力蜚能-150 FORTE_NIFEREX-150 FORTE_力蜚能-150 FORTE胶囊剂IRON ASPARTO说明书

  [caption id="attachment_36237" align="alignleft" width="300"] NIFEREX-150 FORTE(力蜚能-150 FORTE胶囊剂)[/caption] 药店国别： 产地国家：美国 处 方 药：是 所属类别：150毫克/胶囊 90胶囊/瓶 包装规格：150毫克/胶囊 90胶囊/瓶 计价单位：瓶 生产厂家中文参考译名:许瓦兹制药 生产厂家英文名:Schwarz Pharma 原产地英文商品名:NIFEREX-150 FORTE CAPSULE 150mg/Capsule 90Capsules/bottle 原产地英文药品名:IRON ASPARTO GLYCINATE&POLYSACCHARIDE COMPLEX/ASCORBATE 中文参考商品译名:力蜚能-150 FORTE胶囊剂 150毫克/胶囊 90胶囊/瓶 中文参考药品译名:多糖铁复合物/抗坏血酸钙/维生素原B12/叶酸/苏糖酸钙/琥珀酸 简介： 部份中文多糖铁复合物处方资料(仅供参) 商品名:力蜚能 通用名:多糖铁复合物胶囊 英文名:Polysaccharide-Iron　Complex　Capsules 性状:本品为硬胶囊，内容物为棕黑色微丸，溶于水形成深棕色溶液，无味、无臭 药理作用:本品是一种铁元素含量高达46%的低分子量多糖铁复合物。作为铁元素补充剂，可迅速提高血铁水平与升高血红蛋白。大鼠口服本品的LD50大于2800mgFe/kg。大鼠和狗的长期毒性试验证明，每天摄入本品250mgFe/kg，连续使用三个月，未见不良反应。动物试验未发现本品有致畸、致癌和致突变作用。 药代动力学:本品是铁和多糖合成的复合物，以完整的分子形式存在，在消化道中能以分子形式被吸收。经核素标记示踪试验证实其吸收率不低于硫酸亚铁，且吸收率不受胃酸减少、食物成分的影响，有极高的生物利用度。 适应症:用于治疗单纯性缺铁性贫血。 用法用量:成人每日一次，每次口服1~2粒;儿童需在医生的指导下使用 副作用:极少出现胃肠刺激或便秘 禁忌:血色素沉着症及含铁血黄素沉着症禁用此药 注意事项:本品安全性好，安全系数是普通铁剂的13倍以上。多糖铁复合物分子通过肠黏膜吸收阀调节血药浓度，不会导致铁中毒。6岁以下儿童意外服用含铁药品过量可导致致命性中毒，如意外过量，请有经验的医生立即处理;请将本品置于儿童接触不到的地方保存 孕妇及哺乳期妇女用药：对于治疗孕产妇缺铁性贫血，其优越性尤为突出 老年患者用药：无影响 药物相互作用：制酸剂及四环素类药物抑制其吸收 贮藏：室温(15℃-30℃)贮存 有效期：三年 生产企业：德国许瓦兹制药有限公司 【临床研究】国内王耀莉等用多糖铁复合物胶囊(每粒胶囊含铁150mg)治疗缺铁性贫血患儿24例。按患儿年龄和体重，每天剂量为15-150mg，分1-2次服用，持续4或6周。治疗后总有效率为96%，RBC、Hb、红细胞压积(Hct)、血清铁、血清铁饱和度均较治疗前明显上升(P<0.01)。网织红细胞数也上升(P<0.05)。不良反应主要表现为恶心，但不影响治疗。 国内甄学慧等将妊娠合并缺铁性贫血的妇女随机分为实验组(口服力蜚能150mg，bid)和对照组(口服硫酸亚铁0.3g，tid)。治疗4周后复查RBC、Hb、Hct、网织红细胞、血清铁及转铁蛋白。治疗组有效率为90.3%，对照组有效率为84.8%，差异显著。力蜚能治疗19例孕妇贫血，PIC150mg，po，bid，治疗4周后。其Hb、RBC均明显升高。耐受性好。 niferex®-150 forte Capsules DESCRIPTION Each powder-filled capsule for oral administration contains: Iron (elemental iron) Sumalate®* iron. . . . . . . . . . . . . . . . . . . . . . . 50 mg Polysaccharide iron. . . . . . . . . . . . . . . . . . . . . . 100 mg Succinic acid . . . . . . . . . . . . . . . . . . . . . . 50 mg Vitamin C Ester-C® supplement . . . . . . . . . . . . . . . . . . . . . 60 mg Folic acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg Vitamin B12 (cyanocobalamin) . . . . . . . . . . . . . . 25 mcg *Sumalate® is a registered trademark of Albion International, Inc.,Clearfield, Utah and the product is protected under U.S. Patent Nos. 5,516,925 and 6,716,814, licensed exclusively to KV PharmaceuticalCo. for iron products. Other U.S. patents pending. † Ester-C® is a licensed trademark of The Ester C Company. Inactive Ingredients: citric acid, D&C Red No. 28, FD&C Blue No. 1,FD&C Red No. 40, gelatin, magnesium stearate, malic acid, modifiedfood starch, pharmaceutical glaze, silicon dioxide, sodium benzoate,sodium citrate, sorbic acid, and titanium dioxide. CLINICAL PHARMACOLOGY Iron is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, includingcytochromes that are involved in electron transport. Folic acid is required for nucleoprotein synthesis and themaintenance of normal erythropoiesis. Folic acid is converted inthe liver and plasma to its metabolically active form, tetrahydrofolicacid, by dihydrofolate reductase. Vitamin B12 is required for the maintenance of normal erythropoiesis,nucleoprotein and myelin synthesis, cell reproduction and normalgrowth. Intrinsic factor, a glycoprotein secreted by the gastricmucosa, is required for active absorption of Vitamin B12 from thegastrointestinal tract. INDICATIONS AND USAGE Niferex®-150 Forte is indicated for the prevention and treatment ofiron deficiency anemia and/or nutritional megaloblastic anemias. CONTRAINDICATIONS Niferex®-150 Forte is contraindicated in patients with a knownhypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindicationsto iron therapy. WARNINGS Folic acid alone is improper therapy in the treatment of perniciousanemia and other megaloblastic anemias where Vitamin B12is deficient. WARNING: Accidental overdose of iron-containingproducts is a leading cause of fatal poisoning in childrenunder 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poisoncontrol center immediately. PRECAUTIONS General Do not exceed recommended dose. The type of anemia and the underlying cause or causes shouldbe determined before starting therapy with Niferex®-150 Forte. Since the anemia may be a result of a systemic disturbance, suchas recurrent blood loss, the underlying cause or causes should becorrected, if possible. Folic Acid Folic acid in doses above 1.0 mg daily may obscure perniciousanemia in that hematologic remission can occur while neurologicalmanifestations remain progressive. Pernicious anemia should beexcluded before using this product since folic acid may mask thesymptoms of pernicious anemia. Pediatric Use Safety and effectiveness in pediatric patients have notbeen established. Geriatric Use Clinical studies on this product have not been performed insufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.In general, dose selection for an elderly patient should be cautious,usually starting at the low end of the dosing range, reflecting thegreater frequency of decreased hepatic, renal, or cardiac function,and of concomitant disease or other drug therapy. ADVERSE REACTIONS Adverse reactions with iron therapy may include constipation,diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral andparenteral administration of folic acid. OVERDOSAGE The clinical course of acute iron overdosage can be variable. Initialsymptoms may include abdominal pain, nausea, vomiting, diarrhea,tarry stools, melena, hematemesis, hypotension, tachycardia,metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor,cyanosis, lassitude, seizures, shock and coma. The oral LD50 of polysaccharide iron complex was estimated to begreater than 5000 mg iron/kg in the rate. Chronic toxicity studies inrats and dogs administeredpolysaccharide iron complex showedthat a daily dosage of 250 mg iron/kg for three months had noadverse effects. DOSAGE AND ADMINISTRATION Usual adult dose is 1 capsule daily, or as directed by a physician. HOW SUPPLIED Niferex®-150 Forte Capsules are red and clear capsules filled withbrown powder, imprinted in white ink with “THX” on the cap and“164” on the body, in bottles of 90 capsules (NDC 64011-164-26). Store at 25°C (77°F); excursions permitted to 15° - 30°C(59° - 86°F). [See USP Controlled Room Temperature.] Avoidexcessive heat 40°C (104°F). Avoid freezing. Mktd. by Ther-Rx Corp., St. Louis, MO 63044U.S. Patent Nos. 5,516,925; 6,716,814. Other U.S. patents pending.