Mepivacaine

Evidence Level: L5 Predicted Indications: 10

Table of Contents

  1. Mepivacaine
  2. Mepivacaine: From Local Anaesthesia to Gastroduodenitis
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. Singapore Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## Pharmacist Assessment Report

Mepivacaine: From Local Anaesthesia to Gastroduodenitis

One-Sentence Summary

Mepivacaine is an amide-type local anaesthetic (a sodium channel blocker) that is marketed in Singapore as injectable products, mainly for dental use. The TxGNN model predicts it may be effective for gastroduodenitis, but this is a computational prediction only, with 0 clinical trials and 0 publications supporting it. Among the other top-ranked predictions, only gout and hypertensive disorder have any related studies, and these are indirect.


Quick Overview

Item Content
Original Indication Local anaesthesia (the licence records contain no approved indication text; this is inferred from the drug class and product names)
Predicted New Indication Gastroduodenitis
TxGNN Prediction Score 99.49%
Evidence Level L5
Singapore Market Status ✓ Marketed
Number of Registrations 4
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known information, mepivacaine is a sodium channel blocker local anaesthetic. It blocks nerve conduction to produce temporary loss of sensation.

For gastroduodenitis, the data compiled for this report do not support a mechanistic rationale. No trials or publications link mepivacaine to this condition. The high score (0.995) reflects a computational association in the knowledge graph and should not be read as evidence of efficacy. Local anaesthesia would also not address the underlying causes of gastroduodenal inflammation.

Other predictions were checked for supporting evidence:

  • Gout (rank 3, score 98.3%): Mepivacaine was used as a co-injected anaesthetic with intra-articular triamcinolone for gout flares. Pain relief is attributed mainly to the corticosteroid, so mepivacaine's own contribution is not established. This is the most clinically relevant signal among the predictions, but it is indirect.
  • Hypertensive disorder (rank 7, score 95.6%): Studies address haemodynamic effects in hypertensive patients during dental and surgical anaesthesia, and nerve blocks for tourniquet-associated hypertension. These are questions of safe use and procedural effects, not treatment of hypertensive disease. It is also unconfirmed that mepivacaine was the agent in the tourniquet trials.
  • Other predictions (peptic ulcer disease, bronchitis, rhinitis, otitis media, malignant hypertension types, pulmonary hypertension): no meaningful therapeutic support. The retrieved papers are unrelated or are case reports of adverse events.

Clinical Trial Evidence

Currently no related clinical trials are registered for gastroduodenitis.

For reference, trials were found for the lower-ranked prediction of hypertensive disorder, but they are procedural or safety-focused:

Trial Number Phase Status Enrollment Key Findings
NCT03390426 Phase 4 Completed 31 Peri-arterial femoral local anaesthetic injection to reduce tourniquet-associated ischaemic hypertension (agent not confirmed as mepivacaine)
NCT04454203 Phase 4 Recruiting 40 Peri-arterial catheter local anaesthetic for tourniquet hypertension (same limitation)
NCT06927726 N/A Enrolling by invitation 60 4% articaine with epinephrine vs 3% mepivacaine: anaesthetic efficacy and haemodynamic stability in hypertensive patients undergoing maxillary extraction

Literature Evidence

Currently no related literature is available for gastroduodenitis.

Selected publications for the other predictions:

PMID Year Type Journal Key Findings
33431616 2021 RCT Reg Anesth Pain Med Femoral artery block reduced thigh tourniquet-induced hypertension (procedural effect, not treatment of hypertension)
35153037 2022 Clinical study Reumatol Clin Small-dose intra-articular triamcinolone plus mepivacaine gave rapid, sustained relief of gout flares (combination; study design not confirmed)
32593659 2020 Clinical study Reumatol Clin Same gout study as above, earlier record
20835569 2010 Comparative study J Appl Oral Sci Haemodynamic effects of lidocaine, prilocaine and mepivacaine without vasoconstrictor in hypertensive patients
27302432 2016 Comparative study Glob J Health Sci Blood pressure effects of lidocaine, prilocaine and mepivacaine in controlled hypertension
24558534 2012 Review J Clin Exp Dent Use of dental anaesthetics with vasoconstrictors in patients with heart disease
2655365 1989 Randomised trial Acta Anaesthesiol Scand Mepivacaine with epinephrine infiltration prevented hypertension after Mayfield skull-pin application
18661082 2008 Clinical study Shanghai Kou Qiang Yi Xue Efficacy and safety of 3% mepivacaine for oral local anaesthesia

Singapore Market Information

Authorization Number Product Name Dosage Form Approved Indication
SIN06179P Mepivastesin Injection 30 mg/ml (3M Deutschland GmbH) Injection Not stated in the licence record
SIN07075P Scandonest Injection 3% (without vasoconstrictor) (Septodont) Injection Not stated in the licence record
SIN14649P Isocaine (Mepivacaine HCl) Injection 3% (Novocol Pharmaceutical of Canada) Injection Not stated in the licence record
SIN07074P Scandonest 2% Special Injection (Septodont) Injection Not stated in the licence record

Safety Considerations

  • Contraindications suggested by the knowledge graph (these come from model-derived drug-disease links, not from label text): kidney disease, liver disease, gallbladder disease, myasthenia gravis and other neuromuscular junction disease, butyrylcholinesterase deficiency, cardiovascular and heart disease, and pyoureter.
  • Drug interactions: 11 interactions were found, one at Minor and the rest at Moderate level.
    • Moderate: liposomal morphine, and other local anaesthetics or topical/ophthalmic anaesthetics (lidocaine topical and ophthalmic, benzocaine, cocaine topical and nasal, tetracaine topical and ophthalmic, oxybuprocaine, cinchocaine).
    • Minor: hyaluronidase.
  • Safety signals in the literature: neonatal mepivacaine intoxication after paracervical and pudendal blocks, methaemoglobinaemia in an infant after local anaesthesia, hypoxia after interscalene block, a toxic reaction with hypertension and atrial fibrillation after axillary block with mepivacaine and adrenaline, and preclinical mepivacaine-associated myocardial injury.

Please also refer to the package insert for full warnings and contraindications.


Conclusion and Next Steps

Decision: Hold

Rationale: The prediction for gastroduodenitis rests on a model score alone, with no clinical trials, no literature and no plausible mechanistic link. Even the more developed signals (gout, hypertensive disorder) are indirect: mepivacaine acts as a co-administered anaesthetic or the studies concern safe use, not treatment.

To proceed, the following is needed:

  • Package insert warnings and contraindications from the HSA, which are currently missing and block safety screening
  • Mechanism of action data for mepivacaine
  • Approved indication text for the Singapore licences
  • Clarification of whether the gout combination studies isolate any contribution from mepivacaine, and confirmation of the study design
  • Confirmation of which anaesthetic agent was used in the tourniquet-hypertension trials
  • Route compatibility and similarity-to-original-indication assessments, which have not yet been done

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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