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CISATRACURIUM BESYLATE is a brand name for Cisatracurium, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. S. and European clinical studies in the course of a wide variety of procedures in patients receiving opioid, propofol, or inhalation anesthesia.
1%) Post-Market Adverse Drug Reactions In addition to events reported from clinical trials, the following events have been identified during post-approval use of cisatracurium besylate in conjunction with one or more anesthetic agents in clinical practice.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are reported due to their seriousness, frequency of reporting, or potential causal relationship to cisatracurium besylate.
General:
Hypersensitivity reactions including anaphylactic or anaphylactoid reactions which in some cases have been life threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
See WARNINGS AND PRECAUTIONS. There are rare reports of wheezing, laryngospasm, bronchospasm, rash and itching following administration of cisatracurium besylate in children. These reported adverse events were not serious and their etiology could not be established with certainty.
Musculoskeletal System:
Prolonged neuromuscular block, and inadequate neuromuscular block. 0 Page 12 of
General Because of its intermediate onset of action, Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose are not recommended for rapid sequence endotracheal intubation. Patients subjected to hypothermia may necessitate a reduction in the rate of infusion of Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose.
See DOSAGE AND ADMINISTRATION. Acid-base and/or serum electrolyte abnormalities may potentiate or antagonize the action of neuromuscular blocking agents. The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of pre-eclampsia or eclampsia.
As cisatracurium besylate injection has not been studied in patients with asthma, it should be administered with caution to this patient group. See WARNINGS AND PRECAUTIONS, Sensitivity/Resistance, Anaphylaxis and Allergic Reactions.
No data are available to support the use of Cisatracurium Besylate Injection by intramuscular injection. , barbiturate solutions). Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose are also hypotonic and must not be administered Serious Warnings and Precautions • Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose should be administered in carefully adjusted dosage by or under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications of its use.
The drug should not be administered unless personnel and facilities for resuscitation and life support (tracheal intubation, artificial ventilation, oxygen therapy), and an antagonist of cisatracurium besylate are immediately available.
It is recommended that a peripheral nerve stimulator be used to measure neuromuscular function during the administration of cisatracurium besylate in order to monitor drug effect, determine the need for additional doses, and confirm recovery from neuromuscular block.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
• Cisatracurium Besylate Injection has no known effect on consciousness, pain threshold, thinking, or memory. To avoid distress to the patient, neuromuscular block should not be induced before unconsciousness. 0 Page 6 of 37 into the infusion line of a blood transfusion.
The multiple-dose vials of Cisatracurium Besylate Injection Multi-Dose contain benzyl alcohol, which is potentially toxic when administered locally to neural tissue. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants.
There have been reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol.
Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administration. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources.
Single- Dose vials (5 mL) of Cisatracurium Besylate Injection Single-Dose do not contain benzyl alcohol. See WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics. Carcinogenesis and Mutagenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of cisatracurium besylate.
Cisatracurium besylate was evaluated in a battery of four short-term mutagenicity tests. It was non-mutagenic in the Ames Salmonella assay, a rat bone marrow cytogenic assay, and in in vitro human lymphocyte cytogenetics assay. As was the case with atracurium, the mouse lymphoma assay was positive both in the presence and absence of exogenous metabolic activation (rat liver S-9).
In the absence of S-9, cisatracurium besylate was positive at in vitro cisatracurium concentrations of 40 mcg/mL and higher. In the presence of S-9, cisatracurium besylate was positive at a cisatracurium concentration of 300 mcg/mL but not at lower or higher concentrations.
Cardiovascular Recommended doses of cisatracurium besylate injection have no clinically significant effects on heart rate; therefore, Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose will not counteract the bradycardia produced by many anesthetic agents or by vagal stimulation.
Endocrine and Metabolism Malignant Hyperthermia (MH) In a study of MH-susceptible pigs, cisatracurium besylate did not trigger MH. Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose have not been studied in MH-susceptible patients.
0 Page 7 of 37 triggering agents, the clinician should be prepared to recognize and treat MH in any patient undergoing general anesthesia. Hepatic/Biliary/Pancreatic Hepatic See WARNINGS AND PRECAUTIONS, Renal and Hepatic for details.
Neurologic Patients with hemiparesis or paraparesis also may demonstrate resistance to non-depolarizing neuromuscular blocking agents in affected limbs. To avoid inaccurate dosing, neuromuscular monitoring should be performed on the non-paretic limb.
In patients with neuromuscular disease such as myasthenia gravis or myasthenic (Eaton- Lambert) syndrome, small doses of non-depolarizing neuromuscular blocking agents may have profound effects. In these patients, and patients with […]