Dexketoprofeno Cinfa

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Dexketoprofeno Cinfa

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Overview of Dexketoprofeno Cinfa

Quick Facts

Property Description
Active ingredient Dexketoprofen
Form Tablet (Film-coated)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Pain relief, Anti-inflammatory, Antipyretic
Origin Synthetic (S-enantiomer)

Defining Dexketoprofeno Cinfa: Identity and Pharmacological Class

Dexketoprofeno Cinfa is a medicinal product whose active substance, Dexketoprofen, is formally classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) and belongs to the propionic acid derivatives subgroup. This synthetic compound is typically prepared for oral administration, most commonly in the form of a film-coated tablet. It is clinically recognized for its triple action—providing analgesic, anti-inflammatory, and antipyretic effects, which defines its fundamental role in managing symptoms stemming from inflammation and pain.

Composition: The Unique Activity of Dexketoprofen

The chemical identity is centered on Dexketoprofen, which represents the isolated, biologically active portion—the S-enantiomer—of the racemic drug Ketoprofen. This is a single-active ingredient product where the Dexketoprofen is formulated as the highly soluble trometamol salt. The use of this specific trometamol salt formulation results in high solubility and a rapid absorption profile. This focus on the isolated S-enantiomer is a key chemical differentiator, enhancing the efficiency of the compound compared to less refined mixtures.

What is the General Purpose of This Type of Medicine?

The general purpose of this medication is to provide effective symptomatic relief, primarily functioning as a potent analgesic (pain reliever) and anti-inflammatory agent, while also helping to reduce fever. Its core action is achieved by interfering with the body's synthesis of prostaglandins, which are key chemical mediators responsible for initiating pain signals and swelling. The medicine is used in contexts where rapid relief is beneficial, such as managing acute dental discomfort or post-operative tissue inflammation. By interrupting this mechanism, the medicine works to provide timely comfort from acute, peripheral symptoms.

Regulatory References

  1. Dexketoprofeno Cinfa SmPC (CIMA-AEMPS)
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What side effects are possible with Dexketoprofeno Cinfa?

Possible Side Effects and Safety Information

The safety profile of Dexketoprofen, as a non-steroidal anti-inflammatory drug (NSAID), is characterized by adverse reactions grouped according to regulatory frequency categories and physiological systems. All information reflects officially documented safety characteristics.

Officially Documented Adverse Reactions

Classification Examples of Reactions
Common (up to 1 in 10) Nausea, vomiting, abdominal pain, diarrhea, and dyspepsia (indigestion).
Uncommon (up to 1 in 100) Headache, dizziness, insomnia, gastritis, rash, fatigue, and palpitations.
Rare (up to 1 in 1,000) Peptic ulcer, gastrointestinal hemorrhage or perforation, anaphylactic reaction, and elevated liver enzymes.
Very Rare (less than 1 in 10,000) Acute renal failure, severe mucocutaneous reactions (e.g., Stevens-Johnson syndrome), and agranulocytosis.

Regulatory Safety Considerations

The use of this medication is subject to class-specific safety considerations documented by regulatory authorities. The risk of serious gastrointestinal events, such as bleeding, ulceration, or perforation, is considered to increase with the duration of treatment and higher doses. Furthermore, clinical and epidemiological data for NSAIDs suggest a small potential increased risk of arterial thrombotic events, such as myocardial infarction or stroke, which is a class-effect warning.

Specific safety statements exist for certain patient groups. Older adults are officially documented to have an increased frequency and severity of adverse reactions, particularly serious gastrointestinal events. The safety and efficacy of the medicine have not been established in children and adolescents.

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Overdose and Emergency Response

Overdose manifestations are generally mild but require immediate medical attention. Documented presentations of acute overexposure to this type of medicine often include central nervous system (CNS) symptoms such as drowsiness, headache, dizziness, and tinnitus (ringing in the ears). Gastrointestinal signs are common, typically presenting as nausea, vomiting, and epigastric pain.

When to Seek Help

If a potential overdose is suspected, it is a regulatory requirement to seek immediate medical help right away by contacting emergency services or going to the nearest hospital emergency department. This action is crucial because, while symptoms are often mild, serious, life-threatening outcomes can develop, including gastrointestinal bleeding and perforation, acute renal failure, convulsions, or coma. The elderly population is specifically noted in regulatory documents as having an increased risk for these severe, sometimes fatal, gastrointestinal complications.

Management and Monitoring

Management of overexposure is defined as entirely symptomatic and supportive treatment, as no specific antidotes are documented. Emergency care may involve gastrointestinal decontamination procedures such as gastric lavage or the administration of activated charcoal. Hospital monitoring is required, including observation of vital signs and diagnostic testing like ECG and blood/urine tests to evaluate the degree of toxicity and guide supportive care.

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Therapeutic Uses of Dexketoprofeno Cinfa

What Dexketoprofeno Cinfa Treats: Main Uses and Benefits

The medication is used for the symptomatic treatment of pain of mild to moderate intensity. This covers several acute conditions, including musculoskeletal pain, the discomfort of primary dysmenorrhoea (menstrual cramps), and dental pain.

Symptom Relief in Acute Contexts

The medication is primarily applied in clinical settings that involve acute, localized pain and inflammation, providing rapid, short-term symptomatic relief. The analgesic action contributes to improved comfort and contributes to easing the overall symptom load, particularly during sudden flare-ups.

“This approach is relevant when supportive symptom management is appropriate, may assist with symptomatic relief during difficult episodes of discomfort.”

In addition to easing general pain and swelling, the medicine is commonly used to address conditions associated with minor physical trauma, such as sprains, and discomfort in the immediate post-operative setting following minor surgery. Its use in these scenarios provides supportive relief when symptoms interfere with routine activities or when acute manifestations disrupt daily functioning.


QuickFact Block

Property Description
Quick Fact: Relief for mild to moderate acute pain
Main Use: Management of musculoskeletal and episodic pain
Key Benefit: Contributes to easing the overall symptom load

Regulatory References

  1. Summary of Product Characteristics for Dexketoprofen
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Eligibility and Restrictions for Use

Who can and cannot use Dexketoprofeno Cinfa?

Eligibility for Dexketoprofeno Cinfa is strictly defined by regulatory bodies, establishing both the permitted user population and specific groups for whom use is contraindicated (absolutely prohibited).


Populations Not Eligible (Contraindications)

Use of this medicine is prohibited for several groups, including children and adolescents under 18 years of age as safety and efficacy have not been established. It is also contraindicated during the third trimester of pregnancy and while lactating (breastfeeding).

Non-eligibility is mandatory for patients with severe hepatic impairment, severe renal impairment (Creatinine clearance < 30 mL/min), severe heart failure (NYHA Class II–IV), and those with active peptic ulcer/gastrointestinal haemorrhage, a history of recurrent GI bleeding, or active bleeding disorders. Furthermore, individuals with known hypersensitivity to Dexketoprofen or any other Non-Steroidal Anti-Inflammatory Drug (NSAID) must not use this medicine.


Restricted and Conditional Use

Use requires caution and must commence at a reduced initial dose in older adults (typically age 65 and above). A reduced dose and close monitoring are also required for patients with mild to moderate renal or hepatic impairment, as well as those with pre-existing mild to moderate cardiovascular or cerebrovascular disease. These restrictions align with official prescribing information to manage potential population-specific risks.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the official interaction constraints for Dexketoprofeno Cinfa, as documented in government regulatory labeling (e.g., Summary of Product Characteristics).

Combinations Formally Contraindicated

Co-administration with several substances is strictly prohibited due to significantly increased risk, as established in regulatory documents:

  • Other NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) and Selective Cyclooxygenase-2 Inhibitors: Increased risk of gastrointestinal ulceration and hemorrhage.
  • Anticoagulants (e.g., Warfarin, Heparin at curative doses): Increased risk of hemorrhage.
  • Lithium and High-dose Methotrexate (ge 15 mg/week): Risk of toxicity due to reduced clearance and increased plasma levels of these drugs.
  • Alcohol and High-dose Corticosteroids: Increased risk of gastrointestinal adverse effects and bleeding.

Interactions Requiring Close Monitoring

Other combinations require caution and clinical observation due to documented interaction patterns:

Interacting Substance/Class Official Interaction Risk Rationale/Mechanism Stated in Label
Antiplatelet agents (e.g., Clopidogrel) and SSRIs Increased risk of bleeding/hemorrhage. Additive pharmacodynamic effects.
Diuretics, ACE Inhibitors, ARBs Increased risk of acute renal insufficiency. Affects renal prostaglandin synthesis; prohibited if patient is dehydrated.
Digoxin and Hydantoins Increased plasma concentrations of these medicines. Altered drug levels.

Administration with food is documented to delay the absorption rate; therefore, the product is to be taken before meals for a faster effect. Population-specific notes exist, citing that interactions leading to increased GI bleeding are more frequent in elderly patients.

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Mechanism of Action

How Dexketoprofeno Cinfa Works

Blocking the Prostaglandin Synthesis Cascade

The primary mechanism involves the reversible, non-selective inhibition of the Cyclooxygenase (COX) enzymes, targeting both the COX-1 and COX-2 isoforms. By blocking the active site of these enzymes, the drug prevents the conversion of arachidonic acid into pro-inflammatory and pain-sensitizing prostaglandins. This interruption is the essential step that dictates the drug's downstream effects, reducing the availability of chemical messengers that drive key physiological responses.

Modulating Pain and Inflammatory Signals

The resulting reduction in prostaglandin levels directly modifies the peripheral nociceptive and inflammatory pathways. Lower concentrations of PGE2 prevent the sensitization of nerve endings to pain stimuli, thereby raising the activation threshold of pain receptors. This modulation stabilizes the microvascular response and reduces local fluid extravasation, leading to a dampening of microvascular changes that cause local fluid accumulation and reducing the amplification of nociceptive signals.

Central Thermoregulation and Rapid Onset

The mechanism also extends to the central nervous system, where the drug suppresses PGE2 production in the hypothalamus, effectively normalizing the elevated hypothalamic temperature set-point. Furthermore, the use of the highly soluble trometamol salt formulation facilitates the rapid attainment of COX-inhibiting concentrations at the target tissues, leading to an earlier onset of pathway modulation.

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Dosage and Administration Information

Dexketoprofeno Cinfa is officially administered through two primary routes: the oral route, available as 25 mg film-coated tablets or oral solutions, and the parenteral route, utilizing a 50 mg/2 ml solution for intravenous (IV) or intramuscular (IM) injection. The standard dosing regimen for adults is 12.5 mg taken every 4 to 6 hours, or alternatively, a 25 mg dose administered every 8 hours. Regardless of the schedule, the total dose taken within a 24-hour period must not exceed 75 mg.

To maximize the speed of onset for acute pain relief, the oral form of the medicine should be taken at least 30 minutes before meals. The use of this medicine is intended strictly for a short-term duration and must be limited to the symptomatic period. It is not established for use in the pediatric population.

Established protocols define specific dose adjustments for certain patient groups. Older adults and individuals with mild renal or hepatic impairment are required to start therapy with a reduced total daily dose, which should not exceed 50 mg. For parenteral administration, the instructions define the procedure: an IV bolus must be administered slowly over no less than 15 seconds, while a slow IV infusion requires a duration of 10 to 30 minutes. These parameters establish standardized use across different administration contexts.

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Recent Clinical Evidence

Dexketoprofeno Cinfa: Recent Clinical Evidence


Evidence for Use in Acute Pain Following Surgical Procedures

The research base for this condition primarily consists of short-term, controlled trials (RCTs) applied in studies examining patient-reported experiences following minor surgical events, such as dental extractions. Researchers examined specific measurements, including the measured change in pain intensity and the time taken to observe a symptomatic change. Data show patterns related to the speed with which symptomatic changes were measured and tracked metrics for consumption of rescue pain medication.


Evidence for Use in Primary Dysmenorrhoea

Controlled trials have evaluated this medicine for women experiencing episodic manifestations of pain, such as menstrual cramps. These studies examined outcomes describing acute changes in discomfort and monitored the speed of symptomatic change. Reports tracked patterns of how symptoms evolved when compared to inactive treatments, and the need for additional pain-relieving medication.


Evidence for Use in Acute Musculoskeletal Conditions

The research includes controlled trials for acute symptom onset, supplemented by observational settings evaluating daily functioning for conditions like low back pain or soft tissue injuries. Studies explored outcomes related to patient-reported discomfort and overall symptom change over time. Comparative evidence is lacking for long-term management against other standard treatment options.


Duration of Study and Long-Term Follow-up

The majority of controlled research reflects treatment periods of very short duration, typically assessing single doses or spanning only a few days. The data collected reflects observation over limited follow-up durations. Consequently, long-term effects for sustained outcomes or rare, serious events are not fully established based on the core clinical trial data.


Evidence Gaps and Limitations

Research has primarily focused on the general adult population. Data for certain groups, such as children, pregnant populations, or older adults with complex comorbidities, remain insufficient. A primary research limitation across all uses is the limited follow-up duration, which restricts insight into long-term safety and sustained efficacy for chronic conditions.

Key Studies & References

  1. Systematic review of dexketoprofen in acute and chronic pain
  2. Dexketoprofen versus Tenoxicam in Acute Severe Pain Due to Primary Dysmenorrhea: A Randomized-Controlled Trial
  3. Summary of Product Characteristics (SmPC) for Keral 25mg granules (Regulatory Authority Document)
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Frequently Asked Questions (FAQ)

Common questions about Dexketoprofeno Cinfa (FAQ)

Q: Is Dexketoprofeno Cinfa the same type of medicine as ibuprofen or naproxen?

According to official information, Dexketoprofeno Cinfa is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). This places it in the same general pharmacological category as other common medicines like ibuprofen and naproxen, which are also propionic acid derivatives. The classification defines its core pain-relieving, anti-inflammatory, and fever-reducing actions.

Q: Does Dexketoprofeno Cinfa cause drowsiness or make you sleepy?

Official product information lists effects on the central nervous system, such as dizziness or drowsiness, as possible uncommon side effects (affecting up to 1 in 100 people). Regulatory warnings note that due to these possible effects, caution is advised regarding activities that require alertness, such as driving or operating machinery.

Q: How long do the effects of Dexketoprofeno Cinfa last?

The frequency for taking this medicine, as described in dosing guidance, is typically every 4 to 8 hours, which suggests the expected duration of pain relief. Pharmacokinetic properties from regulatory studies indicate the active ingredient has an elimination half-life of approximately 1.65 hours.

Q: Is Dexketoprofeno Cinfa a strong painkiller?

Regulatory documentation classifies this medicine as a potent analgesic, meaning it has significant pain-relieving action. Its official purpose is the symptomatic treatment of mild to moderate acute pain.

Q: Are there certain foods or drinks I should avoid while using Dexketoprofeno Cinfa?

The co-administration of this medicine with alcohol is strictly prohibited, as it significantly increases the risk of gastrointestinal side effects and bleeding. While no specific foods are prohibited, official guidance advises taking the tablets at least 30 minutes before meals for the quickest relief, because food delays the absorption process.

Q: What is the difference between Dexketoprofeno Cinfa and regular Dexketoprofen?

The active substance is Dexketoprofen, which is combined with a trometamol salt. The medicine is formulated as a trometamol salt to aid its solubility and rapid absorption, a characteristic noted in regulatory reports. 'Cinfa' is the brand name of the pharmaceutical company that produces this specific medicine.

Q: What ingredients are in Dexketoprofeno Cinfa besides the main active substance?

In addition to the active substance, Dexketoprofen, the product contains a defined list of inactive ingredients, known as excipients, which are necessary for the tablet form. The complete list of excipients is detailed in the official package leaflet for the product.

Q: What should I do if I notice a possible allergic reaction?

Regulatory patient information advises immediate discontinuation of the medicine if any signs of an allergic reaction are noticed. These signs can include severe skin rashes, swelling of the face, lips, or throat, or difficulty breathing. Official guidance states that immediate consultation with a healthcare professional is necessary in these circumstances.

Q: What are the signs of a serious stomach or digestive side effect from this drug?

Warnings regarding serious gastrointestinal events, such as bleeding or ulceration, are included in the official safety information. Symptoms that may indicate these serious side effects include passing black or bloody stools, vomiting blood, or experiencing severe and persistent abdominal pains.

Q: Is Dexketoprofeno Cinfa a narcotic or addictive substance?

This medicine is classified by regulatory authorities as a Non-Steroidal Anti-Inflammatory Drug (NSAID). It is not classified as a controlled substance, such as an opioid or narcotic, by any government health authority.

Q: Can Dexketoprofeno Cinfa affect my blood pressure?

Official safety warnings advise caution when this medicine is used by patients with high blood pressure (hypertension) or pre-existing heart conditions. Furthermore, the medicine is known to interact with several classes of drugs used to treat high blood pressure, such as diuretics and ACE inhibitors.

Q: What happens if I miss a time I was supposed to take Dexketoprofeno Cinfa?

Official guidance states that if a dose is forgotten, it should be taken as soon as the patient remembers, unless it is almost time for the next scheduled dose. If the next dose is due, the forgotten dose should be skipped entirely. It is advised not to take two doses together to make up for a missed one.

Q: Does Dexketoprofeno Cinfa contain gluten or lactose?

All inactive ingredients, or excipients, used in the formulation are listed in the official package leaflet. If you have concerns about the presence of common substances like lactose, gluten, or certain dyes, this information is available for review in the patient documentation.

Q: Is Dexketoprofeno Cinfa available without a prescription in some places?

The regulatory classification of this medicine, determining whether it is available only by prescription or over-the-counter (OTC), is dependent on the specific national health authority. This legal status can vary significantly from one country to another.

Q: What is the significance of the 'Cinfa' part of the name?

The 'Cinfa' component of the product name is the brand name used by the pharmaceutical laboratory or manufacturer responsible for producing and marketing this specific formulation of the drug.

Q: Is Dexketoprofeno Cinfa appropriate for treating headaches or migraines?

Regulatory documents confirm that Dexketoprofeno is approved for the short-term treatment of mild to moderate pain, which includes acute musculoskeletal pain, painful periods, and certain types of headaches.

Q: What is the proper way to discontinue the use of this medicine?

Since the medicine is intended strictly for short-term use and relief of acute symptoms, regulatory patient information indicates that it can be stopped once the symptoms of the painful condition have passed. Unlike certain other medicines, a specific gradual weaning is not typically required.

Q: What should be done if an accidental amount larger than intended is used?

Official regulatory information states that immediate emergency medical assistance or contact with a poison control center is necessary if a larger amount than intended is suspected.

Q: Can Dexketoprofeno Cinfa be used if I am trying to become pregnant?

Official safety warnings advise caution regarding the use of this medicine in women who are trying to become pregnant. The product information indicates that the medicine may impair female fertility and its use is generally not recommended if you are planning a pregnancy or undergoing fertility investigations.

Q: What is the purpose of the coatings on the tablets?

The tablets are manufactured with a film coating, which is a key part of the pharmaceutical form. This coating helps protect the tablet from the environment, aids in swallowing, and can also help mask any unpleasant taste.

Q: Can this drug cause sensitivity to sunlight?

Official regulatory documents include warnings regarding the potential for photosensitivity (increased sensitivity to sunlight or UV light). Regulatory documents note that, due to the potential for photosensitivity, caution regarding sun exposure may be advised.

Q: Are there any warnings about driving or operating machinery while taking this medicine?

Regulatory warnings explicitly advise caution with activities requiring alertness, such as driving or operating heavy machinery. This is because the medicine may cause side effects like dizziness, drowsiness, or visual disturbances in some people.

Q: Can Dexketoprofeno Cinfa be taken at the same time as paracetamol (acetaminophen)?

Official pain management guidelines often support the combined use of paracetamol (acetaminophen) and an NSAID like Dexketoprofeno. This is due to their complementary effects on pain relief, provided no specific contraindications for either medicine are present.

Q: What is the half-life of Dexketoprofeno Cinfa?

According to pharmacokinetic data contained within the official product characteristics, the biological half-life of the active ingredient, dexketoprofen, is approximately 1.65 hours. The half-life refers to the time it takes for half of the drug to be eliminated from the body.

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How should Dexketoprofeno Cinfa be stored and disposed of?

Storage and Disposal Requirements for Dexketoprofeno Cinfa

The official regulatory labeling defines specific conditions for conserving Dexketoprofeno Cinfa tablets to ensure product stability.

Storage Conditions

Requirement Rule Defined by Regulatory Documents
Temperature Limit Do not store above 30 C.
Protection Store in the original packaging to protect from light.
Stability Do not use the medication after the expiration date (EXP/CAD) printed on the carton.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Pharmaceutical waste protocols prohibit disposing of this medication through domestic waste streams. Unused or expired Dexketoprofeno Cinfa must not be thrown in the trash or flushed down drains. Instead, the official procedure requires that the product and its packaging be returned to a designated pharmacy collection point (such as SIGRE) to ensure proper environmental protection.

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

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