Date of approval:
Date of revision:
Potassium Chloride Granules Instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name
Generic name: Potassium Chloride Granules
English name: Potassium Chloride Granules
Hanyu Pinyin: Lühuajia Keli
Ingredients
The main ingredient of this product is potassium chloride.
Chemical name: Potassium chloride
Molecular Formula: KCl
Molecular weight: 74.55
Properties
This product is light pink to orange soluble granules.
Indications
For the treatment and prevention of hypokalemia with or without metabolic alkalosis, when dietary management with potassium-rich foods or reduction of diuretic doses is not effective in these patients.
Specification
(1) 1.05g per sachet: 1.0g of potassium chloride (2) 1.57g per sachet: 1.5g of potassium chloride
Dosage
Oral potassium salt is used for the treatment of mild hypokalemia or prophylaxis. The regular dose for adults is 0.5~1g (6.7~13.4mmol) per time, dissolved in warm water and taken 1~3 times daily after meals, and the dose is adjusted according to the condition. Generally, the maximum daily dose for adults is 6g (80mmol).
Monitoring
If the blood potassium concentration is below 2.5 mmol/L, replace oral supplementation by intravenous potassium injection.
Monitor blood potassium and adjust the dose accordingly. For the treatment of hypokalemia, monitor blood potassium levels daily or more frequently depending on the severity of the hypokalemia until it returns to normal. For maintenance and prophylaxis, monitor potassium levels monthly to semi-annually.
Treatment of potassium loss, especially in cardiac disease, renal disease or acidosis, requires close attention to acid-base balance, fluid volume, electrolytes including sodium, calcium, magnesium, chloride, phosphorus, ECG and the patient’s clinical status. Volume status, acid-base balance and electrolyte loss should be correctly corrected.
Adverse reactions
(1) Oral administration may have gastrointestinal irritation, such as nausea, vomiting, pharyngeal discomfort, chest pain (esophageal irritation), flatulence abdominal pain, abdominal discomfort, diarrhea, and even peptic ulcer, bleeding, perforation and obstruction. It is more likely to occur on an empty stomach, in higher doses and in those with pre-existing gastrointestinal disorders.
(2) Hyperkalemia.
(3) Rare skin rash.
Contraindications
Contraindicated in the following patients.
1. hypersensitivity to any of the ingredients in this product.
2. patients with hyperkalemia.
3. patients with low urine output and urinary shutdown.
4. Patients who are injecting potassium-protective diuretics.
Precautions
(1) Use with caution in the following cases.
(1) In metabolic acidosis with oliguria. (2) Patients with reduced adrenal cortical function. (3) Acute dehydration, which may lead to reduced urine output and urinary K+ excretion in severe cases. ④Used with caution in acute renal insufficiency and chronic renal insufficiency. ⑤ Familial periodic paralysis and hypokalemic paralysis should be given potassium supplementation, but it is necessary to distinguish between hyperkalemic or normal periodic paralysis. (6) Chronic or severe diarrhea can cause hypokalemia, but it can also cause dehydration and hyponatremia, resulting in prenephrotic oliguria. (7) Gastrointestinal obstruction, chronic gastritis, ulcer disease, esophageal stricture, diverticula, lack of intestinal tone, and ulcerative enteritis are not suitable for oral potassium supplementation, so that the stimulation of potassium on the gastrointestinal tract increases and can aggravate the condition. ⑧Conduction block arrhythmia, especially when applying digitalis drugs. ⑨ Large burns, muscle trauma, severe infection, 24 hours after major surgery and severe hemolysis, the above conditions themselves can cause hyperkalemia. ⑩Adrenal anomaly syndrome with insufficient secretion of salt corticosteroids.
(2) The following follow-up examinations should be done during the drug administration: ① Blood potassium. ②Electrocardiogram. ③Blood magnesium, sodium, calcium, chloride, phosphorus. (4) Acid-base balance index. ⑤ renal function and urine output.
(3) May cause gastrointestinal irritation. Increasing dilution and taking after meals may reduce gastrointestinal irritation.
(4) Patients with cirrhosis should start with the smallest dose range and serum potassium concentration should be monitored frequently.
(5) Patients with impaired renal function have a substantially reduced urinary potassium excretion, along with a substantially increased risk of hyperkalemia. Patients with impaired renal function, especially those sensitive to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor antagonists (ARBs) class of drugs or nonsteroidal anti-inflammatory drugs, should usually be given priority in dose selection for the smallest value of the dose range because of the risk of hyperkalemia. Serum potassium concentrations should be monitored frequently and renal function should be assessed periodically.
For Pregnant and Lactating Women
Pregnant women
Pregnancy Category C.
There are no clinical data on the use of this product during pregnancy, and animal reproduction studies with potassium chloride have not been performed. If potassium supplementation does not cause hyperkalemia, it is unlikely to cause adverse fetal effects or affect fertility.
Lactating women
The normal potassium ion content of breast milk is approximately 13 mmol/L. Since oral potassium is part of the body’s potassium pool, potassium chloride supplementation has little effect on the potassium content of breast milk as long as the body does not become overloaded with potassium.
Pregnant women and nursing mothers should weigh the advantages and disadvantages of using this product.
For children]
Not yet known.
Geriatric use
Clinical studies of potassium chloride granules have not included sufficient numbers of subjects aged 65 years and older to determine whether they respond differently to treatment than younger subjects. Other reported clinical experiences have not identified differences in response between older and younger patients. In general, doses for older patients should be carefully selected and should usually start with the smallest dose range to reflect the frequency of declining hepatic, renal, and cardiac function, as well as the frequency of comorbidities or other drug therapy.
The drug is known to be excreted mostly by the kidneys, so the risk of toxic reactions is greater for patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and monitoring of renal function.
Drug Interactions]
(1) Adrenal glucocorticoids (especially those with more pronounced salt corticosteroid effects), adrenal salt corticosteroids and adrenocorticotropic hormones (ACTH), which promote urinary potassium excretion, reduce the efficacy of potassium salts when used in combination.
(2) Anticholinergic drugs can aggravate the gastrointestinal irritation of oral potassium salts, especially potassium chloride.
(3) Non-steroidal anti-inflammatory and analgesic drugs aggravate the gastrointestinal reaction of oral potassium salts.
(4) The chance of hyperkalemia increases with the combination of stock blood (30 mmol/L of potassium in stock for less than 10 days and 65 mmol/L of potassium in stock for more than 10 days), potassium-containing drugs and potassium-preserving diuretics, especially in those with renal impairment.
(5) Angiotensin-converting enzyme inhibitors, angiotensin receptor blockers and cyclosporine A can inhibit aldosterone secretion and reduce urinary potassium excretion, so hyperkalemia is likely to occur when combined.
(6) Heparin can inhibit the synthesis of aldosterone and reduce urinary potassium excretion, so hyperkalemia is likely to occur when combined. In addition, heparin can increase the chance of gastrointestinal bleeding.
(7) Slow-release potassium salts can inhibit the absorption of vitamin B12 in the intestine.
Drug overdose
Hyperkalemia is likely to occur in case of overdose or pre-existing renal impairment. It is characterized by increased serum potassium concentration (6.5-8.0 mmol/L), weakness, fatigue, numbness of the hands, feet, mouth and lips, unexplained anxiety, confusion, dyspnea, slowed heart rate, arrhythmia, conduction block, and even cardiac arrest. The ECG may show high and sharp T waves, with progressive prolongation of the P-R interval, disappearance of P waves, widening of QRS waves, and appearance of sinusoidal waves. Late symptoms include myocardial paralysis due to cardiac arrest and heart failure (9-12 mmol/L).
Hyperkalemia should be managed immediately once it occurs. Treatment measures for hyperkalemia include.
① Close monitoring of cardiac arrhythmias and electrolyte changes.
(ii) Immediate discontinuation of potassium supplementation and discontinuation of any potassium-preserving drugs, such as potassium-preserving diuretics, angiotensin receptor antagonists (ARBS), angiotensin-converting enzyme inhibitors (ACE inhibitors), nonsteroidal anti-inflammatory drugs, and certain nutritional supplements.
(iii) Application of calcium to counteract the cardiotoxicity of K+. When the ECG suggests P-wave deficiency, QRS wave widening, and arrhythmia without applying digitalis-like drugs, 10 ml of 10% calcium gluconate injection can be given intravenously for 2 minutes and repeated at 2-minute intervals if necessary.
④Import high concentration glucose injection and insulin intravenously to promote the entry of K+ into cells, 10% to 25% glucose injection 300-500ml per hour. 10 units of regular insulin per 20g of glucose.
⑤ If metabolic acidosis is present, 5% sodium bicarbonate injection should be used immediately, and 11.2% sodium lactate injection can be used for those without acidosis, especially for those with widened QRS waves.
⑥Orally administer potassium lowering resin to block intestinal K+ absorption and promote intestinal excretion of K+.
(7) Severe hyperkalemia with renal failure. Hemodialysis or peritoneal dialysis can be performed, while hemodialysis is effective and fast in removing K+.
(8) Apply tab diuretics and supplement with saline if necessary.
In patients who have reached a stable state with digitalis, too rapid a decrease in serum potassium concentration can trigger digitalis toxicity.
Pharmacology and Toxicology
Potassium is the main intracellular cation, with a concentration of 150-160 mmol/L, while the main extracellular cation is sodium, with a potassium concentration of only 3.5-5.0 mmol/L. The body mainly relies on Na+, K+ and ATPase on the cell membrane to maintain the difference in K+ and Na+ concentrations inside and outside the cell. The acid-base balance in the body has an effect on potassium metabolism, such as H+ entering the cell during acidosis, and K+ releasing to the outside of the cell in order to maintain the potential difference between inside and outside the cell, causing or aggravating hyperkalemia. The normal intra- and extracellular potassium ion concentration and concentration difference are closely related to certain cellular functions, such as carbohydrate metabolism, glycogen storage and protein metabolism, excitability and conductivity of nerve and muscle, including cardiac muscle.
Pharmacokinetics]
Potassium chloride can be rapidly absorbed by the gastrointestinal tract after oral administration, and about 90% of the administered amount is absorbed. In the body, it is mainly distributed in the extracellular fluid. In addition to the ionic state, part of the intracellular fluid is bound to protein, and the other part is bound to sugar and phosphate. 90% of potassium is excreted by the kidney, and 10% is excreted by the feces.
Storage】Sealed and stored.
Package】Polyester/Aluminium/Polyethylene composite film for pharmaceutical packaging. Each bag 1.05g: contains 1.0g of potassium chloride, 10 bags/box, 15 bags/box; each bag 1.57g: contains 1.5g of potassium chloride, 10 bags/box.
Effective period】12 months
【Execution standard
【Approval number
1.05g per sachet: containing 1.0g of potassium chloride, State Drug Registration H50020684
1.57g per bag: containing 1.5g of potassium chloride, State Drug Quasi-ZP H50020683
Manufacturer
Company name: Chongqing Yuyou Pharmaceutical Co.
Address: No. 100, Xingguang Avenue, Renhe Town, Yubei District, Chongqing
Postal Code: 401121
Telephone number: 023-67518018
Fax number: 023-67527018
Web address: www.yaopharma.com