Bromelain + Diclofenac + Rutoside + Trypsin Chymotrypsin

Usage

This combination medication is primarily prescribed for reducing pain and inflammation associated with various conditions, including:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Trauma and post-surgical swelling
• Soft tissue injuries

Pharmacological Classification: This is a combination product containing proteolytic enzymes (bromelain, trypsin, chymotrypsin), a non-steroidal anti-inflammatory drug (NSAID) (diclofenac), and a bioflavonoid (rutoside). It can be classified as an analgesic, anti-inflammatory, and proteolytic enzyme combination.

Mechanism of Action: Diclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and thus inflammation and pain. Bromelain, trypsin, and chymotrypsin are proteolytic enzymes that break down proteins, including inflammatory mediators like bradykinin and fibrin, further contributing to anti-inflammatory and anti-edema effects. Rutoside, a bioflavonoid, acts as an antioxidant and may enhance the anti-inflammatory effects of other components by stabilizing capillary walls and reducing capillary permeability.

Alternate Names

While there isn’t a universally recognized alternate name for this specific combination, each component has its own synonyms. This combination is often referred to simply as a proteolytic enzyme and diclofenac combination.

Brand Names: This combination is available under various brand names in India, including Rutoheal, Flamar 3D, Rutimox-D and others.

How It Works

Pharmacodynamics: Diclofenac provides analgesic and anti-inflammatory action through COX inhibition. Proteolytic enzymes contribute to anti-inflammatory and anti-edema effects by breaking down proteins involved in inflammation. Rutoside strengthens capillary walls.

Pharmacokinetics: Diclofenac is well-absorbed orally, metabolized in the liver by CYP enzymes, and excreted primarily through the kidneys. Bromelain is also absorbed orally, though its bioavailability is variable. Trypsin and chymotrypsin are administered as enteric-coated formulations to protect them from gastric acid. Rutoside is generally well-absorbed. Elimination pathways for the enzymes are not fully characterized.

Mode of Action: Diclofenac inhibits COX-1 and COX-2, blocking prostaglandin production. Proteolytic enzymes cleave peptide bonds in proteins associated with the inflammatory cascade. Rutoside strengthens capillary walls and reduces their permeability. Receptor binding or neurotransmitter modulation are not the primary modes of action for this combination.

Dosage

Standard Dosage

Adults: A common dosage is one tablet containing Diclofenac 50mg, Bromelain 90mg, Trypsin 48mg, and Rutoside 100mg, twice daily. The dosage may vary depending on the specific product formulation.

Children: The safety and efficacy of this combination have not been established in children under 12 years of age.

Special Cases:

• Elderly Patients: Dose adjustments may be required based on renal function.
• Patients with Renal Impairment: Reduce the dose according to creatinine clearance.
• Patients with Hepatic Dysfunction: Careful monitoring and dose adjustment are necessary.
• Patients with Comorbid Conditions: Evaluate underlying conditions like diabetes, cardiovascular disease, or peptic ulcer disease before prescribing.

Clinical Use Cases

The use of this combination in specialized settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations are not specifically recommended in medical literature.

Dosage Adjustments

Dosage adjustments are based on renal and hepatic function, age, and other medical conditions. Consult medical references for detailed guidance.

Side Effects

Common Side Effects: Nausea, vomiting, heartburn, indigestion, diarrhea, dizziness, blurred vision.

Rare but Serious Side Effects: Gastrointestinal bleeding, allergic reactions, renal dysfunction, hepatotoxicity.

Long-Term Effects: With prolonged diclofenac use, consider monitoring for cardiovascular and renal complications.

Adverse Drug Reactions (ADR): Severe allergic reactions (anaphylaxis), Stevens-Johnson syndrome.

Contraindications

• Hypersensitivity to any component
• Active peptic ulcer disease
• Severe renal or hepatic impairment
• Aspirin triad (asthma, nasal polyps, aspirin sensitivity)
• Last trimester of pregnancy

Drug Interactions

• Anticoagulants (increased bleeding risk)
• Lithium (increased lithium levels)
• Methotrexate (increased methotrexate toxicity)
• Other NSAIDs (increased risk of side effects)
• Alcohol and smoking should be avoided.

Pregnancy and Breastfeeding

Diclofenac is contraindicated in the third trimester of pregnancy. The safety of the other components during pregnancy and breastfeeding is not well-established. Consult specialist resources for detailed guidelines.

Drug Profile Summary

• Mechanism of Action: Diclofenac inhibits COX, reducing inflammation; enzymes break down inflammatory mediators; rutoside stabilizes capillaries.
• Side Effects: Nausea, vomiting, GI issues, dizziness, rare but serious GI bleeding, allergic reactions.
• Contraindications: Hypersensitivity, peptic ulcer, severe renal/hepatic impairment, pregnancy (third trimester).
• Drug Interactions: Anticoagulants, lithium, methotrexate, other NSAIDs.
• Pregnancy & Breastfeeding: Avoid in third trimester; limited data on other components.
• Dosage: Adults: Diclofenac 50mg + Bromelain 90mg + Trypsin 48mg + Rutoside 100mg twice daily; adjust as needed.
• Monitoring Parameters: Renal and liver function, blood pressure.

Popular Combinations

This specific combination is itself a commonly used formulation.

Precautions

Standard precautions apply, including assessment of renal and hepatic function, allergies, and drug interactions. Caution advised in elderly patients and those with comorbid conditions.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Bromelain + Diclofenac + Rutoside + Trypsin Chymotrypsin?

A: The common dosage is one tablet (Diclofenac 50mg + Bromelain 90mg + Trypsin 48mg + Rutoside 100mg) twice daily. Adjust for specific patient factors.

Q2: What are the main side effects?

A: Common side effects include gastrointestinal issues (nausea, vomiting, heartburn, diarrhea) and dizziness. Rare but serious effects can include GI bleeding and allergic reactions.

Q3: Can this combination be used in pregnancy?

A: Diclofenac is contraindicated in the third trimester. The safety of other components during pregnancy isn’t well-established. Expert consultation is crucial.

Q4: What are the key drug interactions?

A: Significant interactions can occur with anticoagulants, lithium, methotrexate, and other NSAIDs.

Q5: What is the role of each component?

A: Diclofenac reduces inflammation; bromelain, trypsin, and chymotrypsin break down inflammatory proteins; rutoside improves capillary integrity.

Q6: How should dosage be adjusted in patients with renal impairment?

A: Reduce the dosage based on creatinine clearance and consult appropriate guidelines.

Q7: What are the contraindications for this drug?

A: Hypersensitivity to any component, active peptic ulcer, severe renal or hepatic impairment, and late pregnancy.

Q8: Are there any specific monitoring parameters?

A: Monitor renal and liver function, especially with long-term use. Observe for signs of gastrointestinal bleeding or allergic reactions.

Q9: What should patients be advised regarding lifestyle?

A: Advise patients to avoid alcohol and smoking, as these can exacerbate potential side effects. A healthy diet and regular exercise may help manage symptoms. Patients should be advised to use caution while driving or operating heavy machinery due to the risk of dizziness.