Usage
Aceclofenac + Serratiopeptidase is prescribed for pain relief and inflammation reduction in conditions like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, back pain, post-traumatic pain, and other musculoskeletal disorders. It’s also used to manage pain and swelling after surgical procedures.
It is classified pharmacologically as a Non-Steroidal Anti-Inflammatory Drug (NSAID) and proteolytic enzyme combination.
The mechanism of action involves Aceclofenac inhibiting cyclooxygenase (COX) enzymes, reducing prostaglandin production, which are responsible for inflammation and pain. Serratiopeptidase breaks down fibrin, a protein involved in inflammation and blood clotting, further reducing swelling and promoting tissue repair.
Alternate Names
While there isn’t a widely recognized international non-proprietary name for this specific combination, it is sometimes referred to as Aceclofenac-Serratiopeptidase. Brand names include Zerodol-SP, Ano SP and Dolostat-SP. Regional variations may exist.
How It Works
Pharmacodynamics: Aceclofenac exerts its analgesic and anti-inflammatory effects by inhibiting COX-1 and COX-2 enzymes. This action reduces the production of prostaglandins, which mediate pain, fever, and inflammation. Serratiopeptidase acts as a proteolytic enzyme, breaking down fibrin and other proteins involved in inflammation, facilitating fluid drainage and tissue repair.
Pharmacokinetics: Aceclofenac is well-absorbed orally, metabolized in the liver primarily via CYP2C9, and excreted through the kidneys. Paracetamol is rapidly absorbed, metabolized in the liver by several pathways, including CYP2E1, and eliminated in the urine. Serratiopeptidase is absorbed via the intestine. Exact metabolic pathways and elimination routes for serratiopeptidase are less well-defined, but it appears partially degraded in the gastrointestinal tract.
Mode of Action: Aceclofenac inhibits COX enzymes, preventing the conversion of arachidonic acid to prostaglandins. Serratiopeptidase enzymatically degrades proteins involved in inflammation, such as fibrin and bradykinin. These synergistic actions result in reduced pain, swelling, and inflammation. Elimination pathways for this drug include renal and hepatic excretion.
Dosage
Standard Dosage
Adults: The usual recommended dose is one tablet twice daily, taken after meals. A tablet typically contains 100mg Aceclofenac, 325mg Paracetamol, and 15mg Serratiopeptidase. The maximum recommended dose of Aceclofenac is 200mg daily, Paracetamol is 4g daily, and Serratiopeptidase is 60mg daily, all in divided doses.
Children: Use in children is not recommended as safety and efficacy have not been established.
Special Cases:
- Elderly Patients: Use with caution and at the lowest effective dose due to increased risk of adverse effects. Close monitoring is advised, especially for gastrointestinal and renal function.
- Patients with Renal Impairment: Use with caution and dose adjustment may be necessary depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Use with caution and dose adjustment may be necessary depending on the degree of impairment.
- Patients with Comorbid Conditions: Close monitoring and careful consideration are needed for patients with conditions like diabetes, cardiovascular disease, asthma, or bleeding disorders.
Clinical Use Cases
Dosage for clinical use cases such as intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be determined on a case-by-case basis by the treating physician, considering patient-specific factors and the severity of the condition.
Dosage Adjustments
Dosage adjustments should be based on individual patient factors such as renal or hepatic impairment, other comorbid conditions, and concomitant medications.
Side Effects
Common Side Effects
Nausea, vomiting, diarrhea, constipation, indigestion, abdominal pain, heartburn, dizziness, drowsiness.
Rare but Serious Side Effects
Allergic reactions (rash, itching, swelling), severe stomach pain, gastrointestinal bleeding (blood in stools or vomit), liver damage (jaundice, dark urine), kidney problems (changes in urination), heart problems (chest pain, shortness of breath), Steven-Johnson syndrome.
Long-Term Effects
Long-term use of NSAIDs may increase the risk of gastrointestinal ulcers, bleeding, and kidney problems. Chronic use of paracetamol at high doses can lead to liver damage.
Adverse Drug Reactions (ADR)
Clinically significant ADRs include anaphylaxis, angioedema, gastrointestinal perforation, and severe skin reactions.
Contraindications
Hypersensitivity to any component of the drug, active peptic ulcer, history of gastrointestinal bleeding or perforation, severe heart failure, severe hepatic impairment, severe renal impairment, last trimester of pregnancy, asthma, urticaria, acute rhinitis precipitated by aspirin or other NSAIDs, acute porphyria.
Drug Interactions
Clinically significant interactions may occur with other NSAIDs, anticoagulants (warfarin, heparin), antihypertensives, digoxin, lithium, antidepressants (SSRIs), methotrexate, cyclosporine, tacrolimus, quinolone antibiotics, prokinetic agents (metoclopramide, domperidone). Alcohol should be avoided as it may increase the risk of gastrointestinal bleeding and liver damage.
Pregnancy and Breastfeeding
This medication is contraindicated during the last trimester of pregnancy. Use during the first and second trimesters should be avoided unless the potential benefits outweigh the risks. It is not recommended during breastfeeding due to the potential for adverse effects on the infant.
Drug Profile Summary
- Mechanism of Action: Aceclofenac: COX inhibitor, reducing prostaglandin synthesis; Serratiopeptidase: Proteolytic enzyme, breaks down fibrin and inflammatory mediators.
- Side Effects: Nausea, vomiting, diarrhea, gastrointestinal upset, dizziness, serious but rare effects include allergic reactions, gastrointestinal bleeding, and liver/kidney problems.
- Contraindications: Hypersensitivity, active peptic ulcer, severe heart/liver/kidney disease, last trimester of pregnancy.
- Drug Interactions: NSAIDs, anticoagulants, antihypertensives, alcohol.
- Pregnancy & Breastfeeding: Contraindicated in the last trimester of pregnancy, not recommended during breastfeeding.
- Dosage: Adults: 100mg Aceclofenac + 325mg Paracetamol + 15mg Serratiopeptidase twice daily after meals.
- Monitoring Parameters: Liver function tests, renal function tests, blood pressure, signs of gastrointestinal bleeding.
Popular Combinations
Aceclofenac is sometimes combined with a proton pump inhibitor (PPI) like pantoprazole or rabeprazole to reduce the risk of gastrointestinal side effects.
Precautions
General precautions include screening for allergies, assessing renal and hepatic function, and monitoring for gastrointestinal side effects. Specific precautions for pregnant/breastfeeding women and children are noted above. Alcohol should be avoided, and caution should be exercised when driving or operating machinery due to the potential for dizziness and drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Serratiopeptidase?
A: The usual recommended dose for adults is one tablet (containing 100mg Aceclofenac, 325mg Paracetamol, and 15mg Serratiopeptidase) twice daily after meals.
Q2: What are the primary uses of this combination?
A: It is primarily used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and other musculoskeletal disorders.
Q3: Is it safe to use in patients with a history of peptic ulcers?
A: No, it’s contraindicated in patients with active or a history of recurrent peptic ulcers or gastrointestinal bleeding.
Q4: Can pregnant or breastfeeding women take this medicine?
A: It is contraindicated during the last trimester of pregnancy and generally not recommended during pregnancy or breastfeeding.
Q5: What are the common side effects patients should be aware of?
A: Common side effects include nausea, vomiting, diarrhea, constipation, indigestion, abdominal pain, heartburn, dizziness, and drowsiness.
A: Yes. Serious side effects, though rare, include allergic reactions (rash, itching, swelling), severe stomach pain, signs of gastrointestinal bleeding, liver damage (jaundice, dark urine), and kidney problems.
Q7: What are the major drug interactions I should be aware of?
A: Significant drug interactions can occur with other NSAIDs, anticoagulants, antihypertensives, digoxin, lithium, some antidepressants, and certain other medications. Alcohol should also be avoided.
Q8: How should I advise patients regarding lifestyle considerations while on this medication?
A: Advise patients to avoid alcohol, use caution when driving or operating machinery due to potential drowsiness, and report any unusual symptoms promptly.
Q9: What monitoring parameters are essential for patients on long-term therapy?
A: Monitor liver and kidney function through regular tests, check blood pressure regularly, and be vigilant for any signs of gastrointestinal bleeding.
