QUELICIN

Main information

  • Trade name:
  • QUELICIN SOLUTION
  • Dosage:
  • 100MG
  • Pharmaceutical form:
  • SOLUTION
  • Composition:
  • SUCCINYLCHOLINE CHLORIDE 100MG
  • Administration route:
  • INTRAVENOUS
  • Units in package:
  • 10ML
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • QUELICIN SOLUTION
    Canada
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • NEUROMUSCULAR BLOCKING AGENTS
  • Product summary:
  • Active ingredient group (AIG) number: 0105141002; AHFS: 12:20.20

Other information

Status

  • Source:
  • Health Canada
  • Authorization status:
  • APPROVED
  • Authorization number:
  • 00296163
  • Authorization date:
  • 23-04-2004
  • Last update:
  • 29-11-2018

Summary of Product characteristics: dosage,interactions,side effects

PRESCRIBING INFORMATION

QUELICIN

Succinylcholine Chloride Injection, USP

Neuromuscular Blocking Agent

Pfizer Canada Inc.

17300 Trans-Canada Highway

Kirkland, Québec

H9J 2M5

Control Number: 205275

DATE OF REVISION:

June 23, 2017

Prescribing Information - Quelicin Page 2 of 14

PRESCRIBING INFORMATION

NAME OF DRUG

QUELICIN

Succinylcholine Chloride Injection, USP

THERAPEUTIC CLASSIFICATION

Neuromuscular Blocking Agent

ACTION AND CLINICAL PHARMACOLOGY

Succinylcholine is an ultra short-acting, depolarizing-type, 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 i.v. administration), and with single administration

lasts approximately 4 to 6 minutes.

Succinylcholine is rapidly hydrolysed 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 chloride is progressive, initially involving 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, predominantly bradycardia

Prescribing Information - Quelicin Page 3 of 14

and occasional asystoles. Changes in rhythm including cardiac arrest, may also result from vagal

stimulation, which may occur during surgical procedures, or from hyperkalemia, particularly in children

(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 causes 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).

The onset and duration of action of succinylcholine may be altered by dehydration and electrolyte

imbalance, and by the use of other medications such as depolarizing or non-depolarizing muscle

relaxants.

INDICATIONS AND CLINICAL USE

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, unless clinical circumstances

require immediate securing of the airway, 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.

Acute rhabdomyolysis with hyperkalemia can occur when used in individuals with a skeletal muscle

myopathy such as Duchenne's muscular dystrophy (see PRECAUTIONS-Pediatric Use).

Prescribing Information - Quelicin Page 4 of 14

WARNINGS

In infants and children, especially in boys under eight years of age, the rare possibility of inducing

life-threatening hyperkalemia in undiagnosed myopathies by the use of succinylcholine must be

balanced against the risk of alternative means of securing the airway.

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.

Hyperkalemia

Succinylcholine should be administered with GREAT CAUTION to patients suffering from

hyperkalemia 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.

Immediate treatment of hyperkalemia should include hyperventilation, i.v. calcium, i.v. sodium

bicarbonate and I.V. glucose (with or without insulin).

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, increase of

end-tidal carbon dioxide concentrations, 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. In short

Prescribing Information - Quelicin Page 5 of 14

procedures, these symptoms and signs may not appear until the patient is in the recovery room.

Recognition of the syndrome is a signal for discontinuance of anesthesia, attention to increased oxygen

consumption, requirement for a marked increase in minute ventilation to correct respiratory acidosis,

supplementary i.v. bicarbonate to control metabolic acidosis, support of circulation, assurance of adequate

urinary output and institution of measures to control rising temperature. Dantrolene sodium, intravenously,

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

recommended as an aid to early recognition of malignant hyperthermia.

Other

In adults the incidence of bradycardia, which may progress to asystole, is greater after a second dose of

succinylcholine. In infants and young children, bradycardia and transient asystole may occur after one

dose of succinylcholine. The incidence and severity of bradycardia is greater in infants and children than

in adults. Pretreatment with anticholinergic agents (e.g. atropine), in most cases, will 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 this 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) (see PHARMACEUTICAL INFORMATION, Stability -

Compatibility).

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 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

Prescribing Information - Quelicin Page 6 of 14

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.

The action of succinylcholine may be altered by some carcinomas or renal disease.

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, or neuromuscular blockade may be produced by the cautious

administration of a 1 mg/mL solution of succinylcholine by intravenous drip. 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,

Prescribing Information - Quelicin Page 7 of 14

isoflurane, desflurane, metoclopramide and terbutaline. The presence of an inhalational anesthetic may

exacerbate the side effects of succinylcholine in infants and children (see ADVERSE REACTIONS).

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).

Drugs which either inhibit plasma pseudocholinesterase (such as neostigmine) or compete with

succinylcholine for the enzyme (as does intravenous procaine) should not be given concurrently with

succinylcholine.

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.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with succinylcholine chloride. It is also not known

whether succinylcholine can cause fetal harm when administered to a pregnant woman or can affect

reproduction capacity. Succinylcholine should be given to a pregnant woman only if clearly needed.

Nonteratogenic Effects

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 cesarean 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

There are rare reports of ventricular dysrhythmias, cardiac arrest and death secondary to acute

rhabdomyolysis with hyperkalemia in apparently healthy infants and children who receive

Prescribing Information - Quelicin Page 8 of 14

succinylcholine (see WARNINGS). Several of these individuals were subsequently found to be

suffering from a myopathy such as Duchenne's muscular dystrophy whose clinical signs were not

obvious. When a healthy appearing infant or child suddenly develops cardiac arrest soon after

administration of succinylcholine, immediate treatment of hyperkalemia should include hyperventilation,

i.v. calcium, i.v. sodium bicarbonate and i.v. glucose (with or without insulin). Treatment for acute

rhabdomyolysis, including a single dose of dantrolene, should also be considered.

Unlike in adults, the incidence of bradycardia in infants and young children is common after one dose of

succinylcholine. The incidence and severity of bradycardia is greater in infants and children than in adults.

Pre-treatment with anticholinergic agents (e.g. atropine), in most cases, will reduce the occurrence of

bradyarrhythmias.

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.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

Symptoms

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, prolonged respiratory depression or apnea.

Treatment

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).

The decision to use neostigmine to reverse a Phase II succinylcholine-induced block depends on the

judgment of the clinician in the individual case. Valuable information in regard to this decision will be

gained by monitoring neuromuscular function. If neostigmine is used, its administration should be

accompanied by appropriate doses of an anticholinergic agent such as atropine.

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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 colourless

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 USP) 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 (see PHARMACEUTICAL INFORMATION, Stability-Compatibility). 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).

Children

The intravenous dose of succinylcholine is 2 mg/kg for infants and small children; for older children and

adolescents the dose is 1 mg/kg (see WARNINGS and PRECAUTIONS-Pediatric Use).

Rarely, I.V. bolus administration of succinylcholine in infants and children may result in malignant

ventricular arrhythmias and cardiac arrest secondary to acute rhabdomyolysis with hyperkalemia. In such

situations, an underlying myopathy should be suspected.

Prescribing Information - Quelicin Page 10 of 14

Intravenous bolus administration of succinylcholine in infants and young children may result in profound

bradycardia or, rarely, asystole. Unlike in adults, the incidence of bradycardia in infants and children is

greater after a single dose of succinylcholine. The occurrence of bradyarrhythmias, in most cases, will be

reduced by pretreatment with an anticholinergic drug (e.g. atropine) (see PRECAUTIONS-Pediatric

Use).

Intramuscular Use

If necessary, succinylcholine may be given intramuscularly to infants, older children or adults when a suitable

vein is inaccessible. A dose of up to 3 or 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.

Prescribing Information - Quelicin Page 11 of 14

PHARMACEUTICAL INFORMATION

Drug Substance

Trade Name

QUELICIN

Proper Name

Succinylcholine chloride

Chemical Name

2,2'-[1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N,-

trimethylethanaminium]dichloride

Structural Formula

Molecular Formula

Molecular Weight

361.31

Description

Succinylcholine chloride is a white, odorless, slightly bitter powder, that

is very soluble in water. It is unstable in alkaline solutions, but relatively

stable in acid solutions, depending upon the concentration of the solution

and the storage temperature.

Stability - Compatibility

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).

Succinylcholine is rapidly hydrolyzed, quickly loses potency, and may cause a precipitate to form when

mixed with alkaline solutions of other drugs. Preferably, succinylcholine should be separately injected and

should not be mixed in the same syringe nor administered simultaneously through the same needle with

solutions of short-acting barbiturates, such as Pentothal* (sodium thiopental) or other drugs which have an

alkaline pH.

Admixtures containing 1 to 2 mg per mL of succinylcholine may be prepared dy diluting succinylcholine with

a sterile solution, such as 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Such

admixtures should be used within 24 hours after preparation. Aseptic techniques should be used to prepare the

diluted product. Admixtures of succinylcholine should be prepared for single patient use only. The unused

portion of the diluted succinylcholine should be discarded.

Prescribing Information - Quelicin Page 12 of 14

Storage Recommendations

All units must be kept refrigerated (2 to 8°C) to prevent loss of potency. These products are stable for up to

14 days at room temperature without significant loss of potency.

Availability

QUELICIN

(succinylcholine chloride injection USP) is supplied as a sterile solution in ampoules and fliptop

vials as follows:

List

Size (mL)

mg/mL

mg/total unit

06629

06970

List 06629: each mL contains succinylcholine chloride 20 mg, methylparaben 1.8 mg, propylparaben 0.2 mg

as preservatives, sodium chloride for tonicity; it may contain sodium hydroxide and/or hydrochloric acid to

adjust the pH at approximately 4.

List 06970: each mL contains succinylcholine chloride 100 mg; it may contain sodium hydroxide and/or

hydrochloric acid to adjust the pH at approximately 4.

This solution must be diluted for intravenous use: any unused reconstituted portion should be discarded.

Prescribing Information - Quelicin Page 13 of 14

SELECTED BIBLIOGRAPHY

Assem ESK. Anaphylactic reactions affecting the human heart. Agents and Actions 1989; 27:142.

Carrol JB. Increased incidence of masseter spasm in children with strabismus anesthetized with

halothane and succinylcholine. Anesthesiology 1987; 67:559-561.

Crespi G, Lualdi M, Restelli L, Pellerin I, Castiglioni C. Halothane and isoflurane:

succinylcholine-induced heart rate changes in pediatric anaesthesia. Minerva Anestesiol 1988; 54:1-4.

Delphin E, Jackson D, Rothstein P. Use of succinylcholine during elective pediatric anesthesia should

be reevaluated. Anesth Analg 1987; 66:1190-2.

Futter ME, Donati F, Bevan DR. Prolonged suxamethonium infusion during nitrous oxide anaesthesia

supplemented with halothane or fentanyl. Br J Anaesth 1983; 55:947-53.

Goudsouzian NG. Relaxants in paediatric anaesthesia. Clin Anaesthesiol 1985; 3(3):539-51.

Gronert GA. Malignant hyperthermia. Anesthesiology 1980; 53(5):395-423.

Gronert GA, Theye RA. Pathophysiology of hyperkalemia induced by succinylcholine.

Anesthesiology 1973; 43(1):89-99.

Gürgey A. Malignant hyperthermia in a patient with sickle cell anemia. Turk J Pediatr 1989;

31:245-247.

Illes IA, Defensor NC. Incidence and detection of cardiac arrhythmias during halothane anesthesia.

Anesth Analg 1965; 44:529-531.

Kashimoto S, Kanda F, Kumazawa T. Succinylcholine-induced ventricular arrythmia during

halothane anesthesia. Resuscitation 1985; 12:233-236.

Knight J, Mercader M, Bebak D. Anaphylaxis to succinylcholine. J Kans Med Soc 1982; 83:424.

List WFM. Succinylcholine-induced cardiac arrhythmias. Anesth Analg 1971; 50:361- 367.

Mehler J, Bachour H, Simons F, Wolpers K. Cardiac arrest during induction of anesthesia with

halothane and succinylcholine in an infant. Severe hyperkalemia and rhabdomyolysis due to a

suspected myopathy and/or malignant hyperthermia. Anaesthesist 1991; 40:497-501.

Nash CL, Haller R, Brown RH. Succinylcholine, paraplegia, and intra-operative cardiac arrest. A

Case Report. J Bone Joint Surg 1981; 63A(6):1010-2.

Rosenberg H, Gronert GA. Intractable cardiac arrest in children given succinylcholine.

Anesthesiology 1992; 77(5):1054.

Stoelting RK. Comparison of gallamine and atropine as pretreatment before anesthetic induction and

succinylcholine administration. Anesth Analg 1977; 56:493-495.

Prescribing Information - Quelicin Page 14 of 14

Warner LO, Beach TP, Garvin JP, Warner EJ. Halothane and children: The first quarter century.

Anesth Analg 1984; 63:838-840.

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SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

27-7-2018

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)5047 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/03

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

25-6-2018

Xofigo (Bayer AG)

Xofigo (Bayer AG)

Xofigo (Active substance: Radium Ra 223 dichloride) - Centralised - Renewal - Commission Decision (2018)4018 of Mon, 25 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2653/R/30

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety