Cisatracurium Besylate 2 mg/mL
CISATRACURIUM BESYLATE · INJECTION, SOLUTION · Hospira, Inc.
Cisatracurium Besylate is a injection, solution containing cisatracurium besylate at 2 mg/mL, taken intravenous. Manufactured by Hospira, Inc..
Key Facts
- Brand Name
- Cisatracurium Besylate
- Generic Name
- CISATRACURIUM BESYLATE
- NDC Code (Product)
0409-1098- Manufacturer
- Hospira, Inc.
- Strength
- 2 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203236
- Marketing Start
- 03/17/2020
Recall History
SOMERSET THERAPEUTICS LLC
Subpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC
Subpotent product:out of specification assay results observed during long term stability testing.
Fresenius Kabi USA, LLC
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
SOMERSET THERAPEUTICS LLC
Subpotent product:out of specification assay results observed during long term stability testing.
Meitheal Pharmaceuticals Inc
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Cisatracurium besylate injection is indicated: • as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age • to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU • to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older Limitations of Use Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. Cisatracurium besylate injection is a nondepolarizing neuromuscular blocker indicated: as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age (1) to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance (1) for mechanical ventilation in the ICU in adults (1) Limitations of Use: Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Store cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product (2.1) Administer intravenously only by or under the supervision of experienced clinicians familiar with drug’s actions and possible complications (2.1) Use only if personnel and facilities for resuscitation and life support, and a cisatracurium besylate injection antagonist are immediately available (2.1) Use a peripheral nerve stimulator to determine adequacy of blockade (e.g., need for additional doses), minimize risk of overdosage or underdosage, assess extent of recovery from blockade, potentially limit exposure to toxic metabolites through dose titration, and facilitate more rapid reversal of cisatracurium besylate injection-induced paralysis (2.1) See the Full Prescribing Information for: o Dosage and administration instructions in adults, pediatric patients, geriatric patients, patients with neuromuscular disease, burns, end-stage renal disease, and patients undergoing coronary artery bypass graft surgery with induced hypothermia (2.2, 2.3, 2.4, 2.5) o Continuous infusion rates (2.6) o Preparation ins…
Contraindications
4 CONTRAINDICATIONS Cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium.Severe anaphylactic reactions to cisatracurium besylate injection have been reported [ see Warnings and Precautions (5.4) ]. The use of 10 mL cisatracurium besylate injection multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains benzyl alcohol [ see Warnings and Precautions (5.2) and Use in Specific Populations (8.4) ]. • Known hypersensitivity to cisatracurium
Drug Interactions
7 DRUG INTERACTIONS Succinylcholine : May decrease time to onset of maximum neuromuscular blockade. (7.1) I nhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine: May potentiate or prolong neuromuscular blockade action of cisatracurium besylate injection. Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.8, 7.1) Phenytoin and Carbamazepine: May shorten duration of neuromuscular blockade. Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.9, 7.1) 7.1 Clinically Significant Drug Interactions Table 4 displays clinically significant drug interactions with cisatracurium besylate injection. Table 4. Clinically Significant Drug Interactions with Cisatracurium Besylate Injection Drug or Drug Class Clinical Implications* Succinylcholine The use of succinylcholine prior to cisatracurium besylate injection administration may decrease the time to onset of maximum neuromuscular blockade but has no effect on the duration of neuromuscular blockade. Inhalational Anesthetics Administration of inhalational anesthetics with nitrous oxide/oxygen for greater than 30 minutes …
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Surgical Patients The data presented below are based on studies involving 945 surgical patients who received cisatracurium besylate injection in conjunction with other drugs in US and European clinical studies in a variety of procedures [see Clinical Studies (14.1)]. Table 3 displays adverse reactions that occurred at a rate of less than 1%. Table 3. Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Surgical Patients Adverse Reaction Incidence Bradycardia 0.4% Hypotension 0.2% Flushing 0.2% Bronchospasm 0.2% Rash 0.1% Adverse R…
Frequently Asked Questions
What is Cisatracurium Besylate used for?
Cisatracurium Besylate contains CISATRACURIUM BESYLATE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Cisatracurium Besylate a controlled substance?
Cisatracurium Besylate is not classified as a controlled substance by the DEA.
What is the generic name for Cisatracurium Besylate?
The generic name for Cisatracurium Besylate is CISATRACURIUM BESYLATE. There are 5 other brand versions of CISATRACURIUM BESYLATE.
What is the NDC code for Cisatracurium Besylate 2 mg/mL?
The NDC (National Drug Code) for Cisatracurium Besylate 2 mg/mL is 0409-1098, listed by Hospira, Inc..