QUELICIN

QUELICIN is an FDA-registered drug product whose active ingredient is SUCCINYLCHOLINE CHLORIDE. It is labelled by Hospira, Inc. taken by intramuscular and marketed as a human prescription drug product. Identifiers on file: NDC 0409-6629, application NDA008845, label effective 20260818. It is one of 24 FDA drug label records sharing the active ingredient SUCCINYLCHOLINE CHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing SUCCINYLCHOLINE CHLORIDE are most often described in connection with: indicated adults, pediatric patients, adjunct general, anesthesia facilitate, tracheal intubation, provide skeletal, muscle relaxation, surgery mechanical. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

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. • The dosage of QUELICIN should be individualized and should always be determined by the clinician after careful assessment of the patient. • To avoid distress to the patient, do not administer QUELICIN before unconsciousness has been induced [see Warnings and Precautions (5.14) ] . • The occurrence of bradyarrhythmias with administration of QUELICIN may be reduced by pretreatment with anticholinergics (e.g., atropine) [see Warnings and Precautions (5.6) ] . • Monitor neuromuscular function with a peripheral nerve stimulator when using QUELICIN by infusion [see Dosage and Administration (2.2) , Warnings and Precautions (5.8) ] . • Visually inspect QUELICIN for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer solutions that are not clear and colorless. • QUELICIN supplied in multiple-dose vials does not require dilution before use [see Dosage and Administration (2.5) ] . Risk of Medication Errors 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 [see Warnings and Precautions (5.3) ] . 2.2 Dosage Recommendations for Intravenous Use in Adults For Short Surgical Procedures The average dose required to produce neuromuscular blockade and to facilitate tracheal intubation is 0.6 mg/kg QUELICIN given intravenously. The optimum intravenous dose of QUELICIN will vary among patients and may be from 0.3 mg/kg to 1.1 mg/kg for adults. Following intravenous 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. A 5 to 10 mg intravenous test dose of QUELICIN may be used to determine the sensitivity of the patient and the individual recovery time [see Warnings and Precautions (5.9) ] . For Long Surgical Procedures Continuous Intravenous Infusion The dosage of QUELICIN administered by continuous intravenous infusion depends upon the duration of the surgical procedure and the need for muscle relaxation. Diluted QUELICIN solutions containing from 1 mg/mL to 2 mg/mL succinylcholine have commonly been used for continuous intravenous infusion [see Dosage and Administration (2.5) ] . The more dilute solution (1 mg/mL) is probably preferable from the standpoint of ease of control of the rate of administration of QUELICIN and, hence, of relaxation. This diluted QUELICIN solution containing 1 mg/mL succinylcholine may be administered intravenously at a rate of 0.5 mg (0.5 mL) per minute 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. The average rate of continuous intravenous infusion for an adult ranges between 2.5 mg per minute and 4.3 mg per minute. Monitor neuromuscular function with a peripheral nerve stimulator when using QUELICIN 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 Warnings and Precautions (5.8) ] . Intermittent Intravenous Injection Intermittent intravenous injections of QUELICIN may also be used to provide muscle relaxation for long procedures. An intravenous injection of 0.3 mg/kg to 1.1 mg/kg may be given initially, followed, at appropriate intervals, by further intravenous injections of 0.04 mg/kg to 0.07 mg/kg to maintain the degree of relaxation required. 2.3 Dosage Recommendations for Intravenous Use in Pediatric Patients For emergency tracheal intubation or in instances where immediate securing of the airway is necessary, the intravenous dose of QUELICIN is 2 mg/kg for infants and other small pediatric patients; for older pediatric patients and adolescents the intravenous dose is 1 mg/kg [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . The effective dose of QUELICIN 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 mg/kg to 3 mg/kg in neonates and infants up to 6 months of age and 1 mg/kg to 2 mg/kg in infants up to 2 years of age [see Clinical Pharmacology (12.3) ] . 2.4 Dosage Recommendations for Intramuscular Use in Adults and Pediatric Patients If a suitable vein is inaccessible, QUELICIN may be administered intramuscularly at a dose of up to 3 mg/kg to 4 mg/kg to infants, older pediatric patients, or adults. The total dose administered by the intramuscular route should not exceed 150 mg. The onset of effect of succinylcholine given intramuscularly is usually observed in about 2 to 3 minutes. 2.5 Preparation of QUELICIN QUELICIN supplied in multiple-dose vials does not require dilution for intravenous or intramuscular bolus dosing. QUELICIN may be diluted for continuous intravenous infusion to 1 mg/mL or 2 mg/mL in a solution such as: • 5% Dextrose Injection, USP, or • 0.9% Sodium Chloride Injection, USP Prepare the diluted QUELICIN solution for single patient use only. Store the diluted QUELICIN solution in a refrigerator [2°C to 8°C (36°F to 46°F)] and use within 24 hours after preparation. Visually inspect the diluted QUELICIN solution for particulate matter and discoloration prior to administration. Do not administer solutions that are not clear and colorless. Discard any unused portion of the diluted QUELICIN solution. 2.6 Drug Incompatibility QUELICIN is acidic (pH is between 3.0 and 4.5) and may not be compatible with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions). Therefore, do not mix QUELICIN with alkaline solutions.

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 )

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: Increased intraocular pressure Gastrointestinal disorders: Excessive salivation Immune system disorders: Hypersensitivity reactions including anaphylaxis (in some cases life-threatening and fatal) Musculoskeletal disorders: Malignant hyperthermia, rhabdomyolysis with possible myoglobinuric acute renal failure, muscle fasciculation, jaw rigidity, postoperative muscle pain Respiratory disorders: Prolonged respiratory depression or apnea Skin disorders: Rash Adverse reactions reported with succinylcholine are cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

FDA lists 24 drug label records with SUCCINYLCHOLINE CHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is QUELICIN used for?
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 …

Who makes QUELICIN?
Hospira, Inc. is the labeler of record for QUELICIN. 24 FDA label records share the active ingredient SUCCINYLCHOLINE CHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does QUELICIN come in?
administered by intramuscular. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is QUELICIN prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SUCCINYLCHOLINE CHLORIDE?
Yes. 24 FDA drug label records list SUCCINYLCHOLINE CHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has QUELICIN been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.