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Bloxiverz

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Bloxiverz

Side Effects
Interactions

SIDE EFFECTS

Clinical Trials 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.

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 200 adult patients were exposed to the product. The following table lists the adverse reactions that occurred with an overall frequency of 1% or greater.

System Organ Class Adverse Reaction
Cardiovascular Disorders bradycardia, hypotension, tachycardia/heart rate increase
Gastrointestinal Disorders dry mouth, nausea, post-procedural nausea, vomiting
General Disorders and Administration Site Conditions incision site complication, pharyngolaryngeal pain, procedural complication, procedural pain
Nervous System Disorders dizziness, headache, postoperative shivering, prolonged neuromuscular blockade
Psychiatric Disorders insomnia
Respiratory, Thoracic and Mediastinal Disorders dyspnea, oxygen desaturation <90%
Skin and Subcutaneous Tissue Disorders pruritus

Post Marketing Experience

The following adverse reactions have been identified during parenteral use of neostigmine methylsulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

System Organ Class Adverse Reaction
Allergic Disorders allergic reactions, anaphylaxis
Nervous System Disorders convulsions, drowsiness, dysarthria, fasciculation, loss of consciousness, miosis, visual changes
Cardiovascular Disorders cardiac arrest, cardiac arrhythmias (A-V block, nodal rhythm), hypotension, nonspecific EKG changes, syncope
Respiratory, Thoracic and Mediastinal Disorders bronchospasm; increased oral, pharyngeal and bronchial secretions; respiratory arrest; respiratory depression
Skin and Sub-cutaneous Tissue Disorders rash, urticaria
Gastrointestinal Disorders bowel cramps, diarrhea, flatulence, increased peristalsis
Renal and Urinary Disorders urinary frequency
Musculoskeletal and Connective Tissue Disorders arthralgia, muscle cramps, spasms,weakness
Miscellaneous diaphoresis, flushing

Read the Bloxiverz (neostigmine methylsulfate injection) Side Effects Center for a complete guide to possible side effects

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. Use with caution when using BLOXIVERZ with other drugs which may alter the activity of metabolizing enzymes or transporters.

Last reviewed on RxList: 6/14/2013
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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