Succinylcholine Chloride (Page 3 of 3)

Adverse Reactions

Adverse reactions to succinylcholine consist primarily of an extension of its pharmacological actions. Succinylcholine causes profound muscle relaxation resulting in respiratory depression to the point of apnea; this effect may be prolonged. Hypersensitivity reactions, including anaphylaxis, may occur in rare instances. The following additional adverse reactions have been reported: cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea, increased intraocular pressure, muscle fasciculation, jaw rigidity, postoperative muscle pain, rhabdomyolysis with possible myoglobinuric acute renal failure, excessive salivation, and rash.

There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) associated with use of neuromuscular blocking agents, including succinylcholine. These reactions, in some cases, have been life threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see WARNINGS and PRECAUTIONS).

Overdosage

Overdosage with succinylcholine may result in neuromuscular block beyond the time needed for surgery and anesthesia. This may be manifested by skeletal muscle weakness, decreased respiratory reserve, low tidal volume, or apnea. The primary treatment is maintenance of a patent airway and respiratory support until recovery of normal respiration is assured. Depending on the dose and duration of succinylcholine administration, the characteristic depolarizing neuromuscular block (Phase I) may change to a block with characteristics superficially resembling a non-depolarizing block (Phase II) (see PRECAUTIONS).

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.

Risk of Medication Errors
Accidental administration of neuromuscular blocking agents may be fatal. Store Succinylcholine Chloride Injection, USP with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product.

Adults
For Short Surgical Procedures
The average dose required to produce neuromuscular blockade and to facilitate tracheal intubation is 0.6 mg/kg 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, intravenous 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 AdmixturesSuccinylcholine 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 succinylcholine chloride injection to 1000 or 500 mL sterile solution, such as 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Admixtures of succinylcholine chloride injection must be used within 24 hours after preparation. Aseptic techniques should be used to prepare the diluted product. Admixtures of succinylcholine chloride injection should be prepared for single patient use only. The unused portion of diluted succinylcholine chloride injection should be discarded.

To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand.

How Supplied

Succinylcholine chloride injection, USP is supplied as a clear, colorless solution in the following concentrations and packages:

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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.

Manufactured by:
RAFARM S.A., Thesi Pousi-Hatzi, Agiou Louka, 19002,
Paiania, Attiki, Greece

Distributed by:
Breckenridge Pharmaceutical, Inc.Berlin, CT 06037

Revised: 10/2019

30804998

Sample Package Label

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SUCCINYLCHOLINE CHLORIDE succinylcholine chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-9960(NDC:51991-964)
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUCCINYLCHOLINE CHLORIDE (SUCCINYLCHOLINE) SUCCINYLCHOLINE CHLORIDE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
METHYLPARABEN 1.8 mg in 1 mL
PROPYLPARABEN 0.2 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-9960-10 1 VIAL, MULTI-DOSE in 1 BAG contains a VIAL, MULTI-DOSE
1 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the BAG (0404-9960-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212638 01/12/2022
Labeler — Henry Schein, Inc. (012430880)

Revised: 01/2022 Henry Schein, Inc.

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