Usage
Dexketoprofen + Serratiopeptidase is prescribed for short-term management of moderate to severe pain and inflammation. This includes musculoskeletal pain, post-operative pain, dental pain, and dysmenorrhea (painful menstruation). It is also used to reduce swelling and inflammation following injuries or surgical procedures.
Pharmacological Classification:
- Dexketoprofen: Nonsteroidal anti-inflammatory drug (NSAID)
- Serratiopeptidase: Proteolytic enzyme
Mechanism of Action: Dexketoprofen inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis which decreases pain and inflammation. Serratiopeptidase breaks down proteins like bradykinin and fibrin, further reducing inflammation and promoting tissue repair.
Alternate Names
Dexketoprofen is also known as Ketesse, Enantyum, and Dexofen. There are no widely recognized alternate names for Serratiopeptidase.
Brand Names: Veldix XT is a known brand name for the combination of Dexketoprofen and Serratiopeptidase.
How It Works
Pharmacodynamics: Dexketoprofen primarily reduces pain and inflammation through COX inhibition. Serratiopeptidase’s proteolytic action further diminishes inflammation by breaking down inflammatory mediators and facilitating tissue repair.
Pharmacokinetics:
- Dexketoprofen: Rapidly absorbed orally, reaching peak plasma concentration in about 30 minutes on an empty stomach. Metabolized primarily in the liver via glucuronidation and excreted mainly through the kidneys.
- Serratiopeptidase: Absorbed in the intestines and enters the bloodstream, reaching its site of action. Its metabolism and elimination pathways are not fully characterized.
Mode of Action: Dexketoprofen inhibits COX-1 and COX-2 enzymes, reducing prostaglandin synthesis. Serratiopeptidase breaks down proteins that contribute to inflammation.
Receptor Binding, Enzyme Inhibition or Neurotransmitter Modulation: Dexketoprofen primarily acts through COX enzyme inhibition. Serratiopeptidase exerts its effect through proteolytic activity.
Elimination Pathways: Dexketoprofen is eliminated mainly through renal excretion, with some hepatic metabolism via CYP enzymes. The elimination pathways of serratiopeptidase are not fully defined.
Dosage
Standard Dosage
Adults: Dexketoprofen: 25 mg every 8 hours, not to exceed 75 mg daily. Serratiopeptidase: 10 mg three times a day (maximum 60 mg/day). Administer 2 hours after meals.
Children: This combination is not recommended for use in children due to limited safety and efficacy data.
Special Cases:
- Elderly Patients: Initiate dexketoprofen at the lower end of the dosing range (50 mg total daily dose) due to potential age-related decline in renal function.
- Patients with Renal Impairment: For mild renal impairment (creatinine clearance 60–89 mL/min), reduce the initial dexketoprofen dose to 50 mg total daily. Contraindicated in moderate to severe renal impairment (creatinine clearance ≤59 mL/min).
- Patients with Hepatic Dysfunction: For mild to moderate hepatic impairment (Child-Pugh score 5–9), reduce the dexketoprofen dose to 50 mg total daily. Closely monitor liver function. Contraindicated in severe hepatic impairment.
- Patients with Comorbid Conditions: Use with caution in patients with hypertension, cardiac conditions, or a history of gastrointestinal diseases.
Clinical Use Cases
The use of Dexketoprofen + Serratiopeptidase in specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations is not well-established and generally not recommended.
Dosage Adjustments
Dose modifications are necessary based on renal or hepatic dysfunction, as described above. Consult a specialist for dosage adjustments in cases of metabolic disorders or genetic polymorphisms impacting drug metabolism.
Side Effects
Common Side Effects
Nausea, vomiting, dyspepsia, diarrhea, abdominal pain, dizziness, headache, drowsiness, and skin rash are the most common side effects.
Rare but Serious Side Effects
Gastrointestinal bleeding, peptic ulcers, severe allergic reactions (angioedema, anaphylaxis), and Stevens-Johnson syndrome can occur rarely.
Long-Term Effects
Chronic kidney disease, gastrointestinal issues, and cardiovascular complications can potentially arise with long-term NSAID use.
Adverse Drug Reactions (ADR)
Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylaxis, and significant gastrointestinal bleeding are some serious ADRs requiring immediate medical attention.
Contraindications
- Hypersensitivity to dexketoprofen, serratiopeptidase, or any other NSAID.
- History of asthma, urticaria, or rhinitis precipitated by NSAIDs or aspirin.
- Active peptic ulcer or gastrointestinal bleeding.
- Severe heart failure, hepatic impairment, or renal impairment.
- Third trimester of pregnancy and breastfeeding.
Drug Interactions
- Other NSAIDs: Increased risk of gastrointestinal side effects.
- Anticoagulants (e.g., warfarin): Enhanced anticoagulant effect, increasing bleeding risk.
- Lithium, Methotrexate, Digoxin: Elevated serum levels of these drugs.
- Diuretics and Antihypertensives: Reduced effectiveness of these medications.
- Alcohol: Increased risk of gastrointestinal bleeding and liver damage.
Pregnancy and Breastfeeding
Contraindicated in the third trimester of pregnancy and not recommended during breastfeeding. Use in the first and second trimesters only if clearly necessary and under strict medical supervision.
Drug Profile Summary
- Mechanism of Action: Dexketoprofen inhibits COX enzymes, reducing prostaglandin synthesis. Serratiopeptidase breaks down inflammatory mediators.
- Side Effects: Nausea, vomiting, gastrointestinal distress, dizziness, headache, skin rash, and potentially serious effects like gastrointestinal bleeding and allergic reactions.
- Contraindications: Hypersensitivity, asthma/urticaria/rhinitis precipitated by NSAIDs, active peptic ulcer/GI bleeding, severe heart/liver/kidney disease, third-trimester pregnancy, breastfeeding.
- Drug Interactions: Other NSAIDs, anticoagulants, lithium, methotrexate, digoxin, diuretics, and antihypertensives.
- Pregnancy & Breastfeeding: Contraindicated in the third trimester, not recommended during breastfeeding.
- Dosage: Adults: Dexketoprofen 25mg every 8 hours (max 75mg/day); Serratiopeptidase 10mg TID (max 60mg/day). Adjustments for elderly, renal/hepatic impairment.
- Monitoring Parameters: Liver and renal function, blood pressure, complete blood count (CBC), signs of gastrointestinal bleeding.
Popular Combinations
While dexketoprofen is sometimes combined with paracetamol for enhanced analgesic effect, combining it with serratiopeptidase is less common.
Precautions
- Pre-screening for allergies, metabolic disorders, and organ dysfunction is essential.
- Caution is advised in pregnant women (especially in the third trimester), breastfeeding mothers, children, elderly patients, and those with renal or hepatic impairment.
- Avoid alcohol and activities requiring alertness. Monitor for signs of gastrointestinal bleeding.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dexketoprofen + Serratiopeptidase?
A: Dexketoprofen: 25 mg every 8 hours (max 75mg daily). Serratiopeptidase: 10mg three times a day (max 60mg/day). Dosages should be adjusted for elderly patients and those with renal or hepatic impairment.
Q2: What are the common side effects?
A: Common side effects may include nausea, vomiting, dyspepsia, abdominal pain, dizziness, and headache.
Q3: Is this medication safe during pregnancy?
A: It is contraindicated in the third trimester and should be avoided during breastfeeding. Use in the first and second trimesters is generally not recommended unless the potential benefit outweighs the risk and under strict medical supervision.
Q4: What are the serious side effects to watch out for?
A: Rare but serious side effects can include gastrointestinal bleeding, peptic ulcers, severe allergic reactions, and Stevens-Johnson syndrome. Seek immediate medical attention if these occur.
Q5: Can I take this medication with other painkillers like ibuprofen or aspirin?
A: Combining this medication with other NSAIDs is generally not recommended due to the increased risk of gastrointestinal side effects. Consult your doctor before taking other painkillers.
Q6: Are there any specific monitoring parameters?
A: Yes, monitoring liver and renal function, blood pressure, CBC, and signs of gastrointestinal bleeding is important.
Q7: What should patients with renal impairment do?
A: Patients with mild renal impairment should have their dexketoprofen dose reduced. The combination is contraindicated in moderate to severe renal impairment.
Q8: What if a patient has a history of stomach ulcers?
A: This medication is contraindicated in patients with a history of peptic ulcer or gastrointestinal bleeding.
Q9: Can I drink alcohol while taking this medication?
A: Alcohol should be avoided, as it can increase the risk of gastrointestinal bleeding and liver damage.
