Enantyum 25 mg contains the active ingredient dexketoprofen trometamol, a potent non-steroidal anti-inflammatory drug (NSAID) belonging to the arylpropionic acid class. Developed as the water-soluble tromethamine salt of dexketoprofen (the active S-enantiomer of ketoprofen), it provides rapid analgesia for mild to moderate acute pain. This review synthesizes evidence-based information on its pharmacology, clinical applications, safety profile, and risk mitigation strategies.
1. Pharmacology and Mechanism of Action
- COX Inhibition: Dexketoprofen reversibly inhibits cyclooxygenase (COX)-1 and COX-2 enzymes, reducing prostaglandin synthesis. This suppresses inflammation, pain, and fever.
- Rapid Absorption:
- Oral solution/granules: Peak plasma concentration in 15–30 minutes when fasted 213.
- Tablets: Peak in 30–50 minutes.
- Half-life: ~1–2 hours, with excretion primarily renal (70–80%).
2. Approved Indications and Usage
Short-term symptomatic treatment (max 3–4 days) of:
- Musculoskeletal pain: Acute muscle/joint injuries.
- Dysmenorrhea: Primary menstrual pain.
- Dental pain: Post-procedural toothache.
- Other: Headache, post-traumatic pain.
Note: Not approved for chronic pain, fever, or pediatric use (<18 years)
3. Dosage and Administration
Patient Group Standard Dose Max Daily Dose Special Adjustments Adults (≥18 yrs) 25 mg every 8 hrs 75 mg (3 doses) None Elderly 25 mg every 12 hrs 50 mg (2 doses) Increase to 75 mg if tolerated Hepatic/Renal Impairment (mild) 25 mg every 12 hrs 50 mg Avoid in moderate-severe disease Key Administration Guidelines:
- Acute pain: Take 15–30 minutes before meals for faster absorption.
- GI risk mitigation: Take with food if tolerability is a concern.
- Granules/oral solution: Dissolve 1 sachet in water (contains 2.4 g sucrose; caution in diabetes)
4. Contraindications and Boxed Warnings
Absolute Contraindications:
- Hypersensitivity: To dexketoprofen, aspirin, or other NSAIDs (risk of anaphylaxis).
- Cardiovascular: Severe heart failure, post-CABG surgery.
- Gastrointestinal: Active peptic ulcer, history of GI bleeding/perforation.
- Renal/Hepatic: Severe impairment (CrCl <60 ml/min; Child-Pugh score ≥10).
- Third-trimester pregnancy: Risk of fetal ductus arteriosus closure.
High-Risk Populations:
- Asthma with nasal polyps: 10–20% risk of bronchospasm.
- Inflammatory bowel disease: May exacerbate ulcerative colitis/Crohn’s.
5. Adverse Effects
Frequency-Based Classification:
Frequency Adverse Effects Common (≥1/100) Nausea, vomiting, abdominal pain, diarrhea, dyspepsia Uncommon (≥1/1,000) Dizziness, headache, gastritis, rash, hypertension Rare (≥1/10,000) GI ulcer/bleeding, anaphylaxis, acute renal failure, Stevens-Johnson syndrome Serious Risks:
- GI complications: Ulceration/bleeding (up to 1% in long-term users; higher in elderly).
- Cardiovascular: Myocardial infarction/stroke risk ↑ with high doses or pre-existing CVD.
- Renal toxicity: Acute kidney injury in dehydrated patients or those on diuretics.
6. Drug Interactions
High-Risk Combinations:
- Anticoagulants (warfarin, heparin): ↑ Bleeding risk (avoid).
- SSRIs (e.g., fluoxetine): ↑ GI ulcer risk.
- ACE inhibitors (e.g., lisinopril): Reduced antihypertensive effect.
- Methotrexate: ↑ Toxicity at doses >15 mg/week.
Other Notable Interactions:
- Lithium: ↑ Plasma levels (risk of toxicity).
- Diuretics: ↑ Nephrotoxicity.
7. Special Populations
- Pregnancy:
- First/second trimester: Use only if essential (possible embryotoxicity).
- Third trimester: Contraindicated (risk of premature ductal closure).
- Lactation: Avoid (excretion in milk unknown).
- Fertility: May impair ovulation (discontinue pre-conception).
- Elderly: Start at 50 mg/day; ↑ monitoring for GI/renal/CV effects.
8. Overdose and Management
- Symptoms: Nausea, vomiting, lethargy, GI bleeding, acute renal failure.
- Treatment:
- Activated charcoal if recent ingestion.
- Supportive care (IV fluids, antiemetics).
- Hemodialysis ineffective (high protein binding).
9. Formulations and Storage
| Formulation | Key Features | Storage |
|---|---|---|
| Oral granules | 25 mg/sachet; contains sucrose (diabetes caution) | ≤30°C; protect from light |
| Film-coated tablets | 25 mg; no sucrose/sodium | ≤30°C; in original blister |
| Oral solution | 25 mg/sachet; contains methyl parahydroxybenzoate | Room temperature |
10. Clinical Considerations and Conclusion
Enantyum 25 mg is a valuable option for acute pain due to its rapid onset and proven efficacy. However, its use mandates strict adherence to:
- Short duration (≤3–4 days) to minimize risks.
- Dose individualization in elderly/renal/hepatic impairment.
- Vigilance for GI/CV events, especially in high-risk patients.
- Avoidance in children, pregnancy, and severe comorbidities.
Conclusion: While dexketoprofen offers superior analgesia for acute conditions, its safety profile necessitates careful patient selection and adherence to prescribing guidelines. Always weigh benefits against risks, particularly cardiovascular and gastrointestinal hazards inherent to NSAIDs.
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