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METHYLPREDNISOLONE
METHYLPREDNISOLONE is a drug. It is currently FDA-approved (first approved 1957) for Local or Regional Anesthesia for Surgery, Dental and Oral Surgery Procedures, Diagnostic and Therapeutic Procedures.
Bupivacaine blocks nerve impulses by increasing the threshold for electrical excitation, slowing propagation, and reducing the rate of rise of the action potential.
At a glance
| Generic name | METHYLPREDNISOLONE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1957 |
Mechanism of action
Bupivacaine works by interfering with the normal functioning of nerves. It increases the threshold needed for a nerve to fire, slows down the speed at which the nerve signal travels, and reduces the speed at which the nerve signal starts. This leads to a progressive loss of sensation, starting with pain and ending with muscle tone.
Approved indications
- Local or Regional Anesthesia for Surgery
- Dental and Oral Surgery Procedures
- Diagnostic and Therapeutic Procedures
- Obstetrical Procedures
Boxed warnings
- WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of Bupivacaine Hydrochloride Injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary [see Warnings and Precautions (5.1) ]. WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of Bupivacaine Hydrochloride Injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary ( 5.1 ).
Common side effects
- Fluid retention
- Increased appetite
- Nausea
- Headache
- Insomnia
- Mood swings
- Weight gain
- Moon face
- Acne
- Increased sweating
- Rash
- Hypertension
Serious adverse events
- Anaphylaxis
- Cardiac arrest
- Circulatory collapse
- Myocardial rupture
- Peptic ulcer with perforation and hemorrhage
- Hepatitis
- Aseptic necrosis of femoral and humeral heads
- Pathologic fracture of long bones
- Convulsions
- Posterior subcapsular cataracts
Drug interactions
- Local Anesthetics
- Monoamine Oxidase Inhibitors and Tricyclic Antidepressants
- Ergot-Type Oxytocic Drugs
- Nonselective Beta-Adrenergic Antagonists
- Drugs Associated with Methemoglobinemia (e.g., nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants)
- Potent Inhalation Anesthetics
Key clinical trials
- Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS (NA)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) (PHASE3)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas (PHASE4)
- Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction (PHASE2)
- Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- METHYLPREDNISOLONE CI brief — competitive landscape report
- METHYLPREDNISOLONE updates RSS · CI watch RSS
Frequently asked questions about METHYLPREDNISOLONE
What is METHYLPREDNISOLONE?
How does METHYLPREDNISOLONE work?
What is METHYLPREDNISOLONE used for?
When was METHYLPREDNISOLONE approved?
What development phase is METHYLPREDNISOLONE in?
What are the side effects of METHYLPREDNISOLONE?
Related
- Indication: Drugs for Local or Regional Anesthesia for Surgery
- Indication: Drugs for Dental and Oral Surgery Procedures
- Indication: Drugs for Diagnostic and Therapeutic Procedures
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing