Kaltrofen

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Kaltrofen

Property Description
Active Ingredient Ketoprofen
Forms Tablet, Capsule, Suppository, Gel, Injection
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common Purpose Pain relief, reduction of inflammation and fever
Origin Synthetic (Propionic acid derivative)

Kaltrofen is a pharmaceutical product containing the active ingredient, Ketoprofen (INN). This drug is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Ketoprofen is a synthetic molecule belonging to the arylpropionic acid group and functions effectively as an analgesic and antipyretic. As a single-ingredient formulation, its primary therapeutic focus is on controlling the core symptoms of pain and inflammation for managing musculoskeletal discomfort.


Core Function and General Therapeutic Purpose

The general therapeutic purpose of Kaltrofen is to control symptoms associated with localized pain, generalized inflammation, and elevated body temperature. The drug’s mechanism of action involves the reversible inhibition of prostaglandin synthesis, where it acts as a non-selective Cyclooxygenase (COX) inhibitor. This action is fundamental to its therapeutic effect because it controls the production of key chemical messengers that mediate inflammatory responses. It is used for providing symptomatic relief across various conditions requiring anti-inflammatory and pain-reducing actions.


Available Forms and Administration Routes

The active ingredient, Ketoprofen, is designed for flexible delivery. The available dosage forms include capsules and tablets (some with specific coatings for extended or modified release) for oral intake, suppositories for rectal administration, and a gel for localized topical application. This variety, including both systemic and topical preparations, ensures that the compound can be administered in the most appropriate format for the patient’s condition.

Regulatory References

  1. Ketoprofen Mechanism - NIH LiverTox

What side effects are possible with Kaltrofen?

Classification of Officially Documented Adverse Reactions

Adverse reactions associated with Kaltrofen (ketoprofen) are formally categorized by regulatory agencies based on their observed frequency and the body system affected. As a Nonsteroidal Anti-inflammatory Drug (NSAID), the most frequent reports involve the Gastrointestinal (GI) System.

Frequency Example Adverse Reactions (System-Organ Class)
Common (up to 1 in 10) Dyspepsia, nausea, abdominal pain, vomiting (Gastrointestinal Disorders)
Uncommon (up to 1 in 100) Headache, dizziness, somnolence (Nervous System Disorders); rash, pruritus (Skin Disorders)
Rare (up to 1 in 1,000) Peptic ulcer, GI hemorrhage (Gastrointestinal Disorders); hepatitis (Hepatobiliary Disorders)

Serious Adverse Reactions and Safety Constraints

Official safety documentation highlights the risk of serious adverse events that may occur without warning. These include potentially fatal Gastrointestinal Complications such as ulceration, perforation, and bleeding. Furthermore, the use of this NSAID is associated with a risk of serious Cardiovascular Thrombotic Events, including myocardial infarction and stroke, which may increase with the duration of use.

Specific Population-Specific Safety Considerations are noted in official labeling. Older adults are documented to be at a greater risk for serious GI adverse events. Use is generally restricted or subject to caution in patients with severe hepatic or renal impairment and during the third trimester of pregnancy. The systemic safety profile is known to differ significantly between oral/rectal and topical forms, with higher systemic risks associated with the systemic routes of administration.

Overdose and Emergency Response

Overdose and When to Seek Help

The following information details the officially documented overdose manifestations and emergency procedures for Ketoprofen (Kaltrofen), based strictly on government regulatory documents.


Documented Manifestations and Severe Outcomes

Official prescribing information documents that overdose may present with a variety of clinical signs. Commonly reported effects include nausea, vomiting, stomach pain, drowsiness, dizziness, confusion, headache, and ringing in the ears (tinnitus). More severe outcomes explicitly listed in regulatory guidance include seizures, coma, acute renal failure, and significant gastrointestinal bleeding.

Elderly patients are noted in official labeling to be at greater risk for serious gastrointestinal events following overdose. No specific antidote for Ketoprofen is known.


Required Emergency Actions and Management

Official guidance mandates seeking immediate medical help or emergency care immediately if an overdose is suspected. Individuals must contact a Poison Control center right away.

Treatment of an overdose is symptomatic and supportive. Regulatory documents describe procedures such as gastrointestinal decontamination and the use of activated charcoal in appropriate clinical settings. Hospital monitoring and observation of vital signs may be required, particularly when a large ingestion (e.g., five to ten times the usual dose) is involved.

Therapeutic Uses of Kaltrofen

Main Uses of Kaltrofen

Kaltrofen is a non-steroidal anti-inflammatory drug (NSAID) primarily used to manage pain and reduce inflammation. It is effective in treating a variety of acute and chronic conditions characterized by discomfort and swelling.

Inflammatory Conditions

Kaltrofen is frequently used to alleviate the symptoms associated with chronic inflammatory disorders. These include:

  • Rheumatoid Arthritis: Helping to reduce the persistent joint inflammation and stiffness characteristic of this autoimmune condition.
  • Osteoarthritis: Managing the pain and swelling caused by the degeneration of joint cartilage.
  • Ankylosing Spondylitis: Addressing inflammation in the spine and large joints.

Acute Pain Management

Beyond chronic conditions, Kaltrofen is used for the short-term relief of mild to moderate acute pain. Common applications include:

  • Post-operative pain: Managing discomfort following surgical procedures.
  • Musculoskeletal injuries: Treating pain resulting from sprains, strains, and other soft tissue injuries.
  • Dysmenorrhea: Relieving painful menstrual cramps.

Benefits and Mechanism

Pain and Swelling Reduction

The primary benefit of Kaltrofen is its ability to inhibit the production of prostaglandins, which are chemicals in the body that signal pain and promote inflammation. By lowering these levels, the medication helps to improve physical function and comfort.

Improved Mobility

By reducing joint stiffness and inflammatory markers, Kaltrofen can help individuals maintain or regain mobility. This is particularly beneficial for those with arthritic conditions, where physical movement is often limited by discomfort and swelling.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Scope

Category Official Regulatory Statement
Populations for Whom Use is Allowed Adults are the primary eligible population. Use may be established for Adolescents over 15 years in some regions.
Populations for Whom Use is Contraindicated Patients with known hypersensitivity to ketoprofen or who have had allergic reactions to aspirin or other NSAIDs. Contraindicated in severe heart failure, severe hepatic or renal impairment, active GI bleeding/ulceration, and the third trimester of pregnancy. It must not be used for peri-operative pain in the setting of CABG surgery.
Age-Related Eligibility Rules The safety and efficacy are not established in the pediatric population. Older adults (Geriatric) are considered a high-risk population requiring caution due to increased susceptibility to adverse effects.
Condition-Specific Eligibility Rules Use with caution is required for patients with a history of stomach or bowel ulcers, hypertension, mild to moderate organ impairment (hepatic/renal), or cardiovascular risk factors.
Pregnancy and Lactation Eligibility Status Contraindicated in the Third Trimester of Pregnancy. Use is not recommended during the first two trimesters or while breastfeeding.

Eligibility Classifications (High-Level)

Category Official Regulatory Classification
Eligibility Severity Classification Absolute Contraindication, Not Recommended, Use with Caution, Safety Not Established.
Eligibility-Context Constraints Age-Dependent Exclusion, Comorbidity-Dependent Exclusion, Physiological State Exclusion.

Resulting Eligibility Structure

Official eligibility statements:

  • Kaltrofen is contraindicated based on factors including severe organ failure, active GI disease, and NSAID-related allergies.
  • The pediatric population is officially excluded because safety and effectiveness have not been established.
  • Use is restricted and requires caution in the elderly and in patients with known cardiovascular risk or mild/moderate organ impairment.

Connection to the overall eligibility profile: Regulatory documents define who can and cannot use the medicine by establishing absolute contraindications that prohibit use, and by enforcing conditional restrictions for groups like the elderly and those with moderate organ impairment, reflecting the official risk classification assigned to this NSAID by government authorities.

What should I know about interactions with other medicines?

Kaltrofen Interactions with other medicines and products

The interaction profile for Kaltrofen (Ketoprofen) is defined by formal prohibitions and pharmacologic risk amplification as documented in regulatory labels.

Contraindicated Combinations

Kaltrofen is officially contraindicated for co-administration with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including high-dose salicylates, due to a heightened and synergistic risk of gastrointestinal ulceration and hemorrhage. Its use is also prohibited for managing peri-operative pain associated with coronary artery bypass graft (CABG) surgery.

Pharmacodynamic (PD) Risk Amplification

Co-administration with several drug classes carries a documented increased risk of bleeding. These include Anticoagulants (such as Warfarin), Antiplatelet Agents, Oral Corticosteroids, and Selective Serotonin Re-uptake Inhibitors (SSRIs). Furthermore, Ketoprofen may diminish the effect of Diuretics, ACE Inhibitors, and ARBs, creating a documented risk of renal failure secondary to prostaglandin inhibition.

Pharmacokinetic (PK) Exposure Modification

Certain medicines can officially alter drug levels. Probenecid significantly reduces the plasma clearance of Ketoprofen, which is not generally recommended. Combining Ketoprofen with Lithium or Methotrexate can lead to the elevation of their plasma levels and associated toxicity due to changes in elimination.

Interactions with Food and Substances

While food does not change the total amount of drug absorbed (AUC), it delays and reduces the peak concentration of the immediate-release form. Alcohol consumption and certain herbal products (e.g., garlic, ginkgo) are associated with an increased risk of bleeding documented in regulatory materials.

Mechanism of Action

Kaltrofen (Ketoprofen) modifies physiological responses by intervening at specific molecular targets within pathways that modulate inflammatory and thermal responses.

Modulating Inflammatory Mediators via Enzyme Inhibition

The primary mechanistic domain involves the reversible competitive inhibition of the Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) enzymes. This action blocks the rate-limiting step in the Arachidonic Acid Cascade, thereby reducing the synthesis of Prostaglandins (PGE2) that mediate local vascular and nerve excitability. This mechanism results in a suppression of mediator activity, leading to modulation of the signaling within inflammatory pathways.


Attenuating Nociceptive Signals and Central Modulation

A secondary mechanistic domain includes the compound’s interaction with other signaling pathways, such as the Bradykinin response, by functionally inhibiting the action mediated by its B2 receptor. This complements the peripheral desensitization caused by PGE2 reduction. Furthermore, the molecule acts centrally by affecting the hypothalamus to influence the thermal set-point, which contributes to the modulation of core body temperature.

Dosage and Administration Information

How to use Kaltrofen

Kaltrofen is typically used according to the principle of administering the lowest effective dose for the shortest duration necessary. The medicine is available for systemic use via oral forms (capsules and tablets) and, in certain regions, rectal forms (suppositories). It is also used locally via topical gels.

For chronic systemic management, the immediate-release (IR) form is typically administered in divided daily doses, such as 50 mg four times daily or 75 mg three times daily, with a maximum daily limit of 300 mg. The extended-release (ER) 200 mg capsule is intended for a once-daily frequency and is not recommended for acute pain. For short-term acute pain or primary dysmenorrhea, IR doses are typically 25 mg to 50 mg every 6 to 8 hours as needed; doses exceeding 75 mg generally do not provide additional analgesic effect.

Oral administration instructions state that the medicine may be taken with food, milk, or antacids to mitigate potential stomach discomfort, though this may slow the rate of absorption. Extended-release capsules must be swallowed whole and should not be crushed or chewed.

Dosage adjustments are typically implemented for certain populations. Lower initial doses are utilized for older adults. Furthermore, for patients with severe renal or hepatic impairment, there are specific maximum daily dose limitations, such as 100 mg per day for severe renal impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies

This section summarizes the published studies that explored the combination drug in research settings involving the duration and severity of the flu.


Evidence Summary

Early research has examined parameters related to fever in adult patients. Findings from this initial evaluation were published in [Journal Name] in [Year].

Further studies investigated patient-reported outcomes concerning muscle aches and headache pain. These open-label studies explored participant experience following administration of the combination drug.


Specific Findings

  • Nasal Congestion: One key study assessed metrics related to nasal congestion over a 48-hour period, and the use of the study drug in common cold symptoms was also explored. This study included [N] participants and was a randomized design.
  • Duration of Illness: Research has focused on the difference in the duration of overall illness relative to a placebo group. Data points collected included [Data Point 1] and [Data Point 2].
  • Timing of Administration: Research has explored whether the timing of administration in relation to the first sign of symptoms may affect the results. The majority of studies evaluated administration within 24 hours of symptom onset.

Comparisons

Combination A/B was compared to single-agent treatments, with research exploring its role in symptom management. Comparative studies were noted to have primarily focused on [Specific Outcome].

Research Findings on Safety and Tolerability

Research assessed measures of safety and tolerability in adult participants. Reported adverse events included [Adverse Event 1] and [Adverse Event 2].

Studies have included participants with heart conditions, where certain findings related to existing symptoms were observed. This area requires further investigation.

Frequently Asked Questions (FAQ)

Common questions about Kaltrofen (FAQ)

Q: Is Kaltrofen a generic or brand name?

Kaltrofen is a brand name for the drug whose active ingredient is Ketoprofen. Official product information confirms that Ketoprofen is an active substance belonging to the class of Nonsteroidal Anti-inflammatory Drugs (NSAIDs).


Q: Why are older adults given a lower dose?

Official regulatory labels require a lower starting dose for older adults, often referred to as geriatric patients. This is because official documents indicate that this population has an increased risk for developing serious gastrointestinal (GI) adverse effects, which are side effects related to the stomach and intestines.


Q: What is the maximum daily dose for chronic use?

Official labeling specifies a maximum daily limit for the immediate-release form when used for chronic systemic management. Regulatory documents also note a lower maximum daily limit, such as 100 mg, for patients who have been diagnosed with severe renal (kidney) impairment.


Q: What is the typical dose for acute pain or menstrual cramps?

For short-term conditions like acute pain or menstrual cramps, regulatory documents outline typical dose ranges and frequencies for the immediate-release form. Product information indicates that doses exceeding a certain level are generally not associated with increased analgesic effect.

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Q: Can I drink alcohol while taking Kaltrofen?

Regulatory documents advise caution regarding the combination of Kaltrofen and alcohol. Official labeling for the product indicates that consuming alcohol while using this medicine is associated with an increased risk of bleeding.


Q: How long does Kaltrofen take to start working?

Studies summarized in the official regulatory documents, specifically the pharmacokinetics section, indicate that the peak plasma concentration of the immediate-release form is typically reached within 0.5 to 2 hours after oral administration. The measurement of peak plasma concentration is a pharmacokinetic data point that reflects how quickly the active drug enters the bloodstream.


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

Official patient instructions, typically found in the Patient Information Leaflet, provide specific directions for managing a missed dose. These instructions outline conditions for taking a forgotten dose versus skipping it to maintain a proper schedule, and should be consulted directly.


Q: Is Kaltrofen addictive or habit-forming?

Kaltrofen is not classified as a controlled substance by major regulatory authorities like the DEA in the US. Because it is not classified as a controlled substance, the product has not been formally designated as having potential for abuse or physical dependence by these authorities.


Q: How is Kaltrofen supplied (e.g., bottle count, blister pack)?

Regulatory labeling includes a specific section detailing how the product is supplied, which includes various dosage forms, strengths, and packaging formats. This can include bottle counts or unit-dose packaging.


Q: Can I take Kaltrofen while breastfeeding?

Based on official regulatory documents, the use of Kaltrofen is not recommended while breastfeeding. The reason for this official recommendation is documented as the excretion of the active ingredient, Ketoprofen, into human milk.

How should Kaltrofen be stored and disposed of?

How to Store and Dispose of Kaltrofen

Storage and disposal of Kaltrofen (Ketoprofen) must strictly follow official regulatory guidelines to maintain its stability and ensure safety.

Storage Conditions

Kaltrofen should be stored at Controlled Room Temperature, generally 20 C to 25 C (68 F to 77 F). The medication must be kept protected from light and excessive moisture, and it is required to be stored in its original, tightly closed container.

  • Do not freeze the product.
  • The medication must be kept out of the sight and reach of children.

Disposal Instructions

Do not dispose of unused or expired Kaltrofen by flushing it down a toilet or pouring it into a drain. Disposal must be performed according to local regulatory requirements. Consult a pharmacist or local waste management authority for proper guidance on discarding pharmaceutical products.

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

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