Date of approval.
Date of revision.
Potassium chloride extended release tablets instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name]
Generic name: Potassium Chloride Sustained-release Tablets
English name: Potassium Chloride Sustained-release Tablets
Hanyu Pinyin: Lühuajia Huanshipian
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 sugar-coated tablet, which appears white after removing the coating.
Indications
For the treatment and prevention of hypokalemia with or without metabolic alkalosis, when dietary management with potassium-rich foods or reduction of diuretic dose is not effective in these patients.
Specification
(1) 0.5g (2) 0.6g
Dosage
This product should be taken orally as a whole tablet and should not be crushed, chewed or sucked. Do not take this product on an empty stomach, it may be irritating to the stomach.
Adults take 0.5g~1g each time, 2~4 times a day, after meals, and adjust the dose according to the needs of the disease. Generally, the maximum daily dose for adults is 6g. Those who experience gastrointestinal reactions to oral tablets may switch to oral solutions, diluted in cold boiled water or beverages for internal use.
Monitoring
If the blood potassium concentration is below 2.5 mEq/L, replace oral supplementation with intravenous potassium.
Monitor blood potassium and adjust the dose accordingly. Monitor blood potassium levels regularly during maintenance therapy to ensure they are in the desired range.
Treatment of potassium loss, especially in patients with cardiac disease, renal disease or acidosis, requires close attention to acid-base balance, fluid volume, electrolytes (including sodium, calcium, magnesium, chloride, phosphate), electrocardiogram and the patient’s clinical status. Volume status, acid-base balance and electrolyte deficiency should be corrected as appropriate.
[Adverse Reactions].
1. Oral administration may cause gastrointestinal irritation, such as nausea, vomiting, pharyngeal discomfort, chest pain (esophageal irritation), gastrointestinal gas, 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. urticaria, rash, pruritus.
Contraindications
Contraindicated in the following patients.
1. hypersensitivity to any of the ingredients of this product. 2.
2. patients with hyperkalemia. 3.
3. Patients with low urine output and urinary shutdown. 4.
4. Patients using potassium-protective diuretics.
Precautions]
This product should be taken orally as a whole tablet and should not be crushed, chewed or sucked.
1. Use with caution in the following cases.
(1) When metabolic acidosis is accompanied by oliguria.
(2) In persons with reduced adrenocortical function.
(3) Acute dehydration, as it can lead to reduced urine output and urinary K+ excretion in severe cases.
(4) Acute renal insufficiency and chronic renal insufficiency; (5) Familial periodic anesthesia.
(5) Familial periodic paralysis, hypokalemic paralysis should be given potassium supplementation, but need to distinguish between hyperkalemic or normal periodic paralysis.
(6) Chronic or severe diarrhea can cause hypokalemia, but it can also cause dehydration and hyponatremia, causing prenephrotic oliguria.
(7) Gastrointestinal obstruction, chronic gastritis, ulcer disease, esophageal strictures, diverticula, lack of intestinal tone, and ulcerative enteritis are not suitable for oral potassium supplementation, so that the increased stimulation of the gastrointestinal tract by potassium can aggravate the condition.
(8) Conduction block arrhythmias, especially when digitalis drugs are applied.
(9) Large burns, muscle trauma, severe infections, 24 hours after major surgery and severe hemolysis, the above conditions themselves can cause hyperkalemia.
(10) Congenital adrenal cortical hyperplasia with insufficient secretion of salt corticosteroids.
2. The following follow-up examinations are required during the drug administration: (1) blood potassium; (2) electrocardiogram; (3) blood magnesium, sodium, calcium, chloride and phosphate; (4) acid-base balance index; (5) renal function and urine output.
3. Patients with cirrhosis should usually be started on the lowest value of the dose range and serum potassium concentration should be monitored frequently.
4. Patients with renal impairment have reduced urinary potassium excretion and a significantly increased risk of hyperkalemia. Patients with renal impairment, especially if they are on angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor antagonists (ARBs) class of drugs or nonsteroidal anti-inflammatory drugs, should usually be started at the lowest end of the dose range because of the risk of hyperkalemia. Serum potassium levels should be monitored frequently and renal function should be evaluated periodically.
For Pregnant and Lactating Women]
Pregnancy
There are no clinical data on the use of this product during pregnancy and no animal reproduction studies have been conducted on this product. If potassium supplementation does not cause hyperkalemia, no adverse effects on the fetus are expected.
Lactating women
The normal potassium ion content of breast milk is approximately 13 mEq /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 the drug.
Use in children
No trials have been conducted and no reliable references are available.
Geriatric Use
Clinical studies of potassium chloride extended-release tablets did not include sufficient numbers of subjects 65 years of age and older to determine whether older subjects responded differently than younger subjects. Other reported clinical experiences have not established differences in response between older and younger patients. In general, dose selection in elderly patients should be cautious and should usually start at the lowest end of the dose range to reflect declining hepatic, renal, and cardiac function and greater frequency of comorbidities or other drug therapy.
The majority of this product is known to be excreted by the kidneys and the risk of toxic reactions to this product may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, dose selection should be cautious and monitoring of renal function may be required.
In the elderly, the kidneys have a decreased ability to remove K+ and are more likely to develop hyperkalemia when potassium salts are administered. Follow-up potassium checks should be performed during drug administration.
Drug Interactions]
(1) Adrenal glucocorticoids (especially those with obvious salt corticosteroid effects), adrenal salt corticosteroids and adrenocorticotropic hormone (ACTH), which promote urinary potassium excretion, reduce the efficacy of potassium salts when used together.
(2) Anticholinergic drugs can aggravate the gastrointestinal irritation of oral potassium salts, especially potassium chloride.
(3) Non-steroidal anti-inflammatory drugs (NSAIDs) may lead to potassium retention by reducing renal synthesis of prostaglandin E and weakening the renin-angiotensin system. Close monitoring of potassium is required in patients taking concomitant NSAIDs. NSAIDs aggravate the gastrointestinal response to 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) Renin inhibitors (aliskiren), angiotensin-converting enzyme inhibitors (benazepril, captopril, etc.), angiotensin receptor blockers (valsartan, coxsartan potassium, candesartan, temisartan, etc.) and cyclosporine A can inhibit aldosterone secretion and reduce urinary potassium excretion, so hyperkalemia is likely to occur when combined with them.
(6) Heparin can inhibit the synthesis of aldosterone and reduce the excretion of urinary potassium, 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.
(8) Potassium ions are involved in the contractile movement of skeletal muscle, and this product may weaken the effect of muscle relaxants (vecuronium bromide, etc.).
(9) Beta-blockers, digoxin, drospirenone, and ethinyl estradiol increase potassium in the blood, and hyperkalemia may occur when this product is combined.
Drug overdose]
Hyperkalemia is likely to occur with overdose or pre-existing renal impairment. It is characterized by increased serum potassium concentration (6.5-8.0 mEq/L), weakness, fatigue, numbness in the hands, feet, mouth and lips, unexplained anxiety, confusion, dyspnea, slowed heart rate, arrhythmia, conduction block, and even cardiac arrest. The electrocardiogram shows high and sharp T waves, with progressive prolongation of the P-R interval, disappearance of the P waves, widening of the QRS waves, and the appearance of sinusoidal waves. Late manifestations include muscle paralysis and cardiovascular collapse due to cardiac arrest (9-12 mEq/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 cessation of potassium supplementation and any potassium-preserving drugs, such as potassium-preserving diuretics, ARBS, ACE inhibitors, nonsteroidal anti-inflammatory drugs, certain nutritional supplements, etc.
③Apply calcium to counteract the cardiotoxicity of K+. When ECG suggests P-wave deficiency, QRS wave widening and arrhythmia without applying digitalis drugs, 10% calcium gluconate injection 10ml 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 K+ entry 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 mmol/L. The body mainly relies on the Na+-K±ATPase in the cell membrane to maintain the difference in intracellular K+ and Na+ concentrations. The acid-base balance in the body has an effect on potassium metabolism, such as H+ entering the cell during acidosis, and K+ being released outside the cell in order to maintain the potential difference, causing or aggravating hyperkalemia. Metabolic disorders can also affect acid-base balance. Normal intra- and extracellular potassium ion concentrations and concentration differences are closely related to certain important cellular functions, including maintenance of carbohydrate metabolism, glycogen storage, protein metabolism, intracellular osmotic pressure and acid-base balance, myocardial excitability and conductivity; maintenance of normal skeletal muscle tone and nerve impulse conduction, as well as the ability to increase intestinal, uterine and bronchial smooth muscle tone.
Pharmacokinetics]
Potassium is 90% excreted by the kidney and 10% by the intestine.
Storage】Seal and store in dry place.
Package】Polyvinyl chloride solid pharmaceutical hard tablets and aluminum foil for pharmaceutical packaging (plus laminated film bag), 24 tablets/plate, 2 plates/box; 12 tablets/plate, 2 plates/box; 12 tablets/plate, 4 plates/box.
Effective period】24 months
【Execution standard
【Approval number】
[Drug Marketing Licensee
Name: Shanghai Haihong Industry (Group) Chaohu Jinchen Pharmaceutical Co.
Address: No. 43, East Changjiang Road, Chaohu City, Anhui Province
[Manufacturer
Company Name: Shanghai Haihong Industry (Group) Chaohu Jinchen Pharmaceutical Co.
Address: No. 43, Changjiang East Road, Chaohu City, Anhui Province
Postal Code: 238000
Telephone number: 0551-82313196
Fax: 0551-82335533
Website: www.c-dragon.com.cn