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Костарокс

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Костарокс

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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.

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Overview of Костарокс

The following overview defines the medicinal entity Костарокс and establishes its core identity, composition, and general purpose, based on its active substance, Etoricoxib.

Property Description
Active ingredient Etoricoxib (INN)
Form Film-coated tablet
Pharmacological class COX-2 Selective Inhibitor (Coxib)
Common use Symptomatic relief from pain and inflammation
Origin Synthetic

Что такое Костарокс и к какому классу он относится?

Костарокс is a synthetic prescription-only medicine (POM) containing the active ingredient Etoricoxib (INN), utilized for its ability to reduce inflammation and pain. It is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) and, more specifically, belongs to the COX-2 selective inhibitor subclass, known as a coxib. This specific classification, which is clinically recognized for its targeted action, differentiates it from non-selective NSAIDs such as Ibuprofen or Diclofenac. Etoricoxib's function is categorized under the ATC code M01AH05 designation.

Каков состав Костарокс и его форма выпуска?

The product is supplied as a single-ingredient product, consisting of the active ingredient Etoricoxib combined with various inert excipients necessary for formulation. The standard drug form is the film-coated tablet intended for oral administration and is typically designed for once-daily dosing. These tablets are designed for ingestion to support the consistent delivery of the drug into the body, ensuring the medication is released in a controlled, stable manner.

Какова основная цель применения Костарокс?

The primary purpose of Костарокс is to provide effective symptomatic relief by achieving both a pronounced anti-inflammatory effect and an analgesic effect (pain relief). This general benefit is realized through the selective inhibition of COX-2, an enzyme that drives the formation of prostaglandins (PGs)—the chemical messengers responsible for initiating and sustaining pain and inflammation. By disrupting this specific part of the inflammatory process, Костарокс generally helps patients manage the discomfort, swelling, and stiffness associated with chronic musculoskeletal conditions.

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What side effects are possible with Костарокс?

Possible Side Effects and Safety Information

The safety profile of Etoricoxib, the active ingredient in Костарокс, is officially documented across several regulatory domains, focusing on potential adverse reactions and use restrictions.


Officially Documented Adverse Reactions

The possible adverse reactions are formally classified by frequency, based on clinical data. Very Common effects (occurring in ge 1 in 10 individuals, specifically with high-dose use) include headache. Common effects (occurring in ge 1 in 100 to < 1 in 10) include hypertension, fluid retention, oedema, dizziness, and gastrointestinal effects like abdominal pain and dyspepsia. Adverse reactions are grouped by System-Organ Class (SOC), with frequent reports associated with Gastrointestinal disorders and Vascular disorders.


Serious Safety Considerations

Official regulatory labeling highlights the potential for serious adverse reactions. These include thrombotic cardiovascular events such as myocardial infarction (heart attack) and stroke. The drug also carries a risk of serious gastrointestinal complications, including bleeding, ulceration, or perforation. Serious skin reactions, such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are classified as very rare.


Safety-Related Restrictions

Regulatory documents impose several key limitations on use. The cardiovascular risk may increase with dose and duration of exposure, establishing a safety pattern linked to time. The medication is officially contraindicated in patients with established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, uncontrolled hypertension, or congestive heart failure (NYHA Class II-IV). It is also contraindicated in individuals under 16 years of age, during pregnancy or lactation, and in cases of severe hepatic impairment.

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Overdose and Emergency Response

Overdose and when to seek help

Acute overdose with Etoricoxib, the active substance in Костарокс, has resulted in adverse experiences consistent with the medicine’s established safety profile. The documented manifestations involve the exacerbation of risks related to three critical physiological systems: the gastrointestinal system (stomach or intestines), renal function, and the cardiac system. Potential serious outcomes, as noted in official regulatory documents, include severe GI adverse events like bleeding or perforation, as well as an increased potential for myocardial infarction or stroke.


In the event that an amount greater than the prescribed dosage is ingested, regulatory authorities mandate that the patient must seek medical attention immediately. Official instructions state the need to go to the nearest hospital emergency department and notify a doctor.


The management of an overdose is defined solely as symptomatic and supportive treatment. This is necessary because no specific antidote is known for Etoricoxib. Due to the high degree of plasma protein binding (approximately 92%), procedural removal techniques such as haemodialysis are considered ineffective for clearing the drug from the body. Patients who are elderly or have pre-existing renal, hepatic, or cardiac impairment may face greater risks of severe complications following an overexposure.

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Therapeutic Uses of Костарокс

What Костарокс Treats: Main Uses and Benefits

The primary role of Костарокс is to provide supportive symptomatic relief by being used for managing symptoms related to inflammatory or irritative states across key therapeutic domains. It is considered relevant in clinical settings marked by heightened discomfort that interferes with daily stability, and the medication is commonly used to help manage symptoms related to inflammatory and degenerative conditions.

The medicine may be part of symptomatic management for conditions characterized by periods of heightened symptoms such as Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, and acute attacks of Gouty Arthritis. It is also applied in contexts requiring short-term symptomatic assistance to manage moderate pain, including following dental surgery, or for episodic discomfort like Primary Dysmenorrhea.

“The primary goal is to address symptom clusters that may become intense or disruptive, helping to ease the overall symptom load.”

This medication is generally used when symptoms that create noticeable physiological strain interfere with daily functioning. By being applied in addressing symptoms related to inflammatory or irritative states, it supports day-to-day comfort during periods of heightened symptoms and may assist with maintaining functional stability.

Quick Fact: Relief for Inflammation and Pain
Symptom Focus: Persistent pain, joint stiffness, and acute swelling.
Main Benefit: Supports the easing of the overall symptom load, particularly in chronic inflammatory and degenerative joint conditions.
Usage Context: Applied in scenarios where additional management of discomfort is required across acute flares and long-term care.
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Eligibility and Restrictions for Use

Who can and cannot use Костарокс?

Official regulatory labeling defines strict population-based eligibility for the medicine Etoricoxib (Костарокс). These rules are based on physiological status and medical history.

Absolute Contraindications

Use is contraindicated and must be avoided in specific populations due to established risks. These include patients with:

  • Established cardiovascular disease ( CVD), such as congestive heart failure ( NYHA Class II-IV), ischemic heart disease, or cerebrovascular disease.
  • A history of allergic reactions (e.g., bronchospasm, urticaria) to Aspirin or other Non-Steroidal Anti-Inflammatory Drugs ( NSAIDs).
  • Active peptic ulceration or active gastrointestinal ( GI) bleeding.
  • Uncontrolled hypertension or severe hepatic dysfunction (Child-Pugh score ge 10).

Age and Conditional Restrictions

  • Age: The medicine is approved only for adults and adolescents ge 16 years of age. Use is officially contraindicated in children under 16 years old as safety and efficacy are not established.
  • Organ Function: Use is not recommended in patients with severe renal impairment (creatinine clearance lt 30 mL/min). Patients with mild-to-moderate hepatic dysfunction are eligible but require a restricted maximum dose.
  • Reproductive Status: Костарокс is contraindicated during the third trimester of pregnancy and is not recommended for women who are breastfeeding.
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What should I know about interactions with other medicines?

The official regulatory profile for Костарокс (Etoricoxib) identifies specific combinations and interaction types that necessitate monitoring or restriction.

Interaction-Related Restrictions

Concomitant use with other Non-Steroidal Anti-Inflammatory Drugs ( NSAIDs) or with Acetylsalicylic Acid ( Aspirin) at doses exceeding cardiovascular prophylaxis is formally not recommended due to an increased risk of serious gastrointestinal complications.

Pharmacodynamic and Clearance Interactions

  • Oral Anticoagulants: Co-administration with Warfarin is associated with an approximate 13% increase in International Normalised Ratio ( INR), which requires close monitoring upon initiation or dose change.
  • Antihypertensive Agents: The medicine may diminish the antihypertensive and natriuretic effects of Diuretics, ACE Inhibitors, and AIIAs. This combination carries an increased risk of renal function deterioration in elderly or volume-depleted patients.
  • Ethinyl Estradiol: Etoricoxib significantly increases the steady-state plasma exposure ( AUC) of Ethinyl Estradiol (a component of oral contraceptives) by 50% to 60% with the 120 mg dose.
  • Lithium and Methotrexate: Etoricoxib decreases the renal excretion of Lithium, elevating its plasma levels. It also increases Methotrexate plasma concentrations and reduces its renal clearance.

Exposure Modification

Conversely, co-administration with the potent CYP inducer Rifampicin results in a documented 65% decrease in Etoricoxib plasma concentrations, which may reduce therapeutic effect. Pharmacokinetics are not clinically affected by food or Antacids.

Connection to the overall interaction profile

The overall interaction structure is defined by formal restrictions, the need for functional monitoring with INR and blood pressure checks, and close plasma level monitoring for medicines whose clearance is affected by Etoricoxib. This classification ensures adherence to official use-with-caution and not-recommended regulatory categories.

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Mechanism of Action

Selective Targeting of Inducible Cyclooxygenase-2 (COX-2)

The action of Костарокс (Etoricoxib) is precise modulation of the body's inflammatory signaling system, driven by enzyme inhibition. The drug exhibits a marked selectivity for inhibiting the Cyclooxygenase-2 (COX-2) enzyme, which is the primary molecular target responsible for generating pro-inflammatory chemical messengers at sites of tissue damage. This selective interaction suppresses the enzymatic step that converts arachidonic acid into various prostaglandins (PGs).

Modulation of Prostaglandin Signaling and Nociceptive Cascades

By significantly reducing the local concentration of prostaglandins, the drug decreases the chemical sensitization of peripheral nociceptors and reduces the magnitude of localized pro-inflammatory signaling. This suppression of excessive mediator activity initiates a physiological cascade that modulates signaling within the nociceptive and inflammatory pathways. The mechanism also affects central COX-2 activity involved in the modulation of the body's thermoregulatory processes.

Functional Consequence on Vascular Homeostasis

While the mechanism is highly selective, the inhibition of COX-2 extends to homeostatic systems by reducing the production of prostacyclin ( PGI2) in the endothelium. This functional consequence shifts the balance of prostanoids, which are key regulatory elements in vascular tone and platelet aggregation. This functional shift is an inherent consequence of the selective inhibition mechanism.

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Dosage and Administration Information

Костарокс (Etoricoxib) is administered exclusively via the oral route as a film-coated tablet. The dosing is determined by the specific use context and involves once daily dosing across all approved indications. The tablet must be swallowed whole with water and may be taken either with or without food; administration without food may accelerate the onset of action.

Dosing schedules vary by condition. For chronic management of Osteoarthritis, the typical daily dose ranges from 30 mg up to a maximum of 60 mg. For Rheumatoid Arthritis or Ankylosing Spondylitis, the dose is generally 60 mg once daily, with an option to increase to 90 mg. The dosage for acute episodes, such as Acute Gouty Arthritis, is 120 mg once daily, and for postoperative dental surgery pain, 90 mg once daily.

Use duration is a key procedural constraint. The medication is used at the lowest effective dose for the shortest duration necessary for chronic conditions. Acute regimens, such as the 120 mg dose for gout, are strictly limited to the symptomatic period, not exceeding 8 days. If a dose is missed, a double dose is not taken; the schedule is resumed with the next planned dose. Furthermore, dose adjustment is required for impaired liver function: patients with moderate hepatic impairment are restricted to a maximum dose of 30 mg once daily.

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Recent Clinical Evidence

Обзор исследования для основных заболеваний суставов (Overview of Research for Core Joint Conditions)

Research where the medicine was evaluated in studies for osteoarthritis has been conducted using randomized controlled trials (RCTs). These studies explored how outcomes related to physical discomfort, joint stiffness, and daily functioning changed over periods up to about a year, often monitoring patient-reported outcomes using scales like the WOMAC Index. Findings describe patterns where measured changes were observed in some studies when compared to a non-active agent (placebo).

For rheumatoid arthritis and ankylosing spondylitis, the medicine was evaluated in multinational trials that monitored changes in swollen and tender joint counts, as well as functional capacity using scales like the BASDAI. Findings describe patterns observed over periods that extended up to three years in some cohorts. Evidence suggests similar outcomes compared to specific tested non-selective anti-inflammatory drugs in certain study populations.

Исследование для кратковременного купирования острой боли (Research for Short-Term Acute Pain Relief)

Research has explored the use of the medicine for outcomes describing episodic or acute changes, such as pain following dental surgery and during flare-ups of acute gouty arthritis. These studies used short-term RCTs, monitoring acute pain intensity and the need for supplemental analgesic medication. Trials reported very short-term measurements of pain intensity changes compared to placebo and comparator drugs, but follow-up durations were limited (restricted to a few days or up to about a week).

Что остается неясным в отношении исследований Костарокс (What Remains Uncertain About Костарокс Research)

Evidence highlights what is known, but certainty remains low in several areas. For many chronic conditions like RA and AS, long-term effects are not fully established across all dose strengths studied. Research also indicates that comparative evidence is lacking against the full range of alternative treatments available today. Furthermore, data for certain groups remain insufficient due to the exclusion criteria used in initial clinical trials, particularly for patients with pre-existing comorbid conditions. The findings describe group patterns, not personal outcomes, and research is ongoing.

Key Studies & References

  1. Indirect comparison of NSAIDs for ankylosing spondylitis: Network meta‑analysis of randomized, double‑blinded, controlled trials
  2. Etoricoxib improves osteoarthritis pain relief, joint function, and quality of life in the extreme elderly (Special Population evidence)
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Frequently Asked Questions (FAQ)

Common questions about Костарокс (FAQ)

Q: Can I drink alcohol while taking this medication?

The official labeling and patient information include details regarding the potential for interactions or warnings about consuming alcohol while using this medication. This information addresses how alcohol might affect the medicine’s safety or effectiveness, according to regulatory sources.

Q: What is the recommended storage temperature for this medicine?

The official product information specifies the correct conditions for storing this medicine to maintain its stability. This typically describes a specific temperature range, such as controlled room temperature, or other designated conditions defined in the packaging instructions.

Q: Does this medicine cause drowsiness or affect my ability to drive?

Regulatory documents list potential effects on the central nervous system, such as somnolence (drowsiness) or dizziness, as possible side effects. The official information includes cautions against or advises avoiding operating machinery if a person is experiencing these effects.

Q: Can children 2 years old use this product?

The official prescribing information defines the patient age groups for which this drug is approved. It clarifies the age groups for which the drug is not recommended or not studied, and outlines safety criteria for use in children where applicable.

Q: Is it safe to use this medication long-term?

Regulatory documents mention the treatment duration evaluated during clinical studies. They also include specific warnings, precautions, or monitoring recommendations related to long-term use, as outlined in the approved documentation.

Q: What are the common side effects of this medicine?

The official product labeling contains a detailed list of adverse reactions, which are the side effects observed during clinical trials. These effects are categorized by how frequently they occurred, such as common or very common.

Q: Can I take this medication if I am pregnant or breastfeeding?

The official labeling provides information concerning the risks and benefits of using the medicine during pregnancy and while breastfeeding. It includes any specific data on fetal risk or contraindications, as stated by the regulatory authority.

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How should Костарокс be stored and disposed of?

Official Storage and Disposal Requirements

Mandatory Storage Conditions Regulatory Requirement
Temperature Store the tablets at a temperature not exceeding 30 C.
Protection Store in the original container to protect the contents from moisture.
Child Safety Keep the medicine out of the sight and reach of children.

Product Stability and Disposal

Regulatory documentation supports a shelf-life of 36 months when the product is stored under the recommended conditions, maintaining the required temperature and packaging integrity.

Disposal: Unused or expired tablets and any waste material must be managed in accordance with local/national requirements. The product should not be disposed of via wastewater or household waste (drains or soil) and must be submitted to an approved waste disposal plant.

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

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