Date of approval.
Date of revision.
Sodium Potassium Hydrogen Citrate Granules Instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name
Generic name: Potassium Hydrogen Citrate Granules
English name: Potassium Sodium Hydrogen Citrate Granules
Hanyu Pinyin: Juyuansuan Qingjiana Keli
Ingredients
Chemical name: Potassium Sodium Hydrogen Citrate
Molecular formula: K6Na6H3(C6H5O7)5
Molecular weight: 1321.06
Properties
This product is light orange granules with aromatic gas.
Indications
Dissolve uric acid stones and prevent recurrence of uric acid stones.
This product should be taken in conjunction with other common recurrence prevention measures, such as dietary modification, increased fluid intake, etc.
Specification】
2.5g: 2.4275g
Dosage]
Unless otherwise stated, the daily dose is 10g, divided into three doses after meals. 2.5g in the morning and 2.5g at noon, and 5g at night. pellets can be taken with water.
The pH of fresh urine must be within the following range.
Lithotripsy of uric acid stones and prevention of recurrence pH 6.2-6.8
If the pH is below the recommended range, the dose needs to be increased by 1.25 g at night and reduced by 1.25 g at night if the pH is above the recommended range. If the fresh urine pH is measured to remain within the recommended range prior to administration of this product, the current dose is appropriate.
Routine testing of urine pH is recommended to prevent uric acid stones.
Measurement of urine pH.
Before each dose of this product, take one test strip from the test strip, moisten it with fresh urine, then compare the moistened test strip with the colorimetric plate and note down the pH value.
Record the measured pH and the amount of pellets taken on the form and carry it with you at each visit.
[Adverse reactions].
Adverse reactions are classified according to the frequency of occurrence as follows.
Very common: ≥ 1/10.
Common: ≥1/100 to<1/10.
Occasional: ≥1/1,000 to <1/100.
Rare: ≥1/10,000 to <1/1,000.
Very rare: <1/10,000.
Unknown: Cannot be speculated based on available data.
Gastrointestinal disorders.
Mild stomach or abdominal pain is common, and mild diarrhea and nausea are rare.
Other possible adverse reactions.
This product contains the coloring agent sunset yellow (E110) which may cause allergic reactions.
Please inform your doctor or pharmacist if you notice any adverse reactions that are not mentioned in the instructions.
Contraindications]
This product should not be taken by the following patients.
– Impaired renal excretory function.
– Metabolic alkalosis.
– Hyperkalemia.
– Hereditary periodic paralysis.
– Chronic urinary tract infections caused by ureolytic bacilli (risk of infected stones).
– Low sodium diet.
– Hypersensitivity to sodium potassium hydrogen citrate, sunset yellow (E110) or any of the excipients.
[Caution].
Before using this product, diseases causing urinary stones (e.g. parathyroid adenoma, malignancy-associated uric acid stones, etc.) should be excluded, for which targeted treatment is available.
The maximum recommended daily dose is 11.25 g. This corresponds to 1.86 g of potassium and 1.09 g of sodium, or 47.5 mmol of potassium and 47.5 mmol of sodium. The elderly and patients on concomitant potassium-protecting diuretics, aldosterone antagonists, ACE inhibitors, angiotensin receptor antagonists, nonsteroidal anti-inflammatory drugs, or peripheral analgesics need to be aware that interactions with these drugs may lead to hyperkalemia during treatment.
Serum electrolytes should be tested and renal function monitored prior to the first dose of this product. In addition, acid-base status should also be tested when renal tubular acidosis is suspected.
It should be used with caution in patients with severe hepatic impairment.
This product contains the coloring agent sunset yellow (E110), and allergic reactions such as asthma may occur in allergic individuals. Allergic reactions are common in people who are allergic to 2-acetoxybenzoic acid (acetylsalicylic acid).
Pregnant women and nursing mothers
This test has not been conducted and no reliable references are available.
[For children].
No such tests have been conducted and no reliable references are available. This product is not recommended for use in children under 12 years of age.
Geriatric use
No trial has been conducted and there are no reliable references.
Drug Interactions
Increased extracellular potassium concentrations may impair the effect of cardiac glycosides, while decreased extracellular potassium concentrations may increase the incidence of cardiac arrhythmias with cardiac glycosides. Aldosterone antagonists, potassium-preserving diuretics, ACE inhibitors, angiotensin receptor antagonists, nonsteroidal anti-inflammatory drugs, and peripheral analgesics can reduce renal potassium excretion. Please note that 1 gram of sodium potassium hydrogen citrate contains 0.172 grams or 4.4 mmol of potassium.
If a low sodium diet is required, please note that 1 gram of sodium potassium hydrogen citrate contains 0.1 gram or 4.4 mmol of sodium, which is equivalent to 0.26 grams of sodium chloride.
The absorption of aluminum is increased when drugs containing citrate are administered simultaneously with drugs containing aluminum. If both drugs must be used, the time between the administration of the two drugs should be at least 2 hours apart.
[Drug overdose].
Overdose may lead to hyperkalemia (potassium concentration > 5 mmol/L), especially in patients with acidosis or renal failure.
If renal function is normal, no abnormal metabolic indicators will occur even if the above recommended dose is exceeded.
Urine pH above the recommended range for several days in a row should be avoided, as an elevated pH increases the risk of phosphate crystallization formation. On the other hand, a prolonged state of significant alkalosis should be avoided. Occasional overdose can be corrected by reducing the dose taken, and measures should be taken to treat metabolic alkalosis if necessary.
Pharmacology and Toxicology
Pharmacological effects.
Oral administration of sodium potassium hydrogen citrate pellets increases urinary pH and excretion of citrate and reduces urinary calcium ion concentration. This change induced by sodium potassium hydrogen citrate pellets makes the stone forming salts in the urine less likely to form crystals. The resulting decrease in calcium ion concentration decreases the saturation of calcium salts in the urine capable of forming stones. an increase in pH increases the solubility of uric acid and cystine stones.
Toxicological studies.
The LD50 values of different species of animals fed with the drug measured in grams indicate that the acute toxicity of orally administered sodium potassium hydrogen citrate pellets is very low. Signs of toxicity were generally due to electrolyte overload, and long-term toxicity studies in rats and dogs showed no specific target organ toxicity at oral doses up to 3000 mg/kg body weight. The increase in urinary pH was attributed to the pharmacodynamic effect of the citrate complex. Animal studies showed no potential embryonic or teratogenic toxicity of sodium potassium hydrogen citrate pellets. Sodium potassium hydrogen citrate pellets are physiological compounds and can be studied without potential mutagenic or carcinogenic effects.
[Pharmacokinetics].
Citrate is relatively completely metabolized, with only 1.5% to 2% of the prototype drug appearing in the urine. Administration of 10 g of sodium potassium hydrogen citrate produces approximately 36 mmol of citrate; this corresponds to less than 2% compared to the citrate produced in the body’s energy metabolism. One day after administration of sodium potassium hydrogen citrate, the same amount of sodium and potassium as its equivalent is excreted quantitatively from the kidneys within 24 to 48 hours. After long-term administration, the daily excretion of sodium and potassium is balanced with the daily intake.
No significant changes in blood gases or serum electrolytes were observed. This indicates that if renal function is normal, acid-base balance can be maintained through renal alkalization regulation and no sodium-potassium retention will occur.
Storage
Seal and store in a dry place below 25℃. If the drug has been dissolved into water and prepared as a solution, it should be taken immediately.
Package】
Polyester/Aluminium/Polyethylene pharmaceutical compound film, 2.5g/bag×40bag/box.
[Expiration date
24 months
Execution Standard
Approval number】
[Drug Marketing License Holder
Name: Zhejiang Shiqiang Pharmaceutical Co.
Registered address: No. 88, Xingning West Road, Tonglu Economic Development Zone, Tonglu County, Hangzhou
Zip code: 311500
Contact: 0571-29602222
Fax: 0571-29603333
Web address: http://www.cnstrong.cn
【Manufacturing enterprise
Company name: Zhejiang Shiqiang Pharmaceutical Co.
Address: No. 88, Xingning West Road, Tonglu Economic Development Zone, Tonglu County, Hangzhou
Postal code: 311500
Contact：0571-29602222
Fax: 0571-29603333
Web address: http://www.cnstrong.cn