ANECTINE- succinylcholine chloride injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Civica, Inc.

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

ANECTINE is indicated in adults and pediatric patients: ANECTINE is contraindicated in patients with: Risk Summary Available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. If succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see Clinical Considerations). Animal reproduction studies have not been conducted with succinylcholine chloride. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Maternal Adverse Reactions Plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of ANECTINE. Therefore, some pregnant or newly postpartum patients may experience prolonged apnea following administration of ANECTINE. Fetal/Neonatal Adverse Reactions Apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in the mother. Labor or Delivery Succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. Succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. Risk Summary There are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ANECTINE and any potential adverse effects on the breastfed infant from ANECTINE or from the underlying maternal condition. Safety and effectiveness of succinylcholine chloride have been established in pediatric patients age groups, neonate to adolescent. Since there is a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of ANECTINE in pediatric patients 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 suitable vein is inaccessible [see Warnings and Precautions (5.1)] . Intravenous bolus administration of ANECTINE in infants or pediatric patients may result in profound bradycardia or, rarely, asystole. The incidence and severity of bradycardia is higher in pediatric patients than adults [see Warnings and Precautions (5.6)] . The effective dose of ANECTINE in pediatric patients may be higher than that predicted by body weight dosing alone [see Dosage and Administration (2.3)] . Clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Produkt oppsummering:

ANECTINE (Succinylcholine Chloride Injection, USP) is supplied as a clear, colorless solution in multiple-dose vials. 200 mg/10 mL (20 mg/mL) 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 for: Civica, Inc., Lehi, Utah 84043 Manufactured by: Delpharm Boucherville Canada Inc. 145 Rue Jules-Leger Street Boucherville, QC, J4B 7K8

Autorisasjon status:

New Drug Application

Preparatomtale

ANECTINE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
CIVICA, 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.
ANECTINE (SUCCINYLCHOLINE CHLORIDE) INJECTION, FOR INTRAVENOUS OR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1952
WARNING: RISK OF VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST AND DEATH
FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
ANECTINE is a depolarizing neuromuscular blocker indicated in adults
and pediatric patients:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/ 10 mL (20 mg/mL) in multiple-dose vials (3)
CONTRAINDICATIONS
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ACUTE RHABDOMYOLYSIS WITH HYPERKALEMIA FOLLOWED BY VENTRICULAR
DYSRHYTHMIAS,
CARDIAC ARREST, AND DEATH HAS OCCURRED AFTER THE ADMINISTRATION OF
SUCCINYLCHOLINE
TO APPARENTLY HEALTHY PEDIATRIC PATIENTS WHO WERE SUBSEQUENTLY FOUND
TO HAVE
UNDIAGNOSED SKELETAL MUSCLE MYOPATHY, MOST FREQUENTLY DUCHENNE
MUSCULAR
DYSTROPHY. (5.1).
WHEN A HEALTHY APPEARING PEDIATRIC PATIENT DEVELOPS CARDIAC ARREST
WITHIN MINUTES
AFTER ADMINISTRATION OF ANECTINE NOT FELT TO BE DUE TO INADEQUATE
VENTILATION,
OXYGENATION, OR ANESTHETIC OVERDOSE, 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 ANECTINE IN PEDIATRIC PATIENTS SHOULD BE 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
SUITABLE VEIN IS INACCESSIBLE (5.1).
Contraindications (4) 11/2023
Warnings and Precautions (5.5) 11/2023
as an adjunct to general anesthesia (1)
to facilitate tracheal intubation (1)
to provide skeletal muscle relaxation during