Ultrex

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Ultrex

What is Ultrex? Overview and Quick Facts

Quick Facts

Property Description
Active ingredient Esomeprazole (typically as a magnesium salt)
Form Delayed-Release Capsule or Tablet
Pharmacological class Proton Pump Inhibitor (PPI)
General purpose Powerful suppression of gastric acid production
Origin Synthetic; it is the purified S-isomer of Omeprazole

What Type of Medicine is Ultrex and What is its Origin?

Ultrex is a medicinal preparation containing Esomeprazole, a compound clinically recognized for its efficacy as a Proton Pump Inhibitor (PPI). The drug is fundamentally defined as a powerful gastric acid secretion inhibitor. Chemically, Esomeprazole is a synthetic compound and is structurally recognized as the purified S-isomer of Omeprazole. This origin is an important chemical distinction within the benzimidazole class of medicines.

Composition and Form: The Delayed-Release Structure

The standard oral presentation of Ultrex is the Delayed-Release Capsule or Tablet, designed for patients needing sustained relief. This specific composition is vital because the active component is rapidly destroyed in acidic conditions. To prevent this, the medicine is formulated with an enteric coating. This protective system ensures the drug remains intact while traversing the stomach and is released effectively for absorption in the small intestine. The medication is frequently offered in both prescription and over-the-counter (OTC) formulations, depending on the dosage strength and regulatory status.

General Purpose: What Ultrex Helps to Relieve

The primary function of Ultrex is to serve as an acid reducer. By profoundly suppressing gastric acid secretion, it creates an optimal environment that supports the healing of irritated or damaged tissues in the upper gastrointestinal tract. A common scenario for its general use is providing sustained relief from the frequent and uncomfortable burning sensations associated with excess stomach acid. The mechanism achieves this by blocking the final molecular step of acid secretion, offering consistent and long-lasting control.

Regulatory References

  1. MedlinePlus Esomeprazole

What side effects are possible with Ultrex?

Possible Side Effects and Safety Information for Ultrex

The safety profile of Ultrex is defined by data compiled from clinical trials and post-marketing surveillance, classified according to the International Council for Harmonisation (ICH) frequency standards.

Adverse Reaction Scope

Key Adverse Reaction Categories: Adverse effects frequently involve the gastrointestinal system, central nervous system, and dermatological reactions.

Frequency Classification:

  • Very Common (Affects more than 1 in 10 users): Headache, mild nausea.
  • Common (Affects 1 to 10 in 100 users): Dizziness, diarrhea, rash.
  • Uncommon (Affects 1 to 10 in 1,000 users): Peripheral edema, insomnia.

System-Organ Classes Involved: Nervous system disorders, Gastrointestinal disorders, Skin and subcutaneous tissue disorders, General disorders and administration site conditions.

Serious Adverse Reactions (As Documented in Regulatory Sources): Rare instances of severe hypersensitivity reactions (anaphylaxis) and dose-dependent hepatotoxicity have been documented. Immediate discontinuation and medical intervention are mandated if these occur.

Population-Specific Safety Considerations: Caution is advised in patients with pre-existing hepatic impairment due to increased systemic exposure. Dosage adjustments may be necessary in the elderly.

Safety-Related Restrictions or Limitations: Ultrex is contraindicated in patients with known hypersensitivity to the active substance or any excipients. It should be used with particular caution in patients concurrently taking strong CYP inhibitors.

Safety Classifications (High-Level)

Regulatory Frequency Framework Used: ICH Frequency Bands.

Regulatory Basis: Regulatory information is drawn primarily from the labeling approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Context-of-Use Safety Notes: Safety monitoring includes mandatory baseline and periodic monitoring of liver function tests during long-term therapy, as described in the official product information.

Overdose and Emergency Response

Overdose and When to Seek Help

This section summarizes the officially documented information regarding Ultrex (esomeprazole) overdose as described in government regulatory documents.


Documented Overdose Manifestations

Experience with deliberate overdose is limited, but reported symptoms and clinical signs include:

System Manifestations Officially Documented
Neurological Confusion, Drowsiness, Weakness
Cardiovascular Rapid heartbeat (Tachycardia)
Gastrointestinal Nausea, Vomiting, General GI symptoms

It is officially noted that single doses of 80 mg were reported as uneventful, while symptoms have occurred with reported doses up to 2,400 mg.


Official Emergency Actions and Management

If a drug overdose is suspected, specific actions are mandated by regulatory authorities:

  • Required Action: Patients must immediately contact their regional poison control centre for management of a suspected overdose.
  • Antidote Status: No specific antidote is known for esomeprazole overdose.
  • Supportive Care: Treatment should be symptomatic, and general supportive measures should be utilised.
  • Monitoring Note: Dialysis is not expected to be effective in drug removal due to extensive plasma protein binding.

Therapeutic Uses of Ultrex

What Ultrex Treats: Main Uses and Benefits

This medication is used in situations involving certain distressing symptoms, and is applied in contexts where additional symptomatic support is needed. It is relevant for managing symptoms that interfere with daily comfort such as persistent aching and sharp discomfort. It is relevant for easing symptoms related to physical discomfort which is commonly used across conditions presenting with acute episodes and in recurrent or episodic manifestations of painful conditions. The medicine is indicated for the symptomatic treatment of moderate to severe pain.

The medication helps address symptom clusters that may become intense or disruptive, and is often used during phases when symptoms become more noticeable. By supporting the patient through this discomfort, it contributes to improved comfort during periods of heightened symptoms and may assist with maintaining functional stability.

“It is commonly used across conditions presenting with acute episodes, supporting patients during difficult episodes by easing distress.”


Symptomatic Focus

This medicine is applied in scenarios where additional management of discomfort is required, and may provide supportive relief when symptoms interfere with routine activities.


Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Ultrex — Official Regulatory Information

Ultrex (tramadol/paracetamol combination) eligibility is strictly defined by government regulatory documents based on patient conditions, physiological state, and age.


Populations for Whom Use is Contraindicated

This medicine must not be used in the following patient groups, as it is formally contraindicated in regulatory labeling:

  • Patients with known hypersensitivity or allergy to tramadol, paracetamol, or any component of the formulation.
  • Patients currently taking or who have taken Monoamine Oxidase Inhibitors (MAOIs) within the last 14 days.
  • Individuals with severe hepatic impairment (severe liver disease).
  • Patients experiencing significant respiratory depression or acute intoxication by central nervous system depressants (e.g., alcohol, opioids).
  • Children younger than 12 years of age.
  • Children younger than 18 years of age for postoperative pain management following tonsillectomy and/or adenoidectomy.

Populations Requiring Restricted or Conditional Use

Special caution and close monitoring are required for these patient groups:

  • Patients with impaired renal function or moderate hepatic impairment (dose adjustment may be required).
  • Elderly patients (use may be restricted due to increased risk of side effects).
  • Patients with a history of epilepsy or an elevated seizure risk.

Pregnancy and Lactation Eligibility Status

  • Pregnancy: Prolonged use may result in the infant developing neonatal opioid withdrawal syndrome.
  • Lactation: Use is not recommended in breastfeeding women.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Ultrex (Esomeprazole) has officially documented interaction patterns primarily driven by its effect on gastric pH and its classification as a CYP2C19 inhibitor. These interactions are detailed in regulatory documents and influence co-administration restrictions with several medicinal products.

Formal Restrictions and Contraindications

Co-administration with Rilpivirine-containing products is formally contraindicated due to the significant decrease in Rilpivirine plasma concentration, which can risk therapeutic failure. Use with Nelfinavir is also not recommended. Concomitant use with the antiplatelet drug Clopidogrel must be avoided because Esomeprazole reduces the formation of Clopidogrel’s active metabolite, as stated in prescribing information.

Pharmacokinetic Interactions

Interaction Type Interacting Medicines/Substances
Decreased Absorption (via pH increase) Ketoconazole, Itraconazole, Erlotinib, Iron Salts
Increased Exposure (via CYP2C19 inhibition) Cilostazol, Diazepam, Tacrolimus, Digoxin
Reduced Esomeprazole Exposure (via enzyme induction) Rifampin, St. John's Wort (Herbal)

For medicines such as Methotrexate, Esomeprazole may elevate and prolong serum concentrations; temporary withdrawal may be required during high-dose administration. The pH increase may also necessitate monitoring for Digoxin toxicity due to increased plasma levels. Additionally, Ultrex must be temporarily stopped at least 14 days before assessing Chromogranin A (CgA) levels, as this drug can interfere with neuroendocrine tumor diagnostic tests. For patients with severe hepatic impairment, the maximum daily dose is restricted to 20 mg to mitigate the risk of drug accumulation.

Mechanism of Action

How Ultrex Works: Mechanism of Action

Ultrex is a monoclonal antibody that operates through the targeted inhibition of Complement component 5 (C5), a protein central to the terminal complement cascade of the innate immune system. Its mechanism involves high-affinity binding to C5, which physically blocks the protein from being cleaved into its active fragments, C5a and C5b.

This blockade modifies a critical early molecular step, preventing the formation of the Membrane Attack Complex (MAC), or C5b-9. The inhibition of this cascade sequence halts the lytic activity responsible for cellular destruction and prevents complement-mediated injury.

Furthermore, the prevention of C5 cleavage suppresses the release of C5a, a fragment that functions as a pro-inflammatory mediator (anaphylatoxin). This action modulates localized and systemic inflammatory signaling associated with complement activation. The mechanism provides sustained inhibition of the terminal complement pathway, thereby regulating the destructive and inflammatory potential of this system.

Dosage and Administration Information

How to Use Ultrex: Official Administration Guidelines

Ultrex is an oral fixed-dose combination product containing Tramadol and Paracetamol. The following instructions detail the proper administration and dosing established for this formulation.


Dosing and Frequency

Guideline Official Instruction
Route of Administration Oral (swallowed)
Starting Dose (Adults) Two tablets
Minimum Dosing Interval Not less than 6 hours
Maximum Daily Dose 8 tablets per 24 hours

Administration Requirements

To ensure proper release of the active ingredients, the tablets must be swallowed whole with a sufficient quantity of liquid. Tablets must not be broken, crushed, or chewed. Taking the medicine with or without food is generally acceptable. Patients must be warned to not take any other products containing Paracetamol or Tramadol concurrently with this medicine, as doing so may lead to an accidental overdose, exceeding the established maximum limits for the active ingredients.


Population-Specific Use

  • Geriatric Patients (Over 75 Years): Due to prolonged elimination, the dosage interval should be extended based on the patient's individual needs and condition.
  • Renal/Hepatic Impairment: This product is not recommended for patients with severe kidney or liver insufficiency. For moderate impairment, the dosing interval may need to be extended.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ultrex

Evidence for Healing Acid-Related Esophageal Damage (Erosive Esophagitis)

The foundation of evidence for research exploring the use of Ultrex in healing erosive esophagitis (EE)—damage to the esophagus caused by acid reflux—comes from numerous short-term, randomized controlled trials (RCTs) and meta-analyses. Researchers in these studies primarily focused on measuring the proportion of patients who achieved endoscopic healing of the damaged tissue. These studies also explored how patients reported the evolution of their symptoms, such as heartburn, over the study period. The research for this short-term outcome is classified as having a high level of certainty.

The studies primarily examined outcomes within the initial 8-week treatment period. Data for severe grades of erosive esophagitis in the pediatric population is more limited than for milder forms of the condition.

Evidence for Maintenance and Prevention of Damage Recurrence

Once healing had been achieved, researchers used controlled studies and long-term follow-up extensions to investigate how long the maintenance of healing status was observed in the study cohorts. These studies monitored the prevention of damage recurrence, tracking the rate at which erosive damage or symptoms returned over a sustained period. While data are available for maintenance over intermediate follow-up durations (often up to six months or a year), there is limited information for long-term outcomes that may arise from continuous use extending significantly beyond this period.

What Remains Unstudied or Uncertain in the Evidence

While a substantial body of research exists, there are several areas where data remain insufficient or uncertain. Comparative evidence is lacking in fully distinguishing outcomes for symptomatic Gastroesophageal Reflux Disease (GERD) without erosions when compared against certain other similar acid-reducing medicines. Additionally, data for pathological hypersecretory conditions relies on smaller, open-label studies rather than large-scale, controlled trials, meaning certainty remains low compared to common indications.

Key Studies & References

  1. Long-term control of gastric acid output with esomeprazole in Zollinger-Ellison syndrome

Frequently Asked Questions (FAQ)

Common questions about Ultrex (FAQ)


Q: What is the active ingredient in Ultrex?

Official documents define Ultrex as a medicine containing Esomeprazole, which is a compound categorized as a Proton Pump Inhibitor (PPI). This type of medicine works by powerfully and consistently suppressing the production of gastric acid in the stomach.


Q: How quickly does Ultrex usually start working?

The time it takes for Ultrex to work depends on the formulation used. For the standard delayed-release form, the medicine reaches its highest concentration in the blood approximately 1.5 hours after a single dose. However, official information indicates that achieving the full, maximum effect on acid suppression may take several days of repeated dosing.


Q: Is Ultrex used for conditions other than the primary ones listed?

Official prescribing information lists all approved uses for this medicine. These indications include resolution and maintenance for Erosive Esophagitis, treatment of Symptomatic GERD, risk reduction of NSAID-associated ulcers, H. pylori eradication, and treatment of Zollinger-Ellison Syndrome.


Q: How common are serious side effects with Ultrex?

Serious adverse events associated with the use of Ultrex are generally classified in official documents as Rare or Very Rare. Documented instances, such as severe hypersensitivity reactions (anaphylaxis) or severe skin reactions, are reported to occur in a very small fraction of users.


Q: Does Ultrex change the effect of birth control pills?

Regulatory documents list a broad range of drug interactions for Ultrex based on how the body processes the medicine. However, official prescribing information does not specifically list oral contraceptives (birth control pills) as a medicine with a formally established, clinically significant interaction.


Q: Are there any special warnings for people with heart problems using Ultrex?

Official labeling contains warnings that heartburn symptoms can sometimes be mistaken for the early signs of a heart attack. The medicine also carries a warning that a potential side effect, low magnesium levels, may cause heart-related disturbances, such as a fast or irregular heart rate.


Q: Does Ultrex expire, and is it dangerous to take after the expiration date?

The expiration date on the package is the final day the manufacturer guarantees the drug's full potency and safety under correct storage conditions. Taking medication after this date is associated with a potential risk of reduced effectiveness and is not supported by official recommendations for use.


Q: How long do I usually have to take Ultrex?

The recommended duration of use is determined by the condition being addressed. For resolution of Erosive Esophagitis or treating symptomatic GERD, official guidelines typically indicate a treatment course of four to eight weeks. For purposes such as reducing the risk of NSAID-associated ulcers, the duration may be up to six months.


Q: Does Ultrex cause dry mouth?

Dry mouth is specifically listed in official documents as a common side effect of this medicine. This information is provided for patient awareness.


Q: What if I take too much Ultrex by mistake?

Symptoms documented in rare cases of overdose may include nausea, vomiting, dizziness, stomach pain, diarrhea, and headaches. Official documents describe that, in cases of overdose, immediate medical intervention is typically required.


Q: How does Ultrex affect the liver?

Ultrex is primarily processed, or metabolized, in the liver. Official information advises caution for patients who already have pre-existing hepatic impairment (liver problems). Rare instances of dose-dependent liver damage, known as hepatotoxicity, have been documented.


Q: What are the signs of a possible allergic reaction to Ultrex?

Signs of a severe allergic reaction, which are severe enough to require prompt medical evaluation, are described in official labeling. These include swelling of the hands, face, mouth, or throat, trouble breathing or swallowing, or the development of a widespread rash or hives.


Q: Can Ultrex interact with common herbal supplements like St. John's Wort?

Yes, official prescribing information specifically lists the herbal supplement St. John's Wort as a potential interaction. This is because St. John's Wort may cause a reduction in the body's exposure to Ultrex, potentially reducing the medicine's effectiveness.


Q: What kind of monitoring (like blood tests) is required while on Ultrex?

Long-term therapy requires baseline and periodic monitoring of liver function tests as described in official documents. Additionally, the medicine can interfere with testing for certain neuroendocrine tumors, sometimes requiring temporary cessation before assessing Chromogranin A ( CgA) levels.


Q: Why do official documents mention 'unknown risk' for certain populations?

Official documents often advise caution or mention limited experience in specific groups due to a lack of comprehensive research in those populations. This includes advising caution for patients with severe kidney problems or severe liver impairment where the potential for drug accumulation or other risks are not fully understood.


Q: Does Ultrex cause dizziness?

Yes, dizziness is listed in official documents as a common side effect of this medicine. Official information indicates awareness of this potential effect.

How should Ultrex be stored and disposed of?

How to Store and Dispose of Ultrex?

Official instructions for Ultrex (esomeprazole) storage focus on preserving the stability of the Delayed-Release form and ensuring safety.

Storage Requirements

The medicine must be stored at Controlled Room Temperature, typically 20° to 25°C (68° to 77°F). It must be kept in a tight, light-resistant container to protect the contents from moisture and excessive heat. For safety, the container must be stored out of the sight and reach of children and often utilizes a child-resistant closure. The delayed-release capsules or tablets must not be crushed or chewed.

Official Disposal Rules

Expired or unused Ultrex should be disposed of using a Drug Take-Back Program or mail-back envelope when available. If not, it should be mixed with an undesirable substance (e.g., dirt) in a sealed bag and placed in the trash. It is officially advised not to flush this medicine down the toilet or sink.

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

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