Usage
- Medical Conditions: This combination medication is primarily prescribed for pain and inflammation associated with musculoskeletal and joint disorders such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, spondylosis, spondyloarthritis, and other ortho-degenerative disorders. It’s also used to manage pain related to injuries (sprains, strains), post-operative pain (dental, orthopedic, gynecological), and other painful inflammatory conditions.
- Pharmacological Classification: This is a combination drug containing a Non-Steroidal Anti-Inflammatory Drug (NSAID) – Aceclofenac, an analgesic and antipyretic – Paracetamol, and proteolytic enzymes – Trypsin and Chymotrypsin.
- Mechanism of Action: Aceclofenac and Paracetamol inhibit cyclooxygenase (COX) enzymes, reducing prostaglandin production, thereby decreasing pain and inflammation. Trypsin and Chymotrypsin break down proteins at the inflammation site, reducing swelling and facilitating healing.
Alternate Names
- This combination doesn’t have a universally recognized international non-proprietary name (INN). It is often referred to by its constituent drugs.
- Brand Names: Chymoral-AP, Mortrip Plus, Vabdolo-TC, Chymogrip, and others. (Note: Brand names can vary regionally).
How It Works
- Pharmacodynamics: Aceclofenac exerts its anti-inflammatory and analgesic effects through COX inhibition. Paracetamol’s analgesic and antipyretic actions occur through central mechanisms, though its exact mode of action is not fully elucidated. Trypsin and Chymotrypsin reduce inflammation by breaking down proteins and increasing blood supply to the affected area.
- Pharmacokinetics: Aceclofenac is well-absorbed orally, metabolized in the liver, and primarily excreted renally. Paracetamol is rapidly absorbed, undergoes hepatic metabolism, and is eliminated in the urine. Trypsin and Chymotrypsin are absorbed from the gastrointestinal tract.
- Mode of Action: Aceclofenac inhibits COX-1 and COX-2 enzymes, leading to decreased prostaglandin synthesis. Paracetamol’s mechanism is thought to involve inhibition of COX-3 in the central nervous system, along with other central effects on the serotonergic and endocannabinoid systems. Trypsin and Chymotrypsin catalyze the hydrolysis of peptide bonds in proteins, leading to protein breakdown at the inflammation site.
- Elimination Pathways: Aceclofenac is primarily excreted through the kidneys. Paracetamol is excreted in the urine, mainly as glucuronide and sulfate conjugates.
Dosage
Standard Dosage
Adults:
- The typical dose is one tablet twice daily, taken after meals. The tablet typically contains Aceclofenac 100mg, Paracetamol 325mg, and Trypsin Chymotrypsin 50,000 IU.
- The maximum daily dose and duration of treatment should be determined by a physician, depending on the patient’s condition.
Children:
- This combination is generally not recommended for children under 12 years of age, as safety and efficacy have not been established.
Special Cases:
- Elderly Patients: Dose adjustments may be necessary based on renal and hepatic function.
- Patients with Renal Impairment: Dose reduction is advised in patients with moderate to severe renal impairment.
- Patients with Hepatic Dysfunction: Caution is recommended, and dose adjustment may be needed.
- Patients with Comorbid Conditions: Careful monitoring is advised in patients with cardiovascular disease, hypertension, diabetes, or gastrointestinal disorders.
Clinical Use Cases
Dosing for specific clinical situations should be individualized based on the patient’s condition and determined by the treating physician. There are no established standard dosage guidelines for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations specifically for this combination product.
Dosage Adjustments
Dose modifications should be based on patient-specific factors such as renal function, hepatic function, age, and concomitant medications.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, abdominal pain, indigestion, heartburn, loss of appetite, dizziness, drowsiness.
Rare but Serious Side Effects:
Allergic reactions (skin rash, itching, swelling), gastrointestinal bleeding or ulcers, severe hepatic or renal dysfunction.
Long-Term Effects:
Long-term use of NSAIDs like Aceclofenac carries a risk of gastrointestinal complications, cardiovascular events, and renal issues.
Adverse Drug Reactions (ADR):
Severe allergic reactions (anaphylaxis), Stevens-Johnson Syndrome, toxic epidermal necrolysis, hepatotoxicity.
Contraindications
- Hypersensitivity to any component of the medication.
- Active peptic ulcer or gastrointestinal bleeding.
- Severe hepatic or renal impairment.
- Severe heart failure.
- Pregnancy (especially the third trimester).
- Breastfeeding.
Drug Interactions
- Other NSAIDs, corticosteroids, anticoagulants (warfarin, heparin), antihypertensives, diuretics, lithium, methotrexate, cyclosporine, alcohol.
- Concomitant use with other drugs that affect renal function or hepatic metabolism should be carefully monitored.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Contraindicated, especially in the third trimester.
- Fetal Risks: Premature closure of the ductus arteriosus, renal dysfunction, increased risk of bleeding.
- Breastfeeding: Excretion in breast milk is unknown but potential for adverse effects in infants; therefore, contraindicated.
Drug Profile Summary
- Mechanism of Action: Aceclofenac and Paracetamol inhibit COX enzymes, reducing prostaglandins; Trypsin and Chymotrypsin break down inflammatory proteins.
- Side Effects: Nausea, vomiting, diarrhea, abdominal pain, dizziness, drowsiness, potential for GI bleeding, allergic reactions.
- Contraindications: Hypersensitivity, active peptic ulcer, severe hepatic/renal impairment, heart failure, pregnancy, breastfeeding.
- Drug Interactions: Other NSAIDs, anticoagulants, antihypertensives, alcohol.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: One tablet twice daily after meals. Pediatric use not recommended.
- Monitoring Parameters: Renal and hepatic function, signs of GI bleeding, blood pressure.
Popular Combinations
This combination itself is a popular combination used for its synergistic effects on pain and inflammation. Combining it with other analgesics or anti-inflammatory drugs is generally not recommended unless specifically directed by a physician.
Precautions
- Pre-existing medical conditions: Assess renal, hepatic, and cardiovascular function before prescribing.
- Pregnant Women: Avoid use.
- Breastfeeding Mothers: Avoid use.
- Children & Elderly: Use with caution and dose adjustment in elderly; not recommended for children under 12.
- Lifestyle Considerations: Avoid alcohol; caution while driving or operating machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Paracetamol + Trypsin Chymotrypsin?
A: The usual adult dosage is one tablet twice daily, taken after meals. Pediatric use is not recommended. Doses should be adjusted for patients with hepatic or renal impairment.
Q2: What are the common side effects?
A: Common side effects include nausea, vomiting, diarrhea, abdominal pain, indigestion, dizziness, and drowsiness.
Q3: Is this combination safe during pregnancy or breastfeeding?
A: No, it is contraindicated during pregnancy and breastfeeding.
Q4: What are the serious side effects to watch out for?
A: Serious side effects can include allergic reactions, gastrointestinal bleeding, and liver or kidney problems. Seek immediate medical attention if these occur.
Q5: Can this combination be taken with alcohol?
A: No, alcohol should be avoided while taking this medication, as it can increase the risk of gastrointestinal side effects.
Q6: Are there any drug interactions I should be aware of?
A: Yes, this combination can interact with other NSAIDs, anticoagulants, antihypertensives, and some other medications. Inform your doctor about all other medications you are taking.
Q7: 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. Do not double the dose.
Q8: How should this medication be stored?
A: Store in a cool, dry place, away from direct sunlight and moisture. Keep out of reach of children.
Q9: Can this combination be used for long-term pain management?
A: Long-term use should be carefully evaluated by a physician due to the potential for adverse effects, particularly gastrointestinal and cardiovascular complications.
