NEOSTIGMINE METHYLSULFATE injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Meitheal Pharmaceuticals Inc.

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 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, have a background

Produktsammanfattning:

Neostigmine Methylsulfate Injection, USP is supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 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. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2021 Meitheal Pharmaceuticals Inc. Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. Nanjing, China 210061 February 2021 810065-00

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

NEOSTIGMINE METHYLSULFATE- NEOSTIGMINE METHYLSULFATE INJECTION
MEITHEAL PHARMACEUTICALS INC.
----------
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 per mL and 1 mg per mL in 10 mL multi-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