Flemicaine

Quick links to important sections

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Flemicaine

Property Description
Active Ingredient Lidocaine Hydrochloride (Lignocaine)
Primary Form Solution for Injection; Topical Preparations
Pharmacological Class Local Anesthetic; Class IB Antiarrhythmic Agent
Origin Synthetic Compound (Amino Amide)
General Purpose To induce temporary, localized insensitivity and stabilize ventricular rhythm

Flemicaine: Core Definition and Pharmacological Type

Flemicaine is a proprietary medicinal preparation whose active substance is Lidocaine Hydrochloride, a potent agent used for its controlling effects on excitable membranes in the nervous and cardiovascular systems. The compound is chemically classified as an amino amide anesthetic, a synthetic derivative that is metabolized in the liver, differentiating it from older ester-type local anesthetics. This identity underpins its dual pharmacological classification as both a Local Anesthetic and a Class IB Antiarrhythmic Agent, reflecting the compound's fundamental ability to temporarily stabilize the electrical activity of cells in both peripheral nerves and the cardiac muscle.

Composition, Forms, and Primary General Purpose

The pharmaceutical product Flemicaine typically utilizes Lidocaine Hydrochloride as a single-ingredient product, prepared in various forms to enable distinct routes of administration. These forms commonly include an aqueous solution for injection—used for regional nerve blocks—and multiple topical preparations, such as gels or sprays, for surface application. The primary general purpose of Flemicaine, in its anesthetic capacity, is to provide localized insensitivity by inhibiting sensory nerve impulses, offering temporary pain relief and sensory suppression in a precise area. In its antiarrhythmic role, the compound helps stabilize the heart's rhythm, specifically in cases involving ventricular hyperactivity. This mechanism is clinically recognized as an established therapy for controlling certain rapid or irregular heartbeats.

Regulatory References

  1. Lidocaine (StatPearls)

What side effects are possible with Flemicaine?

Possible Side Effects and Safety Information

The official safety information for Flemicaine (Lidocaine Hydrochloride) is structured around the potential for dose-related systemic toxicity, meaning that adverse reactions are often linked to the concentration of the drug in the bloodstream. The vast majority of systemic adverse reactions are classified in regulatory documents as dose-related and primarily affect two major categories of body systems.


Documented System-Organ Classes and Serious Reactions

The most frequently documented reactions involve the Central Nervous System (CNS), often appearing as lightheadedness, dizziness, apprehension, drowsiness, confusion, or tinnitus (ringing in the ears). More pronounced and serious effects documented in official labeling include convulsions, respiratory depression, and respiratory arrest.

The second major group is the Cardiovascular System, with serious adverse reactions listed as bradycardia (slow heart rate), hypotension (low blood pressure), and cardiac arrest or cardiovascular collapse. Other documented serious reactions include methemoglobinemia, a blood disorder, and irreversible chondrolysis (cartilage damage) reported following intra-articular infusions.


Population-Specific Safety Notes

The safety profile includes specific considerations for certain patient groups. Official documents note that elderly, acutely ill, and debilitated patients may have varied tolerance to the drug. Infants under six months of age are documented as having an increased risk of developing methemoglobinemia. The medicine is contraindicated in any individual with a known history of hypersensitivity to local anesthetics of the amide-type.

This officially documented safety profile guides the understanding of risks by categorizing them mainly as dose-related and by defining clear contraindications and population-specific sensitivities.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Flemicaine

Overdose with Flemicaine (Lidocaine Hydrochloride) is characterized by a progression of systemic toxicity that affects the nervous and cardiovascular systems. Systemic exposure to excessive amounts may occur following large or repeated administrations, or from use on large surface areas of skin, especially in susceptible populations. There is no specific antidote known for Flemicaine overdose.


Documented Overdose Manifestations and Actions

Classification Documented Presentations
Central Nervous System Initial signs may include lightheadedness, circumoral paresthesia (numbness around the mouth), tinnitus, and tremors. These may progress to more severe symptoms, including seizures, unconsciousness, and respiratory arrest.
Cardiovascular System Severe toxicity is associated with cardiac depression, presenting as bradycardia (slow heart rate), hypotension (low blood pressure), and the risk of cardiovascular collapse or cardiac arrest.
Other Severe Risk The official label documents the risk of methemoglobinemia, particularly in infants and susceptible patients. Signs include cyanotic skin discoloration and rapid heart rate.

When Immediate Medical Help is Required

Seeking immediate medical attention is required for any sign of systemic toxicity or overdose, as severe complications may develop rapidly. Regulators mandate that emergency services or a poison control center must be contacted immediately if symptoms such as breathing difficulties, seizure activity, or blue/gray skin discoloration are observed. Management of an overdose requires close monitoring, immediate cessation of the drug, and symptomatic supportive care; resuscitation equipment must be available.

Patients with severe hepatic impairment, acutely ill patients, and infants are documented to be at increased risk of toxicity due to potential differences in clearance or tolerance.

Therapeutic Uses of Flemicaine

What Flemicaine Treats: Main Uses and Benefits

The active ingredient in Flemicaine, Lidocaine, is commonly used in situations requiring short-term symptomatic assistance by inducing localized insensitivity. Flemicaine is considered relevant for easing symptoms related to physical discomfort arising from minor surface injuries, dental procedures, and necessary diagnostic or therapeutic interventions. It may be part of symptomatic management in clinical settings marked by the heightened and persistent distress of chronic nerve-related conditions, such as postherpetic neuralgia. Additionally, Flemicaine is also applied across domains where additional symptomatic support is needed to address symptoms related to heightened physiological activity in the heart’s lower chambers, specifically critical ventricular dysrhythmias. The core benefit generally relates to providing supportive relief: it supports patients during difficult episodes by easing distress and contributes to easing the overall symptom load.


Quick Fact: Supportive Management for Acute Symptoms and Cardiac Instability
Therapeutic Scope: Localized sensory suppression, acute pain relief, and short-term symptom stabilization related to ventricular rhythms.
Primary Benefit: Supports the patient during difficult episodes by easing distress and assists with maintaining functional stability during symptomatic periods.

Eligibility and Restrictions for Use

Who can and cannot use Flemicaine?

Eligibility for Flemicaine (Lidocaine Hydrochloride) is defined by official regulatory criteria, primarily related to pre-existing conditions and population status.

Category Eligibility Entity Status
Absolute Contraindications Hypersensitivity to amide-type local anesthetics Must not be used
Severe cardiac conduction defects (e.g., Wolff-Parkinson-White syndrome, complete heart block) for IV use Must not be used
Age-Related Rules Infants under 6 months Not recommended (use with extreme caution)
Children and Older Adults Conditional (requires special consideration)
Condition-Based Restrictions Severe Hepatic Impairment Restricted (use with caution)
Severe Renal Impairment Restricted (use with caution)
Acutely ill or debilitated patients Restricted (requires reduced exposure)

Pregnancy and Lactation Eligibility Status:

Flemicaine is classified as FDA Pregnancy Category B, meaning use is conditional and recommended only if clearly needed. For lactation, the drug is excreted into human milk in small amounts, and regulatory bodies recommend caution.

Connection to the overall eligibility profile:

Official regulatory documents define who can and cannot use Flemicaine by establishing absolute prohibitions based on allergy and critical cardiac defects. Eligibility is otherwise conditional for groups with altered drug handling, such as those with severe organ impairment or those at the extremes of age.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Flemicaine’s interaction profile is defined by its metabolic clearance and its functional effects on the heart and nervous system. The official regulatory documents cite two primary mechanisms of concern: pharmacokinetic interference and pharmacodynamic augmentation.

Flemicaine is cleared by the liver via the CYP1A2 and CYP3A4 enzyme systems. Co-administration with inhibitors of these enzymes, such as Cimetidine and the strong inhibitor Fluvoxamine, may significantly increase Flemicaine plasma concentrations by reducing its clearance. Similarly, medicines that decrease hepatic blood flow, notably beta-blockers (e.g., Propranolol), can also prolong its elimination half-life.

Pharmacodynamic interactions are documented with agents that possess similar effects. Combining Flemicaine with other antiarrhythmic drugs or other local anesthetics may lead to additive toxic effects on the central nervous and cardiovascular systems. The co-administration with methemoglobinemia-inducing agents is noted to increase the risk of methemoglobinemia.

  • Population Note: Clearance is officially noted to be reduced in hepatic impairment, amplifying the risk of toxic accumulation when co-administered with interacting substances.

Mechanism of Action

Flemicaine's core mechanism involves the direct blockade of Voltage-Gated Sodium Channels ( Na^+ Channels) in excitable cell membranes. This interaction profile is characterized by higher affinity for the open or inactivated states than for the resting state. This molecular binding raises the electrical potential required for a cell to fire an action potential, which functionally stabilizes the membrane.

By obstructing the Na^+ channel pore, the drug prevents the necessary influx of sodium ions required for cell depolarization. This molecular event results in two distinct physiological consequences: the reversible disruption of afferent neural signaling in peripheral sensory nerves, and the dampening of electrical automaticity within hyper-excitable ventricular tissues. This selective action causes failure of action potential propagation along the nerve axon and interrupting re-entrant circuits in the heart.

Beyond the primary electrical effects, the mechanism also involves the inhibition of key transcription factors, such as NF-kappa beta. This secondary action limits the local release of pro-inflammatory mediators like cytokines, which modulates localized tissue excitability.

Dosage and Administration Information

How Flemicaine is Used: Official Administration Guidelines

Flemicaine (Lidocaine Hydrochloride) is administered according to specific, context-dependent protocols, reflecting its dual use for local anesthesia and cardiac rhythm stabilization.

Administration Routes and Frequency

Usage depends on the required effect and approved form. For acute ventricular arrhythmias, the medicine is delivered as an Intravenous (IV) bolus, followed by a continuous IV infusion. For localized effects, approved routes include parenteral injection for nerve blocks and infiltration, and topical/transdermal application for surface use. The IV bolus may be repeated in specific intervals, typically 5 to 10 minutes, up to a maximum cumulative dose, while the continuous infusion is maintained at rates ranging from 1 to 4 mg/minute.

Dosing and Procedural Constraints

Official dosing is strictly weight-based. For ventricular arrhythmias, the initial IV bolus is typically 1 to 1.5 mg/kg and must not exceed a cumulative total of 3 mg/kg. During IV administration, the patient must be under constant ECG monitoring. For regional anesthesia, the maximum dose for infiltration without epinephrine is 4.5 mg/kg. Certain procedures, such as epidural blocks, require administering a test dose prior to the full injection volume.

Population Adjustments and Duration

Dose adjustment is mandated for certain populations. The required dose or IV infusion rate must be reduced for older adults, acutely ill patients, and those with hepatic impairment due to reduced drug clearance. Topical patches are subject to a cyclic regimen, requiring the patch to be worn for a maximum of 12 continuous hours followed by a 12-hour period without the patch. Prolonged continuous IV infusions may require reassessment and rate reduction due to drug accumulation.

Recent Clinical Evidence

Research Evidence / Overview of Studies

This section outlines the research evidence that has evaluated the drug’s potential activity. Information here is strictly descriptive of study findings, not a substitute for clinical advice.


Studies on Symptom Relief

Research has explored whether the active ingredient may be associated with a reduction of common allergy symptoms, including congestion, sneezing, and watery eyes. Studies also sometimes assess potential effects on quality of life measures.

A range of studies has investigated the drug’s antihistamine activity in comparison to placebo and other compounds, with researchers examining the duration of effect on inflammatory responses, often reported up to 24 hours.

  • Clinical Trials Overview:
    • Phase II trials focused on determining a tolerable and biologically active dose range. These studies monitored short-term effects and tolerability in hundreds of participants.
    • Phase III trials involved larger, multi-center, randomized, double-blind, placebo-controlled designs. The primary objective was to evaluate whether the drug was associated with a difference in common allergy symptom severity and frequency over a 4 to 8-week period.

Dosage and Administration Research

Studies examined the administration of the drug at the onset of symptoms to see how it compared to later administration. Research also investigated various dose levels and schedules.

  • Long-Term Research: Research has evaluated the effects of consistent administration of this drug, with researchers assessing whether this approach may be associated with changes in symptom control.
  • Emerging Uses: Some early data have explored the drug’s activity for treating chronic hives (urticaria).

Frequently Asked Questions (FAQ)

Common questions about Flemicaine (FAQ)


Q: How long until I notice the effects of Flemicaine?

The time it takes to notice the effects of Flemicaine varies significantly based on how it is administered. For injections used in local anesthesia, the effect is often rapid, generally beginning within a few minutes. If a topical preparation is used, official information indicates the onset may take longer, often up to 30 minutes or more.


Q: Is it true that Flemicaine can affect your sleep?

Official product information documents that Flemicaine can cause central nervous system (CNS) effects, including drowsiness and CNS depression. These documented effects on the CNS may impact an individual’s normal state of wakefulness or sleep patterns.


Q: Is Flemicaine safe to take every day for a long time?

Regulatory documents indicate that long-term studies on the carcinogenic potential of the drug have not been performed in animals. Furthermore, for specific types of administration, such as intra-articular infusions, official warnings note a risk of irreversible chondrolysis (cartilage damage).


Q: Is Flemicaine considered a long-term treatment option?

The drug is primarily intended for acute care, such as local anesthesia or stabilization of acute heart rhythm issues. Official guidance requires careful dose reassessment and continuous monitoring when prolonged intravenous use is necessary, due to the potential for drug accumulation and toxicity.


Q: What are the signs of an allergic reaction to Flemicaine?

Official product labeling warns that allergic-type reactions are possible, which may include severe, systemic reactions like anaphylactic symptoms. These reactions are sometimes associated with other components in the formulation, such as sulfites in certain preparations.


Q: Does Flemicaine have any known interactions with grapefruit?

Evidence indicates that grapefruit and grapefruit juice may interact with the drug. They can inhibit the liver enzymes ( CYP3A4/1A2) that are responsible for breaking down Flemicaine, which could potentially lead to increased drug levels in the bloodstream.


Q: Where can I find official FDA information about Flemicaine?

The official, FDA-approved prescribing information and complete drug safety data for the active ingredient are accessible through the DailyMed service. This resource is maintained by the National Institutes of Health ( NIH) and provides the regulatory label text.


Q: Does Flemicaine need to be taken with food, based on official information?

Official warnings exist for specific topical preparations used in the mouth or throat, such as the viscous solution. To reduce the risk of aspiration (inhalation into the lungs) due to impaired swallowing, the regulatory label states food should be avoided for at least 60 minutes after using the medication.


Q: Are there any restrictions on driving or operating machinery while using Flemicaine?

Official labeling lists central nervous system (CNS) side effects such as drowsiness, dizziness, and lightheadedness. Because these effects are documented, Official labeling notes that patients may experience temporary impairment during activities that require mental alertness, such as driving or operating machinery.


Q: Is Flemicaine the generic drug name or a brand name?

Flemicaine is the proprietary or brand name for this drug formulation. The active substance is Lidocaine Hydrochloride, which is the chemical’s non-proprietary, or generic, name found in all official regulatory documents.


Q: How quickly is Flemicaine eliminated from the body?

Official pharmacokinetics data for intravenous administration show that the drug is rapidly metabolized, primarily by the liver. The typical elimination half-life—the time it takes for half the drug to be cleared from the bloodstream—is generally between 1.5 and 2 hours in healthy adults.


Q: What foods are generally recommended or restricted while using Flemicaine?

Official information suggests certain foods, such as char-grilled meats or cruciferous vegetables, may affect the liver enzymes that metabolize Flemicaine. Additionally, the label states food should be avoided for 60 minutes after using oral topical preparations to reduce the risk of aspiration.


Q: How long is Flemicaine usually prescribed for by healthcare providers?

The expected duration of use is highly variable depending on the condition being treated. For localized use, official documents describe a cyclic regimen for topical patches, which requires 12 continuous hours on, followed by 12 hours off. For intravenous antiarrhythmic use, the process involves an initial dose followed by a continuous, monitored infusion.


Q: What are the long-term safety concerns listed for Flemicaine?

Official warnings focus on the potential for irreversible chondrolysis, which is the destruction of cartilage, particularly when the drug is administered via intra-articular infusions (injections into a joint). This is the most notable long-term safety concern detailed in official labeling for that specific route.


Q: Are there different strengths of Flemicaine available?

Yes, the drug is available in multiple strengths to suit various therapeutic needs and routes of administration. For instance, official documents note concentrations ranging from 0.5% to 2% for injection solutions, and 4% to 5% for topical preparations.


Q: Do any specific laboratory tests need to be monitored while taking Flemicaine?

Official regulatory labeling does not mandate any specific routine laboratory tests (such as blood or urine panels) for monitoring during treatment. However, the label does note that careful monitoring of cardiovascular status is necessary during intravenous administration.

How should Flemicaine be stored and disposed of?

How to Store and Dispose of Flemicaine?

Flemicaine (Lidocaine Hydrochloride) must be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F), with protection from light, as stated in regulatory labeling. The injectable solution should be visually inspected for discoloration or particulate matter before use; if compromised, it must not be administered. Single-dose containers require the discarding of any unused portion immediately after the initial use.

Child-Safety and Disposal Requirements

All forms of Flemicaine must be stored out of the sight and reach of children and pets. Used topical patches must be folded so the adhesive sides stick firmly together before being placed in a secure location for disposal. Both unused and used product must be safely discarded according to local regulations to prevent accidental exposure from residual medication.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Flemicaine found in:

A-Z Index: