Usage
Serratiopeptidase is a proteolytic enzyme, derived from the bacteria Serratia marcescens, used primarily for its anti-inflammatory and mucolytic properties. It is prescribed for conditions involving pain, swelling, and inflammation such as:
- Post-surgical inflammation and edema: Reduces swelling and pain following surgical procedures.
- Traumatic injuries: Helps manage inflammation and pain associated with injuries.
- Upper respiratory tract infections: Thins mucus secretions, aiding in conditions like sinusitis, bronchitis, and laryngitis.
- Dental procedures: Manages inflammation and pain after dental surgeries.
- Breast engorgement: Alleviates pain and swelling in lactating women.
Pharmacological Classification: Anti-inflammatory, mucolytic, proteolytic enzyme.
Mechanism of Action: Serratiopeptidase breaks down proteins like fibrin, bradykinin, and other inflammatory mediators, thereby reducing inflammation, swelling, and pain. It also thins mucus secretions, facilitating their clearance.
Alternate Names
- Serrapeptase
- Serralysin
- Serratia peptidase
How It Works
Pharmacodynamics: Serratiopeptidase exerts its anti-inflammatory effect by reducing the levels of inflammatory mediators. Its mucolytic action stems from its ability to break down mucus proteins, decreasing viscosity and promoting clearance.
Pharmacokinetics: Orally administered serratiopeptidase is absorbed in the intestines after bypassing the stomach due to its enteric coating. It binds to alpha-2-macroglobulin in the bloodstream, retaining its enzymatic activity.
Mode of Action: Serratiopeptidase hydrolyzes peptide bonds in proteins involved in inflammation (bradykinin, histamine), blood clotting (fibrin), and mucus formation, thereby reducing inflammation, improving microcirculation, and facilitating drainage of inflammatory exudates.
Elimination Pathways: Information on specific elimination pathways for serratiopeptidase is limited.
Dosage
Standard Dosage
Adults: 10 mg three times daily, taken on an empty stomach (30 minutes before or 2 hours after a meal). The dosage may range from 10 mg to 60 mg per day depending on the indication. Some sources suggest an initial dose of 62.5 mg twice daily for four weeks, followed by 125 mg twice daily as a maintenance dose for PAH. As of February 17, 2025, this dosing regimen requires further verification and is not universally accepted.
Children: Use in children under 10 is generally not recommended unless specifically directed by a physician. Pediatric dosing guidelines are not well-established and should be determined by a doctor based on weight and health status.
Special Cases: Dose adjustments are necessary in patients with renal or hepatic impairment. Consult a healthcare professional for personalized recommendations. For elderly patients, a lower dose might be considered.
Clinical Use Cases
Dosage in clinical settings varies depending on the specific indication and patient condition. Consultation with a specialist is essential. Currently, there is limited data on serratiopeptidase dosage for clinical situations like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations.
Dosage Adjustments
Dose modifications may be necessary in patients with:
- Renal impairment
- Hepatic dysfunction
- Bleeding disorders
- Concomitant use of anticoagulants
Side Effects
Common Side Effects
- Nausea
- Vomiting
- Abdominal discomfort
- Diarrhea
- Skin rashes
- Cough
Rare but Serious Side Effects
- Eosinophilic pneumonitis
- Bullous pemphigoid
- Hemorrhage (especially in patients with Behçet’s disease)
- Stevens-Johnson syndrome
- Liver toxicity (increased liver enzymes)
Long-Term Effects: Long-term safety data for serratiopeptidase is limited.
Contraindications
- Hypersensitivity to serratiopeptidase
- Active gastric ulcers or bleeding
- Pregnancy and breastfeeding
- Bleeding disorders
- Pre and post-surgical periods (2 weeks before and after)
Drug Interactions
- Anticoagulants/Antiplatelet drugs: Increased risk of bleeding (warfarin, aspirin, clopidogrel)
- Nimesulide, Methotrexate, Lithium, Iodine: Potential drug interactions warrant caution.
- Hormonal contraceptives: Reduced effectiveness
- Cyclosporine: Increased risk of liver toxicity
- Rifampin: Possible reduced effectiveness of serratiopeptidase
Pregnancy and Breastfeeding
Seratiopeptidase should be avoided during pregnancy and breastfeeding due to limited safety data. It is contraindicated during pregnancy due to potential risks of birth defects, and its excretion in breast milk raises concerns about neonatal safety.
Drug Profile Summary
- Mechanism of Action: Proteolytic enzyme reducing inflammation and thinning mucus.
- Side Effects: Nausea, vomiting, diarrhea, skin rashes, cough, serious respiratory and dermatological reactions.
- Contraindications: Hypersensitivity, gastric ulcers, pregnancy, breastfeeding, bleeding disorders.
- Drug Interactions: Anticoagulants, NSAIDs, some antibiotics, hormonal contraceptives.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: 10 mg thrice daily (may range 10-60 mg/day), empty stomach. Children: Not recommended.
- Monitoring Parameters: Monitor for gastrointestinal issues, skin reactions, and signs of bleeding. Liver function tests may be considered.
Precautions
- Assess for allergies and bleeding disorders.
- Monitor liver function, especially with long-term use.
- Caution in patients with renal or hepatic impairment.
- Discontinue use 2 weeks before scheduled surgery.
- Avoid alcohol and other interacting medications.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Serratiopeptidase?
A: The standard adult dose is 10 mg three times daily, taken on an empty stomach. Some sources suggest 62.5mg twice daily for four weeks, followed by 125 mg twice daily for PAH. This dosing requires further confirmation.
Q2: What are the primary uses of Serratiopeptidase?
A: It is primarily used for its anti-inflammatory and mucolytic properties in conditions like post-surgical swelling, traumatic injuries, upper respiratory tract infections, and dental procedures.
Q3: Is Serratiopeptidase safe during pregnancy?
A: No, it is contraindicated during pregnancy and breastfeeding.
Q4: What are the common side effects of Serratiopeptidase?
A: Common side effects include nausea, vomiting, diarrhea, skin rashes, and cough.
Q5: What are the serious side effects of Serratiopeptidase?
A: Rare but serious side effects include eosinophilic pneumonitis, bullous pemphigoid, hemorrhage, and Stevens-Johnson syndrome.
Q6: Does Serratiopeptidase interact with other medications?
A: Yes, it can interact with anticoagulants, some antibiotics, and hormonal contraceptives.
Q7: Can Serratiopeptidase be used in children?
A: It is generally not recommended for children under 10 unless prescribed by a doctor.
Q8: How should Serratiopeptidase be taken?
A: It should be taken on an empty stomach, at least 30 minutes before or 2 hours after a meal.
Q9: How long does it take for Serratiopeptidase to work?
A: The effect of a single dose can last 3-4 hours. When taken regularly, effects may be noticeable within a few days to weeks, depending on the condition.
Q10: Can patients with bleeding disorders take Serratiopeptidase?
A: No, Serratiopeptidase has mild anticoagulant properties and should be avoided in patients with bleeding disorders.
