10% glucose injection

【Drug name】

 Generic name: Glucose Injection                      

 English Name: Glucose  Injection

 Chinese Pinyin: Putaotang   Zhusheye

【Certificate    】

 The main ingredient of this product is glucose, and its chemical name is : D-(+)—pyranose glucose—hydrate.

 分子式：C₆H₁₂O₆·H₂O

 Molecular weight: 198.17

 Auxiliary material name: Water for injection.

【Sex    Condition】

 This product is a colorless or almost colorless clear liquid.

【Indications】

（1）Supplement energy and body fluids; used for insufficient food intake or significant fluid loss due to various reasons (such as vomiting, diarrhea, etc.), total parenteral nutrition, starvation ketosis;

（2）Hypoglycemia；

（3）Hyperkalemia；

（4）Hypertonic solution is used as a tissue dehydrating agent;

Prepare peritoneal dialysis solution;

（6）Drug diluent；

（7）Venous glucose tolerance test；

For preparing GIK (polarizing liquid).

【Specifications】（1）500ml:50g  （2）250ml:25g （3）100ml:10g

【Dosage and Administration】

（1） Supplementary Heat Energy    

 When patients reduce their food intake or are unable to eat for certain reasons, a 25% glucose injection can generally be administered intravenously, while simultaneously supplementing body fluids. The amount of glucose is calculated based on the required energy.

（2）Total Parenteral Nutrition     

 Glucose is the most important energy supply substance in this therapy. In non-protein caloric intake, the ratio of calories provided by glucose to those provided by fat is 2:1. The specific dosage is determined based on clinical caloric needs.

According to the needs of fluid replacement, glucose can be prepared in different concentrations of 25% to 50%, and insulin can be added if necessary, with 1 unit of regular insulin added for every 5 to 10g of glucose. Due to the significant venous irritation caused by the normal application of hypertonic glucose solution, and the need to infuse fat emulsion, a large vein drip infusion is generally selected.

（3）Hypoglycemia      

 For severe cases, an intravenous push of 50% glucose injection 20～40ml may be administered first.

（4）Hunger-induced ketosis      

 For severe cases, intravenous infusion of 5% to 25% glucose injection is applied, and daily 100g of glucose can basically control the condition.

（5）Water loss      

Isotonic dehydration should be treated with intravenous infusion of 5% glucose injection.

（6）Hyperkalemia     

 Administer 10% to 25% injection solution, infusing 1 unit of regular insulin with 2 to 4g of glucose, which can lower serum potassium levels. However, this treatment only facilitates the movement of extracellular potassium ions into the cells, and the total potassium content in the body remains unchanged. If potassium excretion measures are not taken, there is still a possibility of recurrent hyperkalemia.

（7）Organizational Dehydration   

 Hypertonic solution(commonly using50% glucose injection) for rapid intravenous injection20～50ml. However, the effect is short-lived. Clinically, care should be taken to prevent hyperglycemia, and it is currently used less frequently. When used to adjust the osmotic pressure of peritoneal dialysis fluid, 50% glucose injection20ml or10g of glucose can increase the osmotic pressure of1L of peritoneal dialysis fluid by55mOsm/kgH₂O.   

[Adverse Reactions]

（1）Phlebitis occurs during the infusion of hypertonic glucose injection. If a large vein is used for infusion, the incidence of phlebitis decreases.

（2）Extravasation of high-concentration glucose injection can cause local swelling and pain.

（3）Reactive hypoglycemia: It is prone to occur when there is an overdose of insulin combined with a pre-existing tendency for hypoglycemia and when total parenteral nutrition therapy is suddenly stopped.

（4）Hyperglycemic non-ketotic coma: commonly seen in diabetes, stress states, use of large amounts of glucocorticoids, and in patients undergoing peritoneal dialysis for uremia when hypertonic glucose solution and total parenteral nutrition are administered in the abdominal cavity.

（5）Electrolyte disorders: Long-term simple supplementation of glucose can easily lead to hypokalemia, hyponatremia, and hypophosphatemia.

（6）Those with pre-existing heart dysfunction.

（7）Hyperkalemia: It occasionally occurs in patients with type 1 diabetes when using high concentrations of glucose.

【Prohibition    】

（1）Uncontrolled diabetic ketoacidosis;

（2）Hyperglycemic non-ketotic hyperosmolar state.

[Precautions]

（1）Please check carefully before use. If the solution is cloudy, contains foreign objects, has changed color, or if the bottle is cracked or damaged, or if the neck interface and cap are not securely welded, do not use; once this product has been used, do not store the remaining solution for reuse; when puncturing the rubber stopper, please apply vertical and even force within the specified range (center of the circle or center of the concave circle).

Excessive injection of glucose during delivery can stimulate fetal insulin secretion, leading to neonatal hypoglycemia after birth.

Caution should be exercised in the following situations:

 ①Patients who have undergone subtotal gastrectomy are prone to dumping syndrome and hypoglycemic reactions during oral glucose tolerance tests, and should switch to intravenous glucose tests;

 ② Patients with periodic paralysis and hypokalemia;

 ③ Stressful conditions or the use of glucocorticoids can easily induce hyperglycemia;

 ④ Patients with edema and severe heart or kidney failure, as well as those with cirrhotic ascites, are prone to water retention and should have their fluid intake controlled; those with heart failure should especially control the drip rate.

[Medication for Pregnant and Breastfeeding Women] 

Excessive injection of glucose during delivery can stimulate fetal insulin secretion, leading to neonatal hypoglycemia after birth.

[Pediatric Medication]   

 Rapid and excessive fluid infusion can lead to palpitations, arrhythmias, and even acute left heart failure.

[Medication for the Elderly] 

 Rapid or excessive fluid infusion can lead to palpitations, arrhythmias, and even acute left heart failure.

[Drug Interactions]

 Not yet clear.

[Drug Overdose]

 Not yet clear.

[Pharmacology and Toxicology]

 Glucose is one of the main sources of energy for the human body, with each1 gram of glucose producing4 kilocalories (16.7KJ) of heat, thus it is used to supplement energy, and to treat hypoglycemia. When glucose and insulin are infused together intravenously, the synthesis of glycogen requires the participation of potassium ions, which enter the cells, leading to a decrease in blood potassium concentration, hence it is used to treat hyperkalemia. Hypertonic glucose injection has an osmotic dehydration effect when rapidly infused intravenously and can be used as a dehydrating agent. Additionally, glucose is the main substance for maintaining and regulating the osmotic pressure of peritoneal dialysis fluid.

Pharmacokinetics

 Intravenous injection of glucose directly enters the bloodstream. Glucose is completely oxidized in the body to produce CO₂ and water, which are excreted through the lungs and kidneys, while generating energy. It can also be converted into glycogen and fat for storage. Generally, a normal human body utilizes glucose at a rate of 6mg/kg per minute.

【Storage】 Sealed preservation.

【Packaging】 Polypropylene infusion bottles    500ml×30 bottles/box   250ml×40 bottles/box    250ml×50 bottles/box   100ml×100 bottles/box   100ml×120 bottles/box                        

【Validity Period】 24 months

[Implementation Standard] 'Pharmaceutical Standards of China' 2020 Edition, Volume Two

【Approval Number】

【Drug Marketing Authorization Holder】/【Manufacturing Enterprise】

Name    : Guizhou Tiandi Pharmaceutical Co., Ltd.

Address: No. 6 Baokang Road, Hongxing Pharmaceutical Industry Park, Dingxiao Town, Xingyi City, Qiannan Buyei and Miao Autonomous Prefecture, Guizhou Province6

 Postal Code: 562400

 Phone number: 0859-3119928

 Fax number: 0859-3118152

 Website: www.gztiandi.com