QUELICIN- succinylcholine chloride injection, solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Hospira, Inc.

INN (Nama Internasional):

SUCCINYLCHOLINE CHLORIDE

Komposisi:

SUCCINYLCHOLINE CHLORIDE 20 mg in 1 mL

Rute administrasi :

INTRAMUSCULAR

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

QUELICIN is indicated in adults and pediatric patients: QUELICIN is contraindicated: 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 estimated 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 2–4% a

Ringkasan produk:

QUELICIN (Succinylcholine Chloride Injection, USP) is supplied as a clear, colorless solution in the following concentrations and packages: NDC 0409-6970-10 Tray containing 25 Single-dose Fliptop Vials 1,000 mg/10 mL (100 mg/mL) NDC 0409-6629-02 Tray containing 25 Multiple-dose Fliptop Vials 200 mg/10 mL (20 mg/mL) Refrigeration of undiluted QUELICIN will assure full potency until expiration date. Single-dose Fliptop Vials: Discard unused portion. Store in refrigerator 2 °C to 8 °C (36 °F to 46 °F). The multiple-dose vials are stable for up to 14 days at room temperature without significant loss of potency.

Status otorisasi:

New Drug Application

Karakteristik produk

QUELICIN- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUELICIN™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUELICIN™.
QUELICIN™ (SUCCINYLCHOLINE CHLORIDE) INJECTION, FOR INTRAVENOUS OR
INTRAMUSCULAR USE
INITIAL 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_.
•
•
•
RECENT MAJOR CHANGES
Contraindications (4)
11/2022
Warnings and Precautions, Malignant Hyperthermia (5.5)
11/2022
INDICATIONS AND USAGE
QUELICIN is a depolarizing neuromuscular blocker indicated in adults
and pediatric patients:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Injection:
•
•
CONTRAINDICATIONS
•
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 QUELICIN, 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 QUELICIN 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)
as an adjunct to general anesthesia (1)
to facilitate tracheal intubation (1)
to provide skeletal muscle relaxation during surgery or mechanical
ventilation. (1)
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.