CISATRACURIUM BESYLATE injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Civica, Inc.

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. Risk Summary The 10 mL cisatracurium besylate multiple-dose vials contain the preservative benzyl alcohol. Therefore, if cisatracurium besylate is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL cisatracurium besylate single-dose vials). Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.4)] . There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug associated risk of major birth defects, miscarria

Ürün özeti:

Cisatracurium besylate injection, USP 2 mg cisatracurium per mL, is supplied as under: 72572-066-10 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, USP 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 of the unused vial from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium besylate injection within 21 days, even if re-refrigerated.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

CISATRACURIUM BESYLATE- CISATRACURIUM BESYLATE INJECTION
CIVICA, 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
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
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)
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DOSAGE FORMS AND STRENGTHS
Injection:
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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.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
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.