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:

Sandoz Inc

INN (International Name):

CISATRACURIUM BESYLATE

Composition:

CISATRACURIUM 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cisatracurium besylate injection is indicated: 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 have been reported [see Warnings and Precautions (5.4)] . Risk Summary There are no adequate and well-controlled studies of cisatracurium besylate in pregnant women. Animal studies conducted in rats administered cisatracurium besylate during organogenesis found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting IV bolus dose of 0.2 mg/kg. The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth

Product summary:

Cisatracurium besylate injection, 2 mg cisatracurium per mL, is supplied as under: 0781-9037-95 5 mL Single-dose vial Pack of 10's  Cisatracurium besylate injection, 10 mg cisatracurium per mL, is supplied in the following: NDC Container Size 0781-9039-95 20 mL Single-dose vial Pack of 10's Intended only for use in the ICU. Cisatracurium besylate injection should be refrigerated at 2° to 8°C (36° to 46°F) in the carton to preserve potency. Protect from light. DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium besylate injection within 21 days, even if re-refrigerated.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CISATRACURIUM BESYLATE- CISATRACURIUM BESYLATE INJECTION
SANDOZ INC
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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
RECENT MAJOR CHANGES
Dosage and Administration (2.1)
7/2018
Warnings and Precautions, Residual Paralysis (5.1)
7/2018
Warnings and Precautions, Risk of Death Due to Medication Errors (5.5)
7/2018
INDICATIONS AND USAGE
Cisatracurium besylate is a nondepolarizing neuromuscular blocker
indicated:
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Limitations of Use
Cisatracurium besylate is not recommended for rapid sequence
endotracheal intubation due to the time required for its
onset of action (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Inje ction:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 SANDOZ INC., AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
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)
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 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 overdosag