CISATRACURIUM BESYLATE injection

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Sandoz Inc

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 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)] . 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

Ringkasan produk:

Cisatracurium besylate injection, 2 mg cisatracurium per mL, is supplied as under: 0781-9038-95 10 mL Multiple-dose Vial Pack of 10’s Contains 0.9% w/v benzyl alcohol [see Warnings and Precautions (5.2)] Storage 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.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

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.
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 overdosage or underdosage, assess extent of recovery from blockade,
potentially limit exposure to toxic
metabolites through dose titration,