ANECTINE NOV- succinylcholine chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Delpharm Boucherville Canada Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. ANECTINE is contraindicated in patients with: • Known or suspected genetic susceptibility to malignant hyperthermia (see  WARNINGS; Malignant Hyperthermia, CLINICAL PHARMACOLOGY; Pharmacogenomics ) • Skeletal muscle myopathies • Known hypersensitivity to succinylcholine (see WARNINGS; Anaphylaxis) • After the acute phase of injury following major burns, multiple trauma, extensive denervation of the skeletal muscle, or upper neuron injury because succinylcholine administered to such individuals may result in severe hyperkalemia, which may result in cardiac arrest (see WARNINGS; Hyperkalemia )

Product summary:

ANECTINE (Succinylcholine Chloride Injection, USP) is supplied as a clear, colorless solution in Multiple-dose vials 200 mg/10 mL (20 mg/mL), box of 10 vials (NDC 0781-9053-95). 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. Novaplus is a registered trademark of Vizient, Inc. Distributed by Sandoz Inc., Princeton, NJ 08540 Rev. November 2022 46314243

Authorization status:

New Drug Application

Summary of Product characteristics

ANECTINE NOV- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
DELPHARM BOUCHERVILLE CANADA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANECTINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ANECTINE NOV.
ANECTINE
(SUCCINYLCHOLINE
CHLORIDE) INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1952
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
intu