Kcl tiếng anh là gì

DESCRIPTION

Potassium chloride extended-release capsules, USPhường are an oral dosage khung of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USPhường, equivalent to lớn 8 mEq & 10 mEq of potassium, respectively.

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Dispersibility of potassium chloride (KCl) is accomplished by microencapsulation và a dispersing agent. The resultant flow characteristics of the KCl microcapsules và the controlled release of K+ ions by the microcapsular membrane are intended to avoid the possibility that excessive amounts of KCl can be localized at any point on the mucosa of the gastrointestinal tract.

Each crystal of KCl is microencapsulated by a patented process with an insoluble polymeric coating which functions as a semi-permeable membrane; it allows for the controlled release of potassium và chloride ions over an eight- to ten-hour period. Fluids pass through the membrane và gradually dissolve sầu the potassium chloride within the microcapsules. The resulting potassium chloride solution slowly diffuses outward through the membrane. Potassium chloride extended-release capsules, USP.., are electrolyte replenishers. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. Potassium chloride, USP.., occurs as a White granular powder or as colorless crystals. It is odorless và has a saline taste. Its solutions are neutral to lớn litmus. It is freely soluble in water & insoluble in alcohol.

Inactive ingredients: edible ink, ethylcelluthảm bại, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide. May contain FD&C Red No. 40 và FD&C Yellow No. 6 aluminum lakes.


CLINICAL PHARMACOLOGY

Potassium ion is the principal intracellular cation of most toàn thân tissues. Potassium ions participate in a number of essential physiological processes, including the maintenance of intracellular tonicity; the transmission of nerve sầu impulses; the contraction of cardiac, skeletal and smooth muscle; & the maintenance of normal renal function.

The intracellular concentration of potassium is approximately 150 to lớn 160 mEq per liter. The normal adult plasma concentration is 3.5 khổng lồ 5 mEq per liter. An active sầu ion transport system maintains this gradient across the plasma membrane.

Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal lớn the amount excreted in the urine. The usual dietary intake of potassium is 50 khổng lồ 100 mEq per day.

Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops slowly as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to lớn these causes is usually accompanied by a concomitant loss of chloride & is manifested by hypokalemia và metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, và in advanced cases, flaccid paralysis and/or impaired ability khổng lồ concentrate urine.

If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency (e.g., where the patient requires long-term diuretic therapy), supplemental potassium in the size of high potassium food or potassium chloride may be able lớn restore normal potassium levels.

In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.


INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

For the treatment of patients with hypokalemia, with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to lớn the use of a lower dose of diuretic, which may be sufficient without leading to lớn hypokalemia.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were khổng lồ develop, (e.g., digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, & certain diarrheal states).

The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have sầu a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, và if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to lớn control milder cases. In more severe cases, và if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.


CONTRAINIDICATIONS

Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, axinh đẹp dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (e.g., spironolactone, triamterene, amiloride) (see OVERDOSAGE).

Controlled-release formulations of potassium chloride have sầu produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation.

All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis) or pharmacolô ghích (e.g., use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses khổng lồ exert anticholinergic effects) cause for arrest or delay in capsule passage through the gastrointestinal tract.


WARNINGS

Hyperkalemia (see OVERDOSAGE)

In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia và cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration & appropriate dosage adjustments.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin Converting Enzyme Inhibitors

Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given lớn patients receiving ACE inhibitors only with cchiến bại monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of potassium chloride can produce ulcerative sầu and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of potassium chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared khổng lồ sustained-release wax matrix formulations (less than one per 100,000 patient years). Because of the lachồng of extensive kinh doanh experience with microencapsulated products, a comparison between such products và wax matrix or enteric-coated products is not available. Potassium chloride extended-release capsules, USP.., are microencapsulated capsules formulated to lớn provide a controlled rate of release of microencapsulated potassium chloride và thus khổng lồ minimize the possibility of high local concentration of potassium near the gastrointestinal wall.

Prospective trials have sầu been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before và after one week of solid oral potassium chloride therapy. The ability of this mã sản phẩm khổng lồ predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix và microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (i.e., 96 mEq per day in divided doses of potassium chloride administered to fasted patients, in the presence of an anticholinergic drug to lớn delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (hemoccult testing). The relevance of these findings to lớn the usual conditions (i.e., non-fasting, no anticholinergic agent, smaller doses) under which controlled-release potassium chloride products are used is uncertain; epidemioxúc tích và ngắn gọn studies have sầu not identified an elevated risk, compared lớn microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. Potassium chloride extended-release capsules, USP, should be discontinued immediately và the possibility of ulceration, obstruction or perforation considered if severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occur.

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Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt, such as potassium bicarbonate, potassium citrate, potassium acetate or potassium gluconate.


PRECAUTIONS

General

The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium màn chơi, the physician should bear in mind that axinh đẹp alkalosis per se can produce hypokalemia in the absence of a deficit in total body toàn thân potassium, while adễ thương acidosis per se can increase the serum potassium concentration inlớn the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention lớn acid-base balance & appropriate monitoring of serum electrolytes, the electrocardiogram, và the clinical status of the patient.


Information for Patients

Physicians should consider reminding the patient of the following:

 To take each dose with meals and with a full glass of water or other suitable liquid. To take each dose without crushing, chewing, or sucking the capsules. To take this medicine following the frequency và amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations. To kiểm tra with the physician if there is trouble swallowing capsules or if the capsules seem to stiông chồng in the throat. To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

Laboratory Tests

Regular serum potassium determinations are recommended, especially in patients with renal insufficiency or diabetic nephropathy.

When blood is drawn for analysis of plasma potassium it is important lớn recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.


Drug Interactions

Potassium-sparing diuretics, angiotensin converting enzyme inhibitors (see WARNINGS).


Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenithành phố, mutageniđô thị & fertility studies in animals have sầu not been performed. Potassium is a normal dietary constituent.


Pregnancy

Teratogenic Effects: Category C

Animal reproduction studies have sầu not been conducted with potassium chloride extended-release capsules, USPhường. It is unlikely that potassium supplementation that does not lead khổng lồ hyperkalemia would have sầu an adverse effect on the fetus or would affect reproductive capađô thị.


Nursing Mothers

The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body toàn thân potassium is not excessive sầu, the contribution of potassium chloride supplementation should have sầu little or no effect on the level in human milk.


Geriatric Use

Clinical studies of potassium chloride extended-release capsules, USP, did not include sufficient numbers of subjects aged 65 và over lớn determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low kết thúc of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, & 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 greater in patients with impaired renal function. Because elderly patients are more likely to lớn have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


ADVERSE REACTIONS

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, and OVERDOSAGE).

Gastrointestinal bleeding & ulceration have sầu been reported in patients treated with potassium chloride extended-release capsules, USP.. (see CONTRAINDICATIONS & WARNINGS). In addition to lớn gastrointestinal bleeding và ulceration, perforation and obstruction have been reported in patients treated with other solid KCl dosage forms, và may occur with potassium chloride extended-release capsules, USP.

The most common adverse reactions khổng lồ the oral potassium salts are nausea, vomiting, flatulence, abdominal discomfort, and diarrhea. These symptoms are due to lớn irritation of the gastrointestinal tract and are best managed by taking the dose with meals, or reducing the amount taken at one time. Skin rash has been reported rarely with potassium preparations.


OVERDOSAGE

The administration of oral potassium salts khổng lồ persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, or if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS và WARNINGS). It is important to recognize that hyperkalemia is usually asymptomatic và may be manifested only by an increased serum potassium concentration (6.5 - 8.0 mEq/L) và characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of ST segment, and prolongation of the QT interval). Late manifestations include muscle paralysis và cardiovascular collapse from cardiac arrest (9 - 12 mEq/L).

Treatment measures for hyperkalemia include the following: (1) elimination of foods & medications containing potassium and of any agents with potassium-sparing properties; (2) intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to lớn trăng tròn units of crystalline insulin per 1,000 mL; (3) correction of acidosis, if present, with intravenous sodium bicarbonate; (4) use of exchange resins, hemodialysis, or peritoneal dialysis. In treating hyperkalemia, it should be recalled that in patients who have sầu 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.


DOSAGE AND ADMINISTRATION

The usual dietary intake of potassium by the average adult is 50 to lớn 100 mEq per day. Potassium depletion sufficient lớn cause hypokalemia usually requires the loss of 200 mEq or more of potassium from the total toàn thân store.

Dosage must be adjusted lớn the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of trăng tròn mEq per day. Doses of 40 lớn 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than trăng tròn mEq per day is given such that no more than 20 mEq is given in a single dose. Because of the potential for gastric irritation (see WARNINGS), potassium chloride extended-release capsules, USPhường, should be taken with meals và with a full glass of water or other liquid.

Patients who have sầu difficulty swallowing capsules may sprinkle the contents of the capsule onto lớn a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing và followed with a glass of cool water or juice khổng lồ ensure complete swallowing of the microcapsules. The food used should not be hot và should be soft enough khổng lồ be swallowed without chewing. Any microcapsule/food mixture should be used immediately & not stored for future use.


HOW SUPPLIED

Potassium chloride extended-release capsules, USPhường, containing 600 mg of microencapsulated potassium chloride (equivalent khổng lồ 8 mEq K), are pale orange capsules, imprinted "002" on the cap & toàn thân, packaged as follows:

NDC 51477-002-04 bottle of 100 capsules

NDC 51477-002-03 bottle of 500 capsules

Potassium chloride extended-release capsules, USPhường, containing 750 mg of microencapsulated potassium chloride (equivalent to lớn 10 mEq K), are pale orange và opaque white capsules, imprinted "001" on the cap & body, packaged as follows:

NDC 51477-001-04 bottle of 100 capsules

NDC 51477-001-03 bottle of 500 capsules

NDC 51477-001-11 unit dose packages of 100 capsules

Store at 20° - 25°C (68° - 77°F).

Dispense in tight container as defined in the USP.

 

Nesher Pharmaceuticals Inc.St. Louis, MO 63044

P10009-108/11


Principal Display Panel 8 mEq, 100-Count Bottle Label

NDC 51477-002-04

Potassium ChlorideExtended-Release Capsules, USPhường

8 mEq (600 mg)

100 Capsules Rx Only


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