Dexpass Effervescent Tablet 25 Mg

Dexpass Effervescent Tablet 25 Mg is a non-steroidal anti-inflammatory drug (NSAID) containing dexketoprofen trometamol as its active ingredient. This medication is primarily used for the treatment of acute pain of various origins, including musculoskeletal pain, dysmenorrhea (painful menstruation), and post-operative pain. The effervescent formulation allows for rapid dissolution in water, potentially leading to faster absorption compared to conventional tablet forms.

Available predominantly in Turkey and some European markets, Dexpass offers an alternative delivery method for patients who may have difficulty swallowing tablets or require quicker onset of analgesic action.

Introduction to Dexpass

Dexpass is the brand name for an effervescent tablet formulation containing dexketoprofen trometamol. Each tablet contains 36.88 mg of dexketoprofen trometamol, which is equivalent to 25 mg of dexketoprofen, the active analgesic compound. Dexketoprofen is the dextrorotatory enantiomer of ketoprofen, an established NSAID that has been in clinical use for decades.

The isolation of this specific enantiomer allows for potentially improved efficacy and possibly fewer side effects at lower doses compared to traditional ketoprofen. The effervescent formulation of Dexpass is designed to dissolve quickly in water before consumption, which may be beneficial for patients who have difficulty swallowing solid dosage forms or require faster onset of action for acute pain relief.

Manufactured and primarily marketed in Turkey, this medication represents an important option in the pharmacological management of pain. The effervescent format also contains various excipients including sodium bicarbonate, citric acid, sodium carbonate, sorbitol, aspartame, polyvidone, sodium saccharine, and orange flavor, which contribute to its dissolution properties and palatability. These components work together to create a fizzing reaction when the tablet is placed in water, facilitating the dispersion and potential absorption of the active ingredient once consumed.

Chemical Composition and Mechanism of Action

Dexketoprofen trometamol, the active pharmaceutical ingredient in Dexpass, is chemically known as the tromethamine salt of (S)-(+)-2-(3-benzoylphenyl)propionic acid. This dextrorotatory enantiomer constitutes the active component of racemic ketoprofen and possesses enhanced analgesic potency. Each effervescent tablet of Dexpass contains 36.88 mg of dexketoprofen trometamol, which yields 25 mg of pure dexketoprofen upon dissolution. The salt form (trometamol) is utilized to enhance water solubility, which is particularly important for the effervescent formulation and may contribute to more rapid absorption following oral administration.

The mechanism of action of dexketoprofen, like other NSAIDs, primarily involves the inhibition of cyclooxygenase (COX) enzymes, which are responsible for the production of prostaglandins from arachidonic acid. Specifically, dexketoprofen inhibits both COX-1 and COX-2 isoenzymes, thereby reducing the synthesis of prostaglandins that mediate inflammation, pain, and fever.

By blocking these pathways, dexketoprofen effectively reduces pain signals and decreases inflammatory responses at the site of tissue damage. Additionally, the medication may have central effects on pain perception, although the peripheral anti-inflammatory action represents its primary therapeutic mechanism.

Pharmacokinetic Properties

Dexketoprofen is rapidly absorbed from the gastrointestinal tract, with effervescent formulations potentially offering faster absorption compared to conventional tablets due to pre-dissolution. The medication demonstrates high plasma protein binding (approximately 99%) and has a relatively short half-life of 1-2.5 hours.

Metabolism occurs primarily in the liver through glucuronidation, and the resulting metabolites are excreted predominantly via the kidneys, with approximately 80% of the dose recovered in urine within 12 hours of administration. The rapid onset of action and relatively short duration make dexketoprofen particularly suitable for the management of acute pain conditions rather than chronic pain states.

Therapeutic Uses and Indications

Dexpass Effervescent Tablet is primarily indicated for the symptomatic treatment of acute pain of mild to moderate intensity. Its clinical applications encompass a wide spectrum of painful conditions where rapid relief is desired. The primary therapeutic indications include musculoskeletal pain such as osteoarthritis flares, low back pain, and various forms of tendinitis and bursitis.

Additionally, it is effective for the management of post-traumatic pain following minor injuries or sprains. The medication has demonstrated particular efficacy in the treatment of dysmenorrhea (menstrual pain), offering relief from the cramping and discomfort associated with menstruation.

In post-operative settings, Dexpass may be prescribed for the management of acute surgical pain, particularly following minor or outpatient procedures. Dental pain, including post-extraction discomfort and pain associated with dental inflammation, represents another common indication for this medication.

The effervescent formulation may offer advantages in terms of onset of action, which can be particularly valuable in acute pain scenarios where rapid relief is desired. It is important to note that like all NSAIDs, Dexpass is intended for short-term use in most cases, with treatment duration generally limited to the acute phase of pain, typically not exceeding 3-5 days without medical supervision.

Comparative Efficacy

Studies have suggested that dexketoprofen may provide more rapid onset of analgesia compared to many other NSAIDs, with measurable pain relief often beginning within 30 minutes of administration. The effervescent formulation may further enhance this property by facilitating faster absorption.

Clinical trials have demonstrated comparable or superior efficacy to traditional NSAIDs such as ibuprofen and diclofenac at appropriate doses, while potentially offering improved gastrointestinal tolerability due to the use of the single active enantiomer rather than the racemic mixture. This favorable efficacy-to-side-effect profile makes Dexpass a valuable option in the analgesic armamentarium for appropriate patients.

Dosage and Administration

The recommended standard dosage of Dexpass Effervescent Tablet is one 25 mg tablet taken up to three times daily, with a minimum interval of 8 hours between doses. The maximum daily dose should not exceed 75 mg (three tablets) within a 24-hour period. For optimal dissolution and absorption, each tablet should be completely dissolved in a glass of water (approximately 200 mL) immediately before consumption.

The resulting solution should be taken promptly after preparation to ensure maximum efficacy. It is generally recommended to take the medication with or after food to minimize potential gastrointestinal irritation, although the effervescent formulation may be somewhat less irritating to the stomach than standard solid oral dosage forms.

In elderly patients or those with renal or hepatic impairment, dosage adjustment may be necessary. For such patients, it is typically recommended to start with a reduced total daily dose of 50 mg (two tablets) and monitor closely for signs of adverse effects.

Treatment duration should be limited to the symptomatic period and should not be extended unnecessarily. For acute conditions, treatment is generally recommended for 3-5 days, after which continued need should be reevaluated by a healthcare provider. Patients should be instructed not to exceed the prescribed dose and to consult their healthcare provider if pain persists despite treatment.

Special Administration Considerations

For patients with swallowing difficulties, the effervescent formulation offers a significant advantage over conventional tablets. The medication should always be taken as a fully dissolved solution rather than attempting to swallow the tablet whole or partially dissolved. In cases of acute severe pain, the first dose may be taken on an empty stomach to facilitate more rapid absorption, though subsequent doses are generally better tolerated with food. Patients should be advised to drink the solution while it is still effervescing for optimum therapeutic effect, as this may enhance absorption characteristics and provide more rapid onset of action.

Contraindications

Dexpass Effervescent Tablet is contraindicated in several conditions where the use of NSAIDs poses significant risk to patient safety. Patients with a history of hypersensitivity to dexketoprofen, other NSAIDs, or any of the excipients in the formulation should not use this medication. Similarly, those with a history of asthma attacks, acute bronchospasm, rhinitis, urticaria, or angioedema precipitated by aspirin or other NSAIDs should avoid Dexpass due to the risk of cross-sensitivity reactions.

Patients with active peptic ulceration or a history of recurrent peptic ulcer disease should not take this medication due to the increased risk of gastrointestinal bleeding and perforation associated with NSAID use.

Other significant contraindications include patients with active gastrointestinal bleeding or other active bleeding disorders, severe heart failure (NYHA Class III-IV), moderate to severe renal dysfunction (creatinine clearance <50 mL/min), and severe hepatic impairment. The medication is also contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and potential complications during labor.

Patients with inflammatory bowel disease such as Crohn’s disease or ulcerative colitis should not use Dexpass, as it may exacerbate these conditions. Additionally, the presence of aspartame in the effervescent formulation contraindicates its use in patients with phenylketonuria.

Precautions and Warnings

Healthcare providers should exercise caution when prescribing Dexpass to certain patient populations. Elderly patients generally have an increased risk of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal.

These patients should be started on the lowest effective dose and monitored closely during treatment. Patients with a history of hypertension or mild to moderate heart failure require careful monitoring, as NSAIDs can lead to fluid retention and edema, potentially worsening these conditions. Blood pressure should be closely monitored at the initiation of therapy and periodically throughout treatment in such patients.

Renal function should be monitored in patients with mild renal impairment, dehydration, or those taking medications that can affect kidney function, such as diuretics or ACE inhibitors.

NSAIDs can impair renal prostaglandin synthesis, which may lead to decreased renal perfusion and potential acute kidney injury in susceptible individuals. Hepatic function should be monitored in patients with a history of liver disease, as transient elevations in liver enzymes may occur with NSAID therapy. Patients with coagulation disorders or those taking anticoagulants should be closely monitored due to the potential for increased bleeding risk when combined with NSAIDs.

Allergic Reactions and Cross-Sensitivity

Patients with known allergies to other NSAIDs should be monitored carefully when initiating therapy with Dexpass, as cross-sensitivity between different NSAIDs can occur. The first signs of any skin reaction, mucous membrane lesions, or other signs of allergic reaction should prompt immediate discontinuation of the medication. Similarly, patients with asthma combined with chronic rhinitis, chronic sinusitis, or nasal polyps have a higher risk of allergy to NSAIDs and should be treated with caution.

In these patients, administration of Dexpass may precipitate asthma attacks or bronchospasm, particularly in those with known aspirin-induced asthma.

Side Effects and Adverse Reactions

Like all medications, Dexpass Effervescent Tablet can cause a range of side effects, although not all patients will experience them. The most common adverse reactions involve the gastrointestinal system. Nausea, vomiting, dyspepsia (indigestion), abdominal pain, and diarrhea occur in approximately 5-10% of patients.

More serious gastrointestinal adverse events include peptic ulcer formation, gastrointestinal bleeding, and perforation, which occur less frequently but represent significant risks, particularly with prolonged use or in high-risk individuals such as the elderly or those with a history of peptic ulcer disease.

Cardiovascular adverse effects may include mild elevation in blood pressure, peripheral edema, and in rare cases, heart failure exacerbation. All NSAIDs carry some degree of cardiovascular risk, particularly with prolonged use at high doses.

Neurological side effects such as headache, dizziness, drowsiness, and vertigo have been reported in some patients. Dermatological reactions ranging from mild rash to more serious reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis are rare but possible. Renal adverse effects may include transient reductions in renal function, interstitial nephritis, or nephrotic syndrome in susceptible individuals.

Less Common Adverse Effects

Less commonly reported adverse events include hypersensitivity reactions such as urticaria, angioedema, or anaphylactic reactions. Hematological abnormalities including thrombocytopenia, leukopenia, and anemia have been observed rarely. Hepatic effects may include transient elevations in liver enzymes and, very rarely, clinically apparent liver injury. Some patients may experience visual disturbances, tinnitus, or hearing impairment. The effervescent formulation specifically may cause additional side effects related to its excipients, such as increased sodium load (relevant for patients on sodium-restricted diets) or reactions to aspartame in sensitive individuals.

Drug Interactions

Dexpass Effervescent Tablet has the potential to interact with various medications, which may require dosage adjustments or increased monitoring. Concurrent use with other NSAIDs, including cyclooxygenase-2 (COX-2) selective inhibitors, should be avoided due to the increased risk of gastrointestinal adverse effects without significant enhancement of therapeutic benefit. Similarly, concomitant use with aspirin is generally not recommended unless specifically prescribed by a physician, as this combination increases the risk of gastrointestinal complications without necessarily improving efficacy.

Anticoagulants and antiplatelets, including warfarin, heparin, and clopidogrel, may have enhanced effects when used with Dexpass, leading to an increased risk of bleeding complications. Close monitoring of coagulation parameters is essential if such combinations are necessary. Corticosteroids can increase the risk of gastrointestinal ulceration or bleeding when used concurrently with NSAIDs.

Certain antihypertensive medications, particularly ACE inhibitors, angiotensin receptor blockers (ARBs), and diuretics, may have diminished effectiveness when co-administered with dexketoprofen, potentially leading to loss of blood pressure control or worsening of renal function in susceptible individuals.

Additional Significant Interactions

Methotrexate toxicity may be increased when administered concurrently with NSAIDs due to reduced renal elimination of methotrexate. This interaction is particularly significant with high-dose methotrexate therapy. Lithium levels may be elevated when used with NSAIDs, potentially leading to lithium toxicity.

Cyclosporine and tacrolimus may have increased nephrotoxicity when combined with NSAIDs. Quinolone antibiotics, when used with NSAIDs, may increase the risk of seizures in predisposed patients. The effervescent formulation, due to its sodium content, may reduce the effectiveness of antihypertensive medications and diuretics, which is an additional consideration beyond the pharmacological NSAID interactions.

Special Populations

Pregnancy and Lactation

Dexpass is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus, which can lead to pulmonary hypertension in the newborn. It may also inhibit uterine contractions and prolong labor. During the first and second trimesters, Dexpass should only be used if clearly necessary and at the lowest effective dose for the shortest duration possible.

There are limited data on the use of dexketoprofen during pregnancy, but NSAIDs as a class have been associated with increased risk of miscarriage and possibly congenital malformations when used in early pregnancy.

Regarding lactation, it is unknown whether dexketoprofen is excreted in human milk. However, other NSAIDs are known to pass into breast milk, and the potential for adverse effects in the nursing infant cannot be excluded. Therefore, a decision should be made whether to discontinue nursing or to avoid Dexpass treatment, taking into account the importance of the drug to the mother and the potential risks to the infant. Generally, use during breastfeeding is not recommended unless the benefits clearly outweigh the potential risks.

Pediatric Use

The safety and efficacy of Dexpass Effervescent Tablet have not been established in children and adolescents under 18 years of age. Therefore, this medication is not recommended for use in the pediatric population. Alternative analgesics with established safety profiles in children should be considered when pain management is required for pediatric patients. Parents should be counseled not to administer this medication to children without specific medical advice from a healthcare provider familiar with pediatric pain management protocols.

Geriatric Use

Elderly patients (typically defined as those aged 65 years or older) are at increased risk of serious adverse events from NSAIDs, particularly gastrointestinal bleeding, ulceration, perforation, cardiovascular events, and renal dysfunction. The risk increases with age, and patients over 75 years are particularly vulnerable. For these patients, treatment should be initiated at the lowest effective dose and for the shortest duration necessary to control symptoms.

Regular monitoring for signs of gastrointestinal bleeding, changes in renal function, and cardiovascular effects is recommended. The total daily dose should generally not exceed 50 mg (two tablets) in elderly patients unless specifically directed by a healthcare provider after careful assessment of the risk-benefit ratio.

Pharmaceutical Information

Storage and Stability

Dexpass Effervescent Tablets should be stored in the original packaging to protect from moisture. The recommended storage temperature is below 25°C (77°F) in a dry place. The effervescent tablets are particularly sensitive to moisture and should never be removed from their protective packaging until immediately before use.

Once exposed to air, the tablets may begin to absorb atmospheric moisture, potentially leading to premature effervescence and degradation of the active ingredient. Patients should be advised to ensure that the container is tightly closed after each use and to inspect tablets for any signs of deterioration before use.

The shelf life of Dexpass is typically 2-3 years when stored as recommended, although this may vary depending on the specific manufacturer’s formulation and packaging. After this period, the medication should be safely disposed of according to local regulations for pharmaceutical waste. It is important to note that the expiration date refers to the last day of the specified month, and the medication should not be used after this date due to potential changes in stability, potency, and safety.

Pharmaceutical Form and Packaging

Dexpass is available as white to off-white round effervescent tablets with a characteristic orange odor due to the flavoring agents. The tablets are typically supplied in aluminum tubes or strips within cardboard outer packaging. Each package contains specific quantities of tablets (commonly 10, 20, or 30 tablets per package), along with a patient information leaflet detailing usage instructions, warnings, and precautions. The packaging is designed to provide protection from light and moisture, both of which can affect the stability of the effervescent formulation.