NEOSTIGMINE METHYLSULFATE injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Neostigmine Methylsulfate (UNII: 98IMH7M386) (Neostigmine - UNII:3982TWQ96G)

Tillgänglig från:

Sagent Pharmaceuticals

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Neostigmine methylsulfate injection is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). - peritonitis or mechanical obstruction of the intestinal or urinary tract. Risk Summary There are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. It is not known whether neostigmine methylsulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. The incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. All pregnancies, regardless of d

Produktsammanfattning:

Neostigmine Methylsulfate Injection, USP is clear, colorless solution, free from visible particulate matter intended for intravenous use. It is available as follows: Storage Conditions Neostigmine Methylsulfate Injection, USP should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light. Store in carton until time of use. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2021 Sagent Pharmaceuticals, Inc. October 2021 SAGENT Pharmaceuticals ®

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

NEOSTIGMINE METHYLSULFATE- NEOSTIGMINE METHYLSULFATE INJECTION,
SOLUTION
SAGENT PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEOSTIGMINE
METHYLSULFATE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
NEOSTIGMINE METHYLSULFATE INJECTION.
NEOSTIGMINE METHYLSULFATE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
Neostigmine methylsulfate injection, a cholinesterase inhibitor, is
indicated for the reversal of the effects
of non-depolarizing neuromuscular blocking agents (NMBAs) after
surgery (1).
DOSAGE AND ADMINISTRATION
Should be administered by trained healthcare providers (2.1)
Peripheral nerve stimulator and monitoring for twitch responses should
be used to determine when
neostigmine methylsulfate injection should be initiated and if
additional doses are needed (2.2)
−
−
Maximum total dosage is 0.07 mg/kg or up to a total of 5 mg (whichever
is less) (2.2)
An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate,
should be administered prior to or
concomitantly with neostigmine methylsulfate injection (2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 0.5 mg per mL and 1 mg per mL in 10 mL multiple-dose vials
(3)
CONTRAINDICATIONS
Hypersensitivity to neostigmine (4)
Peritonitis or mechanical obstruction of the intestinal or urinary
tract (4)
WARNINGS AND PRECAUTIONS
Bradycardia: Atropine or glycopyrrolate should be administered prior
to neostigmine methylsulfate
injection to lessen risk of bradycardia. (5.1)
Serious Reactions with Coexisting Conditions: Use with caution in
patients with coronary artery disease,
cardiac arrhythmias, recent acute coronary syndrome or myasthenia
gravis. (5.2)
Neuromuscular Dysfunction: Can occur if large doses of neostigmine
methylsulfate injection are
administered when neuromuscular blockade is minimal; reduce dose if
recovery from neuromuscular
blockade is nearly complete. (5.4)
ADVERSE REACTIONS
Most common adverse reactions during tr