NEOSTIGMINE METHYLSULFATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

NEOSTIGMINE METHYLSULFATE

Composition:

NEOSTIGMINE METHYLSULFATE 0.5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery.  Neostigmine 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 urinary or intestinal tracts. 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 drug exposure, h

Product summary:

Neostigmine Methylsulfate Injection, USP is available in 10 mL multiple dose amber glass vials containing a clear, colorless solution. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and protect from light.   Store vials in tray until ready for use. This container closure is not made with natural rubber latex.

Authorization status:

New Drug Application

Summary of Product characteristics

NEOSTIGMINE METHYLSULFATE- NEOSTIGMINE METHYLSULFATE INJECTION,
SOLUTION
FRESENIUS KABI USA, 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, a cholinesterase inhibitor, is indicated
for reversal of the effects of
nondepolarizing neuromuscular blocking agents (NMBA) after surgery (
1).
DOSAGE AND ADMINISTRATION
Dosage
Should be administered by trained healthcare providers ( 2.1)
Recommend use of a peripheral nerve stimulator to determine whether
neostigmine methylsulfate
should be administered and to monitor recovery from neuromuscular
blockade ( 2.1).
Recommended dosage range is 0.03 mg/kg to 0.07mg/kg for reversing
nondepolarizing neuromuscular
block when administered with an anticholinergic agent (atropine or
glycopyrrolate) ( 2.2, 2.3, 2.4)
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 ( 2.4)
Dose of Anticholinergic Agent (atropine or glycopyrrolate)
Administer atropine sulfate (~15 mcg/kg) or glycopyrrolate (~10
mcg/kg) intravenously either several
minutes before or concomitantly with neostigmine methylsulfate (using
separate syringes) ( 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 0.5 mg/mL and 1 mg/mL solution in 10 mL multiple dose vial
in packages of 10 via