Ультрафастин

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Ультрафастин

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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 Ультрафастин

1. Defining Ультрафастин: Class, Composition, and Origin

Ультрафастин is a medication defined by its sole active ingredient, Ketoprofen, which is pharmacologically classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID). Ketoprofen is a synthetic compound belonging to the arylpropionic acid derivative group. The medicine is consistently a single-ingredient (monocomponent) preparation across all its formulations. Its fundamental classification as an NSAID establishes the drug's core functional capability: to mediate the body's inflammatory response, a function recognized for its role in the management of pain and swelling.


2. General Purpose and Core Physiological Action

The general purpose of Ультрафастин is to provide relief from mild to moderate pain and to mitigate symptoms of inflammation. The active component, Ketoprofen, achieves this benefit by interfering with the synthesis of prostaglandins, which are chemical compounds that promote swelling and signal pain at the site of tissue injury. Consequently, the medicine's key physiological action is classified as both analgesic (pain-relieving) and anti-inflammatory. This dual action makes it a suitable option for managing conditions such as acute muscle strain, an effect noted in pharmacological contexts.


3. Available Forms and Pharmaceutical Presentation

Ультрафастин is formulated in multiple pharmaceutical preparations, including those for oral (capsules, tablets, oral soluble films), topical (gels, creams, sprays), and rectal (suppositories) routes of administration. This range of delivery systems allows the therapeutic effects of Ketoprofen to be administered either systemically for generalized discomfort or localized to a specific area, as is common with the topical gel and spray formulations. Medicinal product information indicates its utility in both oral and topical delivery forms.

Regulatory References

  1. U.S. National Institutes of Health

What side effects are possible with Ультрафастин?

Possible side effects and safety information

The safety profile of this medicine, containing the active ingredient Ketoprofen, is formally documented by regulatory agencies and includes classifications of adverse reactions by both frequency and the physiological system affected.

Serious Adverse Reactions

The official labeling mandates warnings regarding the potential for serious, life-threatening events. These include an increased risk of Serious Cardiovascular Thrombotic Events, such as Myocardial Infarction (heart attack) and Stroke, which may be associated with the duration of use. Furthermore, there is a documented risk of Serious Gastrointestinal Adverse Events, specifically Ulceration, Bleeding, and Perforation of the stomach or intestines, which may occur at any time during use without warning symptoms. Severe skin reactions, such as Stevens-Johnson syndrome (SJS), are also officially listed as possible effects.

Common Adverse Effects and System-Organ Classes

The most frequently reported effects, categorized as Common (occurring in 1% to 10% of patients) in official documents, primarily involve the digestive system and the nervous system. Gastrointestinal disorders such as dyspepsia, nausea, abdominal pain, diarrhea, and constipation are often listed. Central Nervous System effects, including headache and dizziness, are also classified as common. The overall profile includes effects documented across several System-Organ Classes, including the Renal and Urinary System, and Skin and Subcutaneous Tissue.

Population and Contextual Safety Notes

Official safety information highlights specific considerations for certain groups and contexts. Older adults are noted to have a higher risk for serious gastrointestinal events. Use during the third trimester of pregnancy is contraindicated due to the risk of foetal cardiopulmonary and renal toxicity. Furthermore, the medicine is restricted from use for pain management following coronary artery bypass graft (CABG) surgery.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Ультрафастин presents a significant, life-threatening risk primarily due to severe organ toxicity, most notably hepatotoxicity (liver damage) which can progress to liver failure and death. The official regulatory profile emphasizes that initial symptoms may be delayed or absent; a patient may experience only non-specific signs such as nausea, vomiting, or general discomfort that may resemble the flu.

Clinical Presentation and Emergency Action

Because of the potential for delayed presentation of severe liver damage, it is critical to seek immediate emergency medical attention for any suspected overdose, even if the person feels well or displays only minor symptoms. Do not wait for symptoms to worsen. The most effective treatment involves the administration of a specific antidote, and its success is heavily reliant on timely delivery, ideally within the established antidote intervention window following ingestion.

Regulatory guidance directs healthcare professionals to initiate this antidote as quickly as possible. Reporting the exact time and amount of the drug taken to medical personnel is vital for determining the necessary emergency response.

Therapeutic Uses of Ультрафастин

What Ультрафастин Treats: Main Uses and Benefits

The active ingredient in Ультрафастин is commonly used to help with symptoms related to physical discomfort, tenderness, swelling, and stiffness associated with inflammatory or irritative states.

This medication is relevant across conditions characterized by periods of heightened symptoms, including Rheumatoid Arthritis, Osteoarthritis, sprains, strains, and Primary Dysmenorrhea. It is also relevant when supportive symptom management is appropriate, such as during episodes of acute physiological stress or following procedures.

It is commonly used to help address symptom clusters that may become intense or disruptive, supporting the patient during difficult episodes. The medication may be part of symptomatic management, which helps when symptoms become more noticeable. This supports general well-being during symptomatic phases and helps improve day-to-day comfort by easing the overall symptom load.


Quick Fact: Relief for Pain, Inflammation, and Stiffness

Ультрафастин is applied in clinical settings that involve acute or unstable symptom patterns, which contributes to symptomatic relief and assists with maintaining functional stability during episodes of heightened discomfort.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Ультрафастин?

This section outlines the official population eligibility and non-eligibility criteria for this medicine, strictly based on government regulatory labeling (e.g., FDA, EMA). Note that the specific eligibility profile is based on the highly regulated combination product containing Tramadol Hydrochloride and Acetaminophen (often associated with the prefix “Ultra”).

Absolute Contraindications (Must Not Use)

  • Age: Children younger than 12 years of age, and individuals under 18 years following tonsillectomy or adenoidectomy.
  • Respiratory/CNS: Patients experiencing significant respiratory depression or acute/severe asthma in an unmonitored setting.
  • Drug Interaction: Individuals taking or having taken Monoamine Oxidase Inhibitors (MAOIs) within the last 14 days.
  • Other: Known hypersensitivity to any component of the product or known/suspected gastrointestinal obstruction, including paralytic ileus.

Restricted or Conditional Use

  • Organ Function: Use is restricted in patients with severe renal (kidney) impairment and is generally not recommended in patients with established hepatic (liver) impairment.
  • Life Stage: Use during pregnancy is advised against due to the risk of Neonatal Opioid Withdrawal Syndrome. Breastfeeding is also not recommended.
  • Elderly: Use in the elderly requires close monitoring due to an increased risk of respiratory depression.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents define the interaction profile of Ультрафастин (Ketoprofen), requiring strict adherence to documented constraints. All statements reflect officially recognized pharmacokinetic or pharmacodynamic interaction patterns.


Formal Contraindicated Combinations

Co-administration is formally prohibited with several medicine classes and substances due to the risk of serious adverse outcomes:

  • Other NSAIDs (including selective COX-2 inhibitors) and Anticoagulants (such as Warfarin) due to synergistic risk of hemorrhage.
  • Lithium and high-dose Methotrexate (above 15 mg/week), as Ketoprofen reduces the renal excretion of these drugs, documented to increase their plasma concentrations to toxic levels.

Documented Interaction Warnings

Special monitoring and caution are required when Ультрафастин is co-administered with the following:

  • Oral Corticosteroids, Antiplatelet Agents, and Selective Serotonin Reuptake Inhibitors (SSRIs): These combinations are officially noted to increase the pharmacodynamic risk of gastrointestinal bleeding or ulceration.
  • Diuretics and ACE Inhibitors/ARBs: Documented interactions may reduce the antihypertensive or diuretic efficacy and compromise renal function.
  • Ciclosporin and Tacrolimus: Co-administration carries an elevated risk of nephrotoxicity.
  • Alcohol: This substance is noted to increase the documented risk of gastrointestinal irritation and bleeding.

Regulatory documentation also emphasizes that all documented interaction risks are heightened in Elderly Patients.

Mechanism of Action

How Ультрафастин Works

The mechanism of action for Ультрафастин (Ketoprofen) focuses on intervening in key biological pathways that regulate signaling processes related to tissue injury, thereby modulating the activity of the Arachidonic Acid Metabolism Cascade.


Inhibition of Eicosanoid Synthesis at the Molecular Level

The drug's primary action is the non-selective, reversible inhibition of the Cyclooxygenase (COX-1 and COX-2) enzymes. By blocking this initial step in the Arachidonic Acid Metabolism Cascade, the drug suppresses the synthesis of prostaglandins—chemical mediators that increase vascular permeability and facilitate nociceptor sensitization. This molecular intervention modifies an early step in the signaling sequence, which affects systemic physiological processes.


Dual Modulation of Nociceptive and Thermal Signaling

This mechanism operates across both the periphery and the central nervous system (CNS). Peripherally, the reduction in prostaglandins decreases the sensitization of peripheral nerve endings (nociceptors). Centrally, the active compound modulates specific pathways in the brain and spinal cord, influencing the processing of signals. This central action also affects the hypothalamic temperature set point, which regulates the body's core temperature.


Constraints of the Non-Selective Mechanism

Because the drug inhibits both COX-2 and COX-1, it also affects systems where constitutive prostaglandins regulate physiological functions. This non-selective profile is a core mechanistic constraint that influences the drug's activity across various biological processes, such as those maintaining gastric mucosal integrity and renal regulation.

Dosage and Administration Information

Official Dosing and Administration Guidelines

Ketoprofen (Ультрафастин) is administered via multiple approved routes: oral (capsules), topical (gel), and rectal (suppositories). The regimen, dose, and frequency are strictly dependent on the formulation.

Administration Route Standard Adult Dosing Regimen Maximum Daily Dose (Adults)
Oral (Immediate-Release) 25 mg to 75 mg per dose, 3 to 4 times daily. 300 mg/day
Oral (Extended-Release) 200 mg once daily (QD). 200 mg/day
Topical Gel 2 to 4 applications daily; approx 2 g to 4 g per application. 15 g/day

For oral forms, the medicine may be taken with food, milk, or antacids to reduce gastrointestinal discomfort; however, food intake can slow the rate of absorption. Extended-Release capsules are designated for chronic conditions and are not recommended for acute pain.

Population-Specific Instructions

Specific dosage adjustments are recommended for certain populations. Treatment should be initiated at the lowest effective dose for the shortest duration necessary.

  • Older Adults: It is recommended to initiate treatment at a lower dose, potentially 33% to 50% below the usual adult dose, due to increased risk factors.
  • Renal/Hepatic Impairment: For patients with severe renal impairment (GFR < 25 mL/min) or reduced serum albumin due to hepatic impairment, the oral dose is restricted to a maximum of 100 mg/day.

In the event of a missed dose, the instruction is to skip the missed dose and continue with the regular schedule, without taking a double dose to compensate. Safety and effectiveness in pediatric patients have not been established for prescription products.

Recent Clinical Evidence

Research evidence / Overview of studies for Ультрафастин (Ketoprofen)

This overview summarizes the structure and focus of official clinical research that was studied for the active ingredient Ketoprofen, based on regulatory and scientific literature. This information describes what has been examined and what remains uncertain, and is not a guide for treatment or use.


1. Evidence for Chronic Inflammatory and Rheumatic Conditions

Research on the oral formulation was assessed in Randomized Controlled Trials (RCTs) focusing on adult patients with conditions characterized by fluctuating or episodic manifestations, such as Osteoarthritis (OA) and Rheumatoid Arthritis (RA). Researchers primarily examined outcomes related to physical discomfort, including patient-reported pain intensity scores, and outcomes reflecting daily functioning. Findings describe patterns observed in these studies regarding how symptoms evolved during the trial periods, which were typically short-term to intermediate-term (up to three months).

However, the current research primarily examined symptom scores. There is limited information for long-term outcomes regarding the maintenance of functional status and symptomatic change extending beyond six months. The evidence contributes to understanding symptom patterns over defined time intervals, but research does not determine whether an individual will respond similarly.


2. Evidence for Acute Pain and Menstrual Discomfort

Research protocols were designed to study both general acute physical discomfort (like strains) and conditions associated with acute or disruptive episodes, such as Primary Dysmenorrhea. These RCTs were conducted during periods of increased symptom activity and specifically examined outcomes describing episodic or acute changes, such as the time until patients reported a noticeable change in pain. Multiple meta-analyses described patterns in the symptomatic measures across the acute pain trials examined.

Data for very high-severity or recurring acute pain is less extensive, and the follow-up durations were limited, typically restricted to the immediate episode being studied.


3. Research Gaps and What Remains Uncertain

While research has explored the agent in various common pain situations, several limitations may apply. Data for certain groups remain insufficient, particularly for patients with complex conditions. Furthermore, research focusing on specialized populations, like some pediatric age ranges, has generally involved smaller study numbers, indicating that the certainty remains low in these specific subgroups compared to the overall adult evidence base.

Key Studies & References

  1. Ketoprofen Monograph and Classification (U.S. National Institutes of Health)
  2. Ketoprofen Drug Information (U.S. National Library of Medicine - MedlinePlus)

Frequently Asked Questions (FAQ)

Common questions about Ультрафастин (FAQ)

Q: How does the mechanism of Ультрафастин differ from similar over-the-counter options?

Ультрафастин (Ketoprofen) is classified as a non-selective NSAID (Nonsteroidal Anti-Inflammatory Drug). Its mechanism of action works by blocking both COX-1 and COX-2 enzymes in the body. While this non-selective profile is shared with some other over-the-counter NSAIDs, it differs from drugs like Acetaminophen, which work through different pathways.

Q: Is feeling dizzy or drowsy a commonly reported side effect of Ультрафастин?

Yes, official product labeling indicates that both dizziness and drowsiness are commonly reported side effects. These effects involve the central nervous system (CNS). If these effects are experienced, regulatory guidance suggests consulting a healthcare professional.

Q: Are there any common foods that should be avoided when taking Ультрафастин?

Regulatory warnings advise avoiding the use of alcohol while taking this medication due to an increased risk of gastrointestinal irritation and bleeding. Additionally, some official patient information suggests limiting the intake of foods and beverages that can irritate the stomach lining, such as coffee or spicy foods.

Q: Can taking Ультрафастин affect blood pressure readings?

Yes, official labeling advises patients to monitor their blood pressure closely. The drug is noted to potentially raise blood pressure or worsen existing high blood pressure. If elevated blood pressure readings are observed, regulatory information indicates that a healthcare provider should be informed.

Q: What are the signs of a serious allergic reaction to Ультрафастин that require immediate attention?

Regulatory information on anaphylactoid reactions indicates signs consistent with a medical emergency. These can include difficulty breathing, swelling of the face, tongue, or throat, hives or a severe rash, and fever.

Q: How is the extended-release form of Ультрафастин different from the immediate-release version?

The extended-release form of Ультрафастин is designed to be taken once daily and is typically prescribed for the long-term management of chronic conditions. In contrast, the immediate-release form is taken multiple times per day and is generally reserved for relieving acute pain as needed.

Q: Is there any difference in side effects based on age or gender for people using Ультрафастин?

Official labeling highlights differences based on age, specifically noting that older adults have a higher risk for serious gastrointestinal and cardiovascular adverse events. No difference in side effects based on gender is highlighted in regulatory documents.

Q: How long does it usually take for Ультрафастин to start working?

Regulatory data from acute pain studies indicate that a noticeable onset of action, where patients report some pain relief, occurs relatively quickly. For a significant number of patients, this onset is reported to happen within 30 minutes following a single oral dose.

Q: What is the expected duration of the effect of a single dose of Ультрафастин?

The duration of the effect is related to the drug’s elimination half-life, which is the time it takes for the concentration of the medicine in the body to be reduced by half. For Ультрафастин, the elimination half-life is documented as being approximately 2 to 2.5 hours.

Q: Is it generally safe to drive or operate machinery while using Ультрафастин?

Official patient information includes warnings that the drug may cause side effects such as dizziness, drowsiness, or blurred vision. The patient information contains warnings advising against driving or operating heavy machinery until a user knows how the medication affects them.

Q: Is there a risk of dependence or addiction associated with Ультрафастин?

Regulatory assessments for Ketoprofen indicate that it is not classified as a controlled substance. The drug is considered to have an extremely low potential for dependence or misuse due to the nature of its pharmacological effects.

Q: Is Ультрафастин available as a prescription drug or over-the-counter?

The regulatory status can vary by formulation and geographic location. In the US and Canada, the oral capsule form of Ketoprofen is primarily a prescription-only medication. However, certain topical forms, such as gels or creams, may be available over-the-counter depending on the specific country's regulations.

Q: Do studies suggest that Ультрафастин can cause changes in mood or behavior?

Regulatory guidance requires that any serious side effects, including mental or mood changes, be reported to a healthcare professional. This includes the possibility of mental or mood changes that may occur during the course of treatment.

Q: Is it possible to become tolerant to the effects of Ультрафастин with continuous use?

Regulatory evidence indicates that the development of tolerance, or a reduced response to the drug's effects over time, is not known to occur with the continuous use of Ketoprofen.

Q: Does Ультрафастин make the skin more sensitive to sunlight?

Yes, the drug carries a specific regulatory warning for the risk of photosensitivity reactions, which is an increased sensitivity to sunlight or UV light. This warning applies particularly to users of the topical (gel or cream) formulations. Regulatory warnings advise that sun exposure should be avoided when using this product.

Q: Are there known interactions between Ультрафастин and commonly used herbal products?

Official patient guidance states that consultation with a healthcare professional or pharmacist is advised before combining the medicine with any other products. This general precaution includes non-prescription medications, vitamins, and natural health products.

How should Ультрафастин be stored and disposed of?

Storage and Handling Requirements

Ультрафастин (Ketoprofen) must be stored at Controlled Room Temperature, which is typically 20 C to 25 C (68 F to 77 F). The product must be protected from excessive heat, moisture, and direct light, and it must not be frozen.

Storage Requirement Detail
Temperature Controlled Room Temperature
Container Tight container, kept tightly closed
Safety Keep out of the reach of children

Official Disposal Instructions

To dispose of unused or expired medicine, a drug take-back option is the preferred method, as outlined in regulatory guidance. If a take-back program is unavailable, the medicine may be disposed of in household trash by mixing it with an unappealing substance (such as dirt or used coffee grounds) in a sealed plastic bag. Pills should not be crushed during this process.

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

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