Serratiopeptidase (10mg)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Serratiopeptidase is a proteolytic enzyme derived from the enterobacterium *Serratia marcescens* (formerly *Serratia E15*). It is a potent anti-inflammatory, anti-edemic, and fibrinolytic agent widely used in India for managing pain and inflammation associated with various surgical and inflammatory conditions. It works by breaking down non-living tissue, exudates, and blood clots without affecting living cells.

OnsetDurationBioavailability
Within 1-2 hours after oral administration.Approximately 4-6 hours.Oral bioavailability is variable and relatively low due to degradation in the GI tract. Enteric-coated formulations are essential for protection from gastric acid, improving absorption in the small intestine. Bioavailability estimates range from 10-30%.

2. Mechanism of Action

Serratiopeptidase exerts its effects through proteolytic (protein-digesting) activity. It selectively hydrolyzes (breaks down) abnormal exudates such as fibrin, fibrinogen, and other denatured proteins found in inflammatory sites, blood clots, and mucous secretions. This reduces edema, improves microcirculation, and facilitates tissue repair. It also modulates inflammatory cytokines (e.g., bradykinin) and enhances the penetration of antibiotics into tissues.

3. Indications & Uses

  • Post-operative inflammation and swelling (e.g., dental, orthopedic, obstetric-gynecological surgeries)
  • Traumatic inflammation and edema (e.g., sprains, fractures, contusions)
  • Chronic inflammatory diseases: Sinusitis, Bronchitis, Tonsillitis
  • Analgesic and anti-inflammatory adjuvant in conditions like osteoarthritis, rheumatoid arthritis

4. Dosage & Administration

Adult Dosage: 10 mg three times daily. In acute conditions, can be initiated at 10 mg three times a day, then reduced to 10 mg twice daily as symptoms improve.

Administration: Must be taken on an EMPTY STOMACH, at least 1 hour before or 2 hours after meals, with a full glass of water. Do NOT crush, chew, or break the enteric-coated tablet. Swallow whole.

5. Side Effects

Common side effects may include:

  • Gastrointestinal disturbances: Nausea, diarrhea, epigastric discomfort, loss of appetite
  • Skin reactions: Itching, skin rash

6. Drug Interactions

DrugEffectSeverity
Warfarin, Acenocoumarol, Dabigatran, Rivaroxaban, ApixabanIncreased risk of bleeding due to additive fibrinolytic/anti-coagulant effect.Major
Aspirin, Clopidogrel, Ticagrelor, NSAIDs (e.g., Ibuprofen, Diclofenac)Increased risk of gastrointestinal bleeding and antiplatelet effect.Major
Antibiotics (especially Penicillins, Cephalosporins)Serratiopeptidase may enhance tissue penetration of antibiotics, potentially improving efficacy. This is often a desired combination.Moderate
Herbal Supplements (Ginkgo biloba, Garlic, Ginseng)Increased risk of bleeding.Moderate

7. Patient Counselling

  • DO take the tablet on an empty stomach, 1 hour before or 2 hours after food.
  • 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) or have a bleeding disorder.
  • DO report any signs of unusual bleeding (gums, nose, dark stools) or severe allergic reaction immediately.
  • DONT take with meals as it will not work properly.
  • DONT take if you are pregnant, planning pregnancy, or breastfeeding without consulting your doctor.

8. Toxicology & Storage

Overdose: Symptoms of overdose may include severe gastrointestinal upset (nausea, vomiting, diarrhea), increased risk of bleeding (bruising, nosebleeds), and potential for anaphylaxis in sensitive individuals.

Storage: Store below 30°C, in a cool, dry place. Protect from moisture and direct sunlight. Keep out of reach of children.