SUCCINYLCHOLINE CHLORIDE- succinylcholine chloride injection, solution

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)
Available from:
Medical Purchasing Solutions, LLC
Administration route:
INTRAMUSCULAR
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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. Succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. It is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see WARNINGS ). The risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. The risk is dependent on the extent and location of the injury. The precise time of onset and the duration of the risk period are not known.
Product summary:
Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentrations and packages: 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. Revised: 12/2018 Manufactured by: Renaissance Pharmaceuticals Inc. Lakewood, NJ 08701 Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312 141092
Authorization status:
Abbreviated New Drug Application
Authorization number:
71872-7167-1

SUCCINYLCHOLINE CHLORIDE- succinylcholine chloride injection, solution

Medical Purchasing Solutions, LLC

----------

SUCCINYLCHOLINE CHLORIDE INJECTION, USP

A short-acting depolarizing skeletal muscle relaxant.

Fliptop Vial

Rx only

WARNING

RISK OF CARDIAC ARREST FROM HYPERKALEMIC

RHABDOMYOLYSIS

There have been rare reports of acute rhabdomyolysis with hyperkalemia followed by ventricular

dysrhythmias, cardiac arrest and death after the administration of succinylcholine to apparently

healthy pediatric patients who were subsequently found to have undiagnosed skeletal muscle

myopathy, most frequently Duchenne’s muscular dystrophy.

This syndrome often presents as peaked T-waves and sudden cardiac arrest within minutes after

the administration of the drug in healthy appearing pediatric patients (usually, but not exclusively,

males, and most frequently 8 years of age or younger). There have also been reports in

adolescents.

Therefore, when a healthy appearing infant or child develops cardiac arrest soon after

administration of succinylcholine, not felt to be due to inadequate ventilation, oxygenation or

anesthetic overdose, immediate treatment for hyperkalemia should be instituted. This should

include administration of intravenous calcium, bicarbonate, and glucose with insulin, with

hyperventilation. Due to the abrupt onset of this syndrome, routine resuscitative measures are

likely to be unsuccessful. However, extraordinary and prolonged resuscitative efforts have

resulted in successful resuscitation in some reported cases. In addition, in the presence of signs

of malignant hyperthermia, appropriate treatment should be instituted concurrently.

Since there may be no signs or symptoms to alert the practitioner to which patients are at risk, it is

recommended that the use of succinylcholine in pediatric patients should be reserved 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 PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION).

This drug should be used only by individuals familiar with its actions, characteristics and

hazards .

DESCRIPTION

Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as an ultra short-

acting, depolarizing, skeletal muscle relaxant. See HOW SUPPLIED for summary of content and

characteristics of the solutions. The solutions are for intramuscular or intravenous use.

Succinylcholine Chloride, USP is chemically designated C

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). 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.

CLINICAL PHARMACOLOGY

Succinylcholine is a depolarizing skeletal muscle relaxant. As does acetylcholine, it combines with the

cholinergic receptors of the motor end plate to produce depolarization. This depolarization may be

observed as fasciculations. Subsequent neuromuscular transmission is inhibited so long as adequate

concentration of succinylcholine remains at the receptor site. Onset of flaccid paralysis is rapid (less

than one minute after intravenous administration), and with single administration lasts approximately 4 to

6 minutes.

Succinylcholine is rapidly hydrolyzed by plasma cholinesterase to succinylmonocholine (which

possesses clinically insignificant depolarizing muscle relaxant properties) and then more slowly to

succinic acid and choline (see PRECAUTIONS). About 10% of the drug is excreted unchanged in the

urine. Succinylcholine levels were reported to be below the detection limit of 2 μg/mL after 2.5 minutes

of an intravenous bolus dose of 1 or 2 mg/kg in fourteen (14) anesthetized patients. The paralysis

following administration of succinylcholine is progressive, with differing sensitivities of different

muscles. This initially involves consecutively the levator muscles of the face, muscles of the glottis

and finally the intercostals and the diaphragm and all other skeletal muscles.

Succinylcholine has no direct action on the uterus or other smooth muscle structures. Because it is

highly ionized and has low fat solubility, it does not readily cross the placenta.

Tachyphylaxis occurs with repeated administration (see PRECAUTIONS).

Depending on the dose and duration of succinylcholine administration, the characteristic depolarizing

neuromuscular block (Phase I block) may change to a block with characteristics superficially

resembling a non-depolarizing block (Phase II block). This may be associated with prolonged

respiratory muscle paralysis or weakness in patients who manifest the transition to Phase II block. When

this diagnosis is confirmed by peripheral nerve stimulation, it may sometimes be reversed with

anticholinesterase drugs such as neostigmine (see PRECAUTIONS). Anticholinesterase drugs may not

always be effective. If given before succinylcholine is metabolized by cholinesterase,

anticholinesterase drugs may prolong rather than shorten paralysis.

Succinylcholine has no direct effect on the myocardium. Succinylcholine stimulates both autonomic

ganglia and muscarinic receptors which may cause changes in cardiac rhythm, including cardiac arrest.

Changes in rhythm, including cardiac arrest, may also result from vagal stimulation, which may occur

during surgical procedures, or from hyperkalemia, particularly in pediatric patients (see

PRECAUTIONS: Pediatric Use). These effects are enhanced by halogenated anesthetics.

Succinylcholine causes an increase in intraocular pressure immediately after its injection and during the

fasciculation phase, and slight increases which may persist after onset of complete paralysis (see

WARNINGS).

Succinylcholine may cause slight increases in intracranial pressure immediately after its injection and

during the fasciculation phase (see PRECAUTIONS).

As with other neuromuscular blocking agents, the potential for releasing histamine is present following

succinylcholine administration. Signs and symptoms of histamine mediated release such as flushing,

hypotension and bronchoconstriction are, however, uncommon in normal clinical usage.

Succinylcholine has no effect on consciousness, pain threshold or cerebration. It should be used only

with adequate anesthesia (see WARNINGS).

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.

CONTRAINDICATIONS

Succinylcholine is contraindicated in persons with personal or familial history of malignant

hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. It is also

contraindicated in patients after the acute phase of injury following major burns, multiple trauma,

extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine

administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest

(see WARNINGS). The risk of hyperkalemia in these patients increases over time and usually peaks at 7

to 10 days after the injury. The risk is dependent on the extent and location of the injury. The precise

time of onset and the duration of the risk period are not known.

WARNINGS

Succinylcholine should be used only by those skilled in the management of artificial respiration and

only when facilities are instantly available for tracheal intubation and for providing adequate ventilation

of the patient, including the administration of oxygen under positive pressure and the elimination of

carbon dioxide. The clinician must be prepared to assist or control respiration.

To avoid distress to the patient, succinylcholine should not be administered before unconsciousness has

been induced. In emergency situations, however, it may be necessary to administer succinylcholine

before unconsciousness is induced.

Succinylcholine is metabolized by plasma cholinesterase and should be used with caution, if at all, in

patients known to be or suspected of being homozygous for the atypical plasma cholinesterase gene.

Anaphylaxis

Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been

reported. These reactions have, in some cases, been life-threatening and fatal. Due to the potential

severity of these reactions, the necessary precautions, such as the immediate availability of appropriate

emergency treatment, should be taken. Precautions should also be taken in those individuals who have

had previous anaphylactic reactions to other neuromuscular blocking agents since cross-reactivity

between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported in

this class of drugs.

Risk of Death due to Medication Errors

Administration of Succinylcholine Chloride, USP results in paralysis, which may lead to respiratory

arrest and death; this progression may be more likely to occur in a patient for whom it is not intended.

Confirm proper selection of intended product and avoid confusion with other injectable solutions that

are present in critical care and other clinical settings. If another healthcare provider is administering the

product, ensure that the intended dose is clearly labeled and communicated.

Hyperkalemia: (see BOX WARNING) Succinylcholine should be administered with GREAT

CAUTION to patients suffering from electrolyte abnormalities and those who may have massive

digitalis toxicity, because in these circumstances succinylcholine may induce serious cardiac

arrhythmias or cardiac arrest due to hyperkalemia.

GREAT CAUTION should be observed if succinylcholine is administered to patients during the acute

phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or

upper motor neuron injury (see CONTRAINDICATIONS). The risk of hyperkalemia in these patients

increases over time and usually peaks at 7 to 10 days after the injury. The risk is dependent on the extent

and location of the injury. The precise time of onset and the duration of the risk period are

undetermined. Patients with chronic abdominal infection, subarachnoid hemorrhage, or conditions

causing degeneration of central and peripheral nervous systems should receive succinylcholine with

GREAT CAUTION because of the potential for developing severe hyperkalemia.

Malignant Hyperthermia: Succinylcholine administration has been associated with acute onset of

malignant hyperthermia, a potentially fatal hypermetabolic state of skeletal muscle. The risk of

developing malignant hyperthermia following succinylcholine administration increases with the

concomitant administration of volatile anesthetics. Malignant hyperthermia frequently presents as

intractable spasm of the jaw muscles (masseter spasm) which may progress to generalized rigidity,

increased oxygen demand, tachycardia, tachypnea and profound hyperpyrexia. Successful outcome

depends on recognition of early signs, such as jaw muscle spasm, acidosis, or generalized rigidity to

initial administration of succinylcholine for tracheal intubation, or failure of tachycardia to respond to

deepening anesthesia. Skin mottling, rising temperature and coagulopathies may occur later in the

course of the hypermetabolic process. Recognition of the syndrome is a signal for discontinuance of

anesthesia, attention to increased oxygen consumption, correction of acidosis, support of circulation,

assurance of adequate urinary output and institution of measures to control rising temperature.

Intravenous dantrolene sodium is recommended as an adjunct to supportive measures in the management

of this problem. Consult literature references and the dantrolene prescribing information for additional

information about the management of malignant hyperthermic crisis. Continuous monitoring of

temperature and expired CO

is recommended as an aid to early recognition of malignant hyperthermia.

Other: In both adults and pediatric patients the incidence of bradycardia, which may progress to

asystole, is higher following a second dose of succinylcholine. The incidence and severity of

bradycardia is higher in pediatric patients than adults. 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.

Pretreatment with anticholinergic agents (e.g., atropine) may reduce the occurrence of

bradyarrhythmias.

Succinylcholine causes an increase in intraocular pressure. It should not be used in instances in which

an increase in intraocular pressure is undesirable (e.g., narrow angle glaucoma, penetrating eye injury)

unless the potential benefit of its use outweighs the potential risk.

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).

PRECAUTIONS: (SEE BOX WARNING)

General: When succinylcholine is given over a prolonged period of time, the characteristic

depolarization block of the myoneural junction (Phase I block) may change to a block with

characteristics superficially resembling a non-depolarizing block (Phase II block). Prolonged

respiratory muscle paralysis or weakness may be observed in patients manifesting this transition to

Phase II block. The transition from Phase I to Phase II block has been reported in 7 of 7 patients studied

under halothane anesthesia after an accumulated dose of 2 to 4 mg/kg succinylcholine (administered in

repeated, divided doses). The onset of Phase II block coincided with the onset of tachyphylaxis and

prolongation of spontaneous recovery. In another study, using balanced anesthesia (N

/narcotic-

thiopental) and succinylcholine infusion, the transition was less abrupt, with great individual variability

in the dose of succinylcholine required to produce Phase II block. Of 32 patients studied, 24 developed

Phase II block. Tachyphylaxis was not associated with the transition to Phase II block, and 50% of the

patients who developed Phase II block experienced prolonged recovery.

When Phase II block is suspected in cases of prolonged neuromuscular blockade, positive diagnosis

should be made by peripheral nerve stimulation, prior to administration of any anticholinesterase drug.

Reversal of Phase II block is a medical decision which must be made upon the basis of the individual,

clinical pharmacology and the experience and judgment of the physician. The presence of Phase II

block is indicated by fade of responses to successive stimuli (preferably "train of four"). The use of an

anticholinesterase drug to reverse Phase II block should be accompanied by appropriate doses of an

anticholinergic drug to prevent disturbances of cardiac rhythm. After adequate reversal of Phase II

block with an anticholinesterase agent, the patient should be continually observed for at least 1 hour for

signs of return of muscle relaxation. Reversal should not be attempted unless: (1) a peripheral nerve

stimulator is used to determine the presence of Phase II block (since anticholinesterase agents will

potentiate succinylcholine-induced Phase I block), and (2) spontaneous recovery of muscle twitch has

been observed for at least 20 minutes and has reached a plateau with further recovery proceeding

slowly; this delay is to ensure complete hydrolysis of succinylcholine by plasma cholinesterase prior

to administration of the anticholinesterase agent. Should the type of block be misdiagnosed,

depolarization of the type initially induced by succinylcholine (i.e., Phase I block) will be prolonged by

an anticholinesterase agent.

Succinylcholine should be employed with caution in patients with fractures or muscle spasm because

the initial muscle fasciculations may cause additional trauma.

Succinylcholine may cause a transient increase in intracranial pressure; however, adequate anesthetic

induction prior to administration of succinylcholine will minimize this effect.

Succinylcholine may increase intragastric pressure, which could result in regurgitation and possible

aspiration of stomach contents.

Neuromuscular blockade may be prolonged in patients with hypokalemia or hypocalcemia.

Since allergic cross-reactivity has been reported in this class, request information from your patients

about previous anaphylactic reactions to other neuromuscular blocking agents. In addition, inform your

patients that severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine

have been reported.

Reduced Plasma Cholinesterase Activity: Succinylcholine should be used carefully in patients with

reduced plasma cholinesterase (pseudocholinesterase) activity. The likelihood of prolonged

neuromuscular block following administration of succinylcholine must be considered in such patients

(see DOSAGE AND ADMINISTRATION).

Plasma cholinesterase activity may be diminished in the presence of genetic abnormalities of plasma

cholinesterase (e.g., patients heterozygous or homozygous for atypical plasma cholinesterase gene),

pregnancy, severe liver or kidney disease, malignant tumors, infections, burns, anemia, decompensated

heart disease, peptic ulcer, or myxedema. Plasma cholinesterase activity may also be diminished by

chronic administration of oral contraceptives, glucocorticoids, or certain monoamine oxidase inhibitors

and by irreversible inhibitors of plasma cholinesterase (e.g., organophosphate insecticides,

echothiophate, and certain antineoplastic drugs).

Patients homozygous for atypical plasma cholinesterase gene (1 in 2500 patients) are extremely

sensitive to the neuromuscular blocking effect of succinylcholine. In these patients, a 5 to 10 mg test

dose of succinylcholine may be administered to evaluate sensitivity to succinylcholine, or

neuromuscular blockade may be produced by the cautious administration of a 1 mg/mL solution of

succinylcholine by slow intravenous infusion. Apnea or prolonged muscle paralysis should be treated

with controlled respiration.

Drug Interactions: Drugs which may enhance the neuromuscular blocking action of succinylcholine

include: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic

blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine,

chloroquine, diethylether, isoflurane, desflurane, metoclopramide and terbutaline. The neuromuscular

blocking effect of succinylcholine may be enhanced by drugs that reduce plasma cholinesterase activity

(e.g., chronically administered oral contraceptives, glucocorticoids, or certain monoamine oxidase

inhibitors) or by drugs that irreversibly inhibit plasma cholinesterase (see PRECAUTIONS).

If other neuromuscular blocking agents are to be used during the same procedure, the possibility of a

synergistic or antagonistic effect should be considered.

Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no long-term studies

performed in animals to evaluate carcinogenic potential of succinylcholine. Genetic toxicology studies

have not been completed to evaluate the genotoxic potential of succinylcholine. There are no studies to

evaluate the potential impact of succinylcholine on fertility.

Pregnancy

Risk Summary: It is also not known whether succinylcholine can cause fetal harm when administered to

a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been

conducted with succinylcholine chloride. Succinylcholine should be given to a pregnant woman only if

clearly needed.

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 to 4% and 15 to 20%, respectively.

Clinal Considerations: Plasma cholinesterase levels are decreased by approximately 24% during

pregnancy and for several days postpartum. Therefore, a higher proportion of patients may be expected

to show increased sensitivity (prolonged apnea) to succinylcholine when pregnant than when

nonpregnant.

Labor and Delivery: Succinylcholine is commonly used to provide muscle relaxation during delivery

by caesarean section. While small amounts of succinylcholine are known to cross the placental barrier,

under normal conditions the quantity of drug that enters fetal circulation after a single dose of 1 mg/kg

to the mother should not endanger the fetus. However, since the amount of drug that crosses the

placental barrier is dependent on the concentration gradient between the maternal and fetal circulations,

residual neuromuscular blockade (apnea and flaccidity) may occur in the newborn after repeated high

doses to, or in the presence of atypical plasma cholinesterase in, the mother.

Nursing Mothers: It is not known whether succinylcholine is excreted in human milk. Because many

drugs are excreted in human milk, caution should be exercised following succinylcholine administration

to a nursing woman.

Pediatric Use: Safety and effectiveness of succinylcholine chloride have been established in pediatric

patient age groups, neonate to adolescent. There are rare reports of ventricular dysrhythmias and

cardiac arrest secondary to acute rhabdomyolysis with hyperkalemia in apparently healthy pediatric

patients who receive succinylcholine (see BOX WARNING). Many of these pediatric patients were

subsequently found to have a skeletal muscle myopathy such as Duchenne’s muscular dystrophy whose

clinical signs were not obvious. The syndrome often presents as sudden cardiac arrest within minutes

after the administration of succinylcholine. These pediatric patients are usually, but not exclusively,

males, and most frequently 8 years of age or younger. There have also been reports in adolescents.

There may be no signs or symptoms to alert the practitioner to which patients are at risk. A careful

history and physical may identify developmental delays suggestive of a myopathy. A preoperative

creatine kinase could identify some but not all patients at risk. Due to the abrupt onset of this syndrome,

routine resuscitative measures are likely to be unsuccessful. Careful monitoring of the

electrocardiogram may alert the practitioner to peaked T-waves (an early sign). Administration of

intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation have resulted in

successful resuscitation in some of the reported cases. Extraordinary and prolonged resuscitative

efforts have been effective in some cases. In addition, in the presence of signs of malignant

hyperthermia, appropriate treatment should be initiated concurrently (see WARNINGS). Since it is

difficult to identify which patients are at risk, it is recommended that the use of succinylcholine in

pediatric patients should be reserved 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.

As in adults, the incidence of bradycardia in pediatric patients is higher following the second dose of

succinylcholine. The incidence and severity of bradycardia is higher in pediatric patients than adults.

Pre-treatment with anticholinergic agents, e.g., atropine, may reduce the occurrence of

bradyarrhythmias.

Geriatric Use: Clinical studies of Succinylcholine Chloride Injection 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.

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 intravenous 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.

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:

NDC No.

Container

Size (mL)

mg/mL mg (total)

mOsmol/mL (calc.)

Multiple-dos e

69918-700-01

Fliptop Vial

0.338

NDC No.

Carton

Size (mL)

mg/mL mg (total)

mOsmol/mL (calc.)

Multiple-dos e

69918-700-25

25 x Fliptop

Vials

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.

Revised: 12/2018

Manufactured by:

Renaissance Pharmaceuticals Inc.

Lakewood, NJ 08701

Manufactured for:

Amring Pharmaceuticals Inc.

Berwyn, PA 19312

141092

PRINCIPAL DISPLAY PANEL

VIAL LABEL

Rx Only

Succinylcholine

Chloride Injection, USP

200 mg/10 mL (20 mg/mL)

WARNING: Paralyzing Agent

For Intravenous or Intramuscular Use

WARNING: Paralyzing Agent. Causes

Respiratory Arrest. Facilities must be

immediately available for artificial

res piration.

10 mL Multiple-Dose Vial

PACKAGE LABEL

NDC 71872-7167-1 Rx Only

Succinylcholine

Chloride Injection , USP

1 - 10 mL Multiple-Dose Vial

200 mg/10 mL (20 mg/mL)

WARNING: Paralyzing Agent

For Intravenous or Intramuscular Use

Store in refrigerator

2° to 8°C (36° to 46°F).

SUCCINYLCHOLINE CHLORIDE

succinylcholine chloride injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code

(S ource )

NDC:718 72-716 7(NDC:6 9 9 18 -

70 0 )

Route of Administration

INTRAMUSCULAR,

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SUCCINYLCHO LINE CHLO RIDE (UNII: I9 L0 DDD30 I) (SUCCINYLCHOLINE -

UNII:J2R8 6 9 A8 YF)

SUCCINYLCHOLINE

CHLORIDE

20 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

METHYLPARABEN (UNII: A2I8 C7HI9 T)

1.8 mg in 1 mL

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

0 .2 mg in 1 mL

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Medical Purchasing Solutions, LLC

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:718 72-716 7-

1 in 1 BAG

0 6 /19 /20 19

1

1 mL in 1 VIAL, MULTI-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA210 231

0 4/10 /20 19

Labeler -

Medical Purchasing Solutions, LLC (601458529)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Medical Purchasing So lutio ns, LLC

6 0 1458 529

re pa c k(718 72-716 7)

Revised: 7/2019

Similar products

Search alerts related to this product

View documents history

Share this information