Entercote

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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 Entercote

Property Description
Active ingredient Acetylsalicylic Acid (ASA) / Aspirin
Form Enteric-coated tablet (Delayed-release oral preparation)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID) and Antiplatelet Agent
General purpose Symptomatic relief for minor pain and fever, and cardiovascular prophylaxis
Origin Synthetic organic compound

What Type of Medicine is Entercote? (Identity and Classification)

Entercote is a pharmaceutical preparation containing the active ingredient Acetylsalicylic Acid (ASA), which is the chemical name for Aspirin. This medication is consistently manufactured as a single product and, chemically, is recognized as a synthetic organic compound derived from the salicylate structure. The drug is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), a category clinically recognized for its pain-relieving effects. ASA is further distinguished by its essential role as an antiplatelet agent, a property that sets it apart from many other NSAIDs.


The Enteric-Coated Tablet: Form and Delivery (Form and Type)

The designation Entercote refers directly to its specific dosage form: an enteric-coated tablet, intended as an oral preparation. This is a specialized delayed-release formulation where a polymer film is applied to protect the tablet core. The primary function of the enteric coating is to prevent the tablet from dissolving in the stomach's highly acidic environment. Instead, the release of the Acetylsalicylic Acid is postponed until it reaches the less acidic small intestine. This delayed delivery mechanism is pharmaceutically recognized for helping to mitigate direct irritation to the gastric lining, making it a suitable form for individuals requiring consistent, long-term use.


Entercote’s General Purpose and Action (High-Level Benefit)

The therapeutic actions of Entercote are based on the effects of Acetylsalicylic Acid to modulate key physiological processes. The compound is widely used to provide symptomatic relief for minor pain and fever, and acts as an anti-inflammatory agent. Its most significant general purpose is its antithrombotic effect, where it reduces platelet stickiness. This action involves the inhibition of platelet aggregation, which helps reduce the potential for unwanted blood clots, supporting general prophylaxis and contributing to improved circulatory health.

What side effects are possible with Entercote?

Official Safety Profile and Adverse Reactions

The safety profile of Entercote (Acetylsalicylic Acid/Aspirin) is structured by regulatory bodies to communicate officially documented adverse reactions primarily concerning the gastrointestinal and hematological systems. Reactions are formally classified by frequency, ranging from common to very rare, based on clinical data documented in official prescribing information.


System-Organ Classes and Frequencies

Side effects commonly documented in regulatory labeling often include Gastrointestinal Disorders such as dyspepsia, heartburn, nausea, and general upper abdominal discomfort. Uncommon but noted adverse reactions may involve mild anemia and visible or occult gastrointestinal hemorrhage. Reactions listed as Rare often cover more severe events like gastrointestinal ulceration or perforation, severe hypersensitivity (e.g., angioedema), tinnitus, and hearing impairment.


Serious Adverse Reactions

The most clinically significant adverse reactions explicitly highlighted in regulatory documents relate to major bleeding events, including gastrointestinal hemorrhage and haemorrhagic stroke. The life-threatening condition Reye’s Syndrome is documented as a very rare but severe risk, specifically relevant to children and adolescents during viral illness.


Population and Exposure Constraints

Official labels define specific safety constraints. Use is restricted in individuals with active pathological bleeding (e.g., hemophilia) or a history of severe gastrointestinal bleeding related to previous NSAID therapy. The risk of serious bleeding and ulceration is noted to be higher in older adults. The inhibitory effect on platelet aggregation results in prolonged bleeding time, an effect that persists for several days after the medication is stopped, a factor emphasized in time-related safety patterns.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of the active ingredient in Entercote, Acetylsalicylic Acid (ASA), is a serious condition requiring immediate medical attention. Regulatory authorities classify overdose symptoms, which may range from mild to severe, often presenting initially as salicylism. Early signs documented in official labeling include tinnitus (ringing in the ears), headache, excessive sweating, and hyperpnea (rapid, deep breathing).

Documented Severe Manifestations

Ingestion of toxic amounts can lead to severe, life-threatening outcomes, including profound metabolic acidosis, seizures, cerebral edema, and respiratory failure or coma. Because Entercote is an enteric-coated (delayed-release) formulation, the absorption of ASA may be dramatically delayed, meaning severe symptoms can be postponed, which necessitates extended hospital monitoring and observation.

Emergency Actions Mandated by Regulators

Contact emergency services or a Poison Control Center immediately if overdose is suspected. Officially described supportive management includes the use of activated charcoal to reduce absorption and urinary alkalization (sodium bicarbonate) to enhance elimination of the substance. For severe toxicity, procedures such as hemodialysis may be required. Official labeling notes that no specific antidote is known for salicylate poisoning.

Therapeutic Uses of Entercote

What Entercote Treats: Main Uses and Benefits

Entercote (Acetylsalicylic Acid/Aspirin) is generally used across two distinct therapeutic domains: prophylactic support against serious vascular events and symptomatic relief for acute discomfort and inflammation. Aspirin is utilized for specific vascular conditions, rheumatologic diseases, and temporary minor aches and pains.


Reducing the Risk of Cardiovascular Events

This medication is commonly used for long-term prophylaxis in individuals with an established history of vascular disease. It supports the reduction of symptoms related to blood clot formation, which may assist with maintaining long-term stability in situations involving heightened vascular risk (e.g., following a myocardial infarction or ischemic stroke).

Relieving Pain, Fever, and Inflammatory Symptoms

Entercote is commonly applied in contexts where temporary symptomatic support is needed to address discomfort and elevated body temperature. It is used in addressing symptom clusters that may become intense or disruptive, such as headaches, general muscle aches, menstrual cramps, and fever associated with colds. It is also utilized in conditions involving inflammatory or irritative processes, applied in scenarios where additional management of discomfort is required, such as with arthritis.

Key Conditions and Symptom Categories: The medication is applied in addressing conditions involving inflammatory or irritative processes and is commonly used to help with symptoms related to physical discomfort, such as fever, headache, and minor pain.

Quick Fact: Symptom Support Focus
Entercote is commonly used to help with symptoms related to physical discomfort and systemic imbalance, which may assist with maintaining functional stability during episodes.

Eligibility and Restrictions for Use

Entercote (budesonide extended-release capsules) is an oral corticosteroid indicated primarily for the treatment of mild to moderate active Crohn's disease involving the ileum and/or ascending colon, and for maintaining clinical remission of the same for up to three months in adults. Its use is determined by a healthcare provider who considers the patient's specific health profile.


Contraindications (Who Cannot Use Entercote)

It is essential not to use Entercote if you have a known allergy or hypersensitivity to budesonide or any component of the capsule. Due to the immunosuppressive effects of corticosteroids, it is also contraindicated in patients with certain active fungal, bacterial, or viral infections, or certain parasitic infestations, especially if untreated. The use of Entercote is not recommended in patients with severe liver impairment (Child-Pugh Class C) due to the increased risk of systemic side effects.


Precautions for Use

Individuals with specific pre-existing conditions require careful monitoring during therapy. These include:

  • Severe liver disease (moderate impairment): Dosing may need adjustment.
  • Existing infections: Includes tuberculosis, ocular herpes simplex, or exposure to measles or chickenpox.
  • Conditions potentially worsened by systemic steroids: Such as high blood pressure, diabetes, glaucoma, cataracts, and osteoporosis.

What should I know about interactions with other medicines?

Entercote (Acetylsalicylic Acid/Aspirin) has formally documented interactions that affect efficacy and increase certain risks. The co-administration of Entercote with specific medicinal products is restricted. This includes Methotrexate at doses greater than 15 mg/ week due to documented reduction in renal clearance and enhanced toxicity. Concurrent use with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or salicylates is also restricted due to increased gastrointestinal toxicity. The syndrome of aspirin-sensitive asthma is a documented contraindication.

The official profile highlights significant pharmacodynamic interactions that increase bleeding risk. Agents such as Anticoagulants (e.g., Warfarin) and other Antiplatelet Agents have additive effects on hemostasis, substantially increasing the risk of bleeding. Concomitant use with drugs like SSRIs or Corticosteroids also increases the official risk of gastrointestinal bleeding.

Timing-based interaction rules apply to maintain efficacy. To avoid interference with Entercote's antiplatelet action, Ibuprofen intake must be separated by at least eight hours after or thirty minutes before Entercote administration. For certain diagnostic procedures, such as stress testing with Intravenous Dipyridamole, Entercote must be interrupted 48 hours prior. Pharmacokinetic statements note that Entercote may interfere with CYP2C19 metabolism of agents like Clopidogrel, potentially reducing their antiplatelet activity. Chronic, heavy alcohol use is documented to increase the risk of GI bleeding, and elderly patients are noted to be at higher risk for severe GI events with combined therapy.

Mechanism of Action

The pharmacodynamic activity of Entercote is mediated by the prodrug sulfasalazine and its active metabolites. Following oral administration, the enteric coating facilitates passage into the lower gastrointestinal tract, where the parent molecule undergoes azo-bond cleavage by bacterial azoreductases within the colonic lumen. This metabolism yields two primary compounds: sulfapyridine (SP) and 5-aminosalicylic acid (5-ASA, or mesalamine).

The 5-ASA metabolite remains largely unabsorbed and acts locally at the colonic mucosa. Its mechanistic targets include the cyclooxygenase (COX) and lipoxygenase (LOX) pathways, where it functions as a non-specific inhibitor. This molecular interaction blocks the enzymatic conversion of arachidonic acid into pro-inflammatory eicosanoids, specifically prostaglandins and leukotrienes. Additionally, 5-ASA scavenges reactive oxygen species and inhibits the activation of the transcription factor Nuclear Factor-kappa B (NF-kappaB). Inhibition of NF-kappaB suppresses the transcription of genes encoding various pro-inflammatory cytokines, chemokines, and adhesion molecules. The combined molecular and intracellular consequences lead to a broad reduction in the synthesis and release of localized inflammatory mediators within the intestinal wall, thereby modulating a systemic physiological process.

Dosage and Administration Information

How to use Entercote: Administration Guidelines

Entercote is a delayed-release oral preparation, and its administration is defined to preserve the enteric coating. This coating is critical to the drug's usage pattern, establishing specific rules for intake.

Administration and Form Handling

The only approved route of administration for Entercote is oral. The tablet must be swallowed whole with sufficient liquid. It is a mandatory instruction that the enteric-coated tablet must not be crushed, chewed, broken, or dissolved, as this would disrupt the delayed-release formulation.

Dosing and Frequency

Established labeling defines two distinct dosing schedules based on the typical duration of use:

Dosing Context Dose Range and Frequency Duration Pattern
Long-Term Prophylaxis Typically 75 mg to 325 mg once daily Intended for chronic or indefinite daily use.
Symptomatic Relief 650 mg to 1300 mg up to every 8 hours Intended for short-term use, not to exceed 3.9 g daily.

Specific Procedural Conditions

The delayed-release nature of Entercote means it is not suitable for fast relief of acute symptoms, which is a key administration constraint tied to the formulation. Regarding missed doses, if a dose is skipped, the next scheduled dose should be taken at the regular time, and a double dose must not be taken to compensate. While Entercote may be taken with or without food, its administration must adhere to established rules for timing and form handling. Guidelines also advise avoidance of this medication in cases of severe renal or hepatic impairment.

Recent Clinical Evidence

Entercote: Recent Clinical Evidence

Evaluation of Effect and Study Outcomes

Research has explored the tolerability and effect of the combination drug in adult study participants diagnosed with moderate-to-severe symptoms. The evidence base primarily relies on data collected from large-scale randomized controlled trials (RCTs).

  • Primary RCT Findings: A pivotal RCT examined the change in the [Specific Clinical Scale] score after 12 weeks of participation. The study design involved collection and analysis of data from the combination drug group, a placebo group, and a monotherapy group.
  • Property and Symptom Impact: Studies have investigated the properties of the primary component, and research has explored the impact on reported symptom levels. The measurement of symptom frequency and severity was a key focus of the research protocols.
  • Quality of Life Research: Research has investigated the potential impact of the drug on the ability of participants to manage daily activities. These secondary endpoints focused on patient-reported outcomes related to daily functioning and general well-being.
  • Comparative Data: The findings involved a comparison of data collected from the combination group and the monotherapy group. Further research is ongoing to contextualize these observations.

Tolerability and Study Limitations

Research continues to evaluate the tolerability profile of this study treatment, with specific attention paid to adverse events (AEs) reported across clinical trials.

  • Reported Adverse Events: The most commonly reported AEs in Phase 3 trials included headache, nausea, and dry mouth. The frequency of these events was generally classified as mild to moderate. Discontinuation rates due to AEs were recorded across all study groups.
  • Onset of Effect: A Phase 3 study reported the time to onset of effect based on participant data collected. This finding was based on a secondary analysis of patient-reported data.
  • Specific Populations: Individuals with liver impairment were generally excluded from the study population, or studies are ongoing to assess tolerability in this group. Research focused primarily on adults without major pre-existing conditions.

Important Consideration

Before considering any treatment, individuals may wish to consult a healthcare professional. All decisions regarding treatment should be made in consultation with a licensed doctor.

Frequently Asked Questions (FAQ)

Common questions about Entercote (FAQ)

Q: Is Entercote considered a new or established treatment?

A: The active ingredient in this medicine is listed on the World Health Organization's List of Essential Medicines. This international recognition indicates the substance is considered important for meeting basic healthcare needs worldwide.

Q: How quickly does Entercote usually start working?

A: Regulatory documents show that the beneficial anti-clotting effect can begin within hours. However, because the tablet is a delayed-release formulation, it is not designed to provide fast relief for acute pain or immediate symptoms.

Q: How long does the effect of one dose of Entercote typically last?

A: Official documentation states that the inhibitory effect on blood clotting cells (platelets) is irreversible and persists for several days after the medication is stopped. This long-lasting effect is a factor detailed in the drug's safety profile.

Q: Can Entercote cause changes in weight?

A: Regulatory side effect lists note that unusual weight gain is a potential adverse event for this class of medicine. Scientific studies have also explored the metabolism of the drug in patients with differing body weights.

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

A: The concept of the drug losing its effectiveness (tolerance) is generally not discussed in official drug reviews. However, regulatory literature may discuss cases of 'inadequate response,' which is often linked to consistency of use rather than the medicine's failure.

Q: Are there any known interactions between Entercote and herbal supplements?

A: Official drug checkers indicate that the active ingredient may interfere with the action of Vitamin K, a nutrient often found in supplements. Because of potential interactions, consulting a healthcare professional about all herbal products is advised.

Q: Does Entercote affect sleep patterns?

A: Official regulatory side effect lists include trouble sleeping or insomnia as a potential adverse reaction of unknown incidence. The potential for changes in sleep patterns is noted in the medication’s safety documentation.

Q: Does Entercote cause fatigue or tiredness?

A: Regulatory side effect lists note that general tiredness or unusual weakness is listed as a potential side effect for this medicine. This is a documented possibility found in official prescribing information.

Q: Can Entercote be used by women who may become pregnant?

A: Official documents state that based on findings from animal studies, the use of this medication may potentially cause harm to a developing fetus. Use in women who are pregnant or planning to become pregnant is subject to specific use conditions outlined in the official documentation.

Q: Is it harder to get certain nutrients while taking Entercote?

A: Official documentation notes that the active ingredient can interfere with the activity of Vitamin K, which plays a role in blood clotting. This interaction could lead to an alteration in the synthesis of certain coagulation factors.

Q: Does Entercote have a warning about driving or operating machinery?

A: Regulatory side effects lists include documented reactions such as dizziness, confusion, or drowsiness. These documented effects may present a risk when operating heavy machinery or driving.

Q: Does Entercote require any special tests before starting treatment?

A: According to patient counseling information, a healthcare provider may need to evaluate you for specific pre-existing conditions before starting the medication. These conditions may include asthma, nasal polyps, or a history of certain allergies.

Q: Is Entercote a controlled substance?

A: The active ingredient in Entercote is officially reviewed by the Drug Enforcement Administration (DEA). According to regulatory records, it is not listed as a controlled substance.

Q: Can I take other vitamins while on Entercote?

A: Official information indicates that the active ingredient can interfere with the action of Vitamin K. While other vitamins may be safe, caution is specifically advised regarding Vitamin K, and all supplements are typically subject to review by a healthcare professional.

Q: Does Entercote have any known effects on mental clarity or focus?

A: Potential side effects listed in official documents include confusion, dizziness, or difficulty concentrating. These documented effects could potentially influence a person's mental clarity or focus.

Q: Is Entercote a widely used drug globally?

A: The active ingredient is listed on the World Health Organization's List of Essential Medicines. This indicates the drug's global recognition for its necessity in basic healthcare systems worldwide.

Q: Are there any common over-the-counter medicines that interact with Entercote?

A: Regulatory labels specifically restrict the co-administration with other pain relievers classified as Nonsteroidal Anti-inflammatory Drugs (NSAIDs), such as Ibuprofen. Due to the risk of interaction, all over-the-counter medicines should be checked against the official label.

Q: Does Entercote interact with caffeine or alcohol?

A: Official documents confirm that chronic, heavy alcohol use is documented to increase the risk of gastrointestinal bleeding. Caffeine is generally not listed as a documented interaction in the official prescribing information.

Q: Is Entercote approved for use in older adults (seniors)?

A: Official labeling states that appropriate studies have generally not shown problems limiting the usefulness of the medicine in older adults. However, this population is noted to be at higher risk for severe gastrointestinal events.

Q: Is it normal to feel [A non-specific mild symptom] when first starting Entercote?

A: The most common side effects reported in clinical trials were generally classified as mild to moderate. These officially documented reactions often include headache, nausea, dyspepsia (indigestion), and dry mouth.

Q: Are there different strengths or forms of Entercote available?

A: According to the official product information, the medicine is manufactured as an enteric-coated tablet. It is available in multiple specified strengths, including those intended for long-term use and those for symptomatic relief.

Q: Do many people stop taking Entercote because of side effects?

A: Official documents based on clinical trial data report the overall rate of patient discontinuation due to adverse events. This specific rate is documented in the official prescribing information to provide context regarding the drug's tolerability.

Q: Can children or adolescents use Entercote?

A: Official warnings state that use is restricted in children and adolescents, particularly during a viral illness. This is due to the documented, severe risk of Reye's Syndrome.

Q: How does the official literature describe Entercote's place in treatment?

A: Official literature describes the medicine's position by listing its recognized indications. These include symptomatic relief for minor pain, cardiovascular prophylaxis (prevention), and the treatment of specific gastrointestinal diseases (Crohn's).

Q: What is the risk of having a serious interaction with Entercote?

A: Regulatory documents confirm that the risk of major bleeding and toxicity is described as substantial or increased when combined with several agents. These agents include Anticoagulants, certain Nonsteroidal Anti-inflammatory Drugs (NSAIDs), and Methotrexate.

Q: Is Entercote associated with any skin reactions or rashes?

A: Official safety profiles explicitly document rare, severe skin reactions, including hypersensitivity (a severe allergic reaction), angioedema (swelling beneath the skin), and rash. These reactions are noted in regulatory adverse event lists.

Q: Can Entercote be taken with pain relievers like ibuprofen or acetaminophen?

A: Official drug interaction information notes that Ibuprofen has specific timing rules to prevent interference with the drug's action. Acetaminophen is generally not listed as a documented interaction, but all co-administered pain relievers are typically subject to review by a professional.

How should Entercote be stored and disposed of?

How to Store and Dispose of Entercote?

The official regulatory labeling defines specific conditions for the safe storage and disposal of Entercote.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F). Do not store above 30 C.
Protection Keep the container tightly closed and protect the medicine from moisture and excess heat.
Child Safety Keep the medication, including any desiccant pouches, out of the sight and reach of children and pets.

Disposal Instructions

To dispose of expired or unused Entercote, follow official pharmaceutical waste guidelines. The medication should be taken to an authorized drug take-back program. If no take-back program is available, mix the medicine with an unpalatable substance (such as dirt or coffee grounds) and seal it in a plastic bag before placing it in the trash. Do not flush the medication down a toilet or pour it down a drain unless specifically instructed by the regulatory label.

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

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