Dexpass Film Coated Tablet 25 Mg

Dexpass Film Coated Tablet 25 mg is a combination medication containing Dexketoprofen Trometamol and Paracetamol, designed to provide effective pain relief through dual mechanisms of action. This pharmaceutical formulation combines the anti-inflammatory properties of an NSAID with the analgesic and antipyretic effects of paracetamol, offering a synergistic approach to pain management. This comprehensive overview explores the composition, mechanism of action, therapeutic uses, dosage recommendations, and safety profile of Dexpass to provide healthcare professionals and patients with essential information about this medication.

Composition and Active Ingredients

Dexpass Film Coated Tablet 25 mg contains two primary active ingredients that work in complementary ways to address pain and inflammation. Each tablet contains precisely measured amounts of these components to ensure optimal therapeutic effect.

Dexketoprofen Trometamol

Each tablet contains 36.88 mg of Dexketoprofen Trometamol, which is equivalent to 25 mg of Dexketoprofen. Dexketoprofen is the S(+)-enantiomer of ketoprofen, an arylpropionic acid derivative belonging to the non-steroidal anti-inflammatory drug (NSAID) class. The trometamol salt formulation significantly enhances water solubility, leading to faster absorption compared to the free acid form. This characteristic makes it particularly valuable for rapid pain relief in acute conditions.

Paracetamol

The second active ingredient is Paracetamol (also known as Acetaminophen), present at a dose of 300 mg per tablet. Paracetamol is a well-established analgesic and antipyretic agent widely used in pain management protocols worldwide. Its inclusion in Dexpass enhances the overall analgesic effect through a different mechanism than Dexketoprofen.

Mechanism of Action

The therapeutic efficacy of Dexpass stems from the complementary mechanisms of its two active components, providing a multi-targeted approach to pain management and fever reduction.

Dexketoprofen works primarily by inhibiting the enzyme cyclooxygenase (COX), which is responsible for the production of prostaglandins. Prostaglandins are chemical mediators that cause pain, inflammation, and fever. By reducing prostaglandin synthesis particularly at peripheral sites of tissue damage, Dexketoprofen effectively addresses the inflammatory component of pain.

Paracetamol operates through a different mechanism, primarily inhibiting prostaglandin production in the brain, specifically within the hypothalamus (the temperature-regulating center). Unlike NSAIDs, Paracetamol has minimal anti-inflammatory properties but exhibits strong analgesic and antipyretic effects by modulating central pain processing pathways. This dual mechanism results in enhanced pain relief compared to either component used alone.

Therapeutic Indications

Dexpass is indicated for the management of various painful conditions, ranging from musculoskeletal disorders to post-surgical pain. Its broad spectrum of applications makes it a valuable option in multiple clinical scenarios.

The primary indications for Dexpass include:

• Osteoarthritis: For joint pain and inflammation caused by cartilage degeneration

• Rheumatoid arthritis: Management of pain associated with this autoimmune inflammatory joint disease

• Ankylosing spondylitis: Relief of pain and stiffness in this inflammatory condition affecting the spine

• Acute gout arthritis: Addressing sudden, severe joint pain due to excess uric acid

• Musculoskeletal pain: For conditions such as back pain, muscle strains, or sprains

• Postoperative pain: Pain management following surgical procedures

• Dysmenorrhea: Relief from painful menstrual cramps and associated discomfort

• Dental pain: Management of toothache and pain after dental procedures

• Headache and mild migraines: Providing relief from various types of headaches

Dosage and Administration

Standard Dosage

The recommended dosage of Dexpass should be determined based on the nature and severity of the condition being treated as well as individual patient factors. The standard dosage recommendations are:

For adults, the typical dosage is one tablet (containing 25 mg Dexketoprofen and 300 mg Paracetamol) every 8 hours, with a minimum interval of 6 hours between doses. The maximum daily dose should not exceed three tablets (75 mg Dexketoprofen) in a 24-hour period.

Special Populations

Elderly patients: Treatment should begin at the lower end of the dosage range, with a total daily dose not exceeding 50 mg of Dexketoprofen (two tablets of Dexpass). The dosage may be increased to the standard adult dose only after confirming good tolerability.

Patients with hepatic impairment: Due to the presence of Paracetamol, particular caution is advised. In patients with alcohol consumption, the daily dose of Paracetamol should not exceed 2000 mg due to increased risk of hepatotoxicity.

Patients with renal impairment: Dosage reduction is recommended, and regular monitoring of renal function should be performed during treatment.

Dexpass should be taken with or after food to prevent gastric irritation. The film-coated formulation should be swallowed whole with adequate fluid, typically water.

Pharmacokinetics

Dexketoprofen Trometamol demonstrates favorable pharmacokinetic properties that contribute to its rapid onset of action and effective pain relief:

The trometamol salt formulation of Dexketoprofen shows significantly faster absorption compared to both Dexketoprofen free acid and racemic ketoprofen. It exhibits the highest Cmax (peak concentration) values and shortest tmax (time to reach peak concentration) – typically around 0.5 hours – making it suitable for acute pain management.

Studies have shown that the absorption of Dexketoprofen from Dexketoprofen Trometamol is bioequivalent to that of ketoprofen, while the free acid form shows significantly lower absorption. After repeated-dose administration, pharmacokinetic parameters remain similar to those observed after single doses, indicating no significant drug accumulation with regular use.

In elderly patients, elimination of Dexketoprofen is reduced, with significant increases in AUC (area under the curve) and t½ (half-life), and decreases in clearance compared to younger subjects. However, no clinically relevant drug accumulation has been observed in elderly patients with normal renal function.

Contraindications

Dexpass is contraindicated in several specific conditions where its use may present significant risks:

• Hypersensitivity to Dexketoprofen, Paracetamol, other NSAIDs, or any excipients in the formulation

• Patients with a history of asthma, urticaria, or allergic-type reactions precipitated by aspirin or other NSAIDs (aspirin triad)

• Active peptic ulcer or history of recurrent peptic ulceration

• Gastrointestinal bleeding or perforation related to previous NSAID therapy

• Severe heart failure, renal failure, or hepatic failure

• During the third trimester of pregnancy and in nursing mothers

• Following coronary artery bypass graft (CABG) surgery

Warnings and Precautions

Gastrointestinal Safety

NSAIDs including Dexketoprofen can increase the risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation. These events can occur at any time during treatment, with or without warning symptoms, and may be fatal, particularly in elderly patients.

Patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) should use Dexpass with caution as it may exacerbate these conditions. Concomitant use of protective agents (e.g., misoprostol or proton pump inhibitors) should be considered in high-risk patients.

Cardiovascular Risk

NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. This risk may increase with duration of use and in patients with existing cardiovascular disease or risk factors.

Dexpass should be used with caution in patients with hypertension, as it may cause new-onset hypertension or worsen existing hypertension. Blood pressure should be closely monitored during treatment initiation and throughout therapy.

Renal and Hepatic Considerations

Long-term administration of NSAIDs has been associated with renal papillary necrosis and other renal injury. Patients with impaired renal function, heart failure, liver dysfunction, and elderly patients are at greater risk of renal toxicity.

Severe hepatic reactions, including jaundice and fatal hepatitis, have been reported with NSAID use. Patients with abnormal liver function tests should be monitored carefully, and Dexpass should be discontinued if liver disease develops or systemic manifestations occur.

Use in Elderly Patients

Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Cautious dosing and regular monitoring are essential in this population.

Side Effects

Dexpass may cause various adverse effects ranging from common and mild to rare and severe. The most frequently reported side effects include:

Common Side Effects

• Gastrointestinal disturbances: nausea, vomiting, abdominal pain, dyspepsia, diarrhea, constipation

• Headache and dizziness

• Drowsiness or insomnia

• Mild skin rash

Serious Side Effects

• Gastrointestinal bleeding or ulceration

• Severe allergic reactions including DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms)

• Cardiovascular events: hypertension, heart failure, myocardial infarction, stroke

• Renal impairment or failure

• Hepatotoxicity: jaundice, elevated liver enzymes, liver failure

• Severe skin reactions: Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis

Drug Interactions

Dexpass may interact with various medications, potentially affecting their efficacy or safety profile:

• Other NSAIDs including aspirin: Increased risk of gastrointestinal adverse effects

• Anticoagulants: Enhanced anticoagulant effect with increased bleeding risk

• Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding

• Selective Serotonin Reuptake Inhibitors (SSRIs): Increased risk of gastrointestinal bleeding

• Antihypertensive agents: Decreased effectiveness of antihypertensive therapy

• Diuretics: Reduced natriuretic effect and potential nephrotoxicity

• Lithium: Increased plasma lithium levels and toxicity

• Methotrexate: Reduced clearance and increased toxicity of methotrexate

• Other paracetamol-containing products: Risk of paracetamol overdose

Dexpass Film Coated Tablet 25 mg: Key Information Table

Special Considerations

Pregnancy and Lactation

Dexpass is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and other adverse fetal effects. During the first and second trimesters, it should only be used if clearly necessary, after careful consideration of risks versus benefits.

NSAIDs may impair female fertility and are not recommended for women attempting to conceive. The use of Dexpass during breastfeeding is not recommended due to potential excretion of both active components in breast milk.

Pediatric Use

The safety and efficacy of Dexpass in children and adolescents have not been established. Therefore, its use is not recommended in pediatric populations.

Conclusion

Dexpass Film Coated Tablet 25 mg represents an effective combination analgesic containing Dexketoprofen Trometamol and Paracetamol for the management of various painful conditions. The complementary mechanisms of action of its two active ingredients provide enhanced pain relief compared to either component used alone. However, like all medications, Dexpass carries potential risks and should be used at the lowest effective dose for the shortest duration necessary to control symptoms.

Healthcare providers should carefully evaluate each patient’s risk profile before prescribing Dexpass, particularly in elderly patients and those with pre-existing cardiovascular, gastrointestinal, renal, or hepatic conditions. Regular monitoring during treatment is essential to ensure safe and effective pain management. Patients should be educated about potential side effects and advised to seek medical attention if they experience any concerning symptoms while taking this medication.