Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)
Hospira, Inc.
SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDE 20 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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
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.
New Drug Application
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. Lestu allt skjalið