Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. 

Dantrium Intravenous

Should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).

Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.

CONTRAINDICATIONS:  None.

WARNINGS:  The use of Dantrium Intravenous in the management of malignant hyperthermia crisis is not a substitute for previously known supportive measures.  These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance.

Since the effect of disease state and other drugs on  Dantrium related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v. Dantrium preoperatively should have vital signs monitored.

If patients judged malignant hyperthermia susceptible are administered intravenous or oral Dantrium preoperatively, anesthetic preparation must still follow a standard malignant hyperthermia susceptible regimen, including the avoidance of known triggering agents.  Monitoring for early clinical and metabolic signs of malignant hyperthermia is indicated because attenuation of malignant hyperthermia, rather than prevention, is possible.  These signs usually call for the administration of additional i.v. dantrolene.

INDICATIONS AND CLINICAL USE: 

Dantrium (dantrolene sodium) Intravenous is indicated in the management of malignant hyperthermia crisis.

As soon as the crisis is recognized (i.e., tachycardia, tachypnea, central venous desaturation, central venous hypercarbia, metabolic acidosis, fever, skeletal muscle rigidity or cyanosis and mottling of the skin) cooling procedures should be instituted and Dantrium Intravenous administered.  If anesthetic agents are being administered they should be promptly discontinued.  It is also important that appropriate supportive measures be instituted for treatment of the physiologic and metabolic abnormalities.  Dantrium Intravenous, when given early in the malignant hyperthermia crisis, has caused abrupt lowering of body temperature, correction of the respiratory and/or metabolic acidosis, decrease of the heart rate, stabilization of blood pressure, and disappearance of the rigidity and/or fasciculations.  Patients who received Dantrium Intravenous during the crisis had less evidence of muscle destruction as shown by serum creatinine phosphokinase measurements than those treated by other measures.

CONTRAINDICATIONS: 

There are no known contraindications when Dantrium (dantrolene sodium) Intravenous is used during an acute malignant hyperthermia crisis.

WARNINGS: 

General: The use of dantrolene sodium intravenous in the management of malignant hyperthermia crisis is not a substitute for previously known supportive measures.  These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance. Please see complete warnings and full prescribing information for further information.

ADVERSE REACTIONS: The more serious reactions reported with repeated doses of oral Dantrium (dantrolene sodium) as a muscle relaxant have been hepatitis, seizures and pleural effusions with pericarditis. Cases of fatal hepatitis have been reported in patients who had received Dantrium for sixty days or longer. Symptomatic hepatitis and laboratory evidence of liver dysfunction have also been reported in a number of patients receiving Dantrium as a muscle relaxant. Acneiform skin reactions have also been infrequently reported. For a list of adverse reactions reported with the use of Dantrium as a muscle relaxant, please consult the Product Monograph for Dantrium Capsules.

The administration of intravenous dantrolene sodium to human volunteers is associated with loss of grip strength and weakness in the legs, as well as subjective central nervous system complaints.

Based upon data in human volunteers, it will sometimes be appropriate to tell patients who receive dantrolene sodium intravenous that decrease in grip strength and weakness of leg muscles, especially walking down stairs, can be expected postoperatively. In addition, symptoms such as “lightheadedness” may be noted. Since some of these symptoms may persist for up to 48 hours, patients must not operate an automobile or engage in other hazardous activity during this time. Caution is also indicated at meals on the day of administration because difficulty swallowing and choking have been reported. Caution should be exercised in the concomitant administration of tranquilizing agents.

AVAILABILITY:  Dantrium Intravenous is available in 70 mL vials containing a sterile lyophilized mixture of 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted.  These are not multiple dose vials.  Available in cartons of 6 vials.

Dantrium Intravenous is available only for use in hospitals or in dental clinics that are equipped to provide the necessary supportive measures used in the treatment of the malignant hyperthermia crisis.

Carton of 6 vials

DIN 01997572

中文别名：1-[[[5-(4-硝基苯)-2-呋喃亚甲基]氨基]-2,4-咪唑烷二酮钠盐;

英文名称：dantrolene sodium

英文别名：Dantrolene, Sodium Salt;1-[[5-(p-Nitrophenyl)furfurylidene]amino]-hydantoin sodium salt; 1-[5-(-4-Nitrophenyl)furfurylideneamino]imidazolidine-2,4-dione sodium;

中文名称：丹曲林钠

产品英文名称：Dantrolene Sodium

功效主治：用于各种原因引起的上运动神经元损伤所遗留的痉挛性肌张力增高状态，如脑卒中、脑外伤、脊髓损伤、脑性瘫痪、多发性脑血管硬化等。

药理作用：丹曲林钠是一种直接作用于骨骼肌的肌松剂。其主要作用部位是骨骼肌的肌浆网，通过抑制肌浆网释放钙离子而减弱肌肉收缩。

不良反应：可能出现肌无力、嗜睡、头晕目眩、疲劳不适、腹泻，罕见的有心动过速、血压不稳、胸腔积液、心包炎、血尿、排尿障碍等，必要时需停药。长期使用可能引起肝肾功能损害。

禁忌症：
1、对本品过敏者。
2、肝肾功能障碍。
3、功能性痉挛状态。
4、关节病变及外伤后肌痉挛。
5、35岁以上及应用雌激素的妇女。

用法用量：口服：应在医师指导下应用，一般情况下，起始量可用25mg，一日1次，以后每周逐渐增加，最高至50mg，一日3次。

贮藏方法：密封，在干燥处保存。

注意事项：
1、服药期间应定期检查肝肾功能。
2、有心血管、呼吸系统疾病及肝病史慎用。

丹曲林钠注射剂
【原产地英文商品名】:DANTROLENE SODIUM(DANTRIUM GENERIC) 20mg/vial 6vials/box 6boxes/case
【原产地英文药品名】:DANTROLENE SODIUM
【中文参考商品译名】:丹曲林钠(DANTRIUM仿制药) 20毫克/瓶 6瓶/盒 6盒/箱
【中文参考药品译名】:丹曲林钠
【生产厂家中文参考译名】:US WORLD MEDS
【生产厂家英文名】:US WORLD MEDS