NEOSTIGMINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medical Purchasing Solutions, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of nondepolarizing 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

Product summary:

Neostigmine methylsulfate injection, USP is available in the following:  The vial stopper is not made with natural rubber latex.  Neostigmine methylsulfate injection, USP should be store at 20° to 25°C (68° to 77°F); (see USP Controlled Room Temperature). Protect from light. Store in carton until time of use.   Rx Only  Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Issued: 0318

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOSTIGMINE- NEOSTIGMINE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEOSTIGMINE
METHYLSULFATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR NEOSTIGMINE
METHYLSULFATE.
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