Neostigmine Methylsulfate .5 mg/mL
Neostigmine Methylsulfate · INJECTION · Hikma Pharmaceuticals USA Inc.
Neostigmine Methylsulfate is a injection containing neostigmine methylsulfate at .5 mg/mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Neostigmine Methylsulfate
- Generic Name
- Neostigmine Methylsulfate
- NDC Code (Product)
0641-6264- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- .5 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA207042
- Marketing Start
- 12/28/2015
Recall History
US Compounding Inc
Labelling: Missing label.
KRS Global Biotechnology, Inc
Lack of Assurance of Sterility
Premier Pharmacy Labs Inc
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
KRS Global Biotechnology, Inc
Lack of Assurance of Sterility
Cantrell Drug Company
Lack of Sterility Assurance.
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Premier Pharmacy Labs Inc
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Nephron Sterile Compounding Center LLC
CGMP Deviations: Potential for cross contamination due to product carry over.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery. Neostigmine Methylsulfate, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery ( 1 ).
Dosage & Administration
2 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) intraveno…
Contraindications
4 CONTRAINDICATIONS 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. Hypersensitivity to neostigmine ( 4 ) Peritonitis or mechanical obstruction of urinary or intestinal tracts ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The pharmacokinetic interaction between neostigmine methylsulfate and other drugs has not been studied. Neostigmine methylsulfate is metabolized by microsomal enzymes in the liver. Closely monitor patients for a longer period of time when using Neostigmine Methylsulfate Injection with other drugs which may alter the activity of metabolizing enzymes or transporters. 7.1 Depolarizing Muscle relaxants Use of neostigmine to reverse the effects of depolarizing muscle relaxants such as succinylcholine is not recommended, because it may prolong the phase-1 block. 7.2 Antibiotics Certain antibiotics, particularly neomycin, streptomycin and kanamycin have nondepolarizing neuromuscular blocking action, and therefore, neostigmine dose adjustments may be required to reverse neuromuscular block in patients who have been taking these drugs. There was no effect on neostigmine action on rocuronium reversal by cefuroxime, metronidazole, cefuroxime or metronidazole.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions include bradycardia and nausea and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions are described below and elsewhere in the labeling: Bradycardia [ see Warnings and Precautions ( 5.1 ) ] Cardiovascular Complications [ see Warnings and Precautions ( 5.2 ) ] Hypersensitivity (Anaphylaxis) [ see Warnings and Precautions ( 5.3 ) ] Adverse reactions to neostigmine methylsulfate are most often attributable to exaggerated pharmacological effects, in particular, at muscarinic receptor sites. The use of an anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, may prevent or mitigate these reactions. Quantitative adverse event data are available from trials of neostigmine methylsulfate in which…
Frequently Asked Questions
What is Neostigmine Methylsulfate used for?
Neostigmine Methylsulfate contains Neostigmine Methylsulfate. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Neostigmine Methylsulfate a controlled substance?
Neostigmine Methylsulfate is not classified as a controlled substance by the DEA.
What is the generic name for Neostigmine Methylsulfate?
The generic name for Neostigmine Methylsulfate is Neostigmine Methylsulfate. There are 6 other brand versions of Neostigmine Methylsulfate.
What is the NDC code for Neostigmine Methylsulfate .5 mg/mL?
The NDC (National Drug Code) for Neostigmine Methylsulfate .5 mg/mL is 0641-6264, listed by Hikma Pharmaceuticals USA Inc..