HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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QUELICIN®(succinylcholine chloride injection, USP)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
QUELICIN® Quick Finder
Highlights
Boxed Warning
WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS
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- Acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest, and death has occurred...
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Indications and Usage
1 INDICATIONS AND USAGE
QUELICIN is indicated in adults and pediatric patients:
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- as an adjunct to general anesthesia
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- to facilitate tracheal intubation
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- to provide...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Information
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- QUELICIN is for intravenous or intramuscular use only.
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- QUELICIN...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
QUELICIN™ (Succinylcholine Chloride Injection, USP) is supplied as a clear, colorless solution as follows:
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- 1,000 mg/10 mL (100 mg/mL) in single-dose fliptop vials contains:...
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Contraindications
4 CONTRAINDICATIONS
QUELICIN is contraindicated:
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- in patients with skeletal muscle myopathies [see Warnings and Precautions (5.1)]
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- in...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Ventricular Dysrhythmias, Cardiac Arrest, and Death From Hyperkalemic Rhabdomyolysis in Pediatric Patients
There have been reports of...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
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- Ventricular Dysrhythmias, Cardiac Arrest, and Death from...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Drugs that May Affect the Neuromuscular Blocking Action of QUELICIN
Drugs that may enhance the neuromuscular blocking action of...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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Overdosage
10 OVERDOSAGE
Overdosage with QUELICIN 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...
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Description
11 DESCRIPTION
QUELICIN (Succinylcholine Chloride Injection, USP) is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. QUELICIN contains...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Succinylcholine is a depolarizing neuromuscular blocker. As does acetylcholine, it combines with the cholinergic...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
QUELICIN (Succinylcholine Chloride Injection, USP) is supplied as a clear, colorless solution in the following concentrations and packages:
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.