NEOSTIGMINE METHYLSULFATE injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

NEOSTIGMINE METHYLSULFATE (UNII: 98IMH7M386) (NEOSTIGMINE - UNII:3982TWQ96G)

Tillgänglig från:

Medical Purchasing Solutions, LLC

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 in pregnant women. It is not known whether neostigmine methylsulfate 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 drug exposure, hav

Produktsammanfattning:

Neostigmine methylsulfate injection, USP is a clear, colorless liquid available in the following presentations: The vial stopper is not made with natural rubber latex. Neostigmine methylsulfate injection, USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Store in carton until time of use. Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Customer Care # 1-800-417-9175   Manufactured by: Caplin Steriles Limited, Gummidipoondi - 601 201, Made in India. Code: TN/Drugs/TN00003457 Revised: 07/2021  13160939

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

NEOSTIGMINE METHYLSULFATE- NEOSTIGMINE METHYLSULFATE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
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)
For reversal of NMBAs with shorter half-lives, when first twitch
response is substantially greater than
10% of baseline, or when a second twitch is present: 0.03 MG /KG BY
INTRAVENOUS ROUTE (2.2)
For reversal of NMBAs with longer half-lives or when first twitch
response is close to 10% of baseline:
0.07 MG /KG BY INTRAVENOUS ROUTE (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/mL and 1 mg/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 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 syndro