SUCCINYLCHOLINE CHLORIDE injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Henry Schein, Inc.

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Succinylcholine chloride injection is indicated in adults and pediatric patients: • as an adjunct to general anesthesia • to facilitate tracheal intubation • to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine chloride is contraindicated: • in patients with skeletal muscle myopathies [see Warnings and Precautions ( 5.1)] • in patients with known hypersensitivity to succinylcholine. Severe anaphylactic reactions to succinylcholine have been reported [see Warnings and Precautions ( 5.2)] • after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see Warnings and Precautions ( 5.4)] • in patients with known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions ( 5.5), Clinical Pharmacology ( 12.5)] 8.1 Pregnancy Risk Summary Available data from published literature from case

Tuoteyhteenveto:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentration and package: 200 mg/10 mL (20 mg/mL) 10 mL Multiple-dose Fliptop Vial:                                                       NDC 31722-981-10 25 Vials in a Carton:                                                                           NDC 31722-981-31 Refrigeration of undiluted Succinylcholine Chloride Injection, USP will assure full potency until expiration date. Store in refrigerator 2° to 8°C (36° to 46°F). The multiple-dose vials are stable for up to 14 days at room temperature without significant loss of potency. For more information, call 1-866-495-1995. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 Manufactured by: Aspiro Pharma Limited Survey No. 321, Biotech Park, Phase-III Karkapatla Village, Markook (Mandal) Siddipet, Telangana-502281, India. Revised: 01/2023

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
HENRY SCHEIN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUCCINYLCHOLINE
CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SUCCINYLCHOLINE CHLORIDE INJECTION.
SUCCINYLCHOLINE CHLORIDE INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR
USEINITIAL U.S.
APPROVAL: 1952
WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM
HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
• ACUTE RHABDOMYOLYSIS WITH HYPERKALEMIA FOLLOWED BY VENTRICULAR
DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH HAS OCCURRED AFTER USE IN
APPARENTLY HEALTHY PEDIATRIC PATIENTS WHO WERE SUBSEQUENTLY FOUND TO
HAVE UNDIAGNOSED SKELETAL MUSCLE MYOPATHY. ( 5.1)
• WHEN A HEALTHY-APPEARING PEDIATRIC PATIENT DEVELOPS CARDIAC ARREST
SOON
AFTER ADMINISTRATION OF SUCCINYLCHOLINE CHLORIDE INJECTION, NOT FELT
TO BE
DUE TO OTHER CAUSES, IMMEDIATE TREATMENT FOR HYPERKALEMIA SHOULD BE
INSTITUTED. IN THE PRESENCE OF SIGNS OF MALIGNANT HYPERTHERMIA,
APPROPRIATE
TREATMENT SHOULD BE INSTITUTED CONCURRENTLY. ( 5.1)
• RESERVE USE OF SUCCINYLCHOLINE CHLORIDE INJECTION IN PEDIATRIC
PATIENTS FOR
EMERGENCY INTUBATION OR INSTANCES WHERE IMMEDIATE SECURING OF THE
AIRWAY
IS NECESSARY, OR FOR INTRAMUSCULAR USE WHEN A SUITABLE VEIN IS
INACCESSIBLE.
( 5.1)
INDICATIONS AND USAGE
Succinylcholine chloride injection is a depolarizing neuromuscular
blocker indicated in adults and pediatric
patients:
• as an adjunct to general anesthesia ( 1)
• to facilitate tracheal intubation ( 1)
• to provide skeletal muscle relaxation during surgery or mechanical
ventilation. ( 1) (1)
DOSAGE AND ADMINISTRATION
• For intravenous or intramuscular use only. ( 2.1)
• Individualize dosage after careful assessment of the patient. (
2.1)
• Accidental administration of neuromuscular blocking agents may be
fatal. Store su