NEOSTIGMINE METHYLSULFATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). - with peritonitis or mechanical obstruction of the intestinal or urinary tract. 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

Product summary:

Neostigmine Methylsulfate Injection, USP is available in the following: NDC 42023-188-10: 0.5 mg/mL, 10 mL multiple-dose vials supplied in packages of 10 NDC 42023-189-10: 1 mg/mL, 10 mL multiple-dose vials supplied in packages of 10 The vial stopper is not made with natural rubber latex. Neostigmine methylsulfate injection 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. Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 R 10/18 OS188J-01-90-02 3003570A

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOSTIGMINE METHYLSULFATE- NEOSTIGMINE METHYLSULFATE INJECTION
PAR PHARMACEUTICAL, 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 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 injection 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 coronar