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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于呼吸系统药物->治疗肺纤维化药物
包装规格: 75毫克 84毫升 28日裝
CAYSTON 吸入液 75毫克 84毫升 28日裝
Respiratory symptoms in cystic fibrosis
日前,美国FDA批准了Gilead科学有限公司的氨曲南(aztreonam)吸入液Cayston,用于改善肺有绿脓杆菌感染证据的囊性纤维化患者的呼吸道症状。这是FDA时隔10多年后批准用于囊性纤维化患者治疗的第一个新的吸入用抗绿脓杆菌药物。 Cayston每次使用剂量75毫克,每天用药3次,疗程28天,通过Altera Nebulizer系统给药(属便携式给药装置,采用了Pari 制药公司的eFlow技术)。 美国首次批准:1986 公司:Gilead Sciences公司 为了减少耐药细菌的发展和保持CAYSTON和其他抗菌药物的有效性,CAYSTON应该仅用于治疗的病人有铜绿假单胞菌肺部囊性纤维化(CF)。 适应症及用法 CAYSTON是一个monobactam抗菌表示,以改善呼吸道症状囊性纤维化(CF)患者铜绿假单胞菌。安全性和有效性还没有被建立在儿童患者中7岁以下的患者FEV1 <25%或> 75%预计值的患者,或与洋葱伯克氏菌的殖民统治。 【用法用量】 管理一个剂量(单一使用小瓶1安瓿的稀释剂)为28天,每天3次。 使用剂量后,立即重建。 用的Altera®喷雾器系统只能管理。不要与任何其他类型的雾化器管理。 剂型和优势 氨曲南冻干粉(75毫克/瓶) 稀释液(0.17%氯化钠):1毫升/安瓿 禁忌 不要给予对氨曲南与已知过敏的患者。 警告和注意事项 过敏性反应,CAYSTON的临​​床试验。停止治疗,如果发生过敏反应。使用时要小心,CAYSTON管理与已知的β-内酰胺类过敏性反应的患者。 已报道与CAYSTON的支气管痉挛。停止治疗,如果胸闷的发展过程中雾化器使用。 不良反应 常见的不良反应(超过5%)更频繁地发生在CAYSTON患者咳嗽,鼻塞,气喘,咽喉痛,发热,胸闷不适,腹痛,呕吐等。 1 INDICATIONS AND USAGE CAYSTON® is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CAYSTON and other antibacterial drugs, CAYSTON should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs. 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information The recommended dose of CAYSTON for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off CAYSTON therapy). Dosage is not based on weight or adjusted for age. Doses should be taken at least 4 hours apart. CAYSTON is administered by inhalation using an Altera® Nebulizer System. Patients should use a bronchodilator before administration of CAYSTON. 2.2 Instructions for CAYSTON Reconstitution CAYSTON should be administered immediately after reconstitution. Do not reconstitute CAYSTON until ready to administer a dose. Take one amber glass vial containing CAYSTON and one diluent ampule from the carton. To open the glass vial, carefully remove the metal ring by pulling the tab and remove the gray rubber stopper. Twist the tip off the diluent ampule and squeeze the liquid into the glass vial. Replace the rubber stopper, then gently swirl the vial until contents have completely dissolved. The empty vial, stopper, and diluent ampule should be disposed of properly upon completion of dosing. 2.3 Instructions for CAYSTON Administration CAYSTON is administered by inhalation using an Altera Nebulizer System. CAYSTON should not be administered with any other nebulizer. CAYSTON should not be mixed with any other drugs in the Altera Nebulizer Handset. CAYSTON is not for intravenous or intramuscular administration. Patients should use a bronchodilator before administration of CAYSTON. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose of CAYSTON. Alternatively, long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of CAYSTON. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: bronchodilator, mucolytics, and lastly, CAYSTON. To administer CAYSTON, pour the reconstituted solution into the handset of the nebulizer system. Turn the unit on. Place the mouthpiece of the handset in your mouth and breathe normally only through your mouth. Administration typically takes between 2 and 3 minutes. Further patient instructions on how to administer CAYSTON are provided in the FDA-approved patient labeling. Instructions on testing nebulizer functionality and cleaning the handset are provided in the Instructions for Use included with the nebulizer system. 3 DOSAGE FORMS AND STRENGTHS A dose of CAYSTON consists of a single-use vial of sterile, lyophilized aztreonam (75 mg) reconstituted with a 1 mL ampule of sterile diluent (0.17% sodium chloride). Reconstituted CAYSTON is administered by inhalation. 4 CONTRAINDICATIONS CAYSTON is contraindicated in patients with a known allergy to aztreonam. 5 WARNINGS AND PRECAUTIONS 5.1 Allergic Reactions Severe allergic reactions have been reported following administration of aztreonam for injection to patients with no known history of exposure to aztreonam. In addition, allergic reaction with facial rash, facial swelling, and throat tightness was reported with CAYSTON in clinical trials. If an allergic reaction to CAYSTON occurs, stop administration of CAYSTON and initiate treatment as appropriate. Caution is advised when administering CAYSTON to patients if they have a history of beta-lactam allergy, although patients with a known beta-lactam allergy have received CAYSTON in clinical trials and no severe allergic reactions were reported. A history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems, may be a risk factor, since cross-reactivity may occur. 5.2 Bronchospasm Bronchospasm is a complication associated with nebulized therapies, including CAYSTON. Reduction of 15% or more in forced expiratory volume in 1 second (FEV1) immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3% of patients treated with CAYSTON. 5.3 Decreases in FEV1 After 28-Day Treatment Cycle In clinical trials, patients with increases in FEV1 during a 28-day course of CAYSTON were sometimes treated for pulmonary exacerbations when FEV1 declined after the treatment period. Healthcare providers should consider a patient's baseline FEV1 measured prior to CAYSTON therapy and the presence of other symptoms when evaluating whether post-treatment changes in FEV1 are caused by a pulmonary exacerbation. 5.4 Development of Drug-Resistant Bacteria Prescribing CAYSTON in the absence of known Pseudomonas aeruginosa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CAYSTON was evaluated in 344 patients from two placebo-controlled trials and one open-label follow-on trial. In controlled trials, 146 patients with CF received 75 mg CAYSTON 3 times a day for 28 days. Table 1 displays adverse reactions reported in more than 5% of patients treated with CAYSTON 3 times a day in placebo-controlled trials. The listed adverse reactions occurred more frequently in CAYSTON-treated patients than in placebo-treated patients. Adverse reactions that occurred in less than 5% of patients treated with CAYSTON were bronchospasm (3%) [see Warnings and Precautions (5.2)] and rash (2%). 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following possible adverse reactions have been identified during post-approval use of CAYSTON. Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot be made. MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia, joint swelling 7 DRUG INTERACTIONS No formal clinical studies of drug interactions with CAYSTON have been conducted. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B No reproductive toxicology studies have been conducted with CAYSTON. However, studies were conducted with aztreonam for injection. Aztreonam has been shown to cross the placenta and enter fetal circulation. No evidence of embryo or fetotoxicity or teratogenicity has been shown in studies with pregnant rats and rabbits. In rats receiving aztreonam for injection during late gestation and lactation, no drug induced changes in maternal, fetal or neonatal parameters were observed. These animal reproduction and developmental toxicity studies used parenteral routes of administration that would provide systemic exposures far in excess of the average peak plasma levels measured in humans following CAYSTON therapy. No adequate and well-controlled studies of aztreonam for injection or CAYSTON in pregnant women have been conducted. Because animal reproduction studies are not always predictive of human response, CAYSTON should be used during pregnancy only if clearly needed. 8.3 Nursing Mothers Following administration of aztreonam for injection, aztreonam is excreted in human milk at concentrations that are less than one percent of those determined in simultaneously obtained maternal serum. Peak plasma concentrations of aztreonam following administration of CAYSTON (75 mg) are approximately 1% of peak concentrations observed following IV aztreonam (500 mg). Therefore, use of CAYSTON during breastfeeding is unlikely to pose a risk to infants. 8.4 Pediatric Use Patients 7 years and older were included in clinical trials with CAYSTON. Fifty-five patients under 18 years of age received CAYSTON in placebo-controlled trials. No dose adjustments were made for pediatric patients. Pyrexia was more commonly reported in pediatric patients than in adult patients. Safety and effectiveness in pediatric patients below the age of 7 years have not been established. 8.5 Geriatric Use Clinical trials of CAYSTON did not include CAYSTON-treated patients aged 65 years of age and older to determine whether they respond differently from younger patients. 8.6 Use in Patients with Renal Impairment Aztreonam is known to be excreted by the kidney. Placebo-controlled clinical trials with CAYSTON excluded patients with abnormal baseline renal function (defined as serum creatinine greater than 2 times the upper limit of normal range). Given the low systemic exposure of aztreonam following administration of CAYSTON, clinically relevant accumulation of aztreonam is unlikely to occur in patients with renal impairment. Therefore, CAYSTON may be administered to patients with mild, moderate and severe renal impairment with no dosage adjustment. 10 OVERDOSAGE No overdoses have been reported with CAYSTON in clinical trials to date. In clinical trials, 225 mg doses of CAYSTON via inhalation were associated with higher rates of drug-related respiratory adverse reactions, particularly cough. Since the peak plasma concentration of aztreonam following administration of CAYSTON (75 mg) is approximately 0.6 mcg/mL, compared to a serum concentration of 54 mcg/mL following administration of aztreonam for injection (500 mg), no systemic safety issues associated with CAYSTON overdose are anticipated. 11 DESCRIPTION A dose of CAYSTON consists of a 2 mL amber glass vial containing lyophilized aztreonam (75 mg) and lysine (46.7 mg), and a low-density polyethylene ampule containing 1 mL sterile diluent (0.17% sodium chloride). The reconstituted solution is for inhalation. The formulation contains no preservatives or arginine. The active ingredient in CAYSTON is aztreonam, a monobactam antibacterial. The monobactams are structurally different from beta-lactam antibiotics (e.g., penicillins, cephalosporins, carbapenems) due to a monocyclic nucleus. This nucleus contains several side chains; sulfonic acid in the 1-position activates the nucleus, an aminothiazolyl oxime side chain in the 3-position confers specificity for aerobic Gram-negative bacteria including Pseudomonas spp., and a methyl group in the 4-position enhances beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. The structural formula is presented below: CAYSTON is a white to off-white powder. CAYSTON is sterile, hygroscopic, and light sensitive. Once reconstituted with the supplied diluent, the pH range is 4.5 to 6.0.
更新日期: 2014-05-11

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