As a general rule, a decrease of 1 mEq/L in serum potassium reflects a 10 - 20% total body deficit; however, there is considerable variation; signs of hypokalaemia appear below 2.5 mEq/L; Levels above 7 mEq/L are dangerous. Clinical signs of hyperkalaemia are not reliable indicators of serum levels. Alkalosis decreases levels and acidosis increases levels.
Fate: When initially administered the rates of absorption and excretion are more rapid with the liquid than the SR forms; however, bioavailability is the same when administered long-term (78-90%). Approximately 10 mEq/day are eliminated in the feces; 7.5mEq/L in sweat and 60 - 90 mEq/day in urine.
Indications/Uses
Hypokalaemia, (treatment): Potassium supplements are indicated in patients with hypokalaemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalaemic familial periodic paralysis.
Hypokalaemia (prophylaxis): Potassium supplements are indicated to prevent hypokalaemia in patients whose dietary intake of potassium is inadequate and who are taking digitalis and diuretics. Potassium supplements are also indicated in patients who suffer from hepatic cirrhosis with ascites, aldosterone excess with normal renal function, severe diarrhoea, and potassium-losing nephropathy.
Dosage/Direction for Use
Adults: Oral, 600mg to 1,200mg of potassium chloride (or equivalence of 8 mEq to 16 mEq of Potassium) three times a day.
Paediatrics: Use is not recommended.
Overdosage
Treatment of hyperkalaemia includes: Discontinuing foods and medication which contain potassium and any potassium sparing diuretics; intravenous administration of insulin in 10 to 25% dextrose injection (using 10 units of insulin per 20 grams of dextrose) at a rate of 300 to 500ml of solution per hour; correction of any existing acidosis with intravenous sodium bicarbonate; and utilization of exchange resins, hemodialysis, or peritoneal dialysis. Caution must be observed when treating hyperkalaemia in digitalized patients since rapid reduction of serum potassium concentrations may induce digitalis toxicity.
Contraindications
Severe renal impairment with oliguria or azotemia, Untreated Addison's disease, Adynamia episodica-hereditaria, Acute dehydration, Heat cramps, Hyperkalaemia, Gastrointestinal obstruction, abnormal motility of ulceration and Metabolic acidosis.
Adverse Reactions
Those indicating need for medical attention: Confusion; Irregular heartbeat; Numbness or tingling in hands, feet, or lips; shortness of breath or difficulty in breathing; unexplained anxiety; unusual tiredness or weakness; weakness or heaviness of legs.
Note: These side effects are considered rare when oral dosage forms of potassium are administered to patients having normal renal function. Irregular heartbeat is usually the earliest clinical indication of hyperkalaemia and is readily detected by electrocardiogram.
Those indicating need for medical attention only if they continue or are bothersome: Diarrhoea, Nausea, Stomach pain and Vomiting.
Note: These side effects occur more frequently when the medication is not taken with food.
Drug Interactions
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate: not necessarily inclusive).
Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
Adrenocorticoids, glucocorticoids, especially with significant mineralocorticoid activity, or Corticotrophin (ACTH): concurrent use of these medications may decrease effects of potassium supplements on serum potassium concentrations, close monitoring of serum potassium concentration is recommended.
Antimuscarinics, especially atropine and related compounds: concurrent use with potassium chloride oral supplements, especially those with wax matrix, may increase severity of gastrointestinal lesions produced by potassium chloride alone; patients should be carefully monitored endoscopically for evidence of lesions.
Blood from blood bank: may contain up to 30 mEq of potassium/liter of plasma or up to 65 mEq/liter of whole blood when stored for more than 10 days or;
Diuretics, potassium-sparing, such as amiloride, spironolactone, or triamterene,
or;
Low-salt milk:
may contain up to 60 mEq of potassium/liter or;
Potassium-containing medications
, other, or Salt substitutes: most contain substantial amount of potassium; concurrent administration with potassium supplements tends to promote serum potassium accumulation with possible resultant hyperkalaemia, especially in patients with renal insufficiency.
Calcium salts: parenteral administration antagonizes the cardiotoxicity of hyperkalaemia; calcium should be used cautiously in patients receiving potassium and digitalis medications because of the danger of precipitating cardiac arrhythmias.
Captopril: concurrent administration may result in hyperkalaemia since reduction of aldosterone production induced by captopril may lead to elevation of serum potassium.
Digitalis glycosides: potassium supplements are not recommended for concurrent use in digitalized patients with severe or complete heart block; however, if potassium supplements need to be used to prevent or correct hypokalaemia in digitalized patients, carefully monitoring of serum potassium concentrations is extremely important to avoid hyperkalaemia, which is very dangerous in digitalized patients.
Exchange resins, sodium cycle, such as sodium polystyrene sulfonate: whether administered orally or rectally, serum potassium concentrations are reduced by sodium replacement of the potassium; fluid retention may occur in some patients because of the increased sodium intake.
Glucose-insulin infusion or Sodium bicarbonate infusion: serum potassium concentrations are reduced by promoting a shift of potassium ion into the cells.
Laxatives: chronic use or overuse of laxatives may reduce serum potassium concentrations by promoting excessive potassium loss from the intestinal tract.
Quinidine: concurrent use with potassium supplements usually enhances quinidine's antiarrhythmic effects.
Vitamin B12: extended-release dosage forms of potassium may reduce absorption of vitamin B12 from gastrointestinal tract, thus increasing requirement for vitamin B12.
Caution For Usage
User instructions: Swallow tablets whole with a full glass of water. Do not chew or crush the tablet.
Take with or immediately after food.
Additional Information: Potrelease TR Tablets utilize an inert wax matrix from which the drug is slowly leached out as it passes through the gastrointestinal tract.
The expended wax matrix may appear intact in the stool.
Storage
Store below 30°C.
Shelf-Life: 3 years.
MIMS Class
ATC Classification
B05XA01 - potassium chloride ; Belongs to the class of electrolyte solutions used in I.V. solutions.
Presentation/Packing
FC tab 600 mg (yellow colour, round shaped with deep concave surface) x 100 x 10's.
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