Anectine

Succinylcholine Chloride


Civica, Inc.
Human Prescription Drug
NDC 72572-750
Anectine also known as Succinylcholine Chloride is a human prescription drug labeled by 'Civica, Inc.'. National Drug Code (NDC) number for Anectine is 72572-750. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Anectine drug includes Succinylcholine Chloride - 20 mg/mL . The currest status of Anectine drug is Active.

Drug Information:

Drug NDC: 72572-750
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Anectine
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Succinylcholine Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Civica, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:SUCCINYLCHOLINE CHLORIDE - 20 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAMUSCULAR
INTRAVENOUS
PARENTERAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 11 Dec, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 17 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: NDA008453
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Civica, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1594589
1594591
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:I9L0DDD30I
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Depolarizing Neuromuscular Blocker [EPC]
Neuromuscular Depolarizing Blockade [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
72572-750-1010 VIAL, MULTI-DOSE in 1 CARTON (72572-750-10) / 10 mL in 1 VIAL, MULTI-DOSE (72572-750-01)11 Dec, 2020N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Anectine succinylcholine chloride succinylcholine chloride succinylcholine sodium chloride hydrochloric acid methylparaben sodium hydroxide

Drug Interactions:

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.

Boxed Warning:

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 ).

Indications and 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.

Warnings:

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 anectine, 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 anectine 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 in susceptible individuals, succinylcholine may trigger malignant hyperthermia, a skeletal muscle hypermetabolic state leading to high oxygen demand. fatal outcomes of malignant hyperthermia have been reported. the risk of developing malignant hyperthermia increases with the concomitant administration of succinylcholine and volatile anesthetic agents. anectine can induce malignant hyperthermia in patients with known or suspected susceptibility based on genetic factors or family history, including those with certain inherited ryanodine receptor ( ryr1 ) or dihydropyridine receptor ( cacna1s ) variants. (see contraindications , clinical pharmacology; pharmacogenomics ) signs consistent with malignant hyperthermia may include hyperthermia, hypoxia, hypercapnia, muscle rigidity (e.g., jaw muscle spasm), tachycardia (e.g., particularly that unresponsive to deepening anesthesia or analgesic medication administration), tachypnea, cyanosis, arrhythmias, hypovolemia, and hemodynamic instability. skin mottling, coagulopathies, and renal failure may occur later in the course of the hypermetabolic process. successful treatment of malignant hyperthermia depends on early recognition of the clinical signs. if malignant hyperthermia is suspected, discontinue all triggering agents (i.e., volatile anesthetic agents and succinylcholine), administer intravenous dantrolene sodium, and initiate supportive therapies. consult prescribing information for intravenous dantrolene sodium for additional information on patient management. supportive therapies include administration of supplemental oxygen and respiratory support based on clinical need, maintenance of hemodynamic stability and adequate urinary output, management of fluid and electrolyte balance, correction of acid base derangements, and institution of measures to control rising temperature. 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 in adults. 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).

General Precautions:

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 nondepolarizing 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 seven of seven 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 2 o/o 2 /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 devel
oped 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 anectine have been reported.

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. risk of medication errors accidental administration of neuromuscular blocking agents may be fatal. store anectine 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 anectine 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 abo
ut 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 iv 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 iv injections of succinylcholine may also be used to provide muscle relaxation for long procedures. an iv 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 iv 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 ). rarely, iv bolus administration of succinylcholine in infants and pediatric patients may result in malignant ventricular arrhythmias 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. 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). anectine injection is stable for 24 hours after dilution to a final concentration of 1 to 2 mg/ml in 5% dextrose injection, usp or 0.9% sodium chloride injection, usp. aseptic techniques should be used to prepare the diluted product. admixtures of anectine should be prepared for single patient use only. the unused portion of diluted anectine should be discarded.

Contraindications:

Contraindications anectine is contraindicated in patients with: • known or suspected genetic susceptibility to malignant hyperthermia (see warnings; malignant hyperthermia , clinical pharmacology; pharmacogenomics ) • skeletal muscle myopathies • known hypersensitivity to succinylcholine (see warnings; anaphylaxis ) • after the acute phase of injury following major burns, multiple trauma, extensive denervation of the skeletal muscle, or upper neuron injury because succinylcholine administered to such individuals may result in severe hyperkalemia, which may result in cardiac arrest (see warnings; hyperkalemia )

Adverse Reactions:

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 anectine. 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 ).

Drug Interactions:

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.

Pediatric Use:

Pediatric use 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 mea
sures are likely to be unsuccessful. careful monitoring of the electrocardiogram may alert the practitioner to peaked t-waves (an early sign). administration of iv 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 in adults. pretreatment with anticholinergic agents, e.g., atropine, may reduce the occurrence of bradyarrhythmias.

Overdosage:

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 nondepolarizing block (phase ii) (see precautions ).

Description:

Description anectine (succinylcholine chloride) is an ultra short-acting depolarizing-type, skeletal muscle relaxant for intravenous (iv) administration. succinylcholine chloride is a white, odorless, slightly bitter powder and very soluble in water. the drug is unstable in alkaline solutions but relatively stable in acid solutions, depending upon the concentration of the solution and the storage temperature. solutions of succinylcholine chloride should be stored under refrigeration to preserve potency. anectine injection is a sterile nonpyrogenic solution for intravenous injection where each ml contains 20 mg succinylcholine chloride as active, 1 mg methylparaben as a preservative, 4.5 mg sodium chloride as an isotonic agent and ph adjusted to 3.5 with hydrochloric acid and sodium hydroxide. the chemical name for succinylcholine chloride is 2,2'-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[ n,n,n -trimethylethanaminium] dichloride, and the structural formula is: anectine succinylcholine chloride chemical structure

Clinical Pharmacology:

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 1 minute after iv 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. 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 nondepolarizing 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 ). pharmacogenomics ryr1 and cacna1s are polymorphic genes, and multiple pathogenic variants have been associated with malignant hyperthermia susceptibility (mhs) in patients receiving succinylcholine, including anectine. case reports as well as ex-vivo studies have identified multiple variants in ryr1 and cacna1s associated with mhs. variant pathogenicity should be assessed based on prior clinical experience, functional studies, prevalence information, or other evidence (see contraindications , warnings ).

Carcinogenesis and Mutagenesis and Impairment of Fertility:

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.

How Supplied:

How supplied anectine (succinylcholine chloride injection, usp) is supplied as a clear, colorless solution in multiple-dose vials 200 mg/10 ml (20 mg/ml), box of 10 vials (ndc 72572-750-10). store in refrigerator at 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 for: civica, inc., lehi, utah 84043 manufactured by: delpharm boucherville canada inc. 145 rue jules-leger street boucherville, qc, j4b 7k8 rev. november 2022 46314244

Package Label Principal Display Panel:

200 mg/10 ml carton ndc 72572-750-10 rx only anectine® (succinylcholine chloride injection, usp) 200 mg/10 ml (20 mg/ml) warning: paralyzing agent for intravenous use 10 x 10 ml multiple-dose vials civica carton


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