Usage
Aceclofenac + Paracetamol + Serratiopeptidase is prescribed for pain and inflammation associated with musculoskeletal conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, back pain, and post-surgical pain and inflammation. It is also used for pain relief in conditions like headache, toothache, and menstrual pain.
Pharmacological Classification:
- Aceclofenac: Non-Steroidal Anti-Inflammatory Drug (NSAID)
- Paracetamol: Analgesic and Antipyretic
- Serratiopeptidase: Proteolytic enzyme
Mechanism of Action: Aceclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, thereby decreasing pain and inflammation. Paracetamol acts centrally to reduce pain and fever. Serratiopeptidase breaks down proteins, reducing inflammation and promoting tissue repair.
Alternate Names
This combination doesn’t have a specific international non-proprietary name (INN). It is known by its constituent drug names. Brand names vary depending on the manufacturer; some examples include Forgesic-SP, Aceforce SP, and Noblinac SP.
How It Works
Pharmacodynamics: Aceclofenac exerts its anti-inflammatory and analgesic effects by inhibiting COX-1 and COX-2 enzymes, decreasing prostaglandin production. Paracetamol is thought to inhibit COX-3 in the central nervous system, leading to analgesic and antipyretic effects. Serratiopeptidase breaks down fibrin, a protein involved in inflammation and blood clotting, improving tissue drainage and reducing swelling.
Pharmacokinetics: Aceclofenac is well-absorbed orally, metabolized in the liver, and excreted primarily through the kidneys. Paracetamol is also well-absorbed orally, metabolized in the liver, and excreted in the urine. Serratiopeptidase is absorbed in the intestines and distributed throughout the body. Elimination pathways for Serratiopeptidase haven’t been fully elucidated.
Dosage
Standard Dosage
Adults: The usual recommended dose is one tablet twice daily, taken after meals. The maximum recommended dose of Aceclofenac is 200 mg daily, Paracetamol is 4g daily, and Serratiopeptidase is 60 mg daily.
Children: This combination is generally not recommended for use in children. Use under strict medical supervision is advised if necessary.
Special Cases:
- Elderly Patients: Lower doses may be required due to potential age-related decline in renal and hepatic function.
- Patients with Renal Impairment: Dose adjustment may be necessary depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Dose adjustment may be required. Close monitoring of liver function is advisable.
- Patients with Comorbid Conditions: Caution should be exercised in patients with cardiovascular disease, hypertension, asthma, or peptic ulcer disease.
Clinical Use Cases
The dosage in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations needs to be determined on a case-by-case basis by the attending physician, considering patient-specific factors and underlying conditions.
Dosage Adjustments
Dose adjustments should be considered in patients with renal or hepatic impairment, metabolic disorders, or other relevant comorbidities. Consult specific product information and clinical guidelines for detailed recommendations.
Side Effects
Common Side Effects: Nausea, stomach pain, diarrhea, dizziness, indigestion, loss of appetite.
Long-Term Effects: Long-term use of NSAIDs like Aceclofenac carries a risk of cardiovascular and gastrointestinal complications.
Contraindications
- Hypersensitivity to any component of the formulation.
- Active peptic ulcer or gastrointestinal bleeding.
- Severe heart failure, hepatic impairment, or renal impairment.
- Asthma, rhinitis, angioedema, or urticaria triggered by NSAIDs or Paracetamol.
- Last trimester of pregnancy.
Drug Interactions
- Other NSAIDs (including COX-2 inhibitors)
- Anticoagulants (warfarin)
- Antihypertensives
- Alcohol
- Methotrexate
Pregnancy and Breastfeeding
This combination is generally not recommended during pregnancy, especially the last trimester. It should be used with caution during breastfeeding, only if clearly needed and under medical supervision. The safety profile in pregnant and breastfeeding women hasn’t been extensively studied.
Drug Profile Summary
- Mechanism of Action: Aceclofenac: COX inhibitor; Paracetamol: Central analgesic and antipyretic; Serratiopeptidase: Proteolytic enzyme.
- Side Effects: Nausea, stomach pain, diarrhea, allergic reactions, liver damage (rare).
- Contraindications: Hypersensitivity, peptic ulcer, severe heart/liver/kidney disease, pregnancy (last trimester).
- Drug Interactions: NSAIDs, anticoagulants, antihypertensives, alcohol.
- Pregnancy & Breastfeeding: Not recommended.
- Dosage: Adults: One tablet twice daily.
- Monitoring Parameters: Liver function tests, renal function tests, signs of gastrointestinal bleeding.
Popular Combinations
This combination itself is a popular combination therapy for pain and inflammation.
Precautions
- Assess for allergies, pre-existing medical conditions, and concomitant medications.
- Use with caution in patients with a history of gastrointestinal disorders, renal/hepatic impairment, or cardiovascular disease.
- Avoid alcohol consumption.
- Monitor for signs of adverse reactions.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Paracetamol + Serratiopeptidase?
A: The usual recommended adult dose is one tablet twice a day, taken after meals.
Q2: What are the common side effects?
A: Common side effects include nausea, stomach pain, diarrhea, and dizziness.
Q3: Who should not take this medication?
A: Individuals with hypersensitivity, active peptic ulcer, severe heart/liver/kidney disease, or pregnant women in the last trimester should not take this medication.
Q4: Can I take this medicine with alcohol?
A: No, alcohol consumption should be avoided as it may increase the risk of liver damage and gastrointestinal issues.
Q5: Can I take this medication if I am breastfeeding?
A: Consult your doctor before taking this medication if you are breastfeeding. It’s generally not recommended.
Q6: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Q7: How should this medicine be stored?
A: Store in a cool and dry place, away from direct sunlight.
Q8: Can I drive after taking this medicine?
A: Use caution while driving or operating machinery as this medication may cause dizziness.
Q9: What if my pain doesn’t improve?
A: Consult your physician if your pain doesn’t improve after a few days of taking this medication. They might adjust your dose or recommend alternative treatments.
