【主要成分】
本品主要成份为：帕米膦酸二钠。其化学名称为：3-氨基-1-羟基亚丙基-1，1-二膦酸二钠五水合物。

【性状】
本品为白色冻干块状物。

【药理作用】
本品为双膦酸类药物，体外和动物试验表明可强烈抑制羟磷灰石的溶解和破骨细胞的活性，对骨质的吸收具有十分显著的抑制作用。对癌症的溶骨性骨转移所致的疼痛有止痛作用，亦可用于治疗癌症所致的高钙血症。

【药代动力学】
文献报道，癌症病人以本品45mg溶于500ml生理盐水后静脉滴注4小时以上，滴注结束后血浓度为0.96?g/ml，平均有51%的药物以原形从尿中排泄；尿的排泄显示双相处置动力学特点，??和??半衰期分别为1.6小时和27.2小时。动物实验表明：给药后迅速从循环系统消除，主要分布在骨骼、肝脏、脾脏和气管软骨中。本品可长期滞留于骨组织中，半衰期最长可达300天。

【适应证】
恶性肿瘤并发的高钙血症和溶骨性癌转移引起的骨痛。

【用法用量】
治疗骨转移性疼痛：临用前稀释于不含钙离子的0.9%生理盐水或5%葡萄糖液中。静脉缓慢滴注4小时以上，浓度不得超过15mg/125ml，滴速不得大于15～30mg/2小时。一次用药30～60mg。治疗高钙血症：应严格按照血钙浓度，在医生指导下酌情用药。

【不良反应】
少数病人可出现轻度恶心、胸痛、胸闷、头晕乏力及轻微肝肾功能改变等，偶见发热反应。

【禁忌】
对本品和双膦酸盐制剂有过敏史者禁用。

【注意事项】
1．本品需以不含钙的液体稀释后立即静脉缓慢滴注，不可将本品直接静脉滴注。
2．本品不得与其他种类双膦酸类药物合并使用。
3．动物实验中使用本品曾发生肾毒性，肾功能损伤者慎用。
4．用于治疗高钙血症时，应同时注意补充液体，使每日尿量达2L以上。使用本品过程中，应注意监测血清钙、磷等电解质水平。

【孕妇及哺乳期妇女用药】
孕妇应权衡利弊用药，药物可进入母乳中，故哺乳期妇女慎用。

【儿童用药】
一般不用，可能影响骨骼成长。

【老人用药】
适当减量。

【药物相互作用】
尚不明确。

【药物过量】
过量或速度过快，可能引起低钙血症，出现抽搐、手指麻木症状，可适量补钙。

【贮藏】
遮光，密闭，在阴凉处保存。

【原产地英文商品名】PAMIDRONATE POWDER 30mg/10mls/Vial
【原产地英文药品名】PAMIDRONATE DISODIUM
【中文参考商品译名】
注：以下产品不同的规格和不同的价格，购买时请以电话咨询为准！
·帕米膦酸液 30毫克/10毫升/瓶
·帕米膦酸粉剂 30毫克/10毫升/瓶
·帕米膦酸液 90毫克/10毫升/瓶
【中文参考药品译名】帕米膦酸二钠

AREDIA (pamidronate disodium) INDICATION(S)
Aredia (pamidronate disodium), in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia with malignancy, with or without bone metastases. The safety and efficacy of Aredia in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.

Aredia (pamidronate disodium) is indicated for the treatment of patients with moderate to severe Paget's Disease of bone. The effectiveness was demonstrated primarily in patients with serum alkaline phosphatase ≥3 times the upper limit of normal.

Aredia (pamidronate disodium) is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.

IMPORTANT SAFETY INFORMATION
AREDIA (pamidronate disodium) is contraindicated in patients with clinically significant hypersensitivity to AREDIA or other bisphosphonates.

Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of AREDIA (pamidronate disodium) should not exceed 90 mg and the duration of infusion should be no less than 2 hours. After the initial or a single dose of AREDIA, renal deterioration, progression to renal failure, and dialysis has been reported in patients. AREDIA-treated patients, particularly those with multiple myeloma and breast cancer, have reported focal segmental glomerulosclerosis (including the collapsing variant) with or without nephrotic syndrome, which may lead to renal failure, and some had gradual renal status improvement upon discontinuation of AREDIA.

Serum creatinine should be assessed prior to each treatment, and those with bone metastses should have the dose withheld if renal function has deteriorated.

AREDIA (pamidronate disodium) should not be used during pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant. If the patient becomes pregnant or plans to breast-feed while taking this drug, the patient should be apprised of the potential harm to the fetus or baby.

AREDIA is excreted intact primarily via the kidney, and the risk of renal adverse reactions may be greater in patients with impaired renal function. Caution is indicated when AREDIA is used with other potentially nephrotoxic drugs, and in multiple myeloma patients, the risk of renal dysfunction is increased when AREDIA is combined with thalidomide.

Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including Aredia. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ. Postmarketing experience and the literature suggest a greater frequency of reports of ONJ based on tumor type (advanced breast cancer, multiple myeloma), and dental status (dental extraction, periodontal disease, local trauma including poorly fitting dentures). Many reports of ONJ involved patients with signs of local infection including osteomyelitis.

Cancer patients should maintain good oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates.

While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. Symptoms were generally relieved after stopping treatment, and a subset of patients had symptoms recur after rechallenge with AREDIA or another bisphosphonate.

Closely monitor serum calcium, phosphate, magnesium, potassium, creatinine, and CBC, differential, and hematocrit/hemoglobin following initiation of treatment with AREDIA. Those patients with anemia, luekopenia or thrombocytopenia should be carefully monitored in the first two weeks following treatment. Asymptomatic hypophosphatemia (12%), hypokalemia (7%) hypomagnesemia (11%) and hypocalcemia (5-12%) were reported in patients treated with AREDIA. Rare cases of symptomatic hypocalcemia (including tetany) have been reported; short-term calcium therapy may be necessary. Patients with a history of thyroid surgery may have relative hypoparathyroidism that may predispose to hypocalcemia with AREDIA.

In post-marketing experience, rare instances of allergic manifestations have been reported, including hypotension, dyspnea, or angioedema, and, very rarely, anaphylactic shock.

The most common adverse events (>15%) in bone metastases clinical trials, regardless of causality, were as follows: Asthenia, fatigue, diarrhea, dyspepsia, fluid overload, abdominal pain, anorexia, constipation, metastases, insomnia, nausea, vomiting, urinary tract infection, skeletal pain, fever, headache, coughing, upper respiratory tract infection, anemia, granulocytopenia, myalgias, sinusitis, and dyspnea. The most common adverse events (>15%) in the Hypercalcemia of Malignancy trials, regardless of causality, include: Fluid overload, generalized pain, hypertension, abdominal pain, anorexia, constipation, nausea, vomiting, urinary tract infection, bone pain, anemia, hypokalemia, hypomagnesemia, and hypophosphatemia. The most common adverse events (>10%) in the Paget's Disease trials, regardless of causality, include: Hypertension, arthrosis, bone pain, and headache.

In hypercalcemia of malignancy trials, rare cases of uveitis, iritis, scleritis, and episcleritis have been reported, and one case each of uveitis and scleritis were found to recur upon separate rechallenge.

In the absence of hypercalcemia, patients at risk of calcium or vitamin D deficiency with predominantly lytic bone metastates or multiple myeloma and patients with Paget's disease of the bone should be administered an oral calcium and vitamin D supplement.