Retoflam

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Retoflam

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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 Retoflam

Property Description
Active Ingredient Meloxicam (INN)
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Forms Tablet, Capsule, Suspension, Solution for injection
General Purpose To reduce systemic inflammation, pain, and fever
Origin Synthetic compound (oxicam derivative)

What Pharmacological Class Does Retoflam Belong To?

Retoflam is categorized as a Nonsteroidal Anti-Inflammatory Drug (NSAID), containing the active substance Meloxicam. This chemical entity is a synthetic compound belonging to the Enolic Acid group of NSAIDs, utilized for its effectiveness against systemic discomfort. Meloxicam is an oxicam derivative whose differentiating pharmacological feature is its role as a Cyclooxygenase-2 (COX-2) preferential inhibitor. This mechanism-based distinction influences its profile within the NSAID class. These agents work by blocking the hormones that cause pain, fever, and inflammation in the body.

Composition and Available Pharmaceutical Forms

The preparation is a single-ingredient product focused entirely on the systemic delivery of Meloxicam, combined with necessary pharmaceutical excipients for stability and absorption. Retoflam is not a combination medicine. It is produced in several high-level Dosage forms to accommodate various administration needs, including the standard Tablet and Capsule for oral use, an oral Suspension, and a sterile Solution for injection (for parenteral use). This range in preparation allows for versatility in treating patients who may require alternative administration routes due to clinical necessity or difficulties with oral intake.

General Therapeutic Purpose and Core Action

The general therapeutic utility of Retoflam is to provide simultaneous Analgesic (pain-relieving), Anti-inflammatory (swelling-reducing), and Antipyretic (fever-reducing) effects. Its high-level action is directed at reducing the concentration of pain- and inflammation-mediating substances, known as prostaglandins. Meloxicam functions as an anti-inflammatory, analgesic, and antipyretic agent, serving to manage the symptomatic discomfort of pain and inflammation.

Regulatory References

  1. NIH confirms

What side effects are possible with Retoflam?

Possible Side Effects and Safety Information

Retoflam (Meloxicam) is associated with officially documented adverse reactions that range from common, expected events to rare, serious adverse events. This information is derived strictly from government regulatory documents.

Serious Safety Warnings

Retoflam carries mandated warnings regarding two major risks:

  • Serious Cardiovascular Thrombotic Events: The drug may increase the risk of serious events such as heart attack (Myocardial Infarction) and stroke, which can be fatal. This risk may increase with longer use and higher doses.
  • Serious Gastrointestinal (GI) Adverse Events: The drug may cause GI bleeding, ulceration, and perforation of the stomach or intestines, which can occur without warning symptoms and may be fatal.

Common Adverse Reactions

The most frequently documented side effects from clinical trials are primarily related to the GI system and general symptoms. These are considered Common (1% incidence):

System-Organ Class Common Adverse Reactions
Gastrointestinal Disorders Dyspepsia, Diarrhea, Abdominal Pain, Nausea, Flatulence
Nervous System Disorders Headache, Dizziness
General Disorders Edema (swelling)

Contraindications and Safety Restrictions

Retoflam is contraindicated (strictly forbidden) in several situations due to increased risk:

  • In the setting of Coronary Artery Bypass Graft (CABG) surgery.
  • In patients with a known history of allergic-type reactions (e.g., asthma, hives) after taking aspirin or other NSAIDs.
  • Pregnancy: Avoid use from 30 weeks gestation onward due to the risk of fetal harm.

Special Caution: Increased risk is noted for older adults and patients with underlying conditions such as severe heart failure or advanced kidney disease.

Overdose and Emergency Response

An overdose of Retoflam (Meloxicam) may initially present with common clinical signs such as lethargy, drowsiness, nausea, vomiting, and epigastric pain. These acute manifestations are generally reported in regulatory documents as reversible with appropriate supportive care.

However, severe poisoning may escalate to life-threatening outcomes requiring immediate emergency medical attention. These serious complications documented in official labeling include gastrointestinal bleeding, hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse, and cardiac arrest. Any occurrence of these severe events constitutes a trigger for urgent medical help.

The official regulatory guidance for managing an NSAID overdose mandates immediate symptomatic and supportive care. No specific antidote for meloxicam is known. Recommended procedural steps in acute situations include gastric lavage and the administration of activated charcoal, especially when administered within one to two hours following ingestion. The use of cholestyramine may also be considered to accelerate drug clearance. Due to high protein binding, procedures such as hemodialysis are indicated as potentially not useful in enhancing elimination.

Therapeutic Uses of Retoflam

What Retoflam Treats: Main Uses and Benefits

Retoflam is commonly used to provide symptomatic relief for a spectrum of joint and musculoskeletal disorders. Its primary application is relevant in conditions involving inflammatory or irritative processes, which include the chronic inflammatory joint disorders Rheumatoid Arthritis and Ankylosing Spondylitis, as well as Osteoarthritis (degenerative joint disease). The medication is also relevant for the symptomatic management of Juvenile Idiopathic Arthritis (JIA) in certain pediatric patients (ages 2 and older).

The therapeutic benefit is commonly used to help address symptom clusters that interfere with daily comfort, such as persistent joint pain, systemic inflammation, and joint stiffness. For patients, the goal is supportive relief:

“The medication supports patients during difficult episodes by easing distress and assists with maintaining functional stability when symptoms are more noticeable.”

Moderating these manifestations may assist with easing the overall symptom burden, contributes to easing the overall symptom load and supports day-to-day comfort, and may assist with maintaining a sense of stability when symptoms are more noticeable.


Quick Fact: Symptomatic Relief

This medication is applied in addressing symptoms related to inflammatory or irritative states, helps with pain and stiffness, and supports patients during difficult episodes by easing distress.

Eligibility and Restrictions for Use

Population Eligibility for Retoflam (Meloxicam)

Retoflam is officially approved for use in Adult Patients and in Pediatric Patients who are 2 years of age and older, specifically for the relief of symptoms associated with specific forms of Juvenile Idiopathic Arthritis (JIA).


Absolute Non-Eligibility (Contraindications)

Regulatory documents state that Retoflam must not be used by individuals with a known hypersensitivity to Meloxicam, or by any patient who has experienced asthma, hives, or allergic-type reactions after taking aspirin or any other Nonsteroidal Anti-Inflammatory Drug (NSAID). Use is also contraindicated for treating pain in the setting of Coronary Artery Bypass Graft (CABG) surgery and in patients with active peptic ulcers.


Restricted or Conditional Use

Age and Health Status: Safety and efficacy have not been established for children younger than two years old. Older adults (65 and over) are noted to be at greater risk for certain serious gastrointestinal events. Use is contraindicated in patients with severe renal impairment not on dialysis and in those with severe heart failure.

Pregnancy and Lactation: Use must be avoided from 30 weeks gestation and later due to potential risk to the fetus. Use is also restricted between 20 and 30 weeks gestation, and caution is recommended when used by nursing mothers.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory interaction profile for Retoflam (Meloxicam) defines specific prohibitions and requirements for co-administration with other medicinal products and substances.

The drug is contraindicated in the setting of peri-operative pain following Coronary Artery Bypass Graft (CABG) surgery. Concomitant use with other NSAIDs or with analgesic doses of Aspirin is not generally recommended due to an officially documented amplified risk of serious gastrointestinal events.

Interactions are generally classified by pharmacokinetic clearance interference and pharmacodynamic risk summation.

Co-administration with Lithium or Methotrexate is documented to increase the plasma concentrations of these respective drugs, an outcome requiring regulatory caution regarding potential toxicity. The interaction with Anticoagulants (e.g., Warfarin), SSRIs/SNRIs, or Corticosteroids is associated with an officially documented increased risk of bleeding complications.

Pharmacodynamic Antagonism may occur with antihypertensives. The antihypertensive effect of ACE Inhibitors, ARBs, and Beta-Blockers may be diminished. Furthermore, co-administration with these agents, or with Diuretics, carries an increased risk of renal function deterioration, particularly noted for the elderly or volume-depleted patients. The use of the oral suspension formulation is prohibited with Sodium Polystyrene Sulfonate due to the risk of intestinal necrosis. Alcohol consumption enhances the documented risk of serious gastrointestinal problems.

Mechanism of Action

The mechanism of action for Retoflam (Meloxicam) is defined by its targeted intervention in the body's inflammatory signaling pathways, exclusively through enzyme inhibition.

Preferential Inhibition of the COX-2 Enzyme

The primary biological targets and the nature of the drug's interaction are defined by its function as a preferential inhibitor of the enzyme Cyclooxygenase-2 (COX-2), which is significantly over-expressed at sites of inflammation. This mechanism involves the molecular blockade of a key step, preventing the conversion of the precursor molecule (arachidonic acid) into pro-inflammatory mediators.


Causal Cascade to Systemic Effect

The resulting suppression of signaling lipids, notably Prostaglandin E2 ( PGE2), reduces the sensitization of peripheral pain neurons. Furthermore, the reduction of PGE2 levels centrally permits the brain’s hypothalamic center to reset the body's elevated temperature set-point, facilitating the re-establishment of a non-fever state within targeted signaling pathways.


Concentration-Dependent Mechanism Limitation

The preferential targeting of COX-2 is highly dependent on the drug's concentration. At higher systemic levels, the inhibition of the constitutive COX-1 enzyme increases, altering the drug's mechanistic profile and diminishing its preferential inhibition ratio.

Dosage and Administration Information

Retoflam, containing Meloxicam, is officially administered via the oral route (tablet, capsule, or suspension) for chronic conditions and, in some jurisdictions, via intravenous (IV) injection for short-term, acute management. All standard regimens for both routes require once-daily administration. For the chronic management of conditions like Osteoarthritis and Rheumatoid Arthritis, the usual maintenance dosage typically falls within the range of 7.5 mg to 15 mg per day, administered as a single dose. The total daily dose must not exceed the stated maximum limit for chronic use.

When using the oral suspension, the preparation must be gently shaken before measuring to ensure accurate dosing. Oral forms may be taken with or without regard to food.

Specific modifications to the administration protocol are mandated for certain populations. The dose for pediatric patients (age 2 and older) receiving the medication for Juvenile Idiopathic Arthritis is calculated based on body weight, at 0.125 mg/kg once daily, but must never exceed 7.5 mg total per day. Furthermore, the intravenous solution is approved only for short-term use and must be administered as a single bolus over a minimum of 15 seconds.

The official instruction emphasizes adherence to the lowest effective dose for the shortest duration possible, and if a dose is missed, a double dose should not be taken to compensate.

Recent Clinical Evidence

Research evidence / Overview of Studies for Retoflam

Evidence for use in Osteoarthritis (OA) and Rheumatoid Arthritis (RA)

Research exploring Retoflam was conducted for conditions characterized by chronic pain and functional limitations, such as Osteoarthritis (OA) and Rheumatoid Arthritis (RA), and primarily comes from short-term Randomized Controlled Trials (RCTs). These studies were designed to observe outcomes compared to a placebo and to active comparators. Research has explored outcomes related to physical discomfort and daily functioning, using measures like the WOMAC Index and patient-reported outcomes describing perceived discomfort. The trials were designed to observe how symptoms evolved in the studied populations over defined time intervals.

For both conditions, studies reported measurements of change in pain scores and functional capacity that were observed over the typical trial period, which was generally short (4 to 12 weeks). Findings describe patterns observed in the studies when the medicine was compared to baseline status and to active comparators. In the context of RA, research examined outcomes related to the count of tender and swollen joints and how the measured outcomes aligned with specific clinical response criteria.

Evidence for use in Juvenile Idiopathic Arthritis (JIA)

Retoflam was studied for use in Juvenile Idiopathic Arthritis (JIA) in a specific group of children aged 2 to 16 years. These evaluations included Multicenter Randomized Controlled Trials (RCTs) and long-term extension studies, with the research focusing on episodes where symptoms become more noticeable. These studies were often active-controlled, meaning the medicine was evaluated in comparison to an active comparator medicine rather than a placebo.

What Research Gaps and Uncertainty Remain

A consistent limitation across all adult indications is that follow-up durations were limited in the primary controlled trials. This means long-term effects are not fully established or characterized by the highest-quality evidence. Data for certain groups, such as the very old or those with specific chronic diseases outside the studied rheumatological conditions, remain insufficient because these populations were often excluded from the initial RCTs. The results apply only to the populations studied, meaning there is limited information for specific outcomes in many specialized clinical subgroups.

Key Studies & References Meloxicam (StatPearls - NIH Bookshelf)

Frequently Asked Questions (FAQ)

Common questions about Retoflam (FAQ)


Q: How long does it take for Retoflam to start working after I take it?

According to the official product information, the mean maximum concentration of the drug in the blood is typically reached within four to five hours after a single oral dose of the tablet. This time point reflects when the active ingredient reaches its highest measured concentration in the blood, according to clinical studies.


Q: What should I do if I experience symptoms of a serious side effect like stomach bleeding?

Regulatory documents advise that if symptoms suggesting a serious event occur, such as bloody or black, tarry stools, or vomit that resembles coffee grounds, the medicine should be discontinued. Patients are advised to seek immediate medical attention if these symptoms develop.


Q: Can I drink alcohol while I am taking Retoflam?

Official information indicates that consuming alcohol while taking this medicine is associated with an increased risk of serious gastrointestinal adverse events. This includes an elevated risk of stomach bleeding.


Q: Is it necessary to stop taking Retoflam before surgery or dental procedures?

Regulatory information advises patients to inform their healthcare provider or dentist that they are taking this medicine before any surgical or dental procedure, due to the potentially increased risk of bleeding. The drug is strictly forbidden (contraindicated) for pain relief following Coronary Artery Bypass Graft (CABG) surgery.


Q: How should I store the Retoflam medicine?

The official product labeling states the medicine should be stored at Controlled Room Temperature, typically between 20 C and 25 C. It must be kept in a tightly closed container, protected from freezing, excessive heat, and moisture, and stored out of the sight and reach of children.


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

Official instructions state that if a dose is missed, a patient should not take a double dose to compensate for the missed one. Consistent with official instructions, the total daily dose should not exceed the maximum limit stated for chronic use.


Q: Can Retoflam be taken with blood thinners like Warfarin?

Regulatory documents confirm that the use of Retoflam with anticoagulants like Warfarin is associated with an officially documented increased risk of bleeding complications. The decision to use this medicine concurrently with other drugs is a matter for the patient's healthcare provider.


Q: How does Retoflam work to relieve pain and swelling?

The drug works by acting as a preferential inhibitor of the Cyclooxygenase-2 (COX-2) enzyme. This mechanism helps to prevent the production of certain substances in the body called pro-inflammatory mediators, which ultimately reduces pain, inflammation, and fever.

How should Retoflam be stored and disposed of?

Retoflam (meloxicam) must be stored and disposed of according to strict requirements defined by regulatory labeling to maintain stability and ensure safety.

Official Storage Conditions

The product must be stored at Controlled Room Temperature, typically maintained between 20 C and 25 C (68 F and 77 F). The medicine must be protected from freezing, excessive heat, and moisture and should be stored in a tight container. For safety, it is mandated that the medication be kept out of the sight and reach of children.

Disposal Instructions

Unused or expired Retoflam must be properly discarded. Disposal must adhere to local and national regulations, which often recommend utilizing authorized drug take-back programs. When such programs are unavailable, disposal should follow the official guidance for non-hazardous pharmaceutical waste.

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

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