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Drug Catalog - Product Detail

QUELICIN INJ SOL 20MG/ML 10ML X 25

NDC Mfr Size Str Form
00409-6629-02 HOSPIRA 10 20MG/ML SOLUTION
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Description
DESCRIPTION Quelicin (Succinylcholine Chloride Injection, USP) is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing, skeletal muscle relaxant See HOW SUPPLIED for summary of content and characteristics of the solutions. The solutions are for I.M. or I.V. use. Succinylcholine Chloride, USP is chemically designated C 14 H 30 Cl 2 N 2 O 4 and its molecular weight is 361.31. It has the following structural formula: Succinylcholine is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. The drug is incompatible with alkaline solutions but relatively stable in acid solutions. Solutions of the drug lose potency unless refrigerated. Solution intended for multiple-dose administration contains 0.18% methylparaben and 0.02% propylparaben as preservatives (List No. 6629). Solution intended for single-dose administration contains no preservatives. Unused solution should be discarded. Product not requiring dilution (multiple-dose fliptop vial) contains sodium chloride to render isotonic. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 3.6 (3.0 to 4.5). See table in HOW SUPPLIED for characteristics. Sodium Chloride, USP, chemically designated NaCl, is a white crystalline compound freely soluble in water. structural formula succinylcholine chloride
How Supplied
HOW SUPPLIED Quelicin™ (Succinylcholine Chloride Injection, USP) is supplied as a clear, colorless solution in the following concentrations and packages: NDC No. Container Size (mL) mg/mL mg (total) mOsmol/mL (calc.) Single-dose 0409-6970-10 Fliptop Vial 10 in 20 100 1000 0.830 Multiple-dose 0409-6629-02 Fliptop Vial 10 20 200 0.338 Refrigeration of the undiluted agent will assure full potency until expiration date. All units carry a date of expiration. Store in refrigerator 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. Hospira, Inc., Lake Forest, IL 60045 USA LAB-1246-1.0 Revised: 01/2018 Logo
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION The dosage of succinylcholine should be individualized and should always be determined by the clinician after careful assessment of the patient (see WARNINGS ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are not clear and colorless should not be used. Adults: For Short Surgical Procedures: The average dose required to produce neuromuscular blockade and to facilitate tracheal intubation is 0.6 mg/kg Quelicin (succinylcholine chloride) Injection given intravenously. The optimum dose will vary among individuals and may be from 0.3 to 1.1 mg/kg for adults. Following administration of doses in this range, neuromuscular blockade develops in about 1 minute; maximum blockade may persist for about 2 minutes, after which recovery takes place within 4 to 6 minutes. However, very large doses may result in more prolonged blockade. A 5 to 10 mg test dose may be used to determine the sensitivity of the patient and the individual recovery time (see PRECAUTIONS ). For Long Surgical Procedures: The dose of succinylcholine administered by infusion depends upon the duration of the surgical procedure and the need for muscle relaxation. The average rate for an adult ranges between 2.5 and 4.3 mg per minute. Solutions containing from 1 to 2 mg per mL succinylcholine have commonly been used for continuous infusion. The more dilute solution (1 mg per mL) is probably preferable from the standpoint of ease of control of the rate of administration of the drug and, hence, of relaxation. This intravenous solution containing 1 mg per mL may be administered at a rate of 0.5 mg (0.5 mL) to 10 mg (10 mL) per minute to obtain the required amount of relaxation. The amount required per minute will depend upon the individual response as well as the degree of relaxation required. Avoid overburdening the circulation with a large volume of fluid. It is recommended that neuromuscular function be carefully monitored with a peripheral nerve stimulator when using succinylcholine by infusion in order to avoid overdose, detect development of Phase II block, follow its rate of recovery, and assess the effects of reversing agents (see PRECAUTIONS ). Intermittent intravenous injections of succinylcholine may also be used to provide muscle relaxation for long procedures. An intravenous injection of 0.3 to 1.1 mg/kg may be given initially, followed, at appropriate intervals, by further injections of 0.04 to 0.07 mg/kg to maintain the degree of relaxation required. Pediatrics: For emergency tracheal intubation or in instances where immediate securing of the airway is necessary, the intravenous dose of succinylcholine is 2 mg/kg for infants and small pediatric patients; for older pediatric patients and adolescents the dose is 1 mg/kg (see BOX WARNING and PRECAUTIONS: Pediatric Use ). It is currently known that the effective dose of succinylcholine in pediatric patients may be higher than that predicted by body weight dosing alone. For example, the usual adult IV dose of 0.6 mg/kg is comparable to a dose of 2-3 mg/kg in neonates and infants to 6 months and 1-2 mg/kg in infants up to 2 years of age. This is thought to be due to the relatively large volume of distribution in the pediatric patient versus the adult patient. Rarely, I.V. bolus administration of succinylcholine in infants and pediatric patients may result in malignant ventricular arrythmias and cardiac arrest secondary to acute rhabdomyolysis with hyperkalemia. In such situations, an underlying myopathy should be suspected. Intravenous bolus administration of succinylcholine in infants or pediatric patients may result in profound bradycardia or, rarely, asystole. As in adults, the incidence of bradycardia in pediatric patients is higher following a second dose of succinylcholine. Whereas bradycardia is common in pediatric patients after an initial dose of 1.5 mg/kg, bradycardia is seen in adults only after repeated exposure. The occurrence of bradyarrhythmias may be reduced by pretreatment with atropine (see PRECAUTIONS: Pediatric Use ). Intramuscular Use: If necessary, succinylcholine may be given intramuscularly to infants, older pediatric patients or adults when a suitable vein is inaccessible. A dose of up to 3 to 4 mg/kg may be given, but not more than 150 mg total dose should be administered by this route. The onset of effect of succinylcholine given intramuscularly is usually observed in about 2 to 3 minutes. Compatibility and Admixtures: Succinylcholine is acidic (pH 3.5) and should not be mixed with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions). Admixtures containing 1 to 2 mg/mL may be prepared by adding 1 g Quelicin to 1000 or 500 mL sterile solution, such as 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Admixtures of Quelicin must be used within 24 hours after preparation. Aseptic techniques should be used to prepare the diluted product. Admixtures of Quelicin should be prepared for single patient use only. The unused portion of diluted Quelicin should be discarded. To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand.