英文药名: FOSRENOL(lanthanum carbonate oral powder) 中文药名: 碳酸镧口服散剂 生产厂家: Shire 药品名称 碳酸镧（lanthanum carbonate，Fosrenol）咀嚼片用于降低终末期肾病（ESRD）患者的高血磷水平。本品为无钙无铝的磷酸盐结合剂在美国上市 通用名：碳酸镧 英文名：Lanthanum carbonate 商品名：FOSRENOL 上市厂商：Shire FOSRENOL（碳酸镧 lanthanum carbonate）咀嚼片，口服使用 FOSRENOL（碳酸镧 lanthanum carbonate）口服散剂，口服使用 最初美国批准：2004年 目前的主要变化 剂量和给药方法 02/2016 警告和注意事项 02/2016 作用机理 FOSRENOL是磷酸盐粘合剂是通过形成通过胃肠（GI）道未被吸收不溶性镧磷酸盐络合物减少磷酸盐的吸收。既血清磷酸盐和磷酸钙产物被还原作为还原饮食磷酸盐吸收的结果。 适应症和用法 FOSRENOL是指示减少患者的终末期肾病（ESRD）的血清磷酸盐的磷酸盐结合剂。 用法用量 FOSRENOL的推荐的初始日总剂量为1500毫克，分次给药。每2-3周滴定基于血清磷酸盐水平; 以FOSRENOL与或饭后立即生效。 FOSRENOL咀嚼片:.咀嚼或咬碎药片完全吞噬前。 上苹果酱或其它类似的食品的少量FOSRENOL口服粉:.撒上粉末和消耗立即考虑患者牙列差或谁粉末制剂有难度咀嚼片 剂型和规格 FOSRENOL咀嚼片:500毫克，750毫克和1000毫克 FOSRENOL口服粉:750毫克和1000毫克 禁忌症 肠梗阻，肠梗阻和粪便嵌塞。 警告和注意事项 消化道梗阻，肠梗阻，subileus，胃肠道穿孔，粪便嵌塞的严重病例。这些风险包括改变胃肠道的解剖，运动不足紊乱，合并用药。建议患者咀嚼或完全压碎药片 FOSRENOL具有不透射线的特性，因此，可以得到外观典型期间腹部X射线的过程的成像剂。 不良反应 在对照试验，这是更频繁的最常见的不良反应（≥5％的差异与安慰剂）的FOSRENOL为恶心，呕吐和腹痛。 批准后的使用FOSRENOL :.便秘，消化不良，过敏性皮肤反应，和牙齿损伤，同时咀嚼片剂的过程中出现如下不良反应已经确定 药物相互作用 存在用于FOSRENOL与结合于阳离子抗酸剂化合物发生相互作用的潜力（即，铝 - ，镁，或钙基），因此，不采取这样的化合物2小时，FOSRENOL给药的范围内。 口服喹诺酮类抗生素必须FOSRENOL之前或之后4小时内采取至少1小时。 不采取甲状腺激素替代治疗中同时接受药剂的患者推荐TSH水平的监测2小时FOSRENOL。给药的范围内。 处方修改：2/2016 FOSRENOL (lanthanum carbonate) chewable tablets, for oral use FOSRENOL (lanthanum carbonate) oral powder, for oral use Fosrenol Information Hyperphosphatemia is a high level of phosphorus in your blood. When your kidneys are not working properly, phosphorus can build up to dangerous levels without proper treatment. FOSRENOL® can help keep your phosphorus levels down. This is important in treating hyperphosphatemia. Fosrenol (lanthanum carbonate) Drug SummaryShire US Inc Fosrenol(lanthanum carbonate)THERAPEUTIC CLASS Phosphate binder DEA CLASS RX ADULT DOSAGE & INDICATIONS Serum Phosphate Reduction in End-Stage Renal Disease Initial: 1500mg/day Titrate: Every 2-3 weeks until an acceptable serum phosphate level is reached Most patients required 1500-3000mg/day to reduce plasma phosphate levels to <6mg/dL. Doses were generally titrated in increments of 750mg/day. Doses up to 4500mg evaluated. ADMINISTRATION Oral route Divide total daily dose. Take w/ or immediately after meals. Consider using the oral powder formulation in patients w/ poor dentition or who have difficulty chewing tabs. Tab, Chewable Chew/crush tabs completely before swallowing; do not swallow intact tabs. Powder Sprinkle on a small quantity of applesauce or other similar food and consume immediately. Do not open until ready to use. Do not store for future use once mixed w/ food. Do not dissolve in liquid for administration. HOW SUPPLIED Powder: 750mg, 1000mg; Tab, Chewable: 500mg, 750mg, 1000mg CONTRAINDICATIONS Bowel obstruction, including ileus and fecal impaction. WARNINGS/PRECAUTIONS Serious cases of GI obstruction, ileus, subileus, GI perforation, and fecal impaction reported. Has radio-opaque properties; may give the appearance typical of an imaging agent during abdominal x-ray procedures. Monitor serum phosphate levels prn during dose titration and on a regular basis thereafter. Tab, Chewable: Risk factors for GI obstruction and GI perforation include altered GI anatomy (eg, diverticular disease, peritonitis, history of GI surgery, GI cancer, GI ulceration) and hypomotility disorders (eg, constipation, ileus, subileus, diabetic gastroparesis); some cases reported in patients w/ no history of GI disease. ADVERSE REACTIONS N/V, abdominal pain. DRUG INTERACTIONS May bind to drugs w/ anionic (eg, carboxyl, carbonyl, hydroxyl) groups. May decrease bioavailability of tetracyclines and fluoroquinolones. For oral medications, where reduction in bioavailability would have clinically significant effect on its safety/efficacy, consider separation of timing of the administration of 2 drugs. Consider monitoring clinical responses or blood levels of concomitant drugs that have a narrow therapeutic range. Do not administer compounds that bind to cationic antacids (eg, ampicillin, tetracyclines, ACE inhibitors, statins, antimalarials) w/in 2 hrs of dosing. May reduce the extent of absorption of quinolone antibiotics; administer oral quinolone antibiotics at least 1 hr before or 4 hrs after therapy. If oral quinolones are given for short courses, consider eliminating lanthanum doses that would be normally scheduled near the time of quinolone intake. Decreases bioavailability of levothyroxine; administer thyroid hormone replacement therapy at least 2 hrs before or 2 hrs after dosing and monitor TSH levels. Tab, Chewable: Risk factors for GI obstruction and GI perforation include concomitant use of calcium channel blockers. PREGNANCY AND LACTATION Pregnancy: Category C. Lactation: Caution in nursing. MECHANISM OF ACTION Phosphate binder; reduces absorption of phosphate by forming insoluble lanthanum phosphate complexes that pass through the GI tract unabsorbed, consequently reducing both serum phosphate and calcium phosphate product. PHARMACOKINETICS Absorption: Cmax=1ng/mL. Distribution: Plasma protein binding (>99%). Elimination: T1/2=53 hrs (dialysis patients). ASSESSMENT Assess for bowel obstruction, ileus, fecal impaction, poor dentition, difficulty chewing tabs, risk factors for GI obstruction and GI perforation, pregnancy/nursing status, and possible drug interactions. MONITORING Monitor for GI obstruction, ileus, subileus, GI perforation, fecal impaction, and other adverse reactions. Monitor serum phosphate levels prn during dose titration and on a regular basis thereafter. PATIENT COUNSELING Instruct to take exactly ud. Advise to take w/ or immediately pc. Instruct patients on concomitant medications that should be dosed apart from therapy. Advise to separate dosing by several hrs in patients who are taking an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety/efficacy. Instruct to notify physician of therapy prior to an abdominal x-ray. STORAGE 25°C (77°F); excursions permitted to 15-30°C (59-86°F). 完整处方资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f10776b2-2c25-4343-aabe-68f302e5cb54 -------------------------------------------------- 注：以下产品不同规格和不同价格，采购以咨询为准！ -------------------------------------------------- 产地国家:美国 原产地英文商品名: Fosrenol 750mg powder 90Powder envelopes 原产地英文药品名: LANTHANUM CARBONATE 中文参考商品译名: FOSRENOL 750毫克 90粉末包 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: SHIRE CORPORATION 生产厂家英文名: SHIRE CORPORATION --------------------------------------------------------------- 产地国家:美国 原产地英文商品名: Fosrenol 1000mg powder 90Powder envelopes 原产地英文药品名: LANTHANUM CARBONATE 中文参考商品译名: FOSRENOL 1000毫克 90粉末包 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: SHIRE CORPORATION 生产厂家英文名: SHIRE CORPORATION --------------------------------------------------------------- 产地国家:西班牙  原产地英文商品名: Fosrenol 750mg powder 90Powder envelopes (minimum order qty: 2) 原产地英文药品名: Lantano Carbonato, Glucosa 中文参考商品译名: FOSRENOL 750毫克 90粉末包 (最低订货量：2) 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: 希尔制药 生产厂家英文名: SHIRE PHARMACEUTICALS --------------------------------------------------------------- 产地国家:西班牙  原产地英文商品名: Fosrenol 1000mg powder 90Powder envelopes (minimum order qty: 2) 原产地英文药品名: Lantano Carbonato, Glucosa 中文参考商品译名: FOSRENOL 1000毫克 90粉末包 (最低订货量：2) 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: 希尔制药 生产厂家英文名: SHIRE PHARMACEUTICALS --------------------------------------------------------------- 产地国家:德国 原产地英文商品名: Fosrenol 750mg powder 90Powder envelopes (minimum order qty: 2) 原产地英文药品名: Lantano Carbonato, Glucosa 中文参考商品译名: FOSRENOL 750毫克 90粉末包 (最低订货量：2) 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: 希尔制药 生产厂家英文名: SHIRE --------------------------------------------------------------- 产地国家:德国 原产地英文商品名: Fosrenol 750mg powder 90Powder envelopes (minimum order qty: 2) 原产地英文药品名: Lantano Carbonato, Glucosa 中文参考商品译名: FOSRENOL 750毫克 90粉末包 (最低订货量：2) 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: 希尔制药 生产厂家英文名: SHIRE