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Fentanyl Citrate injection(枸橼酸芬太尼注射液)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 2500微克/50毫升/瓶 25瓶/盒 
包装规格 2500微克/50毫升/瓶 25瓶/盒 
计价单位: 盒 
生产厂家中文参考译名:
West-ward Pharmaceutical Corp
生产厂家英文名:
West-ward Pharmaceutical Corp
该药品相关信息网址1:
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Fentanyl injection 2500mcg/50mL(0.05mg/mL)/Box
原产地英文药品名:
Fentanyl Citrate
中文参考商品译名:
Fentanyl注射液 2500微克/50毫升(0.05毫克/毫升)/瓶 25瓶/盒
中文参考药品译名:
枸橼酸芬太尼
曾用名:
简介:

 

部份中文枸橼酸芬太尼处方资料(仅供参考)
【药理毒理】
本品为人工合成的强效麻醉性镇痛药。镇痛作用机制与吗啡相似,为阿片受体激动剂,作用强度为吗啡的60~80倍。与吗啡和哌替啶相比,本品作用迅速,维持时间短,不释放组胺、对心血管功能影响小,能抑制气管插管时的应激反应。本品对呼吸的抑制作用弱于吗啡,但静脉注射过快则易抑制呼吸。有成瘾性。纳洛酮等能拮抗本品的呼吸抑制和镇痛作用。急性毒性LD50(mg/kg):小鼠,皮下62;静脉11.2。  
【药代动力学】
口服经胃肠道吸收,但临床一般采用注射给药。静脉注射1分钟即起效,4分钟达高峰,维持30~60分钟。肌内注射时约7~8分钟发生镇痛作用,可维持1~2小时。肌内注射生物利用度67%,蛋白结合率80%,消除T1/2约3.7小时。本品主要在肝脏代谢,代谢产物与约10%的原形药由肾脏排出。  
【适应症】
本品为强效镇痛药,适用于麻醉前、中、后的镇静与镇痛,是目前复合全麻中常用的药物。
1. 用于麻醉前给药及诱导麻醉,并作为辅助用药与全麻及局麻药合用于各种手术。与氟哌利多(Droperidol)2.5mg和本品0.05mg的混合液,麻醉前给药,能使病人安静,对外界环境漠不关心,但仍能合作。
2. 用于手术前、后及术中等各种剧烈疼痛。  
【用法用量】
1. 成人静脉注射;全麻时初量
① 小手术按体重0.001~0.002mg/kg(以芬太尼计,下同);
② 大手术按体重0.002~0.004mg/kg;
③体外循环心脏手术时按体重0.02~0.03mg/kg计算全量,维持量可每隔30~60分钟给予初量的一半或连续静滴,一般每小时按体重0.001~0.002mg/kg;
④全麻同时吸入氧化亚氮按体重0.001~0.002mg/kg;
⑤局麻镇痛不全.作为辅助用药按体重0.0015~0.002mg/kg。
2. 成人麻醉前用药或手术后镇痛:按体重肌内或静脉注射0.0007~0.0015mg/kg。
3.小儿镇痛:2岁以下无规定,2~12岁按体重0.002~0.003mg/kg。
4.成人手术后镇痛:硬膜外给药,初量 0.1mg,加氯化钠注射液稀释到8ml,每2~4小时可重复,维持量每次为初量的一半。  
【不良反应】
1. 一般不良反应为眩晕、视物模糊、恶心、呕吐、低血压、胆道括约肌痉挛、喉痉挛及出汗等。偶有肌肉抽搐。
2. 严重副反应为呼吸抑制、窒息、肌肉僵直及心动过缓,如不及时治疗,可发生呼吸停止、循环抑制及心脏停搏等。
3. 本品有成瘾性,但较哌替啶轻。  
【禁忌症】 支气管哮喘、呼吸抑制、对本品特别敏感的病人以及重症肌无力病人禁用。禁止与单胺氧化酶抑制剂(如苯乙肼、帕吉林等)合用。   
【注意事项】
1.本品为国家特殊管理的麻醉药品,务必严格遵守国家对麻醉药品的管理条例,医院和病室的贮药处均应加锁,处方颜色应与其他药处方区别开。各级负责保管人员均应遵守交接班制度,不可稍有疏忽。2.本品务必在单胺氧化酶抑制药(如呋喃唑酮、丙卡巴肼)停用14天以上方可给药,而且应先试用小剂量(1/4常用量),否则会发生难以预料的、严重的并发症,临床表现为多汗、肌肉僵直、血压先升高后剧降、呼吸抑制、发绀、昏迷、高热、惊厥,终致循环虚脱而死亡。
3. 心律失常、肝、肾、功能能不良、慢性梗阻性肺部疾患,呼吸储备力降低及脑外伤昏迷、颅内压增高、脑肿瘤等易陷入呼吸抑制的病人慎用。
4.本品药液有一定的刺激性,不得误入气管支气管,也不得涂敷于皮肤和黏膜。
5. 硬膜外注入本品镇痛时,一般4~10分钟起效,20分钟脑脊液的药浓度达到峰值,同时可有全身瘙痒,作用时效3.3~6.7小时,而且仍有呼吸频率减慢和潮气量减小的可能,处理应及时。
6.本品决非静脉全麻药.虽然大量快速静脉注射能使神智消失,但病人的应激反应依然存在,常伴有术中知晓。
7.快速推注本品可引起胸壁、腹壁肌肉僵硬而影响通气。  
【孕妇及哺乳期妇女用药】 孕期用药的安全性尚难肯定,慎用。  
【老年患者用药】
年老、体弱的病人首次剂量应适当减量,由首次剂量的效果考虑确定剂量的增加量。  
【药物相互作用】
1.本品与哌替啶因化学结构有相似之处,两药可有交叉敏感。
2.本品与中枢抑制药,如催眠镇静药(巴比妥类、地西泮等)、抗精神病药(如吩噻嗪类)、其他麻醉性镇痛药以及全麻药等有协同作用,合用时应慎重并适当调整剂量。
3.本品与80%氧化亚氮合用,可诱发心率减慢、心肌收缩减弱、心排血量减少,左室功能欠佳者尤其明显。
4. 肌松药的用量可因本品的使用而相应减少,肌松药能解除本品的肌肉僵直,遇有呼吸暂停,持续的时间又长,应识别这是中枢性的(系本品使用所致),还是外周性的(由于肌松药作用于神经肌接头处N2受体)。
5.中枢抑制剂如巴比妥类、安定药、麻醉剂,有加强本品的作用,如联合应用,本品的剂量应减少1/4~1/3。  
【药物过量】
大剂量快速静注可引起颈、胸、腹壁肌强直, 胸顺应性降低影响通气功能。偶可出现心率减慢、血压下降、瞳孔极度缩小等,最后可致呼吸停止、循环抑制或心停搏。中毒解救:出现肌肉强直者,可用肌松药或吗啡拮抗剂(如纳洛酮、丙烯吗啡等)对抗。呼吸抑制时立即采用吸氧、人工呼吸等急救措施,必要时亦可用吗啡特效拮抗药,静脉注射纳洛酮0.005~0.01mg/kg、成人0.4mg。心动过缓者可用阿托品治疗。本品与氟哌利多合用产生的低血压,可用输液、扩容等措施处理,无效时可采用升压药,当禁用肾上腺素。
Fentanyl Citrate Injection, USPCIIRx only | Fentanyl Citrate
Fentanyl Citrate Injection is a sterile, non-pyrogenic solution for intravenous or intramuscular use as a potent narcotic analgesic. Each mL contains fentanyl citrate equivalent to 50 mcg (0.05 mg) fentanyl base in Water for Injection. pH 4.0–7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. Contains no preservative.
Fentanyl citrate is chemically identified as N‑(1‑Phenethyl‑4‑piperidyl)propionanilide citrate (1:1) with the following structural formula:
Fentanyl citrate is a narcotic analgesic. A dose of 100 mcg (0.1 mg) (2 mL) is approximately equivalent in analgesic activity to 10 mg of morphine or 75 mg of meperidine. The principal actions of therapeutic value are analgesia and sedation. Alterations in respiratory rate and alveolar ventilation, associated with narcotic analgesics, may last longer than the analgesic effect. As the dose of narcotic is increased, the decrease in pulmonary exchange becomes greater. Large doses may produce apnea. Fentanyl appears to have less emetic activity than either morphine or meperidine. Histamine assays and skin wheal testing in man indicate that clinically significant histamine release rarely occurs with fentanyl. Recent assays in man show no clinically significant histamine release in dosages up to 50 mcg/kg (0.05 mg/kg) (1 mL/kg). Fentanyl preserves cardiac stability and blunts stress-related hormonal changes at higher doses.
The pharmacokinetics of fentanyl can be described as a three-compartment model, with a distribution time of 1.7 minutes, redistribution of 13 minutes and a terminal elimination half-life of 219 minutes. The volume of distribution for fentanyl is 4 L/kg.
Fentanyl plasma protein binding capacity increases with increasing ionization of the drug. Alterations in pH may affect its distribution between plasma and the central nervous system. It accumulates in skeletal muscle and fat and is released slowly into the blood. Fentanyl, which is primarily transformed in the liver, demonstrates a high first pass clearance and releases approximately 75% of an intravenous dose in urine, mostly as metabolites with less than 10% representing the unchanged drug. Approximately 9% of the dose is recovered in the feces, primarily as metabolites.
The onset of action of fentanyl is almost immediate when the drug is given intravenously; however, the maximal analgesic and respiratory depressant effect may not be noted for several minutes. The usual duration of action of the analgesic effect is 30 to 60 minutes after a single intravenous dose of up to 100 mcg (0.1 mg) (2 mL). Following intramuscular administration, the onset of action is from seven to eight minutes, and the duration of action is one to two hours. As with longer acting narcotic analgesics, the duration of the respiratory depressant effect of fentanyl may be longer than the analgesic effect. The following observations have been reported concerning altered respiratory response to CO stimulation following administration of fentanyl citrate to man:
Fentanyl Citrate Injection is indicated:
Fentanyl Citrate Injection is contraindicated in patients with known intolerance to the drug.
FENTANYL CITRATE SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF INTRAVENOUS ANESTHETICS AND MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS.
AN OPIOID ANTAGONIST, RESUSCITATIVE AND INTUBATION EQUIPMENT AND OXYGEN SHOULD BE READILY AVAILABLE.
See also discussion of narcotic antagonists in PRECAUTIONS and OVERDOSAGE.
If fentanyl is administered with a tranquilizer such as droperidol, the user should become familiar with the special properties of each drug, particularly the widely differing durations of action. In addition, when such a combination is used, fluids and other countermeasures to manage hypotension should be available.
As with other potent narcotics, the respiratory depressant effect of fentanyl may persist longer than the measured analgesic effect. The total dose of all narcotic analgesics administered should be considered by the practitioner before ordering narcotic analgesics during recovery from anesthesia. It is recommended that narcotics, when required, should be used in reduced doses initially, as low as 1/4 to 1/3 those usually recommended.
Fentanyl may cause muscle rigidity, particularly involving the muscles of respiration. In addition, skeletal muscle movements of various groups in the extremities, neck and external eye have been reported during induction of anesthesia with fentanyl; these reported movements have, on rare occasions, been strong enough to pose patient management problems. This effect is related to the dose and speed of injection and its incidence can be reduced by: 1) administration of up to 1/4 of the full paralyzing dose of a non-depolarizing neuromuscular blocking agent just prior to administration of fentanyl citrate; 2) administration of a full paralyzing dose of a neuromuscular blocking agent following loss of eyelash reflex when fentanyl is used in anesthetic doses titrated by slow intravenous infusion; or, 3) simultaneous administration of fentanyl citrate and a full paralyzing dose of neuromuscular blocking agent when fentanyl citrate is used in rapidly administered anesthetic dosages. The neuromuscular blocking agent used should be compatible with the patient’s cardiovascular status.
Adequate facilities should be available for postoperative monitoring and ventilation of patients administered anesthetic doses of fentanyl. Where moderate or high doses are used (above 10 mcg/kg), there must be adequate facilities for postoperative observation, and ventilation if necessary, of patients who have received fentanyl. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.
Fentanyl may also produce other signs and symptoms characteristic of narcotic analgesics including euphoria, miosis, bradycardia and bronchoconstriction.
Severe and unpredictable potentiation by MAO inhibitors has been reported for other narcotic analgesics. Although this has not been reported for fentanyl, there are insufficient data to establish that this does not occur with fentanyl. Therefore, when fentanyl is administered to patients who have received MAO inhibitors within 14 days, appropriate monitoring and ready availability of vasodilators and beta-blockers for the treatment of hypertension is indicated.
Fentanyl should be used with caution in patients who may be particularly susceptible to respiratory depression, such as comatose patients who may have a head injury or brain tumor. In addition, fentanyl may obscure the clinical course of patients with head injury.
The initial dose of fentanyl citrate should be appropriately reduced in elderly and debilitated patients. The effect of the initial dose should be considered in determining incremental doses.
Nitrous oxide has been reported to produce cardiovascular depression when given with higher doses of fentanyl.
Certain forms of conduction anesthesia, such as spinal anesthesia and some peridural anesthetics, can alter respiration by blocking intercostal nerves. Through other mechanisms (See CLINICAL PHARMACOLOGY) fentanyl can also alter respiration. Therefore, when fentanyl is used to supplement these forms of anesthesia, the anesthetist should be familiar with the physiological alterations involved, and be prepared to manage them in the patients selected for these forms of anesthesia.
When a tranquilizer such as droperidol is used with fentanyl, pulmonary arterial pressure may be decreased. This fact should be considered by those who conduct diagnostic and surgical procedures where interpretation of pulmonary arterial pressure measurements might determine final management of the patient. When high dose or anesthetic dosages of fentanyl are employed, even relatively small dosages of diazepam may cause cardiovascular depression. When fentanyl is used with a tranquilizer such as droperidol, hypotension can occur. If it occurs, the possibility of hypovolemia should also be considered and managed with appropriate parenteral fluid therapy. Repositioning the patient to improve venous return to the heart should be considered when operative conditions permit. Care should be exercised in moving and positioning of patients because of the possibility of orthostatic hypotension. If volume expansion with fluids plus other countermeasures do not correct hypotension, the administration of pressor agents other than epinephrine should be considered. Because of the alpha-adrenergic blocking action of droperidol, epinephrine may paradoxically decrease the blood pressure in patients treated with droperidol.
Elevated blood pressure, with and without pre-existing hypertension, has been reported following administration of fentanyl citrate combined with droperidol. This might be due to unexplained alterations in sympathetic activity following large doses; however, it is also frequently attributed to anesthetic and surgical stimulation during light anesthesia.
When droperidol is used with fentanyl and the EEG is used for postoperative monitoring, it may be found that the EEG pattern returns to normal slowly.
Vital signs should be monitored routinely.
Respiratory depression caused by opioid analgesics can be reversed by opioid antagonists such as naloxone. Because the duration of respiratory depression produced by fentanyl may last longer than the duration of the opioid antagonist action, appropriate surveillance should be maintained. As with all potent opioids, profound analgesia is accompanied by respiratory depression and diminished sensitivity to CO stimulation which may persist into or recur in the postoperative period. Intraoperative hyperventilation may further alter postoperative response to CO. Appropriate postoperative monitoring should be employed to ensure that adequate spontaneous breathing is established and maintained in the absence of stimulation prior to discharging the patient from the recovery area.
Fentanyl should be used with caution in patients with chronic obstructive pulmonary disease, patients with decreased respiratory reserve, and others with potentially compromised respiration. In such patients, narcotics may additionally decrease respiratory drive and increase airway resistance. During anesthesia, this can be managed by assisted or controlled respiration.
Fentanyl citrate should be administered with caution to patients with liver and kidney dysfunction because of the importance of these organs in the metabolism and excretion of drugs.
Fentanyl may produce bradycardia, which may be treated with atropine. Fentanyl should be used with caution in patients with cardiac bradyarrhythmias.
Other CNS depressant drugs (e.g., barbiturates, tranquilizers, narcotics and general anesthetics) will have additive or potentiating effects with fentanyl. When patients have received such drugs, the dose of fentanyl required will be less than usual. Following the administration of fentanyl citrate, the dose of other CNS depressant drugs should be reduced.
No carcinogenicity or mutagenicity studies have been conducted with fentanyl citrate. Reproduction studies in rats revealed a significant decrease in the pregnancy rate of all experimental groups. This decrease was most pronounced in the high dosed group (1.25 mg/kg—12.5X human dose) in which one of twenty animals became pregnant.
Fentanyl citrate has been shown to impair fertility and to have an embryocidal effect in rats when given in doses 0.3 times the upper human dose for a period of 12 days. No evidence of teratogenic effects have been observed after administration of fentanyl citrate to rats. There are no adequate and well-controlled studies in pregnant women. Fentanyl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
There are insufficient data to support the use of fentanyl in labor and delivery. Therefore, such use is not recommended.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when fentanyl citrate is administered to a nursing woman.
The safety and efficacy of fentanyl citrate in pediatric patients under two years of age has not been established.
Rare cases of unexplained clinically significant methemoglobinemia have been reported in premature neonates undergoing emergency anesthesia and surgery which included combined use of fentanyl, pancuronium and atropine. A direct cause and effect relationship between the combined use of these drugs and the reported cases of methemoglobinemia has not been established.
As with other narcotic analgesics, the most common serious adverse reactions reported to occur with fentanyl are respiratory depression, apnea, rigidity and bradycardia; if these remain untreated, respiratory arrest, circulatory depression or cardiac arrest could occur. Other adverse reactions that have been reported are hypertension, hypotension, dizziness, blurred vision, nausea, emesis, laryngospasm and diaphoresis.
It has been reported that secondary rebound respiratory depression may occasionally occur postoperatively. Patients should be monitored for this possibility and appropriate countermeasures taken as necessary.
When a tranquilizer such as droperidol is used with fentanyl citrate, the following adverse reactions can occur: chills and/or shivering, restlessness and postoperative hallucinatory episodes (sometimes associated with transient periods of mental depression); extrapyramidal symptoms (dystonia, akathisia and oculogyric crisis) have been observed up to 24 hours postoperatively. When they occur, extrapyramidal symptoms can usually be controlled with anti-parkinson agents. Postoperative drowsiness is also frequently reported following the use of droperidol.
Fentanyl Citrate Injection is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and, therefore, has the potential for being abused.
The manifestations of fentanyl overdosage are an extension of its pharmacologic actions (see CLINICAL PHARMACOLOGY) as with other opioid analgesics. The intravenous LD of fentanyl is 3 mg/kg in rats, 1 mg/kg in cats, 14 mg/kg in dogs and 0.03 mg/kg in monkeys.
In the presence of hypoventilation or apnea, oxygen should be administered and respiration should be assisted or controlled as indicated. A patent airway must be maintained; an oropharyngeal airway or endotracheal tube might be indicated. If depressed respiration is associated with muscular rigidity, an intravenous neuromuscular blocking agent might be required to facilitate assisted or controlled respiration. The patient should be carefully observed for 24 hours; body warmth and adequate fluid intake should be maintained. If hypotension occurs and is severe or persists, the possibility of hypovolemia should be considered and managed with appropriate parenteral fluid therapy. A specific narcotic antagonist such as naloxone should be available for use as indicated to manage respiratory depression. This does not preclude the use of more immediate countermeasures. The duration of respiratory depression following overdosage of fentanyl may be longer than the duration of narcotic antagonist action. Consult the package insert of the individual narcotic antagonists for details about use.
The 2 mL Fentanyl Citrate Injection vial includes a cautionary label that extends above the main label and highlights the drug name, fentanyl. The purpose of the extended label is to prevent selection error with other drugs, such as Sufentanil. Read the label and confirm you have selected the correct medication. Then locate the “Tear Here” point on the label, and remove this cautionary label prior to removing the flip-off cap.
Single Dose - Destroy unused contents.
50 mcg = 0.05 mg = 1 mL
Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Dosage should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
Premedication (to be appropriately modified in the elderly, debilitated and those who have received other depressant drugs)—50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly 30 to 60 minutes prior to surgery.
See Dosage Range Charts.
50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required.
50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly for the control of pain, tachypnea and emergence delirium. The dose may be repeated in one to two hours as needed.
For induction and maintenance in children 2 to 12 years of age, a reduced dose as low as 2 to 3 mcg/kg is recommended.
Dosage Range Chart
Total Dosage (expressed as fentanyl base)
Low dose—2 mcg/kg (0.002 mg/kg) (0.04 mL/kg). Fentanyl in small doses is most useful for minor, but painful, surgical procedures. In addition to the analgesia during surgery, fentanyl may also provide some pain relief in the immediate postoperative period.
Moderate dose—2 to 20 mcg/kg (0.002 to 0.02 mg/kg) (0.04 to 0.4 mL/kg). Where surgery becomes more major, a larger dose is required. With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary, and careful observation of ventilation postoperatively is essential.
High dose—20 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 1 mL/kg). During open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and in the opinion of the anesthesiologist, the stress response to surgery would be detrimental to the well being of the patient, dosages of 20 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 1 mL/kg) of fentanyl with nitrous oxide/oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended post-operative respiratory depression. The main objective of this technique would be to produce “stress free” anesthesia.
Dosage Range Chart
Maintenance Dose (expressed as fentanyl base)
Low dose—2 mcg/kg (0.002 mg/kg) (0.04 mL/kg). Additional dosages of fentanyl are infrequently needed in these minor procedures.
Moderate dose—2 to 20 mcg/kg (0.002 to 0.02 mg/kg) (0.04 to 0.4 mL/kg). 25 to 100 mcg (0.025 to 0.1 mg) (0.5 to 2 mL) may be administered intravenously or intramuscularly when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia.
High dose—20 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 1 mL/kg). Maintenance dosage (ranging from 25 mcg [0.025 mg] [0.5 mL] to one half the initial loading dose) will be dictated by the changes in vital signs which indicate stress and lightening of analgesia. However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short.
When attenuation of the responses to surgical stress is especially important, doses of 50 to 100 mcg/kg (0.05 to 0.1 mg/kg) (1 to 2 mL/kg) may be administered with oxygen and a muscle relaxant. This technique has been reported to provide anesthesia without the use of additional anesthetic agents. In certain cases, doses up to 150 mcg/kg (0.15 mg/kg) (3 mL/kg) may be necessary to produce this anesthetic effect. It has been used for open heart surgery and certain other major surgical procedures in patients for whom protection of the myocardium from excess oxygen demand is particularly indicated, and for certain complicated neurological and orthopedic procedures.
As noted above, it is essential that qualified personnel and adequate facilities be available for the management of respiratory depression.
See WARNINGS and PRECAUTIONS for use of fentanyl with other CNS depressants, and in patients with altered response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Fentanyl Citrate Injection, USP, equivalent to 50 mcg (0.05 mg) fentanyl base per mL, is preservative-free and available as follows:
2 mL DOSETTE ampuls packaged in 10s (NDC 10019-038-67)
2 mL Single Dose vials packaged in 25s (NDC 10019-037-27)
5 mL DOSETTE ampuls packaged in 10s (NDC 10019-033-72)
5 mL Single Dose vials packaged in 25s (NDC 10019-037-30)
For Intravenous Use by Hospital Personnel Specifically Trained in the Use of Narcotic Analgesics:
20 mL DOSETTE ampuls packaged in 5s (NDC 10019-035-74)
20 mL Single Dose vials packaged in 25s (NDC 10019-037-25)
50 mL Single Dose vials packaged individually (NDC 10019-037-83)
PROTECT FROM LIGHT.
Keep covered in carton until time of use. Store at 20˚‑25˚C (68˚‑77˚F), excursions permitted to 15˚‑30˚C (59˚‑86˚F) [see USP Controlled Room Temperature].
Baxter, Dosette, Clear ID and the Diagonal Design are trademarks of Baxter International Inc., its subsidiaries

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