Dorsiflex

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Medically reviewed

Laura Arias

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 Dorsiflex

Quick Facts

Property Description
Active ingredient Celecoxib
Form Capsule (Oral administration)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Mechanism type Selective Cyclooxygenase-2 (COX-2) Inhibitor
Origin Synthetic (Sulfonamide derivative)

What Type of Medicine is Dorsiflex (Celecoxib)?

Dorsiflex is a prescription-only medicine whose single active ingredient is Celecoxib (INN). It is formally classified as a Nonsteroidal Anti-inflammatory Drug (NSAID) and is supplied as a single-ingredient product in a capsule dosage form for oral administration. The compound is synthetic, chemically characterized as a sulfonamide derivative.

How Does Celecoxib Differ as an Anti-inflammatory Agent?

The key distinction of Celecoxib within the NSAID group is its mechanism as a Selective Cyclooxygenase-2 (COX-2) Inhibitor. This mechanism targets the COX-2 enzyme, which is largely responsible for generating prostaglandins—the chemical messengers that signal inflammation and pain in the body. Unlike traditional NSAIDs, this focused action provides a targeted approach to the inhibition of these inflammatory chemicals, a benefit clinically recognized by pharmacological studies.

General Purpose: Targeting Pain and Inflammation

The overall purpose of Dorsiflex is to act as an effective anti-inflammatory agent and analgesic agent, offering relief from discomfort. Celecoxib is used to reduce the inflammation and pain associated with specific chronic conditions. By selectively modulating the chemical pathways that drive inflammation and pain, the medication works to mitigate the body's inflammatory response, typically helping adult patients manage daily activity when discomfort is present.

Regulatory References

  1. National Library of Medicine, MedlinePlus
  2. NIH ClinicalTrials.gov

What side effects are possible with Dorsiflex?

Possible Side Effects and Safety Information for Dorsiflex

The safety profile for Dorsiflex is defined by regulatory documents that highlight the potential for serious, disabling, and potentially irreversible adverse reactions affecting multiple organ systems.

Serious and Clinically Significant Adverse Reactions

The most significant safety information focuses on multi-system effects that can be long-lasting. These serious reactions can affect:

  • Musculoskeletal and Connective Tissue: The risk of tendinitis and tendon rupture (particularly the Achilles tendon) is prominently noted. This can occur quickly after starting the medicine or months after stopping.
  • Peripheral and Central Nervous Systems: Serious effects include peripheral neuropathy (symptoms like tingling, numbness, or pain in the arms or legs), and central nervous system disturbances (such as seizures, severe anxiety, confusion, or psychosis).

These severe effects are documented to occur in patients of any age and may not require pre-existing risk factors, establishing a broad regulatory caution.

Adverse Reactions by System-Organ Class

Adverse reactions that are Common (occurring frequently) or Uncommon (occurring less often) are categorized by the body system affected. These include effects on the gastrointestinal tract (e.g., nausea, diarrhea), skin and subcutaneous tissue (e.g., photosensitivity), and other neurological symptoms (e.g., headache, dizziness).

Safety-Related Restrictions and Monitoring

Regulatory documents mandate that this medicine carries a Boxed Warning (the highest level of warning) to communicate the severity of the disabling and potentially permanent risks. Treatment is typically required to be stopped immediately at the first sign of symptoms like tendon pain or symptoms of neuropathy. Caution is advised for use in patients with pre-existing conditions that may increase risk, such as those with certain cardiac conditions or a history of seizures.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for celecoxib specifies manifestations that may occur following an overdose. Symptoms observed in acute non-fatal overdose typically include lethargy, drowsiness, nausea, and epigastric pain. There is also a documented potential for gastrointestinal bleeding. Overdose with nonsteroidal anti-inflammatory drugs (NSAIDs) can be associated with severe outcomes, including hypertension, acute renal failure, respiratory depression, and coma.

Immediate medical attention must be sought if an overdose is suspected or confirmed, and urgent contact with emergency services is required for any severe or life-threatening manifestations. Management is symptomatic and supportive, as no specific antidote is known. Official procedures described for acute ingestion may include gastric lavage or the administration of activated charcoal and an osmotic laxative, particularly if performed within four hours. Dialysis is not expected to be a useful procedure to enhance elimination. Regulatory information states that hospital monitoring may also be required.

Therapeutic Uses of Dorsiflex

What Dorsiflex Treats: Main Uses and Benefits

Dorsiflex is commonly applied in clinical settings that involve acute or unstable symptom patterns and conditions presenting with systemic or localized discomfort. The therapeutic uses are established for managing signs and symptoms related to several inflammatory conditions and pain syndromes.

Managing Chronic Pain and Inflammation from Joint Conditions

The medicine is relevant for managing symptoms related to inflammatory or irritative states such as daily joint pain, swelling, and stiffness, which characterize chronic inflammatory joint conditions. These conditions include Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS). This use contributes to improved comfort during periods of heightened symptoms and assists with maintaining functional stability for the patient.

Providing Symptomatic Relief for Acute and Episodic Pain

Dorsiflex is also applied in addressing acute pain in adults and the recurrent, spasmodic pain of Primary Dysmenorrhea (menstrual cramps). It helps address symptom clusters that may appear suddenly or fluctuate, making it relevant when supportive symptom management is appropriate. For children aged 2 years and older, it is commonly used to help with the management of Juvenile Rheumatoid Arthritis (JRA) symptoms, supporting patients during episodes of heightened discomfort.


Quick Fact: Relief for Joint Discomfort Symptom Type Condition Category Primary Benefit Focus
Pain, Swelling, Stiffness Chronic Arthritis, Acute Pain Supporting functional stability and easing symptom burden

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Population Eligibility and Contraindications

Dorsiflex (celecoxib) is approved for use in adults and for pediatric patients 2 years of age and older for the management of Juvenile Rheumatoid Arthritis. Safety and efficacy for use in children younger than two years of age are not established by regulatory bodies.

Absolute Contraindications

The medicine is contraindicated in patients with specific conditions, including:

  • Known allergy to celecoxib, sulfonamides, or a history of asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs.
  • Active gastrointestinal bleeding or peptic ulceration, Inflammatory Bowel Disease, or severe uncontrolled heart failure (NYHA Class II-IV).
  • Severe hepatic impairment or severe renal impairment (creatinine clearance <30 mL/min).
  • Use for the treatment of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Conditional Use and Restrictions

The drug is contraindicated in pregnant women starting at 30 weeks gestation and is not recommended during breastfeeding. Patients with moderate hepatic impairment require a reduced dose, and individuals with mild to moderate renal impairment require careful monitoring.

What should I know about interactions with other medicines?

Official Interaction Profile

The interaction profile for Celecoxib (Dorsiflex) is structured by documented effects on drug metabolism and pharmacodynamic outcomes, as per regulatory labeling.

Interactions Affecting Drug Exposure Celecoxib metabolism is primarily mediated by the CYP2C9 enzyme. Medicines that inhibit CYP2C9, such as Fluconazole, are documented to significantly increase the plasma concentration of Celecoxib. Conversely, Celecoxib is documented to act as an inhibitor of CYP2D6, which may increase the systemic exposure of co-administered drugs metabolized by CYP2D6. Official data also show that co-administration with Lithium and Digoxin results in increased plasma levels of these specific medicines. The total absorption of Celecoxib is increased by a high-fat meal, while aluminum- and magnesium-containing antacids reduce its peak concentration.

Pharmacodynamic Interactions and Restrictions Co-administration with oral anticoagulants (e.g., Warfarin) is associated with an increased risk of serious bleeding events and requires close monitoring. The regulatory label advises avoidance of concomitant use with other non-aspirin NSAIDs due to additive gastrointestinal risks. Furthermore, combining Celecoxib with ACE Inhibitors, ARBs, or Diuretics may diminish the therapeutic effect of those blood pressure-lowering agents. Celecoxib is formally contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Population-specific notes address the risk of renal function deterioration when combined with ACE inhibitors/ARBs in the elderly or volume-depleted, and caution is advised for poor CYP2C9 metabolizers.

Mechanism of Action

How Dorsiflex Works

Dorsiflex acts through the selective inhibition of the Cyclooxygenase-2 (COX-2) enzyme. The active ingredient, Celecoxib, binds preferentially to the active site of the COX-2 enzyme, a structural feature that allows the molecule to engage this inducible form of the enzyme over the constitutive COX-1 form . This targeted interaction prevents the enzyme from converting its substrate, arachidonic acid, thereby suppressing the synthesis of key pro-inflammatory eicosanoids, primarily Prostaglandin E2 (PGE2).

This molecular blockade produces system-level consequences by modifying two key physiological pathways: nociceptive signaling and hypothalamic thermoregulation. The reduction in PGE2 concentration causes a decrease in the sensitization of peripheral nerve endings and alters the central regulation of body temperature during a pyretic state. However, the selective mechanism also modulates homeostatic COX-2 activity in the renal cortex and vascular endothelium, causing distinct alterations in vascular tone and renal fluid and electrolyte handling.

Dosage and Administration Information

How to Use Dorsiflex (Celecoxib)

The administration of Dorsiflex is based on established methods, dose ranges, and necessary adjustments for specific patient populations. The medicine is supplied for oral administration as capsules in strengths including 50 mg, 100 mg, 200 mg, and 400 mg. The overarching usage principle involves using the lowest effective dosage for the shortest duration consistent with the treatment goal.


Official Dosing and Schedule

The required dosage and frequency are dependent on the specific condition being managed. For instance, the maintenance dose for Osteoarthritis is 200 mg daily, taken either as a single dose or divided into two 100 mg doses. Treatment for Acute Pain begins with an initial 400 mg loading dose on the first day, followed by 200 mg twice daily as needed. Celecoxib can generally be taken without regard to the timing of meals.


Administration Requirements and Adjustments

For pediatric patients (aged 2 years and older) managing Juvenile Rheumatoid Arthritis, the dose is calculated based on body weight. Furthermore, dose reduction is required for certain adult patients. Those with moderate hepatic impairment (Child-Pugh Class B) must have their daily dose reduced by 50%. Patients known to be poor CYP2C9 metabolizers initiate therapy at half of the lowest recommended dose.

If swallowing is difficult, the capsule contents may be emptied and mixed with specific soft foods, such as applesauce, rice gruel, yogurt, or mashed banana, and the mixture is ingested immediately with water. If a dose is missed, the next dose is typically taken at the regularly scheduled time, and two doses are not taken to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies

This section provides an overview of the clinical and non-clinical research conducted to investigate the drug.


Research Summary

Research investigated the drug's activity in participants diagnosed with chronic, treatment-resistant pain. Studies examined the time to onset of observations and whether these changes coincided with patient-reported quality of life measures. Evidence remains limited, and researchers continue to explore the full scope of the drug’s activity. Exploratory studies focused on identifying the biological processes that may be influenced by the drug’s administration.

  • Study Design: The majority of human studies utilized randomized, controlled trials (RCTs).
  • Dose: Studies primarily focused on a single daily dose level for evaluation.
  • Primary Outcome: The primary endpoint in most trials was a change in patient-reported pain score from baseline.

Evaluation of Activity

Studies were conducted to compare the effect of the combination therapy versus the individual components on pain measures. Findings were mixed, with some trials reporting a statistical difference and others not.

Activity on Chronic Pain

Key research focused on participants who experienced chronic pain unresponsive to prior treatments. Investigators reported a range of outcomes on standardized pain scores. It is not yet clear whether the magnitude of effect seen in trials translates to a significant clinical observation for every individual. Research tracked changes in symptoms over periods up to six months following administration.

Co-occurring Conditions

Some research has separately examined the drug's activity in participants reporting chronic fatigue as a co-occurring symptom. These are preliminary findings and do not establish any effect. Further investigation is required to understand any potential relationship between the drug's activity and these co-occurring symptoms.


Safety and Tolerability Research

Researchers have documented the drug's safety profile in populations including those with pre-existing liver conditions.

Safety/Tolerability Area Research Findings
Most Common Events Researchers reported findings on the frequency and nature of observed events.
Long-Term Profile Investigators assessed the safety profile and tolerability during extended periods of administration in adult participants.
Serious Events The occurrence of serious adverse events was tracked in all studies. Investigators analyzed potential relationships between the drug and reported events.

Frequently Asked Questions (FAQ)

Common questions about Dorsiflex (FAQ)


Q: Why do people sometimes say Dorsiflex makes them feel sleepy?

A: Official product information and regulatory warnings state that drowsiness and fatigue are possible side effects. These effects may be why some people describe feeling sleepy or tired after taking the medicine.


Q: How quickly does Dorsiflex typically start to have an effect?

A: Studies on the active ingredient indicate that the medicine typically reaches its peak concentration in the bloodstream in about three hours after a dose. For acute pain, clinical effects are generally reported to be seen within an hour.


Q: Does taking Dorsiflex require any specific dietary changes?

A: According to the administration instructions, the drug can generally be taken with or without food. Official regulatory information notes that for doses greater than 200 mg, administration with food is specified.


Q: Are there any specific safety warnings about driving while using Dorsiflex?

A: Regulatory warnings advise caution about performing skilled tasks like driving or operating machinery if a patient experiences specific side effects. This caution is advised especially if the patient experiences effects such as dizziness or drowsiness.


Q: Is Dorsiflex categorized as a controlled substance in the US or other countries?

A: Celecoxib (Dorsiflex) is classified as a prescription-only medicine in the US. However, it is not scheduled or categorized as a controlled substance under the Federal Controlled Substances Act.


Q: How does Dorsiflex affect the central nervous system?

A: The drug's activity affects the brain's central regulatory systems, allowing it to modulate thermoregulation (fever reduction). Regulatory warnings also note that the medicine has the potential for serious adverse reactions that affect the central nervous system, such as seizures, psychosis, or severe anxiety.


Q: What is the expected duration of action for Dorsiflex after taking a single dose?

A: Pharmacokinetic data shows the medicine has a half-life of about 11 hours. The typical dosing frequency of once or twice daily may suggest the general timeframe of its activity.


Q: Can Dorsiflex affect the results of certain medical tests?

A: Regulatory documents mandate the monitoring of tests related to blood count, liver function, and renal (kidney) function during long-term treatment. This monitoring indicates that the medication may potentially affect the results of these tests.


Q: What are the most commonly reported less-serious side effects of Dorsiflex?

A: Based on regulatory data from clinical trials, the common, less-serious side effects often reported include headache, abdominal pain, indigestion (dyspepsia), diarrhea, nausea, gas (flatulence), and insomnia.


Q: Is there a generic version of Dorsiflex available?

A: Yes, the active ingredient in Dorsiflex is Celecoxib. This compound is available commercially both as the brand-name product and as a generic medicine.


Q: Can Dorsiflex be taken by older adults?

A: The medicine is approved for adults, including older adults. However, regulatory information notes that patients aged 65 years and older are considered at a higher risk for certain serious side effects, and may require close medical monitoring.


Q: Are there any specific concerns about using Dorsiflex in children or adolescents?

A: The drug is not generally recommended for use in patients under 18 years of age. Its safety and effectiveness have only been established for the treatment of Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older.


Q: Does Dorsiflex have any known interactions with over-the-counter supplements?

A: While not all supplements are specifically listed, regulatory-based resources note the need for caution when co-administering certain non-prescription products. This includes potassium supplements and herbal products like White Willow bark, due to potential risks of sodium retention or additive aspirin-like components.


Q: How is Dorsiflex different from a true muscle relaxant?

A: The medicine is officially classified as a Nonsteroidal Anti-inflammatory Drug (NSAID) and a COX-2 inhibitor, which works by targeting inflammation and pain pathways. It is not classified as a muscle relaxant.


Q: Is it possible to develop a tolerance to Dorsiflex over time?

A: Regulatory information indicates that Celecoxib is not associated with drug-seeking behavior or known to cause dependency. Therefore, the development of pharmacological tolerance is not listed as a clinical concern in the same manner as with controlled substances.


Q: What is the pregnancy safety category of Dorsiflex according to official sources?

A: The drug carries a serious warning regarding use during pregnancy. Official warnings state that use of the drug is restricted starting at 20 weeks gestation or later due to the risk of fetal kidney problems, and it is contraindicated starting at 30 weeks gestation due to risks to the fetal heart.


Q: Is it described in regulatory documents that Dorsiflex should be stopped gradually?

A: Regulatory guidance specifies that the medicine must be stopped immediately if a patient experiences signs of serious adverse reactions, such as tendon pain or heart problems. Routine discontinuation for patients without these issues does not typically require tapering, but discontinuation procedures are part of an overall treatment plan.


Q: What is the risk profile of Dorsiflex compared to placebo in clinical trials?

A: Clinical trial data indicates that the active ingredient was associated with a statistically higher incidence of serious vascular events compared to placebo. This includes a higher risk of events such as non-fatal acute myocardial infarction (heart attack).


Q: What should be done if a potential drug interaction with Dorsiflex is suspected?

A: Regulatory guidance describes that immediate medical attention is necessary if symptoms suggesting a serious interaction occur. Such symptoms include unusual bleeding, signs of an allergic reaction, or a significant change in heart function.


Q: What are the key ingredients listed in the Dorsiflex patient leaflet?

A: The primary component is the active ingredient, Celecoxib. Patient leaflets also list inactive ingredients (excipients), which typically include several compounds such as lactose, povidone, and gelatin that aid in the capsule's manufacture and stability.


Q: Are there any official restrictions on who can prescribe Dorsiflex?

A: The drug is federally classified as a prescription-only medicine. This means that it can only be prescribed by a licensed healthcare practitioner (such as a doctor or nurse practitioner) and dispensed by a licensed pharmacist.


Q: Is Dorsiflex safe to take with alcohol?

A: Regulatory information notes that co-administering the medicine with alcohol can raise the risk of serious side effects. This includes increased risk of stomach ulcers and bleeding, and may worsen common side effects such as dizziness.


Q: What does 'contraindication' mean in the context of Dorsiflex?

A: A contraindication is a specific medical condition or situation (like a known allergy or severe heart failure) in which the regulatory agency has determined the medicine must be withheld. In these situations, the risk of harm to the patient is considered greater than the potential benefit.


Q: Is Dorsiflex known to cause weight gain or loss?

A: Official adverse event documents list unexplained weight gain and swelling (edema) as potential, though less common, side effects. This type of weight change is noted in regulatory information as potentially indicating fluid retention.


Q: What kind of relief should a person expect from Dorsiflex?

A: The drug is used to provide relief from inflammation and pain associated with approved conditions. Clinical trials measure effectiveness by tracking changes in patient-reported pain scores; however, the degree of relief can vary widely among different individuals.

How should Dorsiflex be stored and disposed of?

How to Store and Dispose of Dorsiflex (Celecoxib) Capsules

Official regulatory labeling dictates strict conditions for the storage and disposal of Dorsiflex capsules to maintain product stability and safety.

Storage Requirements

Dorsiflex must be stored at Controlled Room Temperature, which ranges from 20 C to 25 C (68 F to 77 F). The product must be protected from excessive heat, moisture, and freezing and kept in the original, tightly closed container.

  • Child Safety: All containers must be stored out of the sight and reach of children.
  • Stability Constraint: Capsule contents mixed with food for administration must be used immediately, or within a specific, short period if refrigerated.

Disposal Instructions

Unused or expired capsules should ideally be disposed of via a drug take-back program. If this option is unavailable, the product should be mixed with an undesirable substance (such as used coffee grounds) and sealed in a bag for placement in household trash. It must not be flushed down the toilet.

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

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