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:

REMEDYREPACK INC.

INN (International Name):

NEOSTIGMINE METHYLSULFATE

Composition:

NEOSTIGMINE METHYLSULFATE 1 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

NEOSTIGMINE METHYLSULFATE- NEOSTIGMINE METHYLSULFATE INJECTION,
SOLUTION
REMEDYREPACK INC.
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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 vials ( 3