NEOSTIGMINE METHYLSULFATE- 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:

General Injectables and Vaccines, Inc

INN (International Name):

NEOSTIGMINE METHYLSULFATE

Composition:

NEOSTIGMINE METHYLSULFATE 1 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. Pregnancy 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 e

Product summary:

Neostigmine Methylsulfate Injection is available in 10 mL multiple dose amber glass vials containing a clear, colorless solution of 0.5 mg/mL (NDC 63323-413-10) or 1 mg/mL (NDC 63323-415-10) of neostigmine methylsulfate injection supplied in packages of 10 vials. 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. Fresenius Kabi USA, LLC Lake Zurich, IL 60047 451438 Issued: January 2015

Authorization status:

New Drug Application

Summary of Product characteristics

NEOSTIGMINE METHYLSULFATE- NEOSTIGMINE METHYLSULFATE INJECTION,
SOLUTION
GENERAL INJECTABLES AND VACCINES, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
NEOSTIGMINE METHYLSULFATE
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.
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). (1)
DOSAGE AND ADMINISTRATION
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