SUCCINYLCHOLINE CHLORIDE injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)

Sẵn có từ:

Medical Purchasing Solutions, LLC

Tuyến hành chính:

INTRAMUSCULAR

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Succinylcholine chloride injection is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. It is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see WARNINGS ). The risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. The risk is dependent on the extent and location of the injury. The precise time of onset and the duration of the risk period are not known.

Tóm tắt sản phẩm:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution  in 10 mL multiple-dose vials. Each mL contains succinylcholine chloride, USP 20 mg. It is available as follows: 200 mg/10 mL (20 mg/mL) 10 mL Multiple-dose Fliptop Vial:         NDC 70121-1581-1 25 Vials in a Carton:                             NDC 70121-1581-5 Summary of content and characteristics of the solutions: Container Size (mL) mg/mL mg (total) mOsmol/mL Multiple-dose Fliptop Vial 10 mL 20 mg/mL 200 mg 0.338 Refrigeration of the undiluted agent will assure full potency until expiration date. All units carry a date of expiration. Store in refrigerator at 2° to 8°C (36° to 46°F). The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Biosciences LLC Bridgewater, NJ 08807 Rev. 12-2018-01

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
SUCCINYLCHOLINE CHLORIDE INJECTION, USP
200 MG/10 ML (20 MG/ML)
RX ONLY
A short-acting depolarizing skeletal muscle relaxant.
WARNING
RISK OF CARDIAC ARREST FROM HYPERKALEMIC RHABDOMYOLYSIS
There have been rare reports of acute rhabdomyolysis with hyperkalemia
followed
by ventricular dysrhythmias, cardiac arrest and death after the
administration of
succinylcholine to apparently healthy pediatric patients who were
subsequently
found to have undiagnosed skeletal muscle myopathy, most frequently
Duchenne’s
muscular dystrophy.
This syndrome often presents as peaked T-waves and sudden cardiac
arrest within
minutes after the administration of the drug in healthy appearing
pediatric patients
(usually, but not exclusively, males, and most frequently 8 years of
age or
younger). There have also been reports in adolescents. Therefore, when
a healthy
appearing infant or child develops cardiac arrest soon after
administration of
succinylcholine, not felt to be due to inadequate ventilation,
oxygenation or
anesthetic overdose, immediate treatment for hyperkalemia should be
instituted.
This should include administration of intravenous calcium,
bicarbonate, and glucose
with insulin, with hyperventilation. Due to the abrupt onset of this
syndrome,
routine resuscitative measures are likely to be unsuccessful. However,
extraordinary and prolonged resuscitative efforts have resulted in
successful
resuscitation in some reported cases. In addition, in the presence of
signs of
malignant hyperthermia, appropriate treatment should be instituted
concurrently.
Since there may be no signs or symptoms to alert the practitioner to
which
patients are at risk, it is recommended that the use of
succinylcholine in pediatric
patients should be reserved for emergency intubation or instances
where
immediate securing of the airway is necessary, e.g., laryngospasm,
difficult airway,
full stomach, or for intramuscular use when a suitab