Sodium Fructose Diphosphate for Injection

Dextrorotatory 1,6-diphosphate fructose (FDP) is an intermediate product of glycolysis. It regulates several enzymatic reactions in cells by activating phosphofructokinase, pyruvate kinase and lactate dehydrogenase. The concentration of FDP in different cells is different. The concentration of FDP in human erythrocytes is 6-10 mg/L cell. In vivo and in vitro biochemical studies have shown that pharmacological doses of FDP can act on cell membranes. It promotes the cell's uptake of circulating potassium and stimulates the production of high-energy phosphate and 2,3-diphosphoglycerol in cells. In addition, FDP can reduce hemolysis of erythrocytes caused by mechanical trauma and inhibit the production of oxygen free radicals caused by chemical stimulation. Patients with chronic obstructive pulmonary disease (COPD) will suffer from malnutrition during the progression of the disease, which affects respiratory muscle function. In COPD patients, there is a high correlation between hypophosphatemia and renal phosphate reabsorption disorders. Phosphate deficiency in respiratory and peripheral muscles is due to renal phosphate consumption caused by malnutrition or the use of theophylline, diuretics, glucocorticoids and beta-receptor agonists. Phosphorus is a component of cells (membrane phospholipids, nucleic acids, 2,3-bisphosphoglycerate, phosphoproteins). Phosphorus consumption induces changes in neuromuscular and myocardial functions, and can also explain respiratory muscle weakness and fatigue in patients with cachectic COPD. Inducing phosphate consumption with an experimental diet can reduce respiratory muscle function, and correcting phosphate levels can improve its function. Although the efficacy of supplementing phosphate to cachectic COPD patients is not certain, clinical trials have shown that FDP is beneficial for treatment, especially in increasing respiratory intensity, as shown by improvements in PImax, PaO2, and tolerance. Toxicology LD50 of parenteral administration is: Species Intraperitoneal injection (mg/kg) Intravenous injection (mg/kg) Mouse 6256 (6020-7070) 874 (837-913) Rat 4107 (3731-4251) 1160 (1093-1230) Subacute toxicity studies have shown that rabbits and dogs were intravenously injected with 100 mg/kg or 200 mg/kg of this product for 30 consecutive days without any functional and histological pathological changes. Teratogenicity Teratogenicity studies have shown that routine injection of 100 mg/kg FDP to rabbits did not find pathological changes or fetal malformations during pregnancy.

The main ingredient of this product is sodium fructose diphosphate, and its chemical name is: fructose-1,6-diphosphate trisodium salt octahydrate. Molecular formula: C6H11O12P2Na3·8H2O, molecular weight: 550.17.

This product is suitable for hypophosphatemia. Hypophosphatemia can occur in acute situations, such as blood transfusion, surgery under extracorporeal circulation, and parenteral nutrition; it is also related to the depletion of carbonic acid in some chronic diseases, such as chronic alcoholism, long-term malnutrition, and chronic respiratory failure.

The recommended dose is 5-10g per day. The dose for treating hypophosphatemia should be based on the degree of phosphate deficiency to avoid phosphate overload. It is recommended to administer the larger dose twice a day. The dose for children should be based on body weight (70-160mg/Kg). Do not exceed the recommended dose. Administration: Dissolve each lg of powder in 10ml of sterile water for injection, and infuse the mixed solution intravenously (about 10ml/min). The mixed solution must be administered once. If it is not completely infused, the remaining amount will not be used.

When the intravenous infusion rate exceeds 10ml/min, the patient may experience blushing, palpitations, and tingling in the hands and feet. If adverse reactions are found, the patient should inform the doctor. Reports of allergic reactions and anaphylactic shock are rare. If an allergic reaction occurs, stop the drug immediately and give anti-allergic treatment. Rescue measures for anaphylactic shock: stop taking the drug, monitor blood pressure; perform shock-related treatment: intravenous injection of epinephrine, antihistamines, etc.

Patients with hereditary fructose intolerance, those who are allergic to this product, patients with hyperphosphatemia and renal failure, and those who are allergic to fructose are contraindicated to use this product.

This product cannot be used together with drugs that are insoluble between pH 3.5 and 5.8, nor can it be used together with high calcium salt alkaline solutions.

Sealed, stored in a cool and dark place, valid for 2 years.

5g (anhydrous basis)

Hainan Lingkang Pharmaceutical Co., Ltd.

• Founded in:

  2013-04-22

• Address:

  No. 16, Yaogu Erheng Road, Yaogu Industrial Park, Haikou National High-tech Industrial Development Zone, Hainan Province

• Tax NO.:

  91460000062331438Q

• Registered Funds:

  200 million yuan

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