Drugplain

QUELICIN 20 mg/mL

Succinylcholine Chloride · INJECTION, SOLUTION · Hospira, Inc.

5 Recalls on Record
Plain English

QUELICIN is a injection, solution containing succinylcholine chloride at 20 mg/mL, taken intramuscular. Manufactured by Hospira, Inc..

Key Facts

Brand Name
QUELICIN
Generic Name
Succinylcholine Chloride
NDC Code (Product)
0409-6629
Manufacturer
Hospira, Inc.
Strength
20 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #
NDA008845
Marketing Start
04/30/2005

Recall History

5 Recalls on Record
Class II06/22/2017

Advanced Pharma Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II02/26/2013

Hospira Inc.

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

TerminatedVoluntary: Firm initiated
Class II10/24/2017

Ace Surgical Supply Co., Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag

TerminatedVoluntary: Firm initiated
Class III03/15/2016

Hospira Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

OngoingVoluntary: Firm initiated
Class II06/15/2017

Hospira a Pfizer Company

Lack of Sterility Assurance

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective281 reports
hypotension172 reports
cardiac arrest162 reports
anaphylactic shock139 reports
drug interaction118 reports
anaphylactic reaction111 reports
renal failure101 reports
pain98 reports
renal impairment98 reports
hyperthermia malignant94 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE QUELICIN is indicated in adults and pediatric patients: • as an adjunct to general anesthesia • to facilitate tracheal intubation • to provide skeletal muscle relaxation during surgery or mechanical ventilation. QUELICIN is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: • as an adjunct to general anesthesia ( 1 ) • to facilitate tracheal intubation ( 1 ) • to provide skeletal muscle relaxation during surgery or mechanical ventilation. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • For intravenous or intramuscular use only. ( 2.1 ) • Individualize dosage after careful assessment of the patient. ( 2.1 ) • Accidental administration of neuromuscular blocking agents may be fatal. Store QUELICIN with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. ( 2.1 ) • See full prescribing information for QUELICIN dosage recommendations, preparation instructions, and administration information. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) 2.1 Important Dosage and Administration Information • QUELICIN is for intravenous or intramuscular use only. • QUELICIN must be titrated to effect by or under supervision of experienced clinicians who are familiar with its actions and with appropriate neuromuscular monitoring techniques. • QUELICIN should be administered 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 CO 2 . The clinician must be prepared to assist or control respiration. •

Contraindications

4 CONTRAINDICATIONS QUELICIN is contraindicated: • in patients with skeletal muscle myopathies [see Warnings and Precautions (5.1) ] • in patients with known hypersensitivity to succinylcholine. Severe anaphylactic reactions to succinylcholine have been reported [see Warnings and Precautions (5.2) ] • after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see Warnings and Precautions (5.4) ] • in patients with known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions (5.5) , Clinical Pharmacology (12.5) ] • Skeletal muscle myopathies ( 4 ) • Known hypersensitivity to succinylcholine ( 4 ) • After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury ( 4 ) • Known or suspected genetic susceptibility to malignant hyperthermia ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Drugs that May Enhance the Neuromuscular Blocking Action of Succinylcholine : promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity. ( 7.1 ) 7.1 Drugs that May Affect the Neuromuscular Blocking Action of QUELICIN Drugs that 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, 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 Warnings and Precautions (5.9) ]. If other neuromuscular blocking agents are t

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Ventricular Dysrhythmias, Cardiac Arrest, and Death from Hyperkalemic Rhabdomyolysis in Pediatric Patients [see Warnings and Precautions (5.1) ] • Anaphylaxis [see Warnings and Precautions (5.2) ] • Hyperkalemia [see Warnings and Precautions (5.4) ] • Malignant Hyperthermia [see Warnings and Precautions (5.5) ] • Bradycardia [see Warnings and Precautions (5.6) ] • Increase in Intraocular Pressure [see Warnings and Precautions (5.7) ] • Prolonged Neuromuscular Block due to Phase II Block and Tachyphylaxis [see Warnings and Precautions (5.8) ] The following adverse reactions associated with the use of succinylcholine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Cardiovascular disorders: Cardiac arrest, arrhythmias, bradycardia, tachycardia, hypertension, hypotension Electrolyte disorders: Hyperkalemia Eye disorders: In

Frequently Asked Questions

What is QUELICIN used for?

QUELICIN contains Succinylcholine Chloride. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.

Is QUELICIN a controlled substance?

QUELICIN is not classified as a controlled substance by the DEA.

What is the generic name for QUELICIN?

The generic name for QUELICIN is Succinylcholine Chloride. There are 12 other brand versions of Succinylcholine Chloride.

What is the NDC code for QUELICIN 20 mg/mL?

The NDC (National Drug Code) for QUELICIN 20 mg/mL is 0409-6629, listed by Hospira, Inc..