叶酸注射液、肌肉注射，静脉注射
【类别】 抗贫血药
【有效成分/活性成分】
成分名称基础力量强度
叶酸（叶酸）叶酸5毫克，1毫升
【非活性成分】
成分名称强度
乙二胺四乙酸钠在1毫升2毫克
苄醇在1毫升15毫克
盐酸
氢氧化钠
【药理作用】
叶酸为B族维生素。
叶酸经二氢叶酸还原酶及 维生素B12 的作用，形成四氢叶酸（THFA），后者与多种一碳单位（包括CH3、CH2、CHO等）结合成四氢叶酸类辅酶，传递一碳单位，参与体内很多重要反应及核酸和氨基酸的合成。THFA在 丝氨酸 转羟基酶的作用下，形成N5，10甲烯基四氢叶酸，能促使尿嘧啶核苷酸（dUMP）形成胸腺嘧啶核苷酸（dTMP），后者可参与细胞的DNA合成，促进细胞的分裂与成熟。在DNA合成过程中，脱 氧 尿苷酸转变为脱氧胸苷酸，其间所需的甲基由亚甲基四氢叶酸提供。叶酸缺乏时，DNA合成减慢，但RNA合成不受影响，结果在骨髓中生成细胞体积较大而细胞核发育较幼稚的血细胞，尤以红细胞最为明显，及时补充可有治疗效应。 维生素B1 2参与体内甲基转换及叶酸代谢，促进5-甲基四氢叶酸转变为四氢叶酸。缺乏时，导致DNA合成障碍，影响红细胞的成熟。本品还促使甲基丙二酸转变为琥珀酸，参与三羧酸循环。此作用关系到神经髓鞘脂类的合成及维持有髓神经纤维功能完整， 维生素B1 2缺乏症的神经损害可能与此有关。烟酰胺为辅酶Ⅰ及辅酶Ⅱ的组成部分，参与机体的代谢过程，为脂类代谢、组织呼吸的氧化作用和糖原分解所必需。
【适应症】
各种原因引起的叶酸缺乏及叶酸缺乏所致的巨幼红细胞贫血，尤适用于由于营养不良或婴儿期、妊娠期哺乳期妇女预防给药；慢性溶血性贫血所致的叶酸缺乏。预防胎儿先天性神经管畸形
【用法用量】
成人，一次5～10毫克，一日15～30毫克。
儿童，一日5毫克，一日3次；预防用，一次0.4毫克，一日1次。
【不良反应】
长期用药可以出现 厌食 、 恶心 、 腹胀 等胃肠症状。大量服用可使尿呈黄色。罕见【过敏反应】
禁忌对叶酸过敏。以前曾服用任何其他同类药品，引起脸部、嘴唇、舌头、喉咙、手脚肿大，或者引起呼吸困难。因为他们之间可能有交叉过敏的情况。维生素B12缺乏引起的巨幼细胞贫血。如已超过包装上所印的有效期，或者包装破损、或有损坏的痕迹，请不要服用
【注意事项】
小儿使用叶酸 剂量应咨询医师
Folic Acid Injection
Dosage Form: injection, solution
Folic Acid Injection, USP
Folic Acid Injection Description
Folic Acid Injection, USP is a sterile, nonpyrogenic solution of sodium folate (prepared by the addition of sodium hydroxide to folic acid) in Water for Injection intended for intramuscular (IM), intravenous (IV) or subcutaneous (SC) use.
Folic Acid is a complex organic compound present in liver, yeast and other substances, which may be prepared synthetically. It is a yellow or yellowish orange, odorless crystalline powder. It is very slightly soluble in water, insoluble in alcohol, chloroform, ether; readily dissolves in dilute solutions of alkali hydroxides and carbonates. It is chemically designated as: L-Glutamic acid, N-[4-[[(2-amino-1-4-dihydro-4-oxo-6-pteridinyl) methyl] amino]benzoyl]-, and has the following structural formula.

C19H19N7O6                                                     M.W. 441.40
Each mL contains: Sodium folate (equivalent to 5 mg folic acid); edetate disodium 2 mg; benzyl alcohol 15 mg (added as preservative); Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide for pH adjustment (8.0 to 11.0).
Folic Acid Injection - Clinical Pharmacology
In man, an exogenous source of folate is required for nucleoprotein synthesis and maintenance of normal erythropoiesis. Folic acid, whether given by mouth or parenterally, stimulates specifically the production of red blood cells, white blood cells and platelets in persons suffering from certain megaloblastic anemias.
Indications and Usage for Folic Acid Injection
Folic Acid Injection, USP alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.
Warnings
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.  Tissue loading may occur at even lower rates of administration.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
This product contains benzyl alcohol.  Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.
Precautions
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Folic Acid Injection Dosage and Administration
Parenteral Administration: IM, IV and SC routes may be used if the disease is exceptionally severe or if gastrointestinal absorption may be, or is known to be, impaired.
Usual Therapeutic Dosage—In adults and children (regardless of age): up to 1 mg daily.Resistant cases may require larger doses.
Maintenance Level: When clinical symptoms have subsided and the blood picture has become normal, a maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under four years of age, 0.4 mg for adults and children four or more years of age and 0.8 mg for pregnant and lactating women, per day, but never less than 0.1 mg per day. Patient should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.
In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy or chronic infection, the maintenance level may need to be increased.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
How is Folic Acid Injection Supplied
Folic Acid Injection, USP (5 mg/mL) is available as:
10 mL Multiple Dose, in a flip-top vial packaged individually.
10 mL Multiple Dose, in a flip-top vial, 10 vials per tray.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

5 mg/mL 10 mL*10瓶
5 mg/mL  10 mL*10瓶

制造商：APP制药有限责任公司