1. Clinical Overview
A fixed-dose combination of proteolytic enzymes and a bioflavonoid, primarily used as an anti-inflammatory, anti-edematous, and fibrinolytic agent. It is widely prescribed in India for the management of post-operative and post-traumatic inflammation, swelling, and pain, as well as for venous disorders. The combination synergistically reduces inflammation, improves microcirculation, and accelerates tissue healing.
| Onset | Duration | Bioavailability |
|---|---|---|
| Within 2-4 hours for initial anti-inflammatory effects. | Approximately 8-12 hours, supporting a typical twice-daily dosing regimen. | Variable. Bromelain: ~40% (oral). Rutoside: ~10-20% (oral). Trypsin/Chymotrypsin: Poor oral bioavailability as proteins; formulated as enteric-coated tablets for intestinal absorption. |
2. Mechanism of Action
The combination exerts a multi-targeted anti-inflammatory and anti-edema effect. Bromelain and Trypsin-Chymotrypsin break down inflammatory mediators (bradykinin, histamine), fibrin deposits, and exudative proteins, reducing edema and improving tissue permeability. Rutoside reduces capillary fragility and permeability by inhibiting hyaluronidase and prostaglandin synthesis, thereby stabilizing vascular endothelium. Together, they enhance fibrinolysis, reduce blood viscosity, and improve microcirculation at the site of injury.
3. Indications & Uses
- Post-operative inflammation and edema (e.g., dental surgery, orthopedic surgery, episiotomy)
- Post-traumatic swelling and pain (sprains, strains, contusions, fractures)
- Chronic venous insufficiency (CVI) and associated symptoms (pain, heaviness, edema)
- Phlebitis and superficial thrombophlebitis
4. Dosage & Administration
Adult Dosage: One tablet (Bromelain 90mg + Rutoside 100mg + Trypsin Chymotrypsin 50000 AU) twice daily, preferably on an empty stomach (30-60 minutes before meals or 2 hours after meals). In acute conditions, the dose may be initiated as one tablet three times daily for the first 3-4 days, then reduced to twice daily.
Administration: Swallow the enteric-coated tablet whole with a glass of water. Do not crush, chew, or break. Take at least 30 minutes before food for optimal absorption. If gastrointestinal upset occurs, it may be taken with food, but efficacy may be reduced.
5. Side Effects
Common side effects may include:
- Mild gastrointestinal discomfort (heartburn, nausea, epigastric pain)
- Diarrhea or loose stools
- Allergic skin reactions (rash, itching, urticaria) in sensitive individuals
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| Warfarin, Acenocoumarol | Increased anticoagulant effect and risk of bleeding due to antiplatelet and fibrinolytic activity of enzymes and rutoside. | Major |
| Aspirin, Clopidogrel, NSAIDs (e.g., Diclofenac) | Additive risk of gastrointestinal irritation and bleeding. | Moderate |
| Antibiotics (especially Tetracyclines, Amoxicillin) | Bromelain may increase absorption and serum levels of certain antibiotics, potentially increasing both efficacy and toxicity. | Moderate |
| Chemotherapeutic agents (e.g., 5-Fluorouracil, Vinca alkaloids) | Bromelain may enhance absorption and cytotoxicity; use only under strict supervision. | Major |
| Sedatives (e.g., Benzodiazepines, Barbiturates) | Theoretical increased sedation; limited clinical data. | Minor |
7. Patient Counselling
- DO take the tablet on an empty stomach, at least 30 minutes before food, for best results.
- DO swallow the tablet whole with water. Do not crush or chew.
- DO inform your doctor if you are taking any blood thinners (e.g., warfarin, aspirin), antibiotics, or chemotherapy drugs.
- DO report any signs of unusual bleeding (gums, nose, easy bruising, black stools) immediately.
- DONT take this medication if you are pregnant, planning pregnancy, or breastfeeding without consulting your doctor.
- DONT exceed the prescribed dose.
8. Toxicology & Storage
Overdose: Nausea, vomiting, diarrhea, epigastric pain, potential gastrointestinal bleeding, increased risk of bruising/bleeding, and in massive overdose, hypotension and renal impairment.
Storage: Store below 30°C in a cool, dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the pack.