Sodium bicarbonate injection

【Drug name】

 通用名称：Sodium bicarbonate injection

 English name：Sodium  Bicarbonate   Injection

 Pinyin in Chinese：Tansuanqingna   Zhusheye

【Ingredients】

 Chemical name: Sodium bicarbonate

 Chemical structure formula：NaHCO₃

 Molecular formula：NaHCO₃

 Molecular weight：84.01

 Auxiliary material: water for injection。

【Characteristics】  

 This product is a colorless and clear liquid.

【Indications】

（1）Treatment of metabolic acidosis. Oral administration is appropriate for the treatment of mild to moderate metabolic acidosis. Severe metabolic acidosis should be intravenously dripped, such as severe kidney disease, circulatory failure, cardiopulmonary resuscitation, extracorporeal circulation, and severe primary lactic acidosis, diabetes, ketoacidosis, etc.

（2）Alkalised urine. It is used to prevent uricidal kidney stones, reduce the nephrotoxicity of sulfonamide drugs and acute hemolysis to prevent hemoglobin from depositing in the renal tubules.

（3）As an acid-making drug, it treats symptoms caused by excessive gastric acid.

（4）Intravenous infusion has a nonspecific therapeutic effect on certain drug poisoning. Such as barbiturates, salicylic acid drugs and methanol poisoning. However, this product is forbidden to use for gastric lavage during strong acidosis, because this product reacts with strong acids to produce a large amount of carbon dioxide, resulting in acute gastric dilation and even stomach rupture.

【Specification】 250ml:12.5g

【Adverse reactions】

（1）Arrhythmia, muscle spasms, pain, abnormal fatigue and weakness may occur during large injections, mainly due to hypokalemia caused by metabolic alkalosis.

（2）When the dose is too large or renal insufficiency occurs, edema, mental symptoms, muscle pain or convulsions, slow breathing, odor in the mouth, abnormal fatigue and weakness, etc. may occur. It is mainly caused by metabolic alkalosis.

（3）Long-term use can cause frequent urination, urgency, persistent headache, loss of appetite, nausea and vomiting, abnormal fatigue and weakness, etc.

【Taboos】

  This product is forbidden to swallow gastric lavage during strong acidosis. This product reacts with strong acids to produce a large amount of carbon dioxide, resulting in acute gastric dilation and even stomach rupture.

【Things to note】

（1）Interference to diagnosis: tests on gastric acid secretion or blood, urinepHThe measurement results have a significant impact.

（2）Use the following situations with caution：① Oligouria or anuria, because it can increase sodium load;② When sodium retention and edema are present, such as cirrhosis, congestive heart failure, renal insufficiency, pregnancy hypertension syndrome;③ Primary hypertension may aggravate the condition due to increased sodium load.

（3）Do not use intravenous medication in the following situations：① Metabolic or respiratory alkalosis。② Metabolic alkalosis is very likely to occur due to vomiting or continuous gastrointestinal negative pressure attraction.③ In hypocalcemia, alkalosis caused by this product can aggravate the symptoms of hypocalcemia.

【Pregnant and breastfeeding women】 

（1）Long-term or large-scale application can cause metabolic alkalosis, and excessive sodium load can cause edema, etc. Pregnant women should use it with caution.

（2）This product can be secreted by milk, but there is no relevant information on the impact on the baby.

【Children's medication】

  For the treatment of acidosis, refer to the adult dose. During cardiopulmonary resuscitation, the first intravenous weight is applied1mmol/kg，The dosage will be adjusted according to the blood gas analysis results in the future.

【Medication for elderly people】 Not yet clear.

【Drug interactions】

（1）When adrenocorticosteroids are used together (especially those with strong mineralocorticoid effects), hypernatremia and edema are prone to corticotropic hormones and androgens.

（2）It is used in combination with amphetamine and quinidine. The latter two are reduced through renal excretion and are prone to toxic effects.

（3）It is used in combination with anticoagulants such as warfarin and cholinesterase drugs, which absorb less.

（4）Used in conjunction with calcium-containing drugs, milk and dairy products, can cause milk alkali syndrome.

（5）With cimetidine, ranitidine, etc.H₂Receptor antagonists are used in combination, and the absorption of the latter is reduced.

（6）Used in combination with potassium-exhaled diuretics to increase the risk of low-chlorinated alkalosis。

（7）This product can alkalize the urine and affect the kidney's excretion of ephedrine, so the dose of ephedrine should be reduced when used together.

（8）To reduce the absorption of oral iron agents, the two medicines should be taken separately as much as possible.

（9）Increase oral absorption of levodopa.

（10）Increased sodium load increases the kidneys' excretion of lithium, so when used in combination with lithium preparations, the dosage of lithium preparations should be adjusted as appropriate.

（11）Increased sodium load increases the kidneys' excretion of lithium, so when used in combination with lithium preparations, the dosage of lithium preparations should be adjusted as appropriate.

（12）This product alkalizing urine can increase the excretion of salicylic acid preparations by the kidneys.

【Overdose of drugs】

（1）The concentration range for intravenous application is 1.5% (isotonic) to 8.4%；

（2）The additional dose should be determined based on changes in blood pH and bicarbonate concentration;

（3）Large intravenous infusion in a short period of time can cause severe alkalosis, hypokalemia and hypocalcemia. When the dosage exceeds 10 ml of hypertonic solution per minute, it can cause hypernatremia, a decrease in cerebrospinal fluid pressure and even intracranial hemorrhage, which is more likely to occur in neonates and children under the age of 2 years old. Therefore, the speed during intravenous injection cannot exceed 8mmol of sodium per month. However, during cardiopulmonary resuscitation, due to fatal acidosis, rapid intravenous infusion should be performed.

【Pharmacology and Toxicology】

（1）To treat metabolic acidosis, this product increases the concentration of carbonate in plasma, neutralizes hydrogen ions, thereby correcting acidosis;

（2）In alkalizing urine, the pH value increases after the increase in carbonate concentration in the urine, uric acid, sulfonamide drugs, hemoglobin, etc. are less likely to form crystallization or aggregation in the urine;

（3）By making acid, oral administration can quickly neutralize or buffer gastric acid without directly affecting gastric acid secretion. Therefore, the pH in the stomach can quickly increase and relieve the symptoms caused by high gastric acid.

【Pharmacokinetics】

  This product enters the blood circulation directly after intravenous infusion. The sodium bicarbonate in the blood is filtered through the glomerular area and is excreted in the urine. Some bicarbonate ions combine with hydrogen ions in the urine to form carbonic acid, which is then decomposed into carbon dioxide and water. The former can diffuse into renal tubular cells, combine with intracellular water, and produce carbonic acid. The dissociated bicarbonate ions are reabsorbed into the blood circulation. The bicarbonate ions in the blood combine with the hydrogen ions in the blood to form carbonic acid, which then decomposes into carbon dioxide and water, which is exhaled through the lungs.

【Storage】 Store in a closed manner.

【Package】 Neutral borosilicate glass infusion bottle 250ml×30 bottles/box      

【Valid period】 24 months

【Implementation standards】Chinese Pharmacopoeia 2020 Edition Part Two

【Approval number】 National drug approvalH52020416

【Drug marketing authorization holder】/【Manufacturing enterprises】

name：Guizhou Tiandi Pharmaceutical Co., Ltd.

address：No. 6 Baokang Road, Hongxing Pharmaceutical Industrial Park, Dingxiao Town, Xingyi City, Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province

 postal code：562400

 tel：0859-3119928

 fax：0859-3118152

 website：www.gztiandi.com