新型补钙剂PHOSLO GELCAP(CALCIUM ACETATE中文译名：醋酸钙胶囊)-治疗高磷血症为首选药物 通用名称：醋酸钙 商品名称：Phoslo Gel cap 英文名称：Calcium Acetate 成分：醋酸钙 药物毒理 本品为补钙剂，主要有促进骨骼和牙齿的钙化，维持神经与肌肉正常兴奋性，以及毛细血管渗透性等作用。 药代动力学 本品由肠道吸收，经肾脏排泄，未吸收部分可或与磷结合后随粪便排泄。 适应症 本品主要用于纠正高磷血症，也可用于钙的补充。 用法用量 口服，用于纠正高磷血症，应根据血鲈、血磷检验数据，由医师决定。钙的补充每日最高限300mg(以钙元素计，扣除饮食中的钙),服药时间不宜超过一个月。 不良反应 可见嗳气，便秘，腹部不适，大剂量服用可见高钙血症：表现为厌食、恶心、呕吐，便秘，腹痛肌，无力，心律失常以及骨石灰沉着等。 禁忌 高钙血症者禁用。 注意事项 1．本品宜在空腹(饭前一小时)时服用。 2．应尽量通过正常膳食保证钙的摄入。 3．本品不宜大量长期服用，故不宜用于钙缺乏症的治疗。 4．使用时间超过2周时，应进行血钙血磷的监测。 5．肝肾功能不全时应在医嘱下使用。 孕妇及哺乳期妇女用药 孕妇，哺乳期妇女使用本品的安全性尚未确定。 药物相互作用 1．禁止与洋地黄类药物联合使用。 2．避免与草酸盐类同时服用。 Phoslo Gelcap 667mg(Calcium Acetate) PHOSLO (calcium acetate) capsule [Physicians Total Care, Inc.] DESCRIPTION Each opaque gelcap with a blue cap and white body is spin printed in blue and white ink with “PhosLo®” printed on the cap and “667 mg” printed on the body. Each gelcap contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and 10 mg of the inert binder, polyethylene glycol 8000 NF. The gelatin cap and body have the following inactive ingredients: FD&C blue #1, D&C red #28, titanium dioxide, USP and gelatin, USP. PhosLo Gelcaps (calcium acetate) are administered orally for the control of hyperphosphatemia in end stage renal failure. CLINICAL PHARMACOLOGY Patients with advanced renal insufficiency (creatinine clearance less than 30 ml/min) exhibit phosphate retention and some degree of hyperphosphatemia. The retention of phosphate plays a pivotal role in causing secondary hyperparathyroidism associated with osteodystrophy, and soft-tissue calcification. The mechanism by which phosphate retention leads to hyperparathyroidism is not clearly delineated. Therapeutic efforts directed toward the control of hyperphosphatemia include reduction in the dietary intake of phosphate, inhibition of absorption of phosphate in the intestine with phosphate binders, and removal of phosphate from the body by more efficient methods of dialysis. The rate of removal of phosphate by dietary manipulation or by dialysis is insufficient. Dialysis patients absorb 40% to 80% of dietary phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet needs to be reduced by using phosphate binders in most renal failure patients on maintenance dialysis. Calcium acetate (PhosLo) when taken with meals, combines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. PhosLo is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine. Orally administered calcium acetate from pharmaceutical dosage forms has been demonstrated to be systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions. INDICATIONS AND USAGE PhosLo is indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption. CONTRAINDICATIONS Patients with hypercalcemia. WARNINGS Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with PhosLo. Progressive hypercalcemia due to overdose of PhosLo may be severe as to require emergency measures. Chronic hypercalcemia may lead to vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period. The serum calcium times phosphate(CaXP) product should not be allowed to exceed 66. Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft tissue calcification. PRECAUTIONS General Excessive dosage of PhosLo induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. PhosLo should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. PhosLo therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. An estimate of daily calcium intake should be made initially and the intake adjusted as needed. Serum phosphorus should also be determined periodically. Information for the Patient The patient should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia (see ADVERSE REACTIONS section). Drug Interactions PhosLo may decrease the bioavailability of tetracyclines. Carcinogenesis, Mutagenesis, Impairment of Fertility Long term animal studies have not been performed to evaluate the carcinogenic potential, mutagenicity, or effect on fertility of PhosLo. Pregnancy Teratogenic Effects: Category C. Animal reproduction studies have not been conducted with PhosLo. It is not known whether PhosLo can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PhosLo should be given to a pregnant woman only if clearly needed. Pediatric Use Safety https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34a29fae-b549-41ed-bd7d-e98fe2110bef ------------------------------------------------------------ 原产地英文商品名: PHOSLO GELCAP 667mg/cap 200caps/bottle 原产地英文药品名: CALCIUM ACETATE 中文参考商品译名: PHOSLO GELCAP 667毫克/胶囊 200胶囊/瓶 中文参考药品译名: 醋酸钙 生产厂家中文参考译名: FRESENIUS MEDCL 生产厂家英文名: FRESENIUS MEDCL ------------------------------------------------------------ 产地国家: 美国 原产地英文商品名: CALCIUM ACETATE 667mg 30capsules 原产地英文药品名: CALCIUM ACETATE 中文参考商品译名: 醋酸钙 667毫克/胶囊 30胶囊/瓶 中文参考药品译名: 醋酸钙 生产厂家英文名: ROXANE ---------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: Calcium lactate 650mg 1000 tablets 原产地英文药品名: CALCIUM LACTATE 中文参考商品译名: 醋酸钙 650毫克/片 1000片/盒 中文参考药品译名: 醋酸钙