Xtra

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Xtra

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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 Xtra

Property Description
Active ingredient Aceclofenac, Valdecoxib
Type of Formulation Fixed-Dose Combination (FDC)
Pharmacological Class Non-steroidal anti-inflammatory drug (NSAID)
Primary Mechanism Prostaglandin Synthesis Inhibition
Origin Synthetic Compounds
Delivery System Dual (Systemic and Topical)

Defining Xtra: Class, Composition, and Origin

Xtra is a synthetic pharmaceutical entity designated as a Fixed-Dose Combination (FDC) product, which is classified within the Non-steroidal anti-inflammatory drug (NSAID) pharmacological class. Its composition is defined by the inclusion of two distinct active ingredients, Aceclofenac and Valdecoxib. Aceclofenac is a phenylacetic acid derivative, while Valdecoxib is a sulfonamide derivative distinguished as a selective COX-2 inhibitor. This FDC strategy combines two synthetic compounds to achieve a diversified mechanism of action.

The primary function of Xtra is anchored in the suppression of the body’s inflammatory response and associated pain. Valdecoxib’s highly selective targeting of the COX-2 enzyme complements the action of Aceclofenac, a general NSAID, thereby aiming to enhance the therapeutic analgesic and anti-inflammatory effect by interrupting the underlying biochemical cascade from two separate points.

Dual-Delivery Modality and General Therapeutic Purpose

Xtra is further characterized by a dual-delivery modality, utilizing both Systemic preparations (for absorption into the bloodstream) and Topical preparations (for localized application). The formulation includes a component containing Aceclofenac Topical, alongside systemic components. Topical NSAID preparations are intended to deliver active medicine directly to localized sites of inflammation for targeted relief.

This architectural approach is designed to provide comprehensive foundational pain management and inflammation control. The systemic components, Aceclofenac and Valdecoxib, work internally to interrupt prostaglandin synthesis, while the localized cutaneous application ensures a targeted concentration of the anti-inflammatory agent at the specific site of concern. The general therapeutic purpose is to leverage the synergistic dual-action mechanism for relief by addressing inflammatory and pain signals both internally and externally.

What side effects are possible with Xtra?

Possible Side Effects and Safety Information

The officially documented safety profile for Xtra is derived from clinical trial data and post-marketing surveillance, as organized and published by government regulatory authorities.

Adverse Reaction Scope

Adverse reactions associated with Xtra are formally classified by frequency of occurrence and grouped by the affected System-Organ Class (SOC). These classifications help structure the understanding of the medicine’s risks.

  • Frequency Classification: Adverse reactions are categorized according to standard regulatory frequency bands, including Very Common, Common, Uncommon, Rare, Very Rare, and Not Known (where frequency cannot be reliably estimated from available data).
  • System-Organ Classes: Documented side effects affect various body systems, including Gastrointestinal disorders, Nervous system disorders, Psychiatric disorders, Skin and subcutaneous tissue disorders, Musculoskeletal and connective tissue disorders, and General disorders and administration site conditions.

Critical Safety Information

  • Serious Adverse Reactions (SARs): Regulatory documents explicitly list severe events, such as those that are life-threatening, result in hospitalization, or lead to persistent disability, as Serious Adverse Reactions requiring close consideration.
  • Safety-Related Restrictions: Contraindications define conditions or patient characteristics under which Xtra must not be used due to high, unacceptable safety risks. The official label also includes special warnings and precautions for use, noting specific conditions or concurrent medications that require heightened caution or safety monitoring.

Population-Specific Safety Notes

The safety profile includes specific considerations for vulnerable populations. This information addresses the use of the medicine during pregnancy and lactation (breastfeeding), as well as required precautions for use in patients with known impaired hepatic (liver) or renal (kidney) function, or for use in the elderly.

Regulatory Safety Structure

Regulatory authorities use these structured categories to provide a clear, tiered communication of risk. The classification of side effects by frequency and SOC communicates both the likelihood and the location of potential effects. The clear statement of Contraindications and Serious Adverse Reactions defines the medicine's critical safety limits.

Overdose and Emergency Response

Overdose and when to seek help

The regulatory overdose documentation for Xtra establishes a profile based on documented manifestations and the risk of severe systemic toxicity.

Documented Overdose Presentations

Symptoms of overexposure documented in prescribing information include central nervous system effects such as headache, dizziness, and somnolence (drowsiness). Gastrointestinal presentations often involve nausea, vomiting, and epigastric pain or irritation.

Overdose carries a risk of severe toxicity involving the Gastrointestinal system (including bleeding, ulceration, and perforation) and the Renal and Hepatic systems, potentially leading to acute renal failure and liver damage. Life-threatening outcomes, such as convulsions and serious cardiovascular thrombotic events, are noted. Increased severity risks are documented in elderly patients and those with existing impaired renal, cardiac, or liver dysfunction.

Required Emergency Actions

Management is described as symptomatic and supportive. Regulatory procedures may include the use of activated charcoal within one hour or gastric lavage for a potentially life-threatening ingestion amount; no specific antidote is known.

Seek immediate medical attention for any suspected overdose. Contact emergency services immediately upon the development of severe, life-threatening symptoms, such as chest pain, sudden weakness, or slurred speech. Hospital monitoring is required, with close surveillance of renal and liver function.

Therapeutic Uses of Xtra

Xtra (Aceclofenac/Valdecoxib FDC) is applied in contexts where pronounced pain and inflammation create noticeable interference with daily stability, offering supportive therapeutic benefit to ease the overall burden of symptoms across several key domains. Its therapeutic relevance is commonly associated with these chronic and acute inflammatory states.

The formulation is commonly used across conditions characterized by persistent symptomatic discomfort, such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis. It is also relevant in clinical settings marked by heightened physiological activity from sudden onset symptoms, including pain following dental procedures or the discomfort of primary dysmenorrhoea. It is applied in addressing symptom clusters that may become intense or disruptive, providing support that may help ease day-to-day comfort.

“The medication helps address groups of symptoms that may appear suddenly or intensify over time, offers symptomatic relief that may assist with maintaining a sense of stability when symptoms are more noticeable.”

It is commonly used to help with managing symptoms that interfere with daily comfort, particularly joint stiffness, and may assist with maintaining functional stability in these long-term inflammatory joint diseases.


Quick Fact: Relief for Joint Stiffness and Acute Pain

Regulatory References

  1. MHRA drug safety update for Aceclofenac

Eligibility and Restrictions for Use

This section outlines the official population eligibility and non-eligibility for Xtra (Aceclofenac/Valdecoxib FDC), strictly based on governmental regulatory labeling.

Eligibility Status

Population/Condition Regulatory Classification
Established CV Disease (e.g., NYHA Class II-IV Heart Failure) Contraindicated (Prohibited)
Severe Hepatic or Renal Failure Contraindicated (Prohibited)
Third Trimester of Pregnancy (from 30 weeks) Contraindicated (Prohibited)
Known Hypersensitivity (to NSAIDs, aspirin, or sulfonamides) Contraindicated (Prohibited)
Children under 18 years Not Recommended (Use not established)
Elderly Patients (Geriatric use) Conditional Use (Require close monitoring and limited duration/dose)
Mild to Moderate Hepatic Impairment Conditional Use (May require dose reduction and surveillance)

Official Eligibility Statements: Use is prohibited for patients with active or a history of recurrent peptic ulcers or gastrointestinal hemorrhage, and for postoperative pain following Coronary Artery Bypass Graft (CABG) surgery. The medicine is not recommended for women who are attempting to conceive or who are breastfeeding. Conditional use in adults requires careful consideration and monitoring in patients with pre-existing conditions such as hypertension or mild organ dysfunction.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines officially documented interaction patterns for Xtra (Aceclofenac/Valdecoxib) based on regulatory information.


Documented Interaction Classes

The co-administration of Xtra is formally subject to restrictions, including the recommendation to avoid other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 selective inhibitors, and analgesic doses of aspirin due to heightened risk of adverse events.

Pharmacodynamic interactions are documented with Anticoagulants (e.g., Warfarin), which may enhance bleeding risk, and with Diuretics and ACE Inhibitors/ARBs, which carry an increased risk of nephrotoxicity and reduced anti-hypertensive effect. The simultaneous use with systemic Corticosteroids also increases the risk of gastrointestinal bleeding.

Pharmacokinetic interactions center on CYP 2C9 and CYP 3A4 metabolism. Specific inhibitors of these enzymes (e.g., Fluconazole, Ketoconazole) increase the total plasma exposure (AUC) of the Valdecoxib component, while inducers (e.g., Phenytoin) reduce it. Xtra also inhibits the renal clearance of substances like Lithium and Methotrexate, leading to increased plasma concentrations of these medicines.

Timing rules specify that NSAIDs should not be used for 8–12 days after Mifepristone administration. Furthermore, the official profile notes that alcohol may increase the risk of gastric bleeding, and the presence of food delays the rate of absorption but not the total extent of exposure. Population-specific notes document significantly increased Valdecoxib exposure in patients with moderate hepatic impairment.

Mechanism of Action

The physiological outcome of the mechanism is based on a targeted, dual-action approach to key signaling pathways. The drug's primary action involves the inhibition of the Cyclooxygenase-2 ( COX-2) enzyme. COX-2 is the molecular target responsible for synthesizing prostaglandins—chemical messengers that mediate the inflammatory response and sensitize nerve endings. Valdecoxib provides highly selective COX-2 inhibition, complemented by the preferential action of Aceclofenac, reducing prostaglandin concentrations. This mechanism of suppression contributes directly to the attenuation of nociceptive signaling and a decrease in local vascular permeability.

The mechanism extends beyond the Arachidonic Acid Cascade through non-COX-mediated activity. The Aceclofenac component is associated with the suppression of pro-inflammatory cytokines like IL-1beta and TNF-alpha, which are molecular signals that amplify inflammation. Additionally, the mechanism involves inhibiting Matrix Metalloproteinases (MMPs), enzymes linked to the breakdown of cartilage components. This dual pathway modulation supports a broader influence on the inflammatory state and contributes to mechanisms that modulate tissue catabolism. The formulation provides a mechanism of coordinated action by combining two inhibitors and includes a topical component for localized enzyme inhibition, supporting comprehensive modulation of the targeted pathway.

Dosage and Administration Information

How Xtra is Used: Official Administration Guidelines

The systemic administration of Xtra (Aceclofenac/Valdecoxib FDC) is aligned with standard protocols for its non-steroidal anti-inflammatory drug (NSAID) components. The overarching principle is the use of the lowest effective dose for the shortest duration necessary to manage symptoms.


Administration Scope and Regimen

The medication is available in Oral (systemic FDC tablet) and Topical (localized preparation) forms. The standard oral daily dose for the systemic component is a total of 200 mg (Aceclofenac equivalent), which is the maximum dose recommended per 24 hours.

Administration Rule Official Instruction
Dosing Frequency Typically taken in divided doses (e.g., 100 mg morning and 100 mg evening).
Intake Context Oral tablets are designed to be swallowed whole with liquid and taken preferably with or after food.
Pediatric Use Not recommended for use in children and adolescents under 18 years of age.
Hepatic Adjustment The initial daily dose is reduced to 100 mg (Aceclofenac equivalent) for patients with hepatic impairment.

Procedural Summary

The standard protocol involves the oral tablet being administered in divided daily doses, taken with or after food, not exceeding the 200 mg limit. In instances where a systemic dose is missed, the usual procedure is to skip the missed dose and continue with the next scheduled dose; doubling the dose is not part of the administration protocol.

Recent Clinical Evidence

Recent Clinical Evidence

Recent research has continued to explore the profile of the combined treatment, focusing on its use in specific populations and its long-term tolerability. This information supplements the findings from the primary clinical trials.

Studies in Refractory Neuropathic Pain

A Phase IV observational study investigated the use of the combined treatment in individuals with refractory neuropathic pain, defined as pain that did not respond adequately to at least two prior standard-of-care treatments. Researchers assessed reported pain levels using the Visual Analog Scale (VAS).

  • Observed findings: Study participants reported a sustained level of pain reduction compared to baseline, although no placebo control was utilized in this design. The study suggested that the combined approach may offer a potential option where initial therapies have not been sufficient. However, evidence remains limited due to the small size and non-randomized design of the study.

Long-Term Safety and Tolerability Data

A review of post-marketing data and extended open-label extensions from Phase III trials provided insight into the long-term safety profile of the drug combination, extending the observation period beyond one year.

Outcome Assessed Findings Reported
Tolerability beyond 52 weeks The overall incidence of reported adverse events did not significantly increase after the first year of treatment.
Discontinuation rate The rate of discontinuation due to adverse events was low, suggesting that the drug combination was manageable for long-term use in the study population.
Liver function No new or unexpected changes in markers of hepatic function were observed in the long-term data reviewed.

These findings suggest that, based on current observational evidence, the combined treatment is manageable and does not appear to present new safety concerns when used for periods exceeding one year in the studied population.

Frequently Asked Questions (FAQ)

Common questions about Xtra (FAQ)

Q: How quickly does Xtra usually start to work?

A: Studies and official product information indicate that the active ingredients begin to enter the bloodstream relatively quickly. Peak concentrations, which suggest the maximum effect on the body, typically occur between one and three hours after the oral dose is taken.


Q: Is Xtra something I have to take long-term?

A: Official guidelines for this class of medicine advise using the lowest effective amount for the shortest duration necessary to control symptoms. Official guidance indicates that long-term use requires periodic consideration.


Q: What should I do if I miss a scheduled dose of Xtra?

A: If a dose is missed, regulatory guidance indicates skipping the missed dose is advised, and you should continue with your next regularly scheduled dose. Official documents explicitly state that doubling the dose to make up for the missed one is prohibited.


Q: What is the maximum duration of use described in the regulatory information for Xtra?

A: Official regulatory documents do not set a fixed maximum duration of time for use. Instead, they emphasize that the lowest effective dose should be used for the shortest possible duration. Research evidence has examined the tolerability of the medicine for periods extending beyond one year.


Q: What happens if I accidentally take two doses of Xtra close together?

A: Regulatory information on overdose reports that high amounts may lead to effects on the gastrointestinal tract, the central nervous system, and the kidneys. If an overdose is suspected or you experience concerning symptoms, seeking emergency medical attention is advised.


Q: How is Xtra eliminated from the body?

A: The active components are primarily processed and broken down by the liver (hepatic metabolism). The inactive forms (metabolites) are then predominantly excreted from the body via the urine.


Q: What does the Patient Information Leaflet for Xtra say about managing side effects?

A: The patient information documents classify adverse reactions by frequency and type and instruct patients to contact a healthcare professional immediately if they experience any serious adverse reactions, such as severe skin issues or internal bleeding.


Q: Can people with diabetes use Xtra?

A: Official documents identify diabetes mellitus as a cardiovascular risk factor that requires careful consideration with this class of medicine. A healthcare professional can determine if the medicine is appropriate, and monitoring may be required.


Q: What does the official documentation say about Xtra and driving or operating machinery?

A: Regulatory documentation advises that side effects affecting the nervous system, such as dizziness or drowsiness, have been reported. Patients who experience these effects are advised to use caution when performing activities that require concentration, such as driving or operating machinery.


Q: Does Xtra contain any common allergens or ingredients?

A: The inactive ingredients in the tablet formulation include lactose monohydrate. Official documents also note that one of the active components, Valdecoxib, is a sulfonamide derivative, which is listed as a known hypersensitivity contraindication.


Q: Are there any specific foods or drinks that should be avoided when taking Xtra?

A: Official regulatory information notes that consuming alcohol may increase the risk of gastric bleeding while using this medicine. The tablets are described as being taken preferably with or after food.


Q: What are the most common side effects reported with Xtra?

A: Clinical trial data indicate that common adverse reactions affecting more than 2% of participants include gastrointestinal issues. These commonly include abdominal pain, dyspepsia (indigestion), nausea, and diarrhea.


Q: Does Xtra cause weight gain or loss?

A: Regulatory safety data for one of the active components includes reports of both increases and decreases in weight. These were noted as metabolic side effects and were observed in less than 2% of patients during clinical trials.


Q: Is it common to feel tired when starting Xtra?

A: The official safety profile for one of the active ingredients lists general adverse events such as fatigue and asthenia (lack of energy). These have been reported in post-marketing surveillance.


Q: Does Xtra change how other medicines are absorbed in the body?

A: Regulatory documents state that this medicine can affect how the body removes certain substances. Specifically, it can inhibit the renal clearance (kidney removal) of medicines such as Lithium and Methotrexate, leading to increased concentrations of those medicines in the blood.


Q: Why do official prescribing documents mention specific laboratory tests?

A: Official documentation recommends laboratory tests, such as checks of liver function, kidney function, and blood counts. These are advised, especially for patients on long-term treatment, to monitor for potential adverse effects of the medicine.


Q: What should I know about the warning labels on Xtra?

A: The medicine's official labeling includes prominent warnings common to this class of drug. These alerts cover potential serious cardiovascular thrombotic events (like heart attack or stroke) and serious gastrointestinal events (like bleeding or perforation), and they advise against use in certain high-risk patients.


Q: Does Xtra cause any skin reactions or rashes?

A: The official safety profile includes reports of general skin reactions and rashes. Rare, severe skin reactions, such as Stevens-Johnson syndrome (SJS), have been documented as potential risks associated with the active components.


Q: How long does Xtra stay in the system after the last dose?

A: The average time it takes for the body to eliminate half of the dose (the half-life) varies for the two active ingredients. Aceclofenac's half-life is approximately four hours, while Valdecoxib's half-life ranges from eight to eleven hours.

How should Xtra be stored and disposed of?

The official regulatory requirements for Xtra (Aceclofenac/Valdecoxib FDC) mandate specific conditions for storage and handling to maintain product stability and ensure safety.

Detail Requirement
Storage Temperature Store the medicinal product below 30 C and keep it away from excessive heat or freezing.
Protection & Packaging Mandatory to protect from light and moisture, and store the tablets in their original blister packaging.
Shelf Life The product has a labeled shelf life of 3 years when stored under the recommended conditions.
Child Safety The medicine must be kept out of the reach and sight of children.
Disposal Unused or expired product must be disposed of in accordance with local requirements, with the FDA preferring a registered drug take-back program.

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

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