Neostigmine methylsulfate

Neostigmine methylsulfate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Overview

Neostigmine methylsulfate is a cholinesterase Inhibitor that is FDA approved for the treatment of reversal effects of non-depolarizing neuromuscular blocking agents after surgery and yasthenia gravis when oral therapy is impractical. Common adverse reactions include hypotension, nausea and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Symptomatic control of myasthenia gravis

• Dosage: 1 mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly.
• Subsequent doses should be based on the individual patient's response.
• In most patients, however, oral treatment with Neostigmine Bromide tablets, 15 mg each, is adequate for control of symptoms.

Prevention of postoperative distention and urinary retention

• Dosage: 0.25 mg subcutaneously or intramuscularly as soon as possible after operation
• Repeat every 4 to 6 hours for two or three days.

Treatment of postoperative distention

• Dosage: 1 mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly, as required.

Treatment of urinary retention

• Dosage: 1 mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly.
• If urination does not occur within an hour, the patient should be catheterized.
• After the patient has voided, or the bladder has been emptied, continue the 0.5 mg injections every three hours for at least 5 injections.

Reversal Effects of Non-depolarizing Blocking Agents

• When Neostigmine Methylsulfate Injection is administered, it is recommended that Atropine Sulfate (0.6 to 1.2 mg) also be given intravenously using separate syringes.
• Dosage: 0.5 to 2 mg Neostigmine Methylsulfate Injection given by slow intravenous injection, repeated as required.

Only in exceptional cases should the total dose of Neostigmine Methylsulfate exceed 5 mg.

• It is recommended that the patient be well ventilated and a patent airway maintained until complete recovery of normal respiration is assured.
• The optimum time for administration of the drug is during hyperventilation when the carbon dioxide level of the blood is low.
• It should never be administered in the presence of high concentrations of halothane or cyclopropane.
• In cardiac cases and severely ill patients, it is advisable to titrate the exact dose of Neostigmine Methylsulfate required, using a peripheral nerve stimulator device.
• In the presence of bradycardia, the pulse rate should be increased to about 80/minute with Atropine before administering Neostigmine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Neostigmine methylsulfate in adult patients.

Non–Guideline-Supported Use

• Paralytic ileus
• To prolong postoperative peripheral block anesthesia
• Postoperative peripherally administration for analgesia
• Pseudo-obstruction of intestine

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Neostigmine methylsulfate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Neostigmine methylsulfate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Neostigmine methylsulfate in pediatric patients.

Contraindications

There is limited information regarding Neostigmine methylsulfate Contraindications in the drug label.

Warnings

There is limited information regarding Neostigmine methylsulfate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Neostigmine methylsulfate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Neostigmine methylsulfate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Neostigmine methylsulfate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Neostigmine methylsulfate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Neostigmine methylsulfate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Neostigmine methylsulfate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Neostigmine methylsulfate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Neostigmine methylsulfate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Neostigmine methylsulfate in geriatric settings.

Gender

There is no FDA guidance on the use of Neostigmine methylsulfate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Neostigmine methylsulfate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Neostigmine methylsulfate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Neostigmine methylsulfate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Neostigmine methylsulfate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Neostigmine methylsulfate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Neostigmine methylsulfate Administration in the drug label.

Monitoring

There is limited information regarding Neostigmine methylsulfate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Neostigmine methylsulfate and IV administrations.

Overdosage

There is limited information regarding Neostigmine methylsulfate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Neostigmine methylsulfate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Neostigmine methylsulfate Mechanism of Action in the drug label.

Structure

There is limited information regarding Neostigmine methylsulfate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Neostigmine methylsulfate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Neostigmine methylsulfate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Neostigmine methylsulfate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Neostigmine methylsulfate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Neostigmine methylsulfate How Supplied in the drug label.

Storage

There is limited information regarding Neostigmine methylsulfate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Neostigmine methylsulfate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Neostigmine methylsulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Neostigmine methylsulfate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Neostigmine methylsulfate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.