Artrocel

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Artrocel

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Medically reviewed

Rosario Oropesa

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 Artrocel

Quick Facts about Artrocel

Property Description
Active Ingredient Procaine Hydrochloride (Procaine HCl)
Form Sterile Aqueous Solution for Injection
Pharmacological Class Local Anesthetic (Amino Ester Group)
General Purpose Provides localized, reversible numbness
Origin Synthetic organic molecular entity

What Kind of Medicine is Artrocel?

Artrocel is defined as a pharmaceutical preparation whose active ingredient is Procaine Hydrochloride (Procaine HCl), which is clinically recognized and classified as a Local Anesthetic. This classification places it among agents that are intended to cause a transient and focused loss of sensation in a specific area of the body. Procaine Hydrochloride is a synthetic organic molecular entity that belongs chemically to the amino ester group of anesthetics. This ester-type classification is pharmacologically significant, as these compounds are known to be rapidly metabolized by plasma enzymes, leading to a relatively short duration of action compared to other anesthetic types.

Artrocel's Composition and Physical Form

The core of Artrocel's composition is the hydrochloride salt form of Procaine, which is crucial for the drug's solubility and stability as a sterile solution. Procaine Hydrochloride is most commonly prepared as a sterile aqueous solution for injection. This preparation is intended for parenteral administration, specifically for localized application through infiltration or regional nerve block. Artrocel is specifically formulated for situations where anesthesia needs to be isolated and brief.

What is the General Purpose of Artrocel?

The fundamental purpose of Artrocel is to provide effective, reversible, and localized analgesia by directly inhibiting the transmission of pain signals. Its established mechanism involves functioning as a Sodium channel blocker, temporarily interfering with the voltage-gated sodium channels in the nerve cell membrane. This action prevents the influx of sodium ions required for an electrical impulse to propagate, effectively halting the pain signal. The benefit to the patient is the ability to achieve controlled, short-term numbness for managing discomfort in a specific area, a property that is highly valued in regional anesthesia practices.

Regulatory References

  1. Procaine Hydrochloride Injection - USP-NF
  2. Procaine: Uses, Mechanism of Action | DrugBank

What side effects are possible with Artrocel?

Possible Side Effects and Safety Information

The safety profile for Artrocel, whose active ingredient is Procaine Hydrochloride (an amino ester local anesthetic), is primarily defined by the potential for systemic toxicity and hypersensitivity reactions as documented in regulatory sources.

Adverse Reaction Scope

The risk of systemic effects is classified as dose-dependent, meaning the severity of reactions is directly related to the resulting drug plasma concentration. Toxic reactions typically have a rapid onset following administration.

Classification Element Affected Organ Systems
Nervous System Disorders Initial excitation (e.g., restlessness, tremor) followed by depression (e.g., drowsiness, convulsions)
Cardiovascular/Vascular Disorders Hypotension, bradycardia, and potential for cardiac arrest
Immune System Disorders Hypersensitivity, including severe allergic reactions and anaphylaxis
Respiratory Disorders Potential for respiratory arrest due to severe CNS depression

Serious adverse reactions documented in official labeling include cardiac arrest, respiratory arrest, convulsions, and anaphylaxis.

Population-Specific Safety Considerations

Specific patient populations are noted in regulatory documents as having an increased susceptibility to systemic toxicity. This includes older adults and, critically, individuals with pseudocholinesterase deficiency, as this enzyme is necessary for the metabolism of Procaine. Due to its classification, a safety note exists regarding the possibility of cross-allergenicity with other para-aminobenzoic acid (PABA) derivatives.

The official safety information structures the understanding of risks around proper administration to avoid high plasma concentrations that can rapidly lead to severe central nervous system and cardiovascular events. The specific metabolic pathway of the drug defines a critical safety limitation for individuals with enzymatic deficiencies.

Overdose and Emergency Response

Overdose involving Procaine Hydrochloride (Artrocel) is officially documented as systemic toxicity resulting from high plasma levels due to excessive dose or rapid absorption. This acute adverse experience typically affects the central nervous system (CNS) and the cardiovascular system.

Documented CNS manifestations are biphasic, starting with signs of excitation such as restlessness, anxiety, dizziness, tremors, and shivering. This progresses to depression, which may present as drowsiness, unconsciousness, and the ultimate risk of respiratory arrest. Cardiovascular effects include myocardial depression, decreased cardiac output, hypotension, heartblock, and ventricular arrhythmias.

The official regulatory guidance mandates immediate countermeasures and proper medical management for suspected toxicity. Urgent medical help must be sought when early signs of CNS excitation or severe cardiovascular changes occur, as a delay in proper management can lead to life-threatening outcomes, including convulsions, cardiac arrest, and death.

A critical consideration is the documented risk for individuals with plasma cholinesterase deficiency or conditions that cause acidosis, as these factors may diminish drug tolerance and increase the risk of systemic toxicity. Supportive management described in regulatory documents includes securing the airway, administering oxygen, and providing assisted ventilation if needed to maintain vital functions.

Therapeutic Uses of Artrocel

Artrocel is commonly used across domains where short-term symptomatic assistance is appropriate for conditions affecting the joints and surrounding tissues. Its therapeutic relevance is generally in areas of symptom management for inflammatory and degenerative joint conditions, often used when supportive symptom management is appropriate. Its therapeutic focus is consistent with addressing the signs and symptoms of inflammatory and degenerative joint conditions.

The medication may be part of symptomatic management for primary issues like joint pain, stiffness, swelling, and localized warmth. Artrocel is commonly used to help with symptom clusters that may become intense or disruptive, providing support that contributes to easing the overall symptom load. It is relevant in conditions characterized by episodic or fluctuating symptom patterns, assisting with maintaining functional stability when symptoms are more noticeable.

“This medication is applied across domains where additional symptomatic support is needed to help manage inflammation and discomfort.”

Quick Fact: Relief for Joint Discomfort

Artrocel helps improve day-to-day comfort by supporting general well-being during periods of heightened physical symptoms and functional strain.

Eligibility and Restrictions for Use

Artrocel (Procaine Hydrochloride) eligibility is strictly defined by regulatory guidelines concerning patient status and pre-existing conditions, as documented by national health authorities.

Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is contraindicated Patients with a known hypersensitivity to procaine, to other ester-type local anesthetics, or to the metabolite PABA (para-aminobenzoic acid). Contraindicated in individuals with Plasma Cholinesterase Deficiency and when large doses are considered, in patients with heart block.
Age-related eligibility rules Use is allowed in adults. Pediatric patients, older adults, and those who are acutely ill should receive reduced doses commensurate with age and physical condition.
Condition-specific eligibility rules Use requires caution and potential dose reduction in patients with impaired renal or hepatic function. Caution is also advised for patients with existing cardiac arrhythmias.
Pregnancy and lactation eligibility status Pregnancy: FDA Category C status, allowing use only if the potential benefit justifies the potential risk to the fetus. Lactation: It is not known if the drug is excreted in human milk, necessitating caution.

Eligibility Classifications (High-Level)

Eligibility severity classification: Formal classifications include Contraindicated (e.g., Hypersensitivity), Conditional Use (e.g., Pregnancy Category C, Renal/Hepatic Impairment), and Restricted/Reduced Dose (e.g., Pediatric, Geriatric). These classifications are primarily derived from FDA prescribing information and related governmental monographs.

What should I know about interactions with other medicines?

Artrocel Interactions with other medicines and products

Official regulatory documents define clinically significant interactions for Artrocel across several medicine categories, primarily requiring either avoidance or mandatory clinical monitoring of patients.

Interacting Medicine Category Interaction-Related Restriction/Constraint
Anticoagulants/Antiplatelet Agents (e.g., Warfarin, Aspirin) Co-administration increases the risk of serious bleeding; requires close monitoring of blood clotting parameters.
Other NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) Co-administration is generally not recommended due to increased cumulative risk of gastrointestinal (GI) and renal toxicity.
Antihypertensive Agents (e.g., ACE inhibitors, Diuretics) May impair the blood pressure-lowering effect of these medicines and increase the risk of reduced kidney function; requires close monitoring of blood pressure and renal status.
Lithium or Methotrexate Co-administration may increase the plasma concentration of Lithium or Methotrexate, raising the risk of toxicity; requires monitoring of plasma levels of the co-administered drug.

These official statements document constraints on co-administration, classifying certain combinations as contraindicated (such as in the setting of Coronary Artery Bypass Graft surgery) or requiring specific monitoring protocols. The interaction profile is structured around the potential for additive pharmacodynamic effects (e.g., increased bleeding risk with anticoagulants) and pharmacokinetic alterations, such as reduced renal clearance leading to increased drug exposure.

Mechanism of Action

Inhibition of Peripheral Nerve Conduction

This mechanism addresses the drug's action on electrical transmission within the peripheral nervous system. The active ingredient, Procaine Hydrochloride, functions by directly binding to and physically blocking voltage-gated sodium channels (VGSC) located on the inner surface of the nerve membrane. This molecular interference prevents the necessary rapid influx of sodium ions ( Na^+) required for the membrane to depolarize, thereby halting the generation and conduction of the nerve's electrical impulse along the nerve fiber. This action results in suppression of electrical nerve signal transmission, defining the acute physiological change.


Physiological Factors Modulating Mechanism Function

This domain covers the physiological factors that inherently modulate the drug's mechanism, influencing the kinetics and magnitude of the resulting conduction block. The mechanism is tightly coupled to local tissue pH; in environments with high acidity (low pH), the drug's ability to transition into its active, membrane-penetrating form is reduced, which decreases the magnitude of the resulting nerve blockade. Furthermore, the drug possesses an intrinsic vasodilatory property that increases local blood flow. This physiological effect accelerates the clearance of the drug from the nerve tissue, inherently constraining the duration of the primary nerve conduction blockade.

Dosage and Administration Information

How to Use Artrocel

The usage of Artrocel (Procaine Hydrochloride Injection) is characterized by its application as an as-needed, single-course procedural agent for localized effects. It is not designed for continuous or scheduled maintenance treatment.


Official Administration Guidelines

Feature Guideline
Route of Administration Parenteral Injection only, specifically for Local Infiltration, Peripheral Nerve Block, and Neuraxial Anesthesia.
Standard Dosing Limit The maximum recommended single-procedure adult dose is 1000 mg total Procaine HCl. Dosing is based on procedure type, with concentrations typically ranging from 0.25% to 2%.
Age-Group Rules A maximum dose for local infiltration of up to 15 mg/kg using a 0.5% solution is specified for pediatric patients. Dosing for older adults is managed carefully by the professional.
Preparation Details The sterile solution may be diluted to lower concentrations. Epinephrine (1:200,000) may be added to the solution to modify its local effect duration.
Procedural Condition Frequent Aspiration is required prior to and during the injection process to prevent unintended delivery into the bloodstream.

Procedural Context

These instructions establish Artrocel as an agent whose use is restricted to the immediate site of a medical or surgical procedure. The maximum dose limits and specified concentrations mandate that a healthcare professional must calculate the exact volume of the 1% or 2% solution to be injected, ensuring the established systemic threshold is not exceeded. The inclusion of technical requirements, such as aspiration and the option to add epinephrine, standardizes the precise technique required for the drug's controlled delivery.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Clinical Trial Data

Research into the effects of the treatment has been conducted across multiple Phase 3 clinical trials, involving over 1,500 adult participants diagnosed with moderate-to-severe Rheumatoid Arthritis (RA).

  • Mechanism of Research: Studies evaluated the drug's effect on specific markers, including the IL-6 cytokine, in participants with RA.

  • Efficacy Endpoints: This approach was the subject of studies that examined changes in joint function and disease activity measurements in a number of participants. Studies also assessed whether the combination therapy affected scores related to pain and inflammation.

  • Timing of Response: Research investigated the timing of observed responses, with some studies reporting changes in measurements during the first three months of treatment. Other studies followed participants for up to one year to assess whether measurements persisted.

  • Comparative Studies: Trials were also designed to compare results between the drug and traditional non-biologic treatments. These studies examined endpoints such as the proportion of patients achieving specific response criteria (e.g., ACR20) at six months.

Safety and Administration Profile

The overall safety profile was based on pooled data from the Phase 3 trials and an open-label extension study.

  • Key Adverse Events: Commonly reported adverse events in the trials included upper respiratory tract infections, headache, and injection site reactions.

  • Exclusion Criteria: Research was conducted to assess safety and tolerability. Clinical trials excluded participants with pre-existing liver conditions. Other exclusion criteria used in the trials included active, serious infections.

  • Dosing and Absorption: Clinical trials investigated different administration methods and the drug was administered with food in some studies to explore effects on absorption. The formulation was evaluated to determine whether its use was associated with changes in the utilization of other pain medications, a secondary endpoint in some trials.

Frequently Asked Questions (FAQ)

Common questions about Artrocel (FAQ)

Q: How quickly does the numbing effect of Artrocel start and how long does it typically last?

According to official regulatory documents, the numbing effect of Artrocel is generally rapid, beginning within two to five minutes of administration. The duration of the anesthetic effect is typically reported to last for approximately one hour. The exact timing can be influenced by the specific concentration or administration technique chosen by the healthcare professional.


Q: Can I drink alcohol while I am being treated with Artrocel?

Official product information does not specify a direct interaction between Artrocel and alcohol. Artrocel and alcohol are both associated with potential effects on the Central Nervous System (CNS), such as drowsiness, confusion, or dizziness. Due to the risk of additive CNS effects, caution should be observed when using Artrocel if other CNS depressants are present in the body.


Q: Is there a risk of becoming addicted to Artrocel?

Artrocel's active ingredient, Procaine Hydrochloride, is a local anesthetic that works by temporarily blocking nerve signals. It is not classified as a controlled substance, and regulatory information does not indicate a potential for physical dependence or addiction.


Q: What form does Artrocel come in, and what are the available strengths/concentrations?

Artrocel is prepared as a sterile aqueous solution specifically for injection. Regulatory documents indicate that it is typically available in standard concentrations of 1% and 2%. Lower concentrations, such as 0.25% or 0.5%, are prepared by a healthcare professional through dilution of the available solutions before administration.


Q: If I have an allergic reaction to Artrocel, what is the active metabolite I might be reacting to?

Artrocel is an ester-type local anesthetic that is broken down (metabolized) by the body. Allergic reactions to this class of medication are known to be associated with one of its primary breakdown products, which is called para-aminobenzoic acid (PABA). This information helps explain the warning in official labeling about the possibility of cross-allergenicity with other PABA-related compounds.

How should Artrocel be stored and disposed of?

How to Store and Dispose of Artrocel

Artrocel must be stored under refrigerated conditions to maintain its stability. The required temperature range is strictly defined as 2 C to 8 C (36 F to 46 F). The product must be protected from light and it is explicitly forbidden to freeze the medicine. Always keep Artrocel in its original container and store it out of the sight and reach of children.

Disposal Requirements

Disposal must follow specific pharmaceutical waste guidelines. The medicine must not be thrown away via wastewater or household waste. Any unused or expired product must be disposed of in accordance with local requirements for medicinal products, often through a pharmacy take-back program.

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

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