Usage
- Medical Conditions: This combination drug is primarily prescribed for the management of pain and inflammation associated with musculoskeletal disorders like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, tendinitis, bursitis, and soft tissue injuries (sprains, strains). It is also used for post-operative and post-traumatic inflammation, dental pain, and inflammation after tooth extractions.
- Pharmacological Classification: Analgesic, Anti-inflammatory, Proteolytic enzyme combination.
- Mechanism of Action: Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID), inhibits cyclooxygenase enzymes, reducing prostaglandin production, which are mediators of pain and inflammation. Bromelain and Trypsin, proteolytic enzymes, break down proteins, increase blood flow to inflamed areas, and reduce swelling. Rutoside, a flavonoid, acts as an antioxidant, protecting cells from free radical damage and reducing inflammation.
Alternate Names
While there isn’t a universally recognized international non-proprietary name (INN) for this specific combination, the individual components have their own INNs. This combination is often referred to by the names of its constituent drugs.
- Brand Names: Several brand names exist depending on the manufacturer and region, including various combinations of “Trypsin,” “Bromelain,” “Rutoside,” and “Aceclofenac,” often with suffixes like “-A” or similar. Some examples noted include “Genericart,” “Rutomor A,” “Tryson-A,” “Terrizym A,” and “Flamar 3D”.
How It Works
- Pharmacodynamics: Aceclofenac reduces pain and inflammation by inhibiting prostaglandin synthesis. Bromelain and trypsin decrease inflammation by breaking down proteins and increasing blood supply. Rutoside offers antioxidant and anti-inflammatory effects.
- Pharmacokinetics: Aceclofenac is well-absorbed orally, metabolized in the liver, and primarily excreted renally. Bromelain is absorbed orally to some extent. Trypsin is not well absorbed orally and mostly acts locally in the gastrointestinal tract when administered orally. Rutoside is absorbed orally and metabolized. Specific pharmacokinetic parameters for the combination require further clinical investigation.
- Mode of Action: Aceclofenac inhibits COX-1 and COX-2 enzymes, reducing prostaglandin production. Bromelain and Trypsin catalyze the breakdown of proteins involved in inflammation. Rutoside scavenges free radicals, inhibiting oxidative stress and reducing inflammation.
- Elimination Pathways: Aceclofenac is primarily excreted renally. Bromelain and trypsin as oral agents are largely broken down in the digestive tract. Elimination pathways for rutoside require further investigation.
Dosage
Dosage information for this combination is not consistently defined across sources and should be determined by a physician based on individual patient needs and clinical context.
Standard Dosage
Adults:
Dosage varies considerably and must be determined and prescribed by a physician on a case-by-case basis. Typical dosages observed include Aceclofenac 100mg, Bromelain 90mg, Rutoside 100mg, and Trypsin 48mg, administered twice daily after meals. However, this is not a standardized recommendation, and physicians must exercise their judgment based on the patient’s condition.
Children:
Use in children is generally not recommended unless specifically prescribed by a doctor. Safety and efficacy in pediatric populations have not been well-established.
Special Cases:
- Elderly Patients: Dose adjustments may be necessary based on renal and hepatic function.
- Patients with Renal Impairment: Caution is advised, and dose adjustment may be necessary in patients with moderate to severe renal impairment.
- Patients with Hepatic Dysfunction: Caution is advised, and dose adjustments may be necessary for patients with severe liver diseases/conditions.
- Patients with Comorbid Conditions: Careful consideration is needed for patients with conditions such as hypertension, heart problems, gastrointestinal disorders, or bleeding disorders. Consult a specialist where necessary.
Clinical Use Cases
Specific dosage recommendations for clinical scenarios like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations are not established for this particular combination and fall under the purview of a physician’s judgment and current best practices based on the particular situation.
Dosage Adjustments
Dosage adjustments should be made based on individual patient factors such as age, renal function, hepatic function, and comorbid conditions. Consult with a specialist when necessary.
Side Effects
Common Side Effects
Nausea, vomiting, diarrhea, indigestion, stomach pain, heartburn, loss of appetite, fatigue, drowsiness, headache, dizziness.
Rare but Serious Side Effects
Allergic reactions (rash, itching, swelling), gastrointestinal bleeding or ulcers, liver damage, kidney problems.
Long-Term Effects
Long-term use, especially of NSAIDs like Aceclofenac, may increase the risk of gastrointestinal complications and cardiovascular events.
Adverse Drug Reactions (ADR)
Severe allergic reactions, gastrointestinal bleeding or perforation, severe liver or kidney dysfunction.
Contraindications
Hypersensitivity to any component, active peptic ulcer, gastrointestinal bleeding, severe liver or kidney impairment, history of asthma, urticaria, or allergic reactions to NSAIDs, pregnancy (especially third trimester), breastfeeding (caution advised).
Drug Interactions
Other NSAIDs, corticosteroids, anticoagulants, antiplatelet agents, diuretics, ACE inhibitors, lithium, methotrexate, cyclosporine, certain antibiotics (e.g., tetracyclines, amoxicillin), some antidepressants, alcohol. Consult a specialist for clarification and appropriate adjustments.
Pregnancy and Breastfeeding
Use is generally not recommended during pregnancy, especially in the third trimester, and during breastfeeding. If considering use during pregnancy or while breastfeeding, consult a specialist.
Drug Profile Summary (Information to be filled in by the prescribing physician as appropriate to the context)
- Mechanism of Action: [Concise explanation]
- Side Effects: [Common and serious adverse effects]
- Contraindications: [Major conditions where the drug is not advisable]
- Drug Interactions: [Most significant interactions]
- Pregnancy & Breastfeeding: [Summary of safety]
- Dosage: [Standard adult/pediatric dosages, special adjustments]
- Monitoring Parameters: [Key physiological markers to observe]
Popular Combinations
This combination itself represents a common combination aimed at providing synergistic analgesic and anti-inflammatory effects. Concomitant administration with other medications needs to be carefully evaluated by a doctor.
Precautions
Standard precautions regarding screening for allergies, organ dysfunction, and appropriate adjustments for specific populations apply. Driving or operating machinery should be avoided if dizziness or drowsiness occur. Alcohol consumption should be avoided or limited as it may increase the risk of side effects.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Bromelain + Rutoside + Trypsin?
A: The dosage is individualized and must be determined by a physician. Typical observed dosages include Aceclofenac 100mg, Bromelain 90mg, Rutoside 100mg, and Trypsin 48mg twice daily.
Q2: Can this combination be used in children?
A: Use in children is generally not recommended unless specifically prescribed by a doctor.
Q3: What are the common side effects?
A: Common side effects include nausea, vomiting, diarrhea, indigestion, and drowsiness.
Q4: Is it safe to take this combination with other pain relievers?
A: No, avoid combining with other NSAIDs or painkillers without consulting a doctor due to potential drug interactions and increased risk of side effects.
Q5: Are there any contraindications for this drug?
A: Yes, contraindications include hypersensitivity, active peptic ulcer, severe liver/kidney disease, and pregnancy (especially third trimester).
Q6: Can I drive while taking this medication?
A: Use caution while driving or operating machinery as the medication may cause dizziness or drowsiness.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it’s close to your next scheduled dose. Do not double the dose.
Q8: Can I consume alcohol while taking this medicine?
A: Alcohol should be avoided or limited as it may increase the risk of side effects.
Q9: What if I have an allergy to pineapple?
A: Bromelain is derived from pineapple. If you have a pineapple allergy, discuss it with your doctor before taking this combination.
