Licain-Actavis

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Medically reviewed

Laura Arias

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 Licain-Actavis

What is Licain-Actavis?

Licain-Actavis is a medicinal product used to produce local anesthesia, which refers to the temporary loss of sensation in a specific area of the body. It belongs to a group of medicines known as local anesthetics of the amide type.

Composition and Mechanism

The active substance in Licain-Actavis is lidocaine hydrochloride. Lidocaine works by blocking the nerve signals that send pain messages to the brain. When applied or injected, it prevents the initiation and transmission of nerve impulses by stabilizing the neuronal membrane.

Common Applications

This medication is primarily utilized in clinical settings to facilitate various medical and surgical procedures. Its main functions include:

  • Surface Anesthesia: Numbing the skin or mucous membranes before minor interventions.
  • Infiltration Anesthesia: Providing localized pain relief for small-scale surgical tasks.
  • Regional Nerve Blocks: Temporarily desensitizing larger areas of the body by targeting specific nerve pathways.

By localized application, Licain-Actavis allows medical procedures to be performed while the patient remains conscious but feels no pain in the treated area.

Regulatory References

  1. Lidocaine: MedlinePlus Drug Information

What side effects are possible with Licain-Actavis?

Possible Side Effects and Safety Information

Licain-Actavis (Lidocaine Hydrochloride) has an officially documented safety profile where adverse reactions are considered dose-related and concentration-dependent. This means systemic risks are directly tied to the level of the drug in the bloodstream. While adverse reactions are generally noted as rare when the product is administered correctly, systemic effects are classified by the physiological system involved.

Documented Safety Profile

The most commonly affected System-Organ Classes (SOCs) listed in regulatory documents are Nervous System Disorders (including light-headedness, confusion, and tremors) and Cardiac and Vascular Disorders (such as hypotension and bradycardia). These neurological signs often precede more critical systemic toxicity.

Officially documented Serious Adverse Reactions (SARs) include potentially life-threatening events such as Cardiac Arrest, Respiratory Arrest, and generalized Seizures (Convulsions). Severe Hypersensitivity Reactions (anaphylaxis) and Methemoglobinemia are also explicitly listed in regulatory labeling.

Special Safety Considerations

The official labeling notes specific safety considerations for certain patient populations. Elderly patients, the acutely ill, and children may be more susceptible to toxic effects and require cautious use. Patients with severe hepatic (liver) impairment or severe renal (kidney) dysfunction are at increased risk due to altered drug clearance, which can lead to drug accumulation. The risk of Methemoglobinemia is officially noted as being higher in infants under 6 months of age.

Safety-related restrictions include a known history of hypersensitivity to amide-type local anesthetics. For its antiarrhythmic use, the medicine is restricted in the presence of severe cardiac conduction defects like Stokes-Adams syndrome.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Licain-Actavis (Lidocaine Hydrochloride) may result in dose-related systemic toxicity due to elevated plasma levels. Manifestations are primarily documented in two physiological systems:

Central Nervous System (CNS) effects may begin with signs of excitement such as lightheadedness, tremors, or tinnitus. This may rapidly progress to CNS depression, including generalized convulsions, unconsciousness, and respiratory depression or respiratory arrest.

Cardiovascular effects are typically depressant, characterized by bradycardia (slow heart rate) and hypotension (low blood pressure), potentially leading to severe arrhythmias and cardiac arrest. A separate risk is documented for methemoglobinemia, signaled by cyanotic skin discoloration.

When Immediate Medical Help is Required

Official regulatory information mandates to seek immediate medical attention if any signs of systemic toxicity occur, such as shallow breathing, lethargy, or seizure activity. Delay in the proper management of dose-related toxicity may lead to severe outcomes, including acidosis and death.

Management measures include the immediate establishment of a patent airway and the provision of assisted or controlled ventilation with oxygen. Standard cardiopulmonary resuscitative measures must be instituted for cardiac arrest. No specific general antidote is known for overall systemic toxicity, but methylene blue is a required treatment for symptomatic methemoglobinemia.

Regulatory documents note that acutely ill or elderly patients, as well as children under 3 years, may have altered tolerance and require closer monitoring.

Therapeutic Uses of Licain-Actavis

Licain-Actavis is applied across therapeutic domains where both symptoms related to physical discomfort and symptoms related to heightened physiological activity (cardiac) are typically addressed. The medication is relevant for managing acute symptomatic episodes and chronic conditions presenting with disruptive manifestations.


Acute and Supportive Care

This medicine is commonly used for managing symptoms within several key areas, including local anesthesia for procedures, support for ventricular arrhythmias in critical care settings, and symptomatic relief for chronic neuropathic pain. For patients requiring necessary interventions, the medication provides temporary, targeted numbing that contributes to improved comfort during essential care. As a supportive agent in critical settings, it is used to help address rapid, disorganized ventricular rhythms. This application plays a role in managing electrical activity, which provides supportive relief when symptoms intensify.

“The medication is used to provide symptomatic relief and help patients manage symptoms when they become noticeable.”


Chronic Symptom Management

The medication is considered relevant in the management of specific types of chronic neuropathic pain, such as the persistent burning and aching associated with postherpetic neuralgia. Used topically, it addresses symptoms that interfere with daily functioning, offering targeted symptomatic relief that assists with functional stability during symptomatic periods.

Quick Fact: Relief for Acute Discomfort Description
Symptom Domain Acute, localized pain; surface irritation; ventricular instability
Common Scenario Minor procedures (dental, suturing); critical cardiac events
Core Benefit Contributes to targeted numbing and supports physiological stability

Regulatory References

  1. NIH DailyMed Drug Information

Eligibility and Restrictions for Use

Eligibility for Licain-Actavis

Defining who can and cannot use any medicine is a critical function of official governmental regulatory bodies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These agencies establish the definitive rules for eligibility based on comprehensive clinical data.

Authoritative regulatory documents, including the official Prescribing Information or Summary of Product Characteristics (SmPC), outline specific eligibility criteria. This includes populations for whom the drug is allowed, groups requiring special consideration (such as those with severe hepatic or renal impairment), and populations where use is strictly prohibited (contraindicated).

For a product specifically named Licain-Actavis, the official, publicly available regulatory documents that define these specific contraindications and eligibility limitations are not readily accessible from primary governmental sources at this time. Standard eligibility profiles would typically address factors like age, pre-existing conditions (e.g., severe heart block or hypersensitivity to components), and specific physiological states (e.g., defined pregnancy/lactation status).

Patients should always consult with a qualified healthcare provider who has access to the comprehensive and current regulatory label and their full clinical history before starting treatment with any medication.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Licain-Actavis describes two main classes of interactions: those affecting the drug’s concentration in the body (pharmacokinetic) and those causing additive physiological effects (pharmacodynamic).


Pharmacokinetic and Exposure Modification

The co-administration of certain medicinal products can significantly alter the body’s ability to clear Licain-Actavis. Drugs classified as CYP450 1A2 and CYP450 3A4 inhibitors (including agents like Fluvoxamine, Itraconazole, and Cimetidine) reduce hepatic clearance and lead to increased plasma concentrations. This reduced clearance can result in a risk of toxic accumulation. Medicines like the beta-adrenergic blocker Propranolol may similarly increase drug levels by reducing the liver’s blood flow. Conversely, CYP inducers and cigarette smoking can potentially reduce Licain-Actavis exposure. These kinetic changes are more pronounced in patient populations with hepatic impairment, severe shock, or advanced age, which compromises drug elimination.


Additive Physiological Effects and Restrictions

Licain-Actavis’s toxic effects are officially considered additive when co-administered with other Local Anesthetics of the amide type. This combination increases the documented risk for cumulative central nervous system and cardiovascular toxicity. Furthermore, co-exposure to any drug associated with inducing methemoglobinemia (such as certain nitrates or antibiotics) raises the combined risk for this specific hematological disorder. For oral and pharyngeal topical preparations, regulatory documentation mandates a restriction: ingestion of food or chewing gum must be avoided following application until sensation returns, to prevent impaired swallowing and subsequent trauma.

Mechanism of Action

Licain-Actavis (Lidocaine) exerts its action through a single, fundamental mechanism: voltage-gated sodium channel blockade, which modulates electrical conduction in both nerve impulses and the heart.

Molecular Mechanism: Blocking the Sodium Ion Flux

The drug's primary activity is the physical inhibition of voltage-gated sodium channels (Nav channels), which are essential for initiating and propagating electrical impulses in excitable cells. Licain-Actavis binds to the inner pore of these channels, predominantly when they are in their inactivated state (a mechanism known as use-dependence). This immediately stops the influx of sodium ions (Na^+), preventing the cell from reaching the threshold potential required to generate or propagate an electrical impulse. This action results in the cessation of electrical signaling in targeted pathways.

Physiological Consequence: Conduction Blockade and Membrane Alteration

In nerve tissue, the mechanism results in a conduction blockade, which inhibits the transmission of sensory signals and results in the blockade of efferent and afferent nerve conduction. In the heart's ventricular conduction system, the blockade elevates the threshold for spontaneous firing and alters the resting potential and refractory period of the cell membrane. The blockade interrupts aberrant electrical circuits, establishing functional control over spontaneous depolarization. The Na^+ channel block is functionally constrained in low pH environments, as the local acidosis reduces the quantity of uncharged molecules able to cross the lipid bilayer.

Dosage and Administration Information

Official Administration Guidelines

The use of Licain-Actavis is governed by specific protocols for its designated parenteral (injection/infusion) and topical routes. The injectable solution is for administration as an antiarrhythmic via the intravenous (IV) route and for local anesthesia via methods such as infiltration or peripheral nerve blocks.

For ventricular arrhythmia management, treatment typically begins with an IV initial bolus of 50 mg to 100 mg. A second bolus may be administered five minutes later, though the total dose must not exceed 200 mg to 300 mg within a one-hour period. This initial dosing is generally followed by a continuous intravenous infusion, commonly set at a rate of 1 mg/ minute to 4 mg/ minute. The solution for this continuous infusion must be correctly diluted (e.g., 1 g to 1 L solution) using aseptic technique.

For local anesthesia, the maximum single dose is limited to 4.5 mg/ kg (not to exceed 300 mg) when administered without a vasoconstrictor. Procedural use often requires a small test dose prior to the full injection volume. Topical preparations are intended for localized effect and are constrained by a defined usage period, such as a 12-hour maximum within a 24-hour cycle.

All intravenous use requires constant ECG and blood pressure monitoring. Reduced doses are mandated for vulnerable populations, including the elderly and patients with severe hepatic or cardiac impairment, ensuring the use of the lowest effective dosage.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Licain-Actavis

This section provides a factual overview of the clinical research conducted on Licain-Actavis (Lidocaine Hydrochloride), drawing exclusively from official regulatory and peer-reviewed scientific sources. It describes the structure of available evidence, the types of outcomes researchers studied, and the acknowledged limits of the data.


Evidence for Use in Acute Ventricular Arrhythmias (Intravenous)

Research has been studied for the intravenous use of Licain-Actavis in critical care settings for abnormal heart rhythms, particularly during periods of heightened symptom activity (e.g., following a heart attack). Researchers used randomized controlled trials (RCTs) to monitor the incidence of severe electrical activity. Findings describe patterns observed where the medicine was associated with measurements related to existing, sustained rhythms. However, studies examining preventative use in uncomplicated cases showed inconsistent results and did not provide findings indicating an observed change in all-cause mortality when research examined this application. The certainty remains low for the medicine as a preventative agent, and data for pediatric patients remain insufficient.


Evidence for Use in Anesthesia and Postherpetic Neuralgia

The use for local and regional anesthesia was studied for decades using numerous comparative studies. Research examined outcomes related to physical discomfort and daily functioning during procedures, monitoring the onset and duration of numbness. Studies note that measurements may differ when administered into tissue with high inflammation or high acidity.

For the topical patch, studies were evaluated in comparisons against a non-medicated control patch for chronic nerve pain (Postherpetic Neuralgia). Researchers examined patient-reported outcomes describing perceived discomfort. Findings describe patterns where pain intensity scores were associated with different measurements when the medicated patch was observed in comparison to the control patch. The evidence quality varies across studies, and follow-up durations for primary trials were typically short-term (2 to 3 weeks).


Research Gaps and Uncertainty

A review of the evidence highlights several areas where certainty remains low. These include the need for more controlled data in special populations and inconsistencies in the evidence regarding the medicine's preventative role in acute cardiac events. The prevalence of small sample sizes and limited follow-up durations contribute to the variation in evidence quality.

Key Studies & References

  1. Lidocaine Drug Information: Classification, Mechanism of Action, and Clinical Use (StatPearls)
  2. Topical capsaicin (low concentration) and lidocaine for chronic neuropathic pain in adults: a systematic review and economic evaluation

Frequently Asked Questions (FAQ)

Common questions about Licain-Actavis (FAQ)


Q: Are there any foods or drinks I should avoid while using Licain-Actavis?

Official product information for topical formulations applied to the mouth or throat (pharyngeal/oral) recommends avoiding the ingestion of food or chewing gum until normal sensation returns. This precaution is to prevent accidental trauma or impaired swallowing due to the numbing effect. No specific systemic dietary restrictions are specified for injectable or patch forms.


Q: What other medications should I avoid taking with Licain-Actavis?

Regulatory documents indicate that caution is necessary with medicines that can interfere with the breakdown of Licain-Actavis, such as certain CYP450 inhibitors (including some antifungals and antidepressants). Toxicity is also officially considered additive in the presence of other local anesthetics of the same type or drugs that can cause the specific blood disorder called methemoglobinemia. Using these combinations may increase the risk of accumulation or serious side effects.


Q: What are the signs of Licain-Actavis overdose or toxicity?

Signs of toxicity are concentration-dependent, relating directly to the level of the drug in the bloodstream. Early signs often affect the Central Nervous System (CNS) and may include light-headedness, confusion, tremors, or dizziness. If toxicity progresses, official warnings indicate the potential for more serious events, including generalized seizures, respiratory arrest, and cardiac arrest.


Q: How long does it take for the numbing effect of the Licain-Actavis topical patch to wear off?

The topical patch is typically used for a defined period, often 12 hours on and 12 hours off. After the patch is removed, official product information indicates that the drug’s elimination from the bloodstream has a half-life of approximately 1.5 to 2 hours. Due to the short half-life, drug levels in the blood decline relatively quickly after the application period ends.


Q: Can Licain-Actavis be used during pregnancy or while breastfeeding?

According to official regulatory classifications, animal studies have not shown harm to a fetus, but there are no adequate, controlled studies in pregnant women. For breastfeeding, the drug is known to be excreted into human milk in small amounts. Regulatory caution is advised for administration to a nursing mother.


Q: How quickly does the IV bolus start working for an irregular heartbeat?

Regulatory documents indicate that when Licain-Actavis is given as an intravenous (IV) bolus injection for antiarrhythmic purposes, the onset of action is rapid. The duration of this antiarrhythmic effect is typically maintained for approximately 15 to 20 minutes after the initial dose.

How should Licain-Actavis be stored and disposed of?

Storage and Disposal Requirements

The official storage and disposal requirements for Licain-Actavis (Lidocaine Hydrochloride Injection, USP) are governed by regulatory labeling to maintain quality and safety.

Storage Conditions

The medication must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The product must be protected from light and should not be permitted to freeze. As with all medicines, it must be kept out of the sight and reach of children.

Handling and Disposal

For single-dose containers, any unused portion must be immediately discarded after use, as the solution contains no preservative. The container and any remaining contents must be disposed of in accordance with all applicable federal, state, and local regulations for pharmaceutical waste. This product is not on the U.S. FDA’s list for disposal by flushing.

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

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