"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
- Clinician Information:
Bloxiverz Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Bloxiverz (neostigmine methylsulfate) injection is a cholinesterase inhibitor used after surgery to reverse the effects of non-depolarizing neuromuscular blocking agents. Common side effects include slow heartbeat, nausea and vomiting, gas, frequent urination, dry mouth, dizziness, headache, insomnia, rash, or itching.
Dosage of Bloxiverz is based on the patient's weight. The drug is administered intravenously and is injected slowly over a period of at least 1 minute. Bloxiverz may interact with other drugs that may alter the activity of metabolizing enzymes or transporters. Tell your doctor all medications and supplements you use. During pregnancy, Bloxiverz should be used only if needed. It is unknown if this drug passes in breast milk. Consult your doctor before breastfeeding.
Our Bloxiverz (neostigmine methylsulfate) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Bloxiverz FDA Prescribing Information: 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|
|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|
Read the entire FDA prescribing information for Bloxiverz (Neostigmine Methylsulfate Injection) »
Additional Bloxiverz Information
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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