NEOSTIGMINE METHYLSULFATE

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Overview

What is NEOSTIGMINE METHYLSULFATE?

Neostigmine methylsulfate, a cholinesterase inhibitor, is (m-hydroxyphenyl) trimethylammonium methylsulfate dimethylcarbamate. The structural formula is:

Neostigmine methylsulfate is a white crystalline powder and is very soluble in water and soluble in alcohol. Neostigmine Methylsulfate Injection, USP, is a sterile, nonpyrogenic solution intended for intravenous use.

Each mL of the 0.5 mg/mL strength contains neostigmine methylsulfate 0.5 mg, phenol 4.5 mg (used as preservative) and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to a value of 5.5.

Each mL of the 1 mg/mL strength contains neostigmine methylsulfate 1 mg, phenol 4.5 mg (used as preservative), and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to achieve a value of 5.5.

What does NEOSTIGMINE METHYLSULFATE look like?

What are the available doses of NEOSTIGMINE METHYLSULFATE?

Injection: 0.5 mg/mL and 1 mg/mL in 10 mL multiple-dose vials

What should I talk to my health care provider before I take NEOSTIGMINE METHYLSULFATE?

How should I use NEOSTIGMINE METHYLSULFATE?

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, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. Doses of Neostigmine Methylsulfate Injection, USP, should be individualized, and a peripheral nerve stimulator should be used to determine the time of initiation of Neostigmine Methylsulfate Injection, USP, and should be used to determine the need for additional doses.

Neostigmine Methylsulfate Injection, USP, is for intravenous use only and should be injected slowly over a period of at least 1 minute. The Neostigmine Methylsulfate Injection, USP, dosage is weight-based

Prior to Neostigmine Methylsulfate Injection, USP, administration and until complete recovery of normal ventilation, the patient should be well ventilated and a patent airway maintained. Satisfactory recovery should be judged by adequacy of skeletal muscle tone and respiratory measurements in addition to the response to peripheral nerve stimulation.

An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, should be administered prior to or concomitantly with Neostigmine Methylsulfate Injection, USP

What interacts with NEOSTIGMINE METHYLSULFATE?

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What are the warnings of NEOSTIGMINE METHYLSULFATE?

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What are the precautions of NEOSTIGMINE METHYLSULFATE?

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What are the side effects of NEOSTIGMINE METHYLSULFATE?

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What should I look out for while using NEOSTIGMINE METHYLSULFATE?

Neostigmine Methylsulfate Injection, USP, is contraindicated in patients with:

What might happen if I take too much NEOSTIGMINE METHYLSULFATE?

Muscarinic symptoms (nausea, vomiting, diarrhea, sweating, increased bronchial and salivary secretions, and bradycardia) may appear with overdosage of Neostigmine Methylsulfate Injection, USP (cholinergic crisis), but may be managed by the use of additional atropine or glycopyrrolate. The possibility of iatrogenic overdose can be lessened by carefully monitoring the muscle twitch response to peripheral nerve stimulation. Should overdosage occur, ventilation should be supported by artificial means until the adequacy of spontaneous respiration is assured, and cardiac function should be monitored.

Overdosage of Neostigmine Methylsulfate Injection, USP, can cause cholinergic crisis, which is characterized by increasing muscle weakness, and through involvement of the muscles of respiration, may result in death. Myasthenic crisis, due to an increase in the severity of the disease, is also accompanied by extreme muscle weakness and may be difficult to distinguish from cholinergic crisis on a symptomatic basis. However, such differentiation is extremely important because increases in the dose of Neostigmine Methylsulfate Injection, USP, or other drugs in this class, in the presence of cholinergic crisis or of a refractory or “insensitive” state, could have grave consequences. The two types of crises may be differentiated by the use of edrophonium chloride as well as by clinical judgment.

Treatment of the two conditions differs radically. Whereas the presence of myasthenic crisis requires more intensive anticholinesterase therapy, cholinergic crisis calls for the prompt withdrawal of all drugs of this type. The immediate use of atropine in cholinergic crisis is also recommended. Atropine may also be used to lessen gastrointestinal side effects or other muscarinic reactions; but such use, by masking signs of overdosage, can lead to inadvertent induction of cholinergic crisis.

How should I store and handle NEOSTIGMINE METHYLSULFATE?

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Protect from light and moisture.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 OnlyAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, CA 91730 USARev. 09/176996016CNeostigmine 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 OnlyAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, CA 91730 USARev. 09/176996016CNeostigmine 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 OnlyAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, CA 91730 USARev. 09/176996016CNeostigmine 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 OnlyAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, CA 91730 USARev. 09/176996016CNeostigmine 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 OnlyAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, CA 91730 USARev. 09/176996016CNeostigmine 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 OnlyAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, CA 91730 USARev. 09/176996016CNeostigmine 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 OnlyAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, CA 91730 USARev. 09/176996016CNeostigmine 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 OnlyAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, CA 91730 USARev. 09/176996016C

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Neostigmine methylsulfate is a competitive cholinesterase inhibitor. By reducing the breakdown of acetylcholine, neostigmine methylsulfate induces an increase in acetylcholine in the synaptic cleft which competes for the same binding site as nondepolarizing neuromuscular blocking agents, and reverses the neuromuscular blockade.

Non-Clinical Toxicology

Neostigmine Methylsulfate Injection, USP, is contraindicated in patients with:

Temporary resistance to prothrombin-depressing anticoagulants may result, especially when larger doses of phytonadione are used. If relatively large doses have been employed, it may be necessary when reinstituting anticoagulant therapy to use somewhat larger doses of the prothrombin-depressing anticoagulant, or to use one which acts on a different principle, such as heparin sodium.

Neostigmine has been associated with bradycardia. Atropine sulfate or glycopyrrolate should be administered prior to Neostigmine Methylsulfate Injection, USP, to lessen the risk of bradycardia

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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