部分中文美洛昔康处方资料（仅供参考）
美洛昔康( Meloxicam )
化学名：4-羟基-2-甲基-N-(5-甲基-1,3-噻唑-2-基)-2H-1,2-苯并噻嗪-3-羧酸乙酯 1,1-二氧化物
类别：美洛昔康是非甾体抗炎药，用来减轻一些关节炎的症状，治疗风湿药
适应症：使用于类风湿性关节炎的症状治疗，疼痛性骨关节炎（关节病、退行性骨关节病）的症状治疗。
用法用量：口服，用水或流质送服吞咽。 　　
类风湿性关节炎：每天15mg（2片），根据治疗后反应，剂量可减至一日7.5mg（1片）。 　　
骨关节炎：一日7.5mg（1片），如果需要，剂量可增值一日15mg（2片）。 　　
对于不良反应有可能增加的病人：治疗开始剂量一日7.5mg(1片)。 　　
严重肾衰竭的病人透析时：剂量不应超过一日7.5mg（1片）。 　　
本品每日最大建议剂量为15mg(2片)。 　　
儿童适用的剂量尚未确定，目前只限于成人使用。
不良反应
根据国外研究资料报道，以下罗列的不良反应系在本品给药后发生，然而他们的发生频率是根据临床实验记录结果，而无论与本品用药是否有因果关系。这些信息是基于对3750个病人进行的超过18个月的临床实验得到的，病人每日口服本品剂量为7.5或15毫克。（治疗用药的平均时间为127天）。
1、胃肠道：频率超过1％：消化不良、恶心、呕吐、腹痛、便秘、胀气、腹泻。频率介于0.1％和1％之间：短暂的肝功能指标异常（如转氨酶或胆红素升高）。食道炎、胃十二指肠溃疡，隐伏或肉眼可见的胃肠道出血。频率小于0.1％：胃肠道穿孔，结肠炎。
2、血液：频率超过1％：贫血。介于0.1％和1％之间：血细胞计数失调，包括白细胞分类计数，白细胞减少和血小板减少，同时使用潜在的骨髓毒性药物，特别是氨甲喋呤，是导致出现血细胞减少的一个因素。
3、皮肤：频率超过1％：瘙样、皮疹。介于0.1％和1％之间：口炎、寻麻疹。少于0.1％：感光过敏。 　　
4 、呼吸道：频率少于0.1％：已有报道在使用阿斯匹林或其他NSAID，包括本品之后有个体出现急性哮喘。 　　
5、中枢神经系统：频率多于1％：轻微头晕、头痛。介于0.1％和1％：眩晕、耳鸣、嗜睡。 　　
6、心血管：频率多于1％：水肿。介于0.1％和1％之间：血压升高、心悸、潮红。 　　
7、泌尿系统：介于0.1％和1％之间：肾功能指标异常（血清肌酐和／或血清尿素升高）。
禁忌
以下情况禁用：对药物活性成分美洛昔康或其赋形剂已知过敏者。与乙酰水杨酸和其他NSAID可能会有交叉过敏反应。对使用乙酰水杨酸或其他NSAID后出现哮喘、鼻腔息肉、血管水肿或寻麻疹等症状的病人不宜使用本品。活动性消化性溃疡，严重肝功能不全者，非透析严重肾功能不全者，儿童和年龄小于15岁的青少年，孕妇或哺乳者。
【孕妇及哺乳期妇女用药】
虽然在临床前的试验中没有发现致畸作用，但本品不应用于孕妇和哺乳者。 　　
【儿童用药】
儿童的适用剂量尚未确定，儿童和年龄小于15岁的青少年禁用。 　　
【老年用药】
对可能有肝、肾及心功能不全的老年患者应慎用。
药物过量：因为没有已知的解毒药，所以在过剂量情况时应采取胃排空及支持疗法。有临床试验表明消胆胺可促进本品的排泄。
贮藏：遮光、密封保存。放在儿童伸手不及处。

Metacam Injection
Generic Name: meloxicam injection
Dosage Form: FOR ANIMAL USE ONLY
Metacam®
(meloxicam)
5 mg/mL Solution for Injection
Package Insert for Dogs
NADA 141-219, Approved by FDA
Non-steroidal anti-inflammatory drug for use in dogs and cats only
Caution
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Warning: Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do not administer additional injectable or oral meloxicam to cats. See Contraindications, Warnings, and Precautions for detailed information.
Description
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. Each mL of this sterile product for injection contains meloxicam 5.0 mg, alcohol 15%, glycofurol 10%, poloxamer 188 5%, sodium chloride 0.6%, glycine 0.5% and meglumine 0.3%, in water for injection, pH adjusted with sodium hydroxide and hydrochloric acid.
Indications
Dogs: Metacam (meloxicam) 5 mg/mL Solution for Injection is indicated in dogs for the control of pain and inflammation associated with osteoarthritis.
Dosage and Administration
Carefully consider the potential benefits and risk of Metacam and other treatment options before deciding to use Metacam. Use the lowest effective dose for the shortest duration consistent with individual response.
Dogs: Metacam 5 mg/mL Solution for Injection should be administered initially as a single dose at 0.09 mg/lb (0.2 mg/kg) body weight intravenously (IV) or subcutaneously (SQ), followed, after 24 hours, by Metacam Oral Suspension at the daily dose of 0.045 mg/lb (0.1 mg/kg) body weight, either mixed with food or placed directly in the mouth.
Contraindications
Dogs with known hypersensitivity to meloxicam should not receive Metacam 5 mg/mL Solution for Injection.
Warnings
Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. For IV or SQ injectable use in dogs. All dogs should undergo a thorough history and physical examination before administering any NSAID. Appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to, and periodically during use of any NSAID in dogs.
Owner should be advised to observe their dogs for signs of potential drug toxicity.
Precautions
The safe use of Metacam 5 mg/mL Solution for Injection in dogs younger than 6 months of age, dogs used for breeding, or in pregnant or lactating bitches has not been evaluated. Meloxicam is not recommended for use in dogs with bleeding disorders, as safety has not been established in dogs with these disorders. Safety has not been established for intramuscular (IM) administration in dogs. When administering Metacam 5 mg/mL Solution for Injection, use a syringe of appropriate size to ensure precise dosing. As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Dogs that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or preexisting disease that has not been previously diagnosed.
Since NSAIDs possess the potential to induce gastrointestinal ulcerations and/or perforations, concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. If additional pain medication is needed after the administration of the total daily dose of Metacam Oral Suspension, a non-NSAID or noncorticosteroid class of analgesia should be considered. The use of another NSAID is not recommended. Consider appropriate washout times when switching from corticosteroid use or from one NSAID to another in dogs. The use of concomitantly protein-bound drugs with Metacam 5 mg/mL Solution for Injection has not been studied in dogs. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of Metacam 5 mg/mL Solution for Injection has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. The effect of cyclo-oxygenase inhibition and the potential for thromboembolic occurrence or a hypercoagulable state has not been studied.
Adverse Reactions
Dogs: A field study involving 224 dogs was conducted. Based on the results of this study, GI abnormalities (vomiting, soft stools, diarrhea, and inappetance) were the most common adverse reactions associated with the administration of meloxicam. The following table lists adverse reactions and the numbers of dogs that experienced them during the study. Dogs may have experienced more than one episode of the adverse reaction during the study.
In foreign suspected adverse drug reaction (SADR) reporting, adverse reactions related to meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).
Post-Approval Experience (Rev. 2009)
The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system:
Gastrointestinal: vomiting, diarrhea, melena, gastrointestinal ulceration
Urinary: azotemia, elevated creatinine, renal failure
Neurological/Behavioral: lethargy, depression
Hepatic: elevated liver enzymes
Dermatologic: pruritus
Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with the use of meloxicam in cats.
To report suspected adverse reactions, to obtain a Material Safety Data Sheet, or for technical assistance, call 1-866-METACAM (1-866-638-2226).
Information for Dog Owners
Meloxicam, like other NSAIDs, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with NSAID intolerance. Adverse reactions may include vomiting, diarrhea, lethargy, decreased appetite and behavioral changes. Dog owners should be advised when their pet has received a meloxicam injection. Dog owners should contact their veterinarian immediately if possible adverse reactions are observed, and dog owners should be advised to discontinue Metacam therapy.
Clinical Pharmacology
Meloxicam has nearly 100% bioavailability when administered orally or after subcutaneous injection in dogs. The terminal elimination half life after a single dose is estimated to be approximately 24 hrs (+/-30%) in dogs regardless of route of administration. Drug bioavailability, volume of distribution, and total systemic clearance remain constant up to 5 times the recommended dose for use in dogs. However, there is some evidence of enhanced drug accumulation and terminal elimination half-life prolongation when dogs are dosed for 45 days or longer.
Peak drug concentrations of 0.734 mcg/mL can be expected to occur within 2.5 hours following a 0.2 mg/kg subcutaneous injection in dogs. Based upon intravenous administration in Beagle dogs, the meloxicam volume of distribution in dogs (Vdλ) is approximately 0.32 L/kg and the total systemic clearance is 0.01 L/hr/kg. The drug is 97% bound to canine plasma proteins.
Effectiveness
Dogs: The effectiveness of Metacam 5 mg/mL Solution for Injection was demonstrated in a field study involving a total of 224 dogs representing various breeds, all diagnosed with osteoarthritis. This placebo-controlled, masked study was conducted for 14 days. Dogs received a subcutaneous injection of 0.2 mg/kg Metacam 5 mg/mL Solution for Injection on day 1. The dogs were maintained on 0.1 mg/kg oral meloxicam from days 2 through 14. Variables evaluated by veterinarians included lameness, weight-bearing, pain on palpation, and overall improvement. Variables assessed by owners included mobility, ability to rise, limping, and overall improvement.
In this field study, dogs showed clinical improvement with statistical significance after 14 days of meloxicam treatment for all variables.
Animal Safety:
Dogs: 3 Day Target Animal Safety Study - In a three day safety study, Metacam 5 mg/mL Solution for Injection was administered intravenously to Beagle dogs at 1, 3, and 5 times the recommended dose (0.2, 0.6 and 1.0 mg/kg) for three consecutive days. Vomiting occurred in 1 of 6 dogs in the 5X group. Fecal occult blood was detected in 3 of 6 dogs in the 5X group. No clinically significant hematologic changes were seen, but serum chemistry changes were observed. Serum alkaline phosphatase (ALP) was significantly increased in one 1X dog and two of the 5X dogs. One dog in the 5X group had a steadily increasing GGT over 4 days, although the values remained within the reference range. Decreases in total protein and albumin occurred in 2 of 6 dogs in the 3X group and 3 of 6 dogs in the 5X group. Increases in blood urea nitrogen (BUN) occurred in 3 of 6 dogs in the 1X group, 2 of 6 dogs in the 3X group and 2 of 6 dogs in the 5X group. Increased creatinine occurred in 2 dogs in the 5X group. Increased urine protein excretion was noted in 2 of 6 dogs in the control group, 2 of 6 dogs in the 1X group, 2 of 6 dogs in the 3X group, and 5 of 6 dogs in the 5X group. Two dogs in the 5X group developed acute renal failure by Day 4. Bicarbonate levels were at or above normal levels in 1 of the 3X dogs and 2 of the 5X dogs.
Histological examination revealed gastrointestinal lesions ranging from superficial mucosal hemorrhages and congestion to erosions. Mesenteric lymphadenopathy was identified in 2 of 6 dogs in the 1X group, 4 of 6 dogs in the 3X group, and 5 of 6 dogs in the 5X group. Renal changes ranged from dilated medullary and cortical tubules and inflammation of the interstitium, to necrosis of the tip of the papilla in 2 of 6 dogs in the 1X group, 2 of 6 dogs in the 3X group, and 4 of 6 dogs in the 5X group.
Injection SiteTolerance - Metacam 5 mg/mL Solution for Injection was administered once subcutaneously to Beagle dogs at the recommended dose of 0.2 mg/kg and was well-tolerated by the dogs. Pain upon injection was observed in one of eight dogs treated with meloxicam. No pain or inflammation was observed post-injection. Long term use of Metacam 5 mg/mL Solution for Injection in dogs has not been evaluated.
Effect on Buccal Mucosal Bleeding Time (BMBT) - Metacam 5 mg/mL Solution for Injection (0.2 mg/kg) and placebo (0.4 mL/kg) were administered as single intravenous injections to 8 female and 16 male Beagle dogs. There was no statistically significant difference (p>0.05) in the average BMBT between the two groups.
Storage Information
Store at controlled room temperature, 68-77°F (20-25°C).
附件：

20123418011835.PDF
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产地国家: 澳大利亚
原产地英文商品名:
METACAM INJ 5MG/ML 10ML/VIAL
原产地英文药品名:
MELOXICAM
中文参考商品译名:
METACAM注射剂 5毫克/毫升 10毫升/瓶
中文参考药品译名:
美洛昔康
生产厂家中文参考译名:
勃林格殷格翰
生产厂家英文名:
BOEHRINGER INGELHEIM
---------------------------------------------------------------
产地国家: 澳大利亚
原产地英文商品名:
METACAM INJ 5MG/ML 20ML/VIAL
原产地英文药品名:
MELOXICAM
中文参考商品译名:
METACAM注射剂 5毫克/毫升 20毫升/瓶
中文参考药品译名:
美洛昔康
生产厂家中文参考译名:
勃林格殷格翰
生产厂家英文名:
BOEHRINGER INGELHEIM