Index
USP Potassium Chloride Extended Release Tablets, 20 mEq are electrolyte replenishers.
The chemical name of the active ingredient is panangin chloride ( potassium aspartate ) and the structural formula is KCl.
Panangin chloride (potassium aspartate) occurs as a white granular powder or as colorless crystals. It is odorless and has a salty taste. Their solutions are litmus neutral. It is freely soluble in water and insoluble in alcohol.
Panangin is a tablet formulation (non-enteric or wax matrix) containing individually microencapsulated panangin chloride crystals that disperse as the tablet disintegrates.
In simulated gastric fluid at 37 ° C and in the absence of external agitation, USP Potassium Chloride Extended Release Tablets, 20 mEq begin to disintegrate into microencapsulated crystals in seconds and fully disintegrate in 1 minute.
The microencapsulated crystals are formulated to provide a sustained release of panangin chloride.
Inactive Ingredients: Colloidal Silicon Dioxide, Crospovidone, Diethyl Phthalate, Ethyl Cellulose, Microcrystalline Cellulose.
Clinical pharmacology
The panangin ion (potassium aspartate) is the main intracellular cation of most body tissues .
Panangin ions participate in a number of essential physiological processes including maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of the cardiac, skeletal and smooth muscle; and the maintenance of normal kidney function.
The intracellular concentration of panangin is approximately 150 to 160 mEq per liter. The normal plasma concentration in adults is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.
Panangin is a normal dietary component and, under steady state conditions, the amount of panangin that is absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of panangin is 50 to 100 mEq per day.
Panangine depletion will occur whenever the rate of panangin loss through renal excretion and / or loss from the gastrointestinal tract exceeds the rate of ingestion of panangin.
Such exhaustion usually develops as a consequence of diuretic therapy, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate panangin replacement in patients on prolonged parenteral nutrition.
Depletion can develop rapidly with severe diarrhea, especially if it is associated with vomiting.
Panangin depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Panangin depletion can lead to weakness and fatigue.
If panangin depletion associated with metabolic alkalosis cannot be controlled by correcting the root cause of the deficiency, for example when the patient requires long-term diuretic therapy, supplementing panangin in the form of high panangin food can restore normal levels by panangin.
Indications and use
Due to reports of intestinal and gastric ulceration and bleeding with controlled-release panagin chloride preparations, these medications should be reserved for those patients who cannot or refuse to ingest effervescent fluids (panangin) or for those who have problems complying with the preparations. .
- For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis.
If hypokalemia is the result of diuretic therapy, a lower dose of diuretic should be considered, which may be sufficient without causing hypokalemia.
- For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, for example digitized patients or patients with significant cardiac arrhythmias.
The use of panangin salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used.
However, panangin serum should be monitored regularly, and if hypokalemia occurs, dietary supplements with potassium-containing foods may be adequate to control milder cases.
In more severe cases, and if the diuretic dose adjustment is ineffective or unwarranted, panangin supplementation may be indicated.
Contraindications
Panangin supplements are contraindicated in patients with hyperkalaemia, as a further increase in serum panangin concentration in such patients can lead to cardiac arrest. Hyperkalemia can complicate any of the following conditions:
- Chronic renal insufficiency.
- Systemic acidosis, such as diabetic acidosis, acute dehydration.
- Extensive tissue destruction as in severe burns, adrenal insufficiency.
- Administration of a potassium-sparing diuretic (eg, spironolactone, triamterene, amiloride).
Controlled-release formulations of panangin chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium.
Panangin supplementation, when indicated in such patients, should be administered as a liquid preparation or as an aqueous suspension of panangin chloride.
All solid oral pharmaceutical forms of panangin are contraindicated in patients in whom there is a structural (eg, diabetic gastroparesis) or pharmacological pathology (use of anticholinergic agents or other agents with anticholinergic properties in sufficient doses to exert anticholinergics).
The effects of these are the cause of arrest or delay in the passage of the tablet through the gastrointestinal tract.
Warnings
Hyperkalemia
In patients with altered mechanisms for excreting panangin, administration of panangin salts can cause hyperkalemia and cardiac arrest. This occurs most often in patients receiving intravenous panangin, but can also occur in patients receiving oral panangin.
Life-threatening hyperkalemia can develop rapidly and be asymptomatic.
The use of panangin salts in patients with chronic kidney disease or any other condition affecting the excretion of panangin requires particularly careful monitoring of the serum panangin concentration and appropriate dose adjustment.
Interaction with potassium-sparing diuretics
Hypokalaemia should not be treated with concomitant administration of panangin salts and a potassium-sparing diuretic (eg, spironolactone, triamterene, or amiloride) as simultaneous administration of these agents can lead to severe hyperkalaemia.
Interaction with Angiotensin Converting Enzyme Inhibitors
Angiotensin converting enzyme (ACE) inhibitors (eg, Captopril, enalapril) will cause some retention of panangin by inhibiting aldosterone production. Panangin supplements should be given to patients receiving ACE inhibitors only with close monitoring.
Gastrointestinal injuries
Solid oral dosage forms of panangin chloride can produce ulcerative and / or stenotic lesions of the gastrointestinal tract.
According to reports of spontaneous adverse reactions, enteric coated preparations of panangin chloride are associated with a higher frequency of small bowel injury compared to sustained release wax matrix formulations.
Due to the lack of extensive marketing experience with microencapsulated products, there is no comparison between such products and the wax matrix or enteric coated products.
Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after 1 week of solid oral therapy with panangin chloride.
The ability of this model to predict events that occur in routine clinical practice is unknown. Trials that approximated routine clinical practice did not reveal any clear difference between wax matrix and microencapsulated dosage forms.
In contrast, there was a higher incidence of gastric and duodenal lesions in subjects who received a high dose of a wax matrix controlled release formulation under conditions that did not resemble usual or recommended clinical practice.
That is, 96 mEq per day in divided doses of panangin administered to fasting patients in the presence of an anticholinergic drug to delay gastric emptying.
The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult test).
The relevance of these findings to routine conditions (ie, non-fasting, no anticholinergic agent, smaller doses) using panangin controlled release chloride products is uncertain.
Epidemiological studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations.
Potassium Chloride Extended Release Tablets USP, 20 mEq should be discontinued immediately and the possibility of ulceration, obstruction or perforation should be considered if severe vomiting, abdominal pain, bloating,
Metabolic acidosis
Hypokalemia in patients with metabolic acidosis should be treated with an alkaline salt of panangin such as panangin bicarbonate, panangin citrate, potassium aspartate (panangin) acetate, or panangin gluconate.
Precautions
General
The diagnosis of panangin depletion is usually made by demonstrating hypokalemia in a patient with a medical history suggesting some cause of panangin depletion.
In interpreting the serum level of panangin, the clinician should take into account that acute alkalosis per se can produce hypokalemia in the absence of a total body deficit of panangin.
While acute acidosis per se can increase serum panangin (potassium aspartate concentration) in the normal range even in the presence of a reduced total body panangin.
Treatment of panangin depletion, particularly in the presence of heart disease, kidney disease, or acidosis, requires careful attention to acid-base balance and proper control of serum electrolytes.
Lab tests
When drawing blood for plasma panangin analysis, it is important to recognize that artificial elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the specimen.
Drug interactions
Potassium-sparing diuretics, angiotensin converting enzyme inhibitors.
Carcinogenesis, mutagenesis, impaired fertility
Carcinogenicity, mutagenicity, and fertility studies have not been performed in animals. Panangin is a normal dietary component.
Pregnancy category C
Animal reproduction studies have not been performed with panangin potassium chloride extended-release tablets, 20 mEq. Panangin supplements that do not lead to hyperkalemia are unlikely to have an adverse effect on the fetus or affect reproductive ability.
Nursing mothers
The normal panangin ion content of human milk is approximately 13 mEq per liter.
Since oral panangin is part of the panangin group, as long as panangin is not excessive in the body, the contribution of panangin chloride supplementation should have little or no effect on the level in human milk.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
Geriatric use
Clinical studies of panangin chloride did not include a sufficient number of subjects 65 years of age and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between older and younger patients.
In general, dose selection for an elderly patient should be cautious, generally starting at the lower end of the dosage range, reflecting the greater frequency of decreased liver, kidney, or heart function, and of concomitant disease or other drug therapy. .
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be higher in patients with kidney failure.
Because elderly patients are more likely to have decreased kidney function, care must be taken in the selection of the dose; and it can be helpful in monitoring kidney function.
Adverse reactions
One of the most serious adverse effects is hyperkalemia. Upper and lower gastrointestinal problems including obstruction, bleeding, ulceration, and perforation have also been reported.
The most common adverse reactions to oral panangin salts are nausea, vomiting, flatulence, abdominal pain / discomfort, and diarrhea.
These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation, taking the dose with meals, or reducing the amount taken at the same time.
Overdose
Administration of oral panangin salts to persons with normal excretory mechanisms for panangin rarely causes severe hyperkalemia. However, if excretory mechanisms are impaired or panangin is given too rapidly intravenously, life-threatening hyperkalemia may occur.
It is important to recognize that hyperkalemia is generally asymptomatic and can manifest itself only by an increase in serum panangin concentration (6.5-8.0 mEq / L) and characteristic electrocardiographic changes (T-wave spikes, P-wave loss, ST segment depression, and QT interval prolongation).
Late manifestations include muscle paralysis and cardiovascular collapse due to cardiac arrest (9-12 mEq / L).
Treatment measures for hyperkalemia include the following:
- Patients should be closely monitored for arrhythmias and electrolyte changes.
- Elimination of foods and medications that contain panangin and any agent with potassium-sparing properties, such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDs, certain nutritional supplements, and many others.
- Intravenous calcium gluconate if the patient is not at risk of developing digitalis toxicity.
- Intravenous administration of 300 to 500 ml / h of 10% dextrose solution containing 10-20 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 the treatment of hyperkalaemia, it should be remembered that in patients who have been stabilized with digitalis, too rapid a decrease in the serum concentration of panangin can lead to digitalis toxicity.
The time-release feature means absorption and toxic effects can be delayed for hours.
Consider standard measures to eliminate any unabsorbed drugs.
Dosage and administration
The usual dietary intake of panangin for an average adult is 50 to 100 mEq per day. Depletion of panangin sufficient to cause hypokalemia generally requires the loss of 200 or more mEq of panangin from the total body store.
The dose should be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day.
Doses of 40-100 mEq per day or more are used for the treatment of panangin depletion. The dose should be divided if more than 20 mEq is given per day, so that no more than 20 mEq is given in a single dose.
Each 20 mEq USP Potassium Chloride Extended Release Tablet provides 20 mEq of panangin chloride.
Potassium Chloride Extended Release Tablets USP, 20 mEq should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach due to its potential gastric irritation.
Patients who have difficulty swallowing tablets whole can try one of the following alternative methods of administration:
- Break the tablet in half and take each half separately with a glass of water.
- Prepare an aqueous suspension (water) as follows:
- Place the entire tablet (s) in about 1/2 glass of water (4 fluid ounces).
- Wait approximately 2 minutes for the tablet (s) to disintegrate.
- Shake for about half a minute after the tablet (s) have disintegrated.
- Shake the suspension and consume the entire contents of the glass immediately by drinking or through a straw.
- Add another 1 ounce of liquid water, shake, and consume immediately.
- Then add an additional 1 ounce of water, shake, and consume immediately.
The aqueous suspension of panangin chloride that is not taken immediately should be discarded. The use of other liquids is not recommended to suspend Potassium Chloride Extended Release Tablets USP, 20 mEq.
