АРТОКСАН

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АРТОКСАН

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Overview of АРТОКСАН

Quick Facts

Property Description
Active ingredient Tenoxicam
Form Tablets, Lyophilized Powder for Injection, Solution for Injection
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Relief of pain, inflammation, and stiffness
Origin Synthetic, Thienothiazine derivative

The Identity and Classification of АРТОКСАН

АРТОКСАН is a prescription-only medicinal product of synthetic origin whose active component, Tenoxicam, belongs to the Nonsteroidal Anti-inflammatory Drug (NSAID) class. Tenoxicam is specifically categorized as an Oxicam, a chemical subclass known for its ability to modulate key inflammatory pathways. This long-acting profile within the Oxicam group is clinically recognized for providing sustained therapeutic action, distinguishing it from shorter-acting NSAIDs. Its formal therapeutic role is as a systemic anti-inflammatory and analgesic agent.

Composition, Origin, and Available Forms of АРТОКСАН

The preparation is formulated as a single active ingredient product, containing only Tenoxicam as the primary therapeutic substance. АРТОКСАН is produced in multiple standard dosage forms, a key differentiating factor. These include tablets for oral use and preparations for parenteral administration—a lyophilized powder requiring reconstitution, or a pre-prepared solution for injection. The availability in injectable forms makes the drug a relevant option in settings where rapid or non-oral administration is clinically necessary.

General Purpose: Relief from Inflammation and Pain

The core therapeutic purpose of АРТОКСАН is to provide effective relief from the symptoms of inflammation and pain. As an NSAID, the drug's action helps to mitigate the primary signs associated with inflammatory responses, including localized swelling, tenderness, and pain, while also possessing antipyretic properties to help manage fever. By acting upon these fundamental symptoms, the medication assists in managing the discomfort and functional limitations characteristic of inflammatory disorders, providing a key benefit in long-term symptomatic management.

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What side effects are possible with АРТОКСАН?

The safety profile of АРТОКСАН, based on official regulatory documents, covers a range of possible side effects classified by the organ system affected and their reported frequency.

Documented Adverse Reactions

Side effects are primarily categorized by System Organ Class (SOC), including the Nervous system, Gastrointestinal system, Immune system, Skin and subcutaneous tissue, and the Vestibular system. Reactions are further classified based on frequency, although specific frequency bands for all reported events may vary across sources.

Serious Adverse Reactions

Official documents highlight the risk of rare but serious reactions requiring immediate attention, such as:

  • Severe Skin Reactions: Oculomucocutaneous syndrome (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell syndrome).
  • Hypersensitivity: Anaphylactoid symptoms, including dyspnea, decreased blood pressure, and laryngeal edema.
  • Organ Toxicity: Acute renal failure, hepatic function disorder, hepatitis, jaundice, and rhabdomyolysis.
  • Neurological/Visual Effects: Eye disorders, including optic neuritis or papilledema, and symptoms such as photophobia, blurred vision, or vision disorder which may become persistent even after the product is discontinued.
  • Other: Hyponatremia (especially in the elderly) and impulse-control disorders (when used concomitantly with levodopa).

Safety Considerations and Restrictions

Safety documents specify restrictions and patient-specific cautions:

  • Contraindications include a history of hypersensitivity to the drug or other non-steroidal anti-inflammatory drugs (NSAIDs), active peptic ulcer/bleeding, severe heart failure (NYHA III-IV stage), severe renal or hepatic insufficiency, and pregnancy or lactation.
  • Population-Specific Caution: The elderly should use the drug with particular caution due to an increased frequency of adverse reactions, particularly in those with cardiovascular pathology. Patients with a known risk of bleeding or impaired hemostasis also require special attention.

Regulatory Safety Summary

The regulatory summary structures the understanding of risks by categorizing all documented undesirable effects by their System Organ Class and explicitly differentiating between common and serious adverse reactions. This is paired with specific patient-group warnings and defined contraindications, legally establishing the boundaries of the drug's approved safety profile.

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Overdose and Emergency Response

Overdose Scope

Property Official Regulatory Statement
Documented overdose presentations Overdose with Tenoxicam (an NSAID) is often asymptomatic or may result in minor, self-limiting gastrointestinal symptoms in most cases.
Physiological systems affected (as stated in label) Potential severe outcomes include effects on the renal system (acute renal failure), central nervous system (convulsions, coma), and gastrointestinal system (bleeding, perforation).
Dose-related or exposure-related factors (if applicable) The risk of severe outcomes is associated with acute NSAID overdose generally. Specific regulatory documents note that cases of overdose with Tenoxicam have not always been reported.
Population-specific overdose notes (if applicable) None are explicitly detailed within the Overdosage section of the primary regulatory labels.
Emergency-response statements (as written in official documents) Supportive and symptomatic therapy is indicated for overdose management. Monitoring and treatment of potential complications are required.
When immediate medical help is required (label-derived phrasing only) For management of a suspected drug overdose, individuals must contact your regional poison control centre or get medical care right away.

Overdose Classifications (High-Level)

Property Official Regulatory Statement
Severity classification (as defined in official documents) Overdose is classified as requiring supportive and symptomatic therapy, acknowledging the potential for serious clinical sequelae.
Regulatory basis Information derived from government-authorized Product Monograph/Prescribing Information and NSAID Toxicity Reviews.
Overdose-context constraints (as defined in official documents) No specific antidote is known for Tenoxicam overdose.

Resulting Overdose Structure

Official Overdose Statements:

  • Initial overdose may be asymptomatic or characterized by minor gastrointestinal symptoms.
  • Severe outcomes associated with acute NSAID overdose include convulsions, coma, acute renal failure, and serious gastrointestinal complications.
  • Management of suspected overdose requires supportive and symptomatic therapy and the monitoring of complications.
  • No specific antidote is known for Tenoxicam overdose.
  • In the event of overdosage, individuals must contact a regional poison control centre or get medical care right away.

Connection to the overall overdose profile (2–4 sentences): The official regulatory profile defines the overdose response by explicitly stating that a specific antidote does not exist and by mandating a management strategy based on supportive and symptomatic care. The critical requirement for seeking immediate medical attention is driven by the potential for severe, life-threatening outcomes affecting the renal, gastrointestinal, and central nervous systems, which may occur despite a mild initial presentation.

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Therapeutic Uses of АРТОКСАН

What АРТОКСАН Treats: Main Uses and Benefits

АРТОКСАН (Tenoxicam) is considered relevant for symptomatic management across domains involving inflammatory and degenerative disorders. As an anti-inflammatory and analgesic agent, it is commonly used to help with conditions where symptoms related to physical discomfort create noticeable physiological strain. The medicine is relevant for the symptomatic treatment of conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

The medicine is also commonly used when symptoms associated with acute or episodic changes intensify, which includes tendinitis, bursitis, and the intense inflammation of acute gouty arthritis, as well as managing anticipated post-operative pain and the discomfort of primary dysmenorrhea.

In situations where patients experience persistent joint pain, stiffness, and localized swelling, АРТОКСАН supports the patient during difficult episodes by easing distress and assists with maintaining functional stability during periods of heightened symptoms.


Quick Fact Block

Quick Fact: Used for Managing Clinical Context
Inflammatory Pain (joints, tissues) Chronic arthropathies (Osteoarthritis, Rheumatoid Arthritis) and acute exacerbations (Gout).
Acute Musculoskeletal Symptoms Short-term symptomatic assistance for tendinitis, bursitis, and sprains.
Relevant for Easing Specific Discomfort Post-operative pain and pain associated with primary dysmenorrhea.

Regulatory References

  1. National Drug Information, Thailand FDA-related document
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Eligibility and Restrictions for Use

The official regulatory profile for ARTOKSAN is defined by strict rules regarding patient eligibility, primarily to prevent serious adverse outcomes related to its classification as an NSAID.

Eligibility Status Population / Condition
Contraindicated (Must Not Use) Patients with severe uncontrolled heart failure, severe hepatic or renal impairment, active peptic ulceration, or a history of gastrointestinal bleeding related to NSAID use.
Contraindicated (Must Not Use) Individuals with known hypersensitivity to Tenoxicam or other NSAIDs/Aspirin that cause asthma, rhinitis, or urticaria, and patients in the third trimester of pregnancy.

Age and Special Population Restrictions

The medicine is generally designated for adult patients. It is not recommended for use in children and adolescents under 16 years of age because safety and efficacy data have not been established for this population. Use in elderly patients requires special caution; treatment must employ the lowest effective dose for the shortest duration possible, with close monitoring.

Conditional Use and Prohibitions

Patients with non-severe renal or hepatic impairment require careful functional monitoring if the medicine is prescribed. Use is not recommended for women who are breastfeeding or who are actively attempting to conceive due to labeled concerns regarding fertility impairment.

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What should I know about interactions with other medicines?

The official regulatory profile for АРТОКСАН (Tenoxicam) documents specific interaction patterns with other medicines and substances. This drug is contraindicated in patients with a history of hypersensitivity reactions, such as asthma or hives, following exposure to aspirin or any other Nonsteroidal Anti-inflammatory Drug (NSAID). Consequently, co-administration with other NSAIDs is not generally recommended due to the high risk of serious adverse effects.

A primary interaction domain is the elevated risk of bleeding and ulceration. This risk is officially noted when Tenoxicam is combined with Anticoagulants, Antiplatelet agents, Oral Corticosteroids, and Selective Serotonin-Reuptake Inhibitors (SSRIs). Furthermore, Tenoxicam can alter the clearance of co-administered drugs, potentially causing accumulation. Regulatory documentation indicates Tenoxicam may increase Lithium serum concentrations and reduce the clearance of Methotrexate.

Pharmacodynamic interactions may result in the diminution of efficacy for certain medicines, including Diuretics and Antihypertensives (such as ACE Inhibitors and ARBs). Separately, co-administration with Quinolone Antibiotics carries a documented potential for CNS excitation. Regarding timing, food intake is officially noted to delay the rate of drug absorption. Population-specific notes include the need for caution in elderly patients due to a heightened risk of renal function deterioration when used with ACE Inhibitors or ARBs. The overall interaction structure is defined by pharmacodynamic risks and the pharmacokinetic inhibition of drug clearance.

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Mechanism of Action

️ Molecular Targeting of the COX Pathway

The primary mechanism of АРТОКСАН (Tenoxicam) is the non-selective inhibition of the Cyclooxygenase (COX-1 and COX-2) enzymes within the Arachidonic Acid Cascade. This molecular blockade suppresses the biosynthesis of pro-inflammatory prostaglandins ( PGE2), which are chemical mediators responsible for sensitizing peripheral nociceptors and increasing local vascular permeability. The resulting physiological effect is the reduction of peripheral nociceptor sensitization and the decrease in local vascular permeability.

Cellular and Persistence Mechanisms

Tenoxicam also limits the processes associated with tissue breakdown by stabilizing lysosomal membranes within cells and inhibiting the activity of metalloproteinases, enzymes that degrade connective tissue structures. Furthermore, the molecule's long elimination half-life translates into a sustained state of enzyme inhibition at the molecular level, allowing for prolonged biochemical pathway suppression.

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Dosage and Administration Information

АРТОКСАН (Tenoxicam) is administered through both oral and parenteral routes. The medicine is available as 20 mg tablets for oral use, and as a 20 mg lyophilized powder for injection. The injectable form is intended for intramuscular (IM) or intravenous (IV) bolus administration and is typically reserved for initiating treatment over a short period (generally one to two days) before transitioning the patient to the oral dosage form.

The standard regimen for most indications is a single daily dose of 20 mg. To maintain consistent therapeutic levels, the dose should be administered at the same time each day. Specific acute conditions may require different initial dosing patterns; for example, postoperative pain may utilize a higher dose of 40 mg once daily for a maximum of five days. The lyophilized powder must be reconstituted with the supplied sterile water prior to administration, and injection should be by bolus, as infusion use is not recommended.

For oral administration, tablets must be swallowed whole and are generally instructed to be taken with liquid, preferably during or immediately after a meal. Duration of use is condition-dependent; treatment for acute musculoskeletal disorders should generally not exceed 7 to 14 days. Dose adjustment principles apply to specific populations: the approach for older adults involves the use of the lowest effective dose, and no dosage recommendations have been established for pediatric patients.

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Recent Clinical Evidence

Research evidence / Overview of Studies for АРТОКСАН


Evidence for Chronic Joint and Musculoskeletal Conditions

The examination of АРТОКСАН (Tenoxicam) in conditions characterized by fluctuating or episodic manifestations, such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis, was studied for extensive research. Studies conducted for these conditions included multicenter Randomized Controlled Trials (RCTs), many of which were double-blind and comparative, alongside analyses of large long-term observational data. The research examined outcomes related to physical discomfort and daily functioning, using standardized tools to measure pain intensity, the duration of joint stiffness, and overall functional status.

These long-term studies, which sometimes monitored patients for periods of up to one to two years, reported patterns observed in the studies related to sustained use and patient status maintenance over time. Research describes patterns observed in the studies related to symptom measurement across the observed populations with chronic conditions. It is important to understand that while the evidence base is extensive, some of the initial comparative trials were conducted with relatively smaller patient groups, limiting the ability to describe minor differences between agents in comparative trials.


Evidence for Acute Pain and Short-Term Inflammation

Research has been conducted for АРТОКСАН in conditions associated with acute or disruptive episodes, such as Acute Gouty Arthritis, tendinitis, bursitis, and general soft tissue injuries. The evidence includes short-term clinical trials which compared the medicine against a placebo or other active pain management agents, focusing on episodes where symptoms become more noticeable.

In these studies, researchers monitored patient-reported outcomes describing perceived discomfort and objective changes in mobility (range of motion) over defined time intervals. Evidence for certain specialized applications, such as local injection formulations, remains limited or inconsistent, with some studies reporting patterns of observed symptom changes that were not consistently established for long-term patient outcomes.


Areas of Ongoing Research and Uncertainty

Research highlights what is known and what is still uncertain about this medicine. Sample sizes were modest in some of the older, foundational studies, meaning the results apply only to the populations studied. Evidence quality varies across studies, particularly for specialized uses like local injection for soft tissue injuries, where findings were mixed or follow-up durations were limited. Comparative evidence against some newer therapeutic agents is still emerging, and data for certain groups or very specific types of joint inflammation remain insufficient.

Key Studies & References

  1. National Drug Information (Thailand) - Document on Tenoxicam Uses
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Frequently Asked Questions (FAQ)

Common questions about АРТОКСАН (FAQ)

Q: What is the active substance in АРТОКСАН and how does it work?

АРТОКСАН contains the active substance tenoxicam. According to official product information, tenoxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is described as having anti-inflammatory (reducing swelling and irritation), analgesic (pain-relieving), and antipyretic (fever-reducing) effects.


Q: For what medical conditions is АРТОКСАН typically prescribed?

Regulatory documents state that АРТОКСАН is prescribed for relief in various painful and inflammatory conditions. This includes joint disorders such as rheumatoid arthritis and osteoarthritis, as well as soft-tissue disorders like tendinitis and bursitis. It is also indicated for extra-articular conditions, such as lumbago (lower back pain).


Q: Can АРТОКСАН be used for both acute (short-term) and chronic (long-term) pain?

Official product information indicates that АРТОКСАН can be used for both acute and chronic conditions. Examples include short-term treatment of acute gout and the management of chronic inflammatory diseases like rheumatoid arthritis. The specific duration of treatment is determined by a healthcare professional based on the patient's individual condition.


Q: How quickly does АРТОКСАН start to relieve pain?

According to the official prescribing information, tenoxicam, the active substance in АРТОКСАН, is rapidly absorbed after administration. The onset of therapeutic action, meaning the start of pain relief, is typically observed relatively quickly following administration, according to official data.


Q: Does АРТОКСАН require a prescription from a doctor?

Regulatory documents classify tenoxicam as a prescription-only medicine (POM). Therefore, a valid prescription from a healthcare professional is necessary for АРТОКСАН.

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How should АРТОКСАН be stored and disposed of?

How to Store and Dispose of ARTOXAN (Tenoxicam)

Storage and disposal must strictly follow the official regulatory guidelines to maintain the medicine's stability and ensure environmental safety.


Storage Requirements

ARTOXAN preparations must be stored out of the sight and reach of children.

  • Temperature: Store the medicine at room temperature, typically not exceeding 25 C to 30 C, depending on the formulation.
  • Protection: The product must be kept in the original container to protect it from light and moisture.
  • Injection Stability: The powder for injection must be reconstituted and used immediately; delayed use is not supported by the official label.

Disposal Instructions

Do not dispose of ARTOXAN via wastewater or regular household trash. Unused or expired medicine must be discarded according to local, regional, and national pharmaceutical waste regulations.

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

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