CISATRACURIUM BESYLATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N)

Available from:

PIRAMAL CRITICAL CARE INC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to cisatracurium besylate injection have been reported [see Warnings and Precautions ( 5.4)] . Risk Summary There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal

Product summary:

Cisatracurium besylate injection USP is a clear solution supplied as follows: Strength (mg of cisatracurium) Containers/Package sizes NDC# Preservative 10 mg/5 mL (2 mg/mL) 10 inner cartons. each with one single-dose vial (NDC 66794-245-02), packaged in an outer carton 66794-245-41 Does not contain benzyl alcohol 200 mg/20 mL (10 mg/mL) 10 inner cartons. each with one single-dose vial (NDC 66794-246-02), packaged in an outer carton 66794-246-41 Does not contain benzyl alcohol Discard unused portion of the 5 mL and 20 mL single-dose vials. Refrigerate cisatracurium besylate, USP injection at 2° to 8°C (36° to 46°F) in the carton to preserve potency. Protect from light. DO NOT FREEZE. Upon removal of the unused vial from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium besylate injection, USP within 21 days, even if re-refrigerated.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CISATRACURIUM BESYLATE- CISATRACURIUM BESYLATE INJECTION
PIRAMAL CRITICAL CARE INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CISATRACURIUM
BESYLATE INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CISATRACURIUM
BESYLATE INJECTION.
CISATRACURIUM BESYLATE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
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 ( 1)
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 fromblockade,
potentially limit exposure to toxic
metabolites through dose titration, and facilitate more rapid reversal
of cisatracuriumbesylate injection-
induced paralysis ( 2.1)
• See Full Prescribing information for:
○ Dosage and administration instructions in adults,
pediatricpatients, ge