Country: United States
Language: English
Source: NLM (National Library of Medicine)
NEOSTIGMINE METHYLSULFATE (UNII: 98IMH7M386) (NEOSTIGMINE - UNII:3982TWQ96G)
General Injectables and Vaccines, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
Neostigmine Methylsulfate Injection, USP, is a cholinesterase inhibitor indicated for the reversal of the effects of nondepolarizing neuromuscular blocking agents after surgery. Neostigmine Methylsulfate Injection, USP, 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. 8.1. Pregnancy Risk Summary There are no adequate or well-controlled studies of Neostigmine Methylsulfate Injection, USP, in pregnant women. It is not known whether Neostigmine Methylsulfate Injection, USP, 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
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 stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Protect from light. Store in carton until time of use. Rx Only Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA 91730 USA Rev. 09/17 6996016C
Abbreviated New Drug Application
NEOSTIGMINE METHYLSULFATE- NEOSTIGMINE METHYLSULFATE INJECTION GENERAL INJECTABLES AND VACCINES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION NEOSTIGMINE METHYLSULFATE HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NEOSTIGMINE METHYLSULFATE INJECTION, USP, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEOSTIGMINE METHYLSULFATE INJECTION, USP. NEOSTIGMINE METHYLSULFATE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1939 INDICATIONS AND USAGE Neostigmine Methylsulfate Injection, USP, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery. (1) (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, USP, 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, USP (2.4) DOSAGE FORMS AND STRENGTHS Injection: 0.5 mg/mL and 1 mg/mL in 10 mL multiple-dose vials (3) (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, USP, to lessen risk of bradycardia. (5.1) Serious Reactions with Coexisting C Read the complete document