Roxazin

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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 Roxazin

Quick Facts

Property Description
Active ingredient Piroxicam
Forms Tablets, Capsules, Gel, Injection
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Relief of pain and inflammation
Origin Synthetic

Roxazin is a brand name for a medication whose active ingredient is Piroxicam. It is a foundational medicine used to address and provide relief from symptoms associated with pain, inflammation, and stiffness.

What Type of Medicine is Roxazin?

Roxazin is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), a large class of synthetic compounds used to manage pain and swelling. Piroxicam belongs to a specific chemical subgroup within the NSAID family known as the oxicams, which are recognized for their typically long duration of action compared to many other common pain relievers. This extended effect is clinically recognized for providing sustained symptomatic management in adults.

Piroxicam is a potent anti-inflammatory agent. This action highlights that the medicine has a confirmed role in reducing swelling and heat in affected tissues, which is particularly valuable for managing chronic inflammatory conditions.

Composition and Available Forms

The active ingredient in Roxazin is Piroxicam, a synthetic compound that forms the basis of this single-ingredient product. Piroxicam is available in several high-level dosage forms, including standard capsules or tablets for swallowing, gels or creams for topical use, and solutions intended for parenteral (injection) administration. The availability of these various forms, which allows for oral, topical, or other routes of administration, provides flexibility to target inflammation and pain either locally or systemically.

Roxazin's General Role and Purpose

The general purpose of Roxazin is to reduce the chemical signaling that causes discomfort and swelling in the body. As an NSAID, its role is to directly intervene in the processes of inflammation and pain sensation, thereby providing relief and improving mobility. This action makes it broadly suitable for managing symptoms where tissue inflammation and resulting pain are key issues.

What side effects are possible with Roxazin?

Possible side effects and safety information

The general principles governing how side effects appear in clinical use emphasize that the safety characteristics of Roxazin (Piroxicam) are consistent with its classification as a Nonsteroidal Anti-inflammatory Drug (NSAID).

Regulatory documentation outlines adverse reactions by frequency and physiological system, establishing the overall safety profile.

Key Safety Classifications and Organ Systems

Category Description and Examples
Common Effects Reactions occurring in geq1/100 individuals, primarily affecting the Gastrointestinal Disorders (e.g., nausea, abdominal discomfort, flatulence) and Nervous System Disorders (e.g., headache, dizziness).
Uncommon Effects Reactions occurring in geq1/1,000 to <1/100 individuals, often related to changes in laboratory results, such as decreased haemoglobin or elevated serum creatinine.
Rare Effects Serious, life-threatening reactions (<1/1,000) listed in the official label, including severe cutaneous adverse reactions like Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Serious Adverse Reactions and Safety Patterns

The medicine is associated with risks of serious adverse reactions explicitly documented in official labeling, particularly involving the cardiovascular and gastrointestinal systems. These include potentially fatal cardiovascular thrombotic events (such as myocardial infarction and stroke) and severe complications like gastrointestinal bleeding, ulceration, and perforation. Official safety notes indicate that the risk of these serious events generally increases with the duration of use.

Population-Specific Safety Notes

The safety documentation highlights that older adults are at a greater regulatory risk for developing serious gastrointestinal events and fatal outcomes from cardiovascular events. Furthermore, the medicine is subject to specific safety limitations, including being contraindicated for the treatment of peri-operative pain following Coronary Artery Bypass Graft (CABG) surgery.

Overdose and Emergency Response

Roxazin (Piroxicam) overdosage is documented in regulatory prescribing information as a serious event that may involve multiple physiological systems. Documented manifestations can include gastrointestinal symptoms such as nausea, vomiting, stomach pain, and diarrhea. More severe effects involving the central nervous system may present as agitation, confusion, seizures, decreased level of consciousness, and potentially coma. Other signs of systemic toxicity include cardiorenal effects like low blood pressure (hypotension) and little or no urine production, suggesting acute kidney injury. Urgent medical help must be sought immediately if overdosage is suspected or if severe symptoms, such as difficulty breathing or signs of internal bleeding, are observed. The official regulatory stance confirms that no specific antidote for Piroxicam overdosage is known. Therefore, the required treatment involves entirely symptomatic and supportive measures, including administering activated charcoal, monitoring vital signs, and ensuring continuous observation in a controlled setting. Individuals with pre-existing kidney or liver conditions are noted to be more susceptible to serious adverse outcomes in such scenarios.

Therapeutic Uses of Roxazin

What Roxazin Treats: Main Uses and Benefits

Roxazin is commonly used to manage conditions presenting with systemic or localized discomfort such as Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Acute Gout, and Primary Dysmenorrhea. It is applied in addressing symptom clusters that create noticeable physiological strain, including joint pain, swelling, and stiffness. This approach is generally applied in clinical settings that involve acute or unstable symptom patterns, such as during sudden, intense flares or in post-operative recovery scenarios.

The medication is considered relevant for easing symptoms that interfere with daily functioning. The relief provided is applied in addressing symptoms related to physical discomfort, such as reducing fever and discomfort.

“The medication supports patients during difficult episodes by easing distress.”


Quick Fact Block

Property Description
Main Therapeutic Role Supports symptomatic management across key domains
Symptoms Targeted Helps address symptom clusters that may become intense, such as pain, swelling, and stiffness
Use Context Commonly used for both chronic management and acute flare intervention

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

The eligibility profile for Roxazin (Piroxicam) is defined by multiple absolute contraindications and age-based restrictions documented in governmental regulatory labeling.

Classification Population or Condition
Contraindicated History of asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
Contraindicated History of gastrointestinal ulceration, bleeding, or perforation
Contraindicated Severe uncontrolled heart failure, severe renal insufficiency, or severe hepatic insufficiency
Contraindicated Treatment of pain during the peri-operative period of Coronary Artery Bypass Graft (CABG) surgery
Contraindicated Third trimester of pregnancy (from approximately 30 weeks gestation and later)
Contraindicated Children under 12 or 15 years of age (varies by regional label)
Use Not Established General pediatric population (safety and efficacy not formally established)

Restricted and Conditional Use: Use should be avoided in patients over 80 years and monitored closely in those over 70 due to increased risk of complications. Caution is mandatory for patients with impaired renal, hepatic, or cardiac function and for those with severe dehydration (which must be corrected prior to use). The use of Roxazin is generally restricted to adults for officially approved chronic inflammatory conditions. It is not recommended for use in nursing mothers or in women attempting to conceive.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Roxazin is defined by specific regulatory restrictions and classifications involving co-administered substances, and not by therapeutic claims or safety narratives.

Prohibited Combinations and Formal Restrictions

Co-administration of Roxazin is strictly restricted with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including COX-2 selective inhibitors and analgesic doses of Aspirin. This rule is documented due to an enhanced risk of serious gastrointestinal events. Similarly, co-use with Oral Anticoagulants (such as Warfarin and Direct Oral Anticoagulants) is prohibited because of a significantly increased risk of bleeding. The medicine is also contraindicated for use in the peri-operative setting of coronary artery bypass graft (CABG) surgery.

Pharmacodynamic and Exposure Risks

The simultaneous administration of Roxazin with certain medicines creates additive pharmacodynamic risks. These include an increased risk of gastrointestinal bleeding when combined with Corticosteroids, Antiplatelet agents, or SSRIs/SNRIs. Conversely, Roxazin can reduce the intended effects of Anti-hypertensives, such as ACE Inhibitors and Diuretics. From a pharmacokinetic perspective, Roxazin co-administration is known to increase the serum concentrations and systemic exposure of agents like Lithium and Digoxin.

Substance and Population-Specific Notes

The metabolism of Roxazin involves the CYP2C9 enzyme; individuals who are CYP2C9 poor metabolizers may exhibit abnormally high systemic plasma levels due to reduced metabolic clearance. The co-ingestion of alcohol is formally documented to increase the risk of gastrointestinal mucosal bleeding.

Mechanism of Action

Roxazin's action involves modulation of biochemical and neural pathways related to inflammatory and nociceptive pathways.


Modulating the Eicosanoid Pathway via Enzyme Inhibition

The drug acts primarily by non-selectively inhibiting the activity of both Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) enzymes. This molecular interaction blocks the conversion of arachidonic acid into pro-inflammatory mediators, such as Prostaglandins ( PGE2). By suppressing the synthesis of these chemicals, the drug modifies early molecular steps that shape systemic physiological outcomes. The modification of this pathway results in a reduction of local vasodilation and fluid extravasation.


Peripheral and Central Modulation of Nociceptive Signaling

Roxazin's mechanisms influence nociceptive processes via both peripheral and central components. Peripherally, the reduced availability of Prostaglandins alters the activation threshold of peripheral nociceptors (pain receptors). Centrally, the drug also acts as an agonist at Alpha-2 Adrenoceptors (alpha2-adrenoceptors) to influence descending inhibitory pathways in the spinal cord. The combined effect results in an altered state of transmission within nociceptive signaling pathways. This alters the signaling output driven by chemical and neural activation.

Dosage and Administration Information

Roxazin, which contains the active ingredient Piroxicam, is primarily administered via the oral route as a capsule or tablet for systemic action, although topical and parenteral formulations may also be available. The core usage principle is to utilize the lowest effective dose for the shortest necessary duration.

For chronic conditions such as Osteoarthritis and Rheumatoid Arthritis, the standard maintenance regimen is typically 20 mg taken once daily. An alternative divided dose of 10 mg twice daily is also permitted. It is essential not to exceed the 20 mg daily limit for long-term use. Higher dosing is reserved for the management of acute episodes; for instance, the dosage for acute gout is initiated at 40 mg daily, but this regimen must be strictly limited to a short duration of four to six days.

Due to the drug’s long half-life, the full therapeutic effect should not be assessed for up to two weeks, and a clinical review of the treatment benefit and tolerability is conducted within the first 14 days of initiation. To minimize the potential for local gastric effects, oral forms of the medicine should be ingested with or immediately after food. For certain populations, including older adults or those with impaired renal or hepatic function, a lower starting dose should be considered and use requires close monitoring.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Roxazin

Evidence for Use in Acute Uncomplicated Influenza

Research examined Roxazin for the conditions associated with acute or disruptive episodes of influenza through several controlled, short-term research scenarios, including Phase III multi-center trials. The primary research explored measurements of core influenza symptoms, including time to alleviation, and other patient-reported outcomes describing perceived discomfort. The main populations was observed in otherwise healthy patients aged 12 and older, with separate research also including high-risk patients and certain pediatric groups (5+ years).

The research describes patterns observed in the short-term symptom measurements in the observed populations, comparing these to the placebo group. These studies also monitored the duration that the virus could be detected in the body (viral shedding). What remains uncertain is that there is limited information for long-term outcomes due to the short follow-up durations. Research exploring short-term symptom changes, data for certain groups remain insufficient, particularly for patients with complex chronic medical conditions who may have been underrepresented in initial structured trials.

Evidence for Use as Post-exposure Prophylaxis

Research examined Roxazin's role as a treatment given after close contact with a person diagnosed with influenza. This was evaluated in randomized, placebo-controlled trials, primarily focusing on the household contact environment. The studies monitored one specific outcome: the proportion of household contacts developing laboratory-confirmed influenza during the monitoring period. The findings indicate patterns related to the incidence rate of confirmed influenza within the monitoring period for the Roxazin group compared to the placebo group.

What is Still Uncertain About Roxazin Research

Evidence quality varies across studies. One key gap is that comparative evidence is lacking in some areas where research has explored Roxazin against other therapies. Furthermore, long-term effects are not fully established, meaning the impact of Roxazin several months or years after treatment is not yet well understood by dedicated trials. Subgroup findings regarding specific, complex comorbidities are still emerging, and certainty remains low in some of these smaller research contexts.

Frequently Asked Questions (FAQ)

Common questions about Roxazin (FAQ)

Q: Is fatigue a commonly reported side effect of Roxazin?

According to regulatory documentation, fatigue or unusual tiredness is not consistently listed among the most common adverse reactions. However, this symptom is documented in official information as a potential sign of a serious health event, or as part of the known effects of taking too much of the medication. Official documents describe that severe or persistent tiredness may be relevant to discuss with a healthcare provider.

Q: Is it described that Roxazin can affect a person's mood or energy levels?

Official product information does classify Roxazin with a risk of Nervous System Disorders, which typically include effects like headache and dizziness. While less frequent, adverse mood changes such as anxiety or depression have been reported in rare cases or in situations of overdose. The full range of potential effects is detailed in the regulatory safety documents.

Q: Is Roxazin known to cause weight changes (gain or loss)?

Regulatory documents note that unusual weight gain or fluid retention is a potential adverse effect associated with Roxazin use. This fluid retention, technically known as edema, is an effect that official documents suggest requires observation. Official safety information indicates that this effect can sometimes be an indication of a more serious underlying condition, such as heart failure.

Q: Does Roxazin need a prescription from a healthcare provider?

Yes. The active ingredient in Roxazin, Piroxicam, is classified by major regulatory bodies as a prescription-only medication. This classification indicates that the medicine is available by valid prescription from a licensed healthcare provider.

Q: Does Roxazin have any black box warnings from the FDA or similar agencies?

Yes, the FDA label for this medication includes a Boxed Warning, which is a type of serious safety alert. This warning addresses the increased risk of potentially life-threatening cardiovascular thrombotic events, like heart attack or stroke. It also highlights the risk of serious gastrointestinal events, including bleeding and perforation, that can occur with use.

Q: Can people with diabetes use Roxazin without complications?

Official documents state that the use of Roxazin in individuals with diabetes mellitus is subject to caution and close monitoring. This is necessary because the medicine may interact with and alter the effects of oral hypoglycemics, which are common medications used to manage blood sugar.

Q: What happens if someone accidentally takes too much Roxazin?

The official product information documents the symptoms that may occur following an overdose of Roxazin. These may include effects such as dizziness, nausea, and stomach pain, and potentially more serious effects like seizures or severely low blood pressure. Official information states that medical personnel administer supportive care in cases of suspected overdose.

Q: Are there any warnings about sun exposure while taking Roxazin?

Yes. Regulatory safety information indicates that Roxazin may cause photosensitivity, which means an increased physical sensitivity to sunlight. Due to this effect, exposure to the sun may lead to an adverse skin reaction or rash while taking the medication.

Q: Does Roxazin have different trade names in other countries?

Yes. The active ingredient, Piroxicam, is a globally recognized molecule and is marketed under many different brand names around the world. Regulatory databases show that various trade names, such as Feldene and Apo-Piroxicam, are used depending on the region.

How should Roxazin be stored and disposed of?

How to Store and Dispose of Roxazin (Piroxicam)

The official storage requirements for Roxazin (Piroxicam) are designed to maintain its stability. The medication must be kept in its original, tightly closed container and stored at a controlled room temperature, typically 20 C to 25 C. Storage environments must protect the product from freezing, light, and excess moisture, which means avoiding locations like the bathroom.

Child Safety and Disposal

All medicines must be stored out of the sight and reach of children for safety. Expired or unused Roxazin must be properly disposed of. The preferred method is using a community drug take-back program. If a take-back option is unavailable, the unused product should be mixed with an unappealing substance, sealed in a container, and discarded in the household trash. Do not flush the medication down the toilet unless specifically instructed by the official labeling.

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

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