ferricsaccharate
Iron saccharate
CAS: 8047-67-4
Molecular Formula: C18H24Fe2O24
ferricsaccharate - Names and Identifiers
| Name | Iron saccharate |
| Synonyms | feojectin Iron Sucrose collironi.v. Iron saccharate ferricsaccharate Saccharated iron oxide saccharated iron oxide FERRIC OXIDE, SACCHARATED IRON (III) OXIDE, SACCHARATED Ferric hydroxide sucrose complex ferric hydroxide sucrose complex Iron-sorbitol-citric acid complex. iron(2+) (2R,3S,4S,5S)-2,3,4,5-tetrahydroxyhexanedioate (non-preferred name) |
| CAS | 8047-67-4 |
| EINECS | 232-464-7 |
| InChI | InChI=1/C6H10O8.Fe/c7-1(3(9)5(11)12)2(8)4(10)6(13)14;/h1-4,7-10H,(H,11,12)(H,13,14);/q;+2/p-2/t1-,2-,3-,4+;/m0./s1 |
ferricsaccharate - Physico-chemical Properties
| Molecular Formula | C18H24Fe2O24 |
| Molar Mass | 736.06 |
| Melting Point | 168-171°C |
| Boling Point | 766.4°C at 760 mmHg |
| Flash Point | 431.2°C |
| Solubility | Water (Slightly) |
| Vapor Presure | 4.04E-27mmHg at 25°C |
| Appearance | Brown solid |
| Color | Brown to Dark Brown |
| Storage Condition | Refrigerator |
ferricsaccharate - Risk and Safety
| HS Code | 29400090 |
| Toxicity | LD50 in mice (mg Fe/kg): >2500 orally; >200 i.v. (Geisser) |
ferricsaccharate - Reference Information
| (IARC) carcinogen classification | 3 (Vol. 2, Sup 7) 1987 |
| EPA chemical substance information | information provided by: ofmpeb.epa.gov (external link) |
| intravenous iron supplement | Iron sucrose has been safely used for many years abroad and has been marketed in 68 countries and regions worldwide, its injection preparation is the longest used intravenous iron supplement. The use of iron sucrose injection in the treatment of iron deficiency anemia can promote the rapid entry of iron into endothelial cells, which is of great significance to the formation of red blood cells. Iron sucrose injection is one of the most clinically used methods of iron supplementation. Compared with oral ferrous succinate, it has better absorption effect on iron, and it is not easy to appear gastrointestinal symptoms. Compared with other types of iron supplementation, Iron sucrose has a safe, rapid and effective iron treatment effect, and its side effects are much lower than those of other dosage forms such as iron dextran, iron sucrose has become the fastest growing class of iron supplement products in the domestic market. In addition, the study found that the treatment of iron sucrose injection in patients with diabetes mellitus complicated with iron deficiency anemia can obtain ideal therapeutic effect, which is conducive to improving the clinical indexes of patients, and is worthy of clinical popularization and application. Iron sucrose injection is an effective drug for the treatment of iron deficiency anemia, and it has achieved good clinical effect as an iron supplement in actual medical activities. |
| effect | Iron sucrose is more suitable for people with oral iron intolerance or people with poor absorption of oral iron, directly to the injection, can be effective for the human body to supplement iron, and need to pay attention to the point, that is, when we use the injection, in general, the following infusion methods are used together with normal saline, to understand the relevant blood loss or the amount of iron that needs to be supplemented, etc., and to use it after the calculation is completed under the doctor's guidance, when using iron sucrose injection, the injection rate is controlled, and if the injection is too fast, it may lead to the occurrence of hypoglycemia. |
| Background | anemia is an important complication of chronic renal failure, however, many dialysis patients do not respond to erythropoietin therapy or have poor efficacy. Iron deficiency is the most common cause of erythropoietin resistance. There are two ways to supplement iron, oral and intravenous. Patients who still have moderate anemia after taking oral iron will be examined for serum ferritin, serum iron, folic acid and vitamin B12, the results showed that the folic acid and vitamin B12 in the body of the patients with anemia were in normal levels, while the serum ferritin and serum iron were significantly lower than normal. After long-term oral administration of iron, the serum ferritin and serum iron in the patients were still obviously insufficient, this may lead to renal replacement therapy in patients with regular use of erythropoietin but HB is not an important reason for the standard. The vast majority of patients receive oral iron before intravenous iron use, and studies have shown that oral iron is difficult to achieve or maintain the therapeutic goals of renal anemia, which may be due to inadequate intake, the average daily intake of iron is only 10~15 mg, and only 10% ~ 20% of them can be absorbed; Excessive loss, such as repeated blood tests, dialyzer and pipeline residual blood, gastrointestinal bleeding and so on; the use of rhEPO increases the body's need for iron. More and more studies have shown that intravenous iron can significantly improve anemia. K/DOQI guidelines recommend that hemodialysis patients should be given intravenous iron supplementation routinely to treat anemia. Iron sucrose injection is a polynuclear iron hydroxide (III)-sucrose complex solution, given oral iron can not be corrected in patients with moderate anemia after intravenous use of iron sucrose serum iron, serum ferritin was significantly higher than before use, hemoglobin and Hct were significantly increased. Thus, Iron sucrose injection is more effective than oral iron in correcting anemia. At present, Iron sucrose is the safest intravenous iron, which has the advantages of rapid onset, less allergic reaction and acute iron poisoning, and is widely used in clinic. After intravenous iron supplementation, the combination of iron and transferrin quickly reaches the bone marrow, which can quickly supplement the patient's iron deficiency, maintain iron reserve, and improve the patient's response to EPO. |
| Overview | Common name: Iron sucrose , venofer Cas No:8047-67-4 Molecular Weight: 736.06 Molecular formula: C18H24Fe2O24 structural formula: |
| trait | dark brown solution. |
| pharmacological action | Iron sucrose is polynuclear ferric hydroxide (Ⅲ), the core surface is surrounded by a large number of non-covalently bound sucrose molecules, forming a complex with an average molecular weight of 43kDa. This macromolecular structure can be prevented from being eliminated from the kidney. This complex is structurally stable and releases iron ions under reasonable conditions. |
| pharmacokinetics | , the average was 538 μmol/L. distribution: the distribution volume of the central chamber was about 3L, and the steady-state distribution volume was about 8L. metabolism and excretion: the injected iron is rapidly eliminated in the plasma, and the Half-Life is about 6H; The iron clearance is less than 5% of the total clearance 4H before injection, about 75% of the sucrose was excreted after 24h. |
| indications | clinically applicable to the treatment of iron deficiency anemia that cannot be effectively alleviated by oral iron, such as those with severe iron deficiency requiring rapid iron supplementation, impaired absorption of oral iron and oral iron cannot be tolerated. |
| specification | injection: 5ml:100mg;5ml:200mg. |
| dosage | Iron sucrose: the preferred mode of administration of this product is drip (this product is not suitable for intramuscular injection). 1mL can only be diluted to 20ml of 0.9% sodium chloride injection, dilution should be used immediately after the preparation. The drip rate of the liquid medicine should be: mg of iron at least 15 minutes; 1.5 mg at least 2.5 hours; 3.5 mg at least hours; Mg at least hours. If the clinical needs, the goods of 0.9% sodium chloride injection diluent volume can be less than a specific number, with a higher concentration of the goods liquid. However, the rate of instillation must be determined according to the dose of iron given per minute (e. G. 10ml of this product = 200mg of iron, should be at least 30 minutes to drip; 25ml of this product = 500mg of iron, should be at least 3.5 hours to finish). In order to ensure the stability of the liquid medicine, the liquid medicine is not allowed to be prepared into a more dilute solution. intravenous injection: This product can be injected slowly without dilution, the recommended speed is 1ml per minute, each time the maximum injection dose is 10ml. After intravenous injection, the patient's arm should be stretched. injection into the dialyzer: This product can be directly injected into the venous end of the dialyzer, and the dosage is calculated as follows: total iron deficiency (mg)= body weight (kg)×(Hb target-Hb actual value)(g/L)× 0.24 + stored iron (mg) body weight less than 35kg:Hb Target = 130(g/L) stored iron amount = 15mg/kg. body weight greater than 35kg:Hb target value = 150(g/L) stored iron amount = mg/kg. if the total requirement exceeds the maximum single dose, it should be administered in divided doses. If no changes in hematological parameters are observed 1 to 2 weeks after administration, the initial diagnosis should be reconsidered. usual dosage: adults and the elderly should take 5~100 (~ 200mg iron) 2 to 3 times a week according to hemoglobin level, the frequency of administration should not exceed 3 times a week. Children received 0.15/kg(3mg iron) 2-3 times a week depending on hemoglobin level. |
| drug interaction | cannot be used together with oral iron, will reduce its absorption, oral iron should be in the injection of this product 5 days after the start of use. |
| side effects | According to the description of iron sucrose, the following side effects may occur in clinical application: 1. Rare allergic reactions. 2. Occasionally the following adverse reactions occur: metallic taste, Head Pain, Nausea, Vomit, Diarrhea, hypotension, increased liver enzymes, cramps/leg cramps, chest pain, drowsiness, Dyspnea, Pneumonia, Cough, pruritus, etc. 3. Rarely parasympathetic excitation, gastrointestinal dysfunction, myalgia, Fever, rubella, facial flushing, limb swelling, Dyspnea, allergic (pseudo-allergic) reactions, varicose veins, occurred at the infusion site, venous spasm. |
| note | 1. This product can only be mixed with 0.9% sodium chloride injection, but not with other therapeutic drugs. 2. This product should be used within 12 hours after opening. 3. This product should be used with cardiopulmonary resuscitation equipment, and intravenous administration by drip or slow injection, or direct injection to the venous end of the dialyzer. 4. For the first administration, a small dose test should be given according to the recommended method, and adults should use 1 to 2.5 (20 to 50mg) of iron. 5. 1ml(20mg) iron was used for children weighing less than 14kg, and 1.5mg iron was used for children weighing more than 14kg. 6. If there is no adverse reaction after 15 minutes of administration, the remaining liquid medicine should be continued. |
| contraindication | 1. Non-iron deficiency anemia. Iron excess or iron utilization disorder. 3. Allergic to iron complex of monosaccharide or disaccharide. |
| pregnant and lactating women using | pregnant women in the first 3 months not recommended for parenteral iron. |
| Use in Children | may have adverse effects on infected children. |
| combined medication | 1. Iron sucrose combined with erythropoietin can effectively improve moderate anemia in maintenance hemodialysis patients, which is safe and effective with significant curative effect. 2. Intravenous iron sucrose combined with Levocarnitine can significantly improve the clinical efficacy of maintenance dialysis patients with chronic renal anemia, which is worthy of promotion. 3., in the treatment of renal anemia in maintenance hemodialysis patients with iron deficiency, the effect of increasing Hb SF and Hct is faster than that of oral power (polysaccharide iron complex), with higher rise and lower incidence of adverse reactions, can be used as one of the preferred method of iron in patients with renal anemia. |
| preparation | Route 1: ferric salt is reacted with inorganic base at 5~20 ℃ to obtain ferric hydroxide colloid, ferric hydroxide colloid is then complexed with sucrose at 100~120 ℃ to obtain iron sucrose solution, and the iron sucrose solution is spray dried to obtain solid. The specific reaction process is as follows: Route 2: 1) Crystallization: the pH value of the sucrose solution is adjusted to 1~4 with acetic acid, and the iron salt solution is added to the sucrose solution to form a mixture, the pH value of the mixed solution is adjusted to 1~3 with Na2CO3 solution, stirred, and the Na2CO3 solution is further added until the mixed solution becomes turbid and the pH value of the mixed solution is adjusted to 4~7, filtered, and water is added to obtain discus solution; 2) complexation: heating the sucrose solution, adding alkali solution for alkalization, adding discus solution to the alkalized sucrose solution, and standing overnight to obtain complexation solution; 3) purification: the complex liquid after standing overnight is filtered, and the filtrate is precipitated with 2 to 3 times of 95% ethanol, and filtered, that is, Iron sucrose. |
| Main reference material | [1] antrum et al. The role of Iron sucrose in the treatment of moderate anemia in dialysis patients. Clinical medical engineering. 2009,16(6):19-21. [2] Zhang Junjun et al. Comparison of the efficacy and safety of iron dextran and iron sucrose in the treatment of iron deficiency anemia after Subtotal gastrectomy. China pharmacy. 2015,26(9):1205-1207. [3] Pan Jinlin et al. Clinical observation of iron sucrose combined with recombinant human erythropoietin in improving moderate anemia in hemodialysis patients. Chinese medical innovation. 2013, 10(32):47-49. [4] Instructions for Iron sucrose injection. [5] Liu Fuqiang and other editors. Physician's Desk medication reference. Beijing: Chinese Medicine Press. 2012. [6] Xu Jingfeng, Edited by Yang Benming. Handbook of clinical prescription drugs. Nanjing: Jiangsu Science and Technology Publishing House. 2009. [7] Pan Jinlin et al. Clinical observation of iron sucrose combined with recombinant human erythropoietin in improving moderate anemia in hemodialysis patients. Chinese medical innovation. 2013, 10(32):47-49. [8] Qu Zhaoli. Efficacy and safety of iron sucrose combined with L-carnitine in maintenance hemodialysis patients with chronic renal anemia. Practical Medicine and clinic. 2014,17(5):623-626. [9] Zhu Kaiyan et al. Observation on the effect of iron sucrose and expertise combined with recombinant human erythropoietin in the treatment of renal anemia. China practical medicine. 2010,5(18):159-160. [10] Cao Zhihua et al. Preparation of iron sucrose. Cn201310317696.0, Filing Date: 10/29/2013. [11] Chen Qingzhong et al. Preparation of iron sucrose raw material and injection. CN200910070762.8, Filing Date: 10/10/2009. |
Last Update：2024-04-09 21:11:58
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