Diclofenac + Serratiopeptidase

Usage

• Medical Conditions: Diclofenac + Serratiopeptidase is prescribed for pain and inflammation associated with various conditions, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, post-operative pain, dental pain, sprains, fractures, and lower back pain. It is effective in managing acute pain arising from tissue damage in muscles, bones, or organs.

• Pharmacological Classification: This drug is a combination of a Non-Steroidal Anti-Inflammatory Drug (NSAID) and a proteolytic enzyme. Diclofenac is the NSAID component, while Serratiopeptidase is the enzyme component.

• Mechanism of Action: Diclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin production, which are responsible for pain and inflammation. Serratiopeptidase breaks down fibrin, a protein involved in inflammation, and also deactivates bradykinin, another inflammatory mediator. The combination results in synergistic pain and swelling reduction.

Alternate Names

• No widely recognized alternate names exist for the combination itself. The individual components are sometimes referred to as Diclofenac Sodium or Diclofenac Potassium and Serrapeptase.

• Brand Names: Brand names can vary depending on the manufacturer and region. Some examples include Diclogesic SP, Lyser-DP, and Zorvolex (Diclofenac only).

How It Works

• Pharmacodynamics: Diclofenac exerts its analgesic and anti-inflammatory effects by inhibiting COX-1 and COX-2 enzymes, thereby reducing prostaglandin synthesis. Serratiopeptidase reduces swelling and inflammation by breaking down fibrin and other inflammatory mediators.

• Pharmacokinetics:

  • Diclofenac: Well-absorbed orally, peak plasma concentration reached in 1-2 hours. Metabolized primarily in the liver via CYP2C9. Excreted renally and in bile.
  • Serratiopeptidase: Absorbed orally and enters the bloodstream. Mechanism of absorption and metabolism not fully elucidated.

• Mode of Action: Diclofenac acts on COX enzymes, preventing the conversion of arachidonic acid to prostaglandins. Serratiopeptidase acts directly on fibrin and bradykinin, breaking them down and reducing their inflammatory effects.

• Receptor Binding/Enzyme Inhibition: Diclofenac inhibits COX-1 and COX-2 enzymes. Serratiopeptidase is a proteolytic enzyme.

• Elimination Pathways: Diclofenac is primarily eliminated through hepatic metabolism and renal excretion. Elimination pathway of Serratiopeptidase is not fully understood.

Dosage

Standard Dosage

Adults: The usual recommended dose is one tablet containing 50 mg Diclofenac and 10 mg Serratiopeptidase two to three times daily. Administer preferably after meals. The maximum daily dose of diclofenac is 150 mg and serratiopeptidase is 60 mg.

Children: Use is not recommended for children below 18 years of age due to lack of sufficient safety and efficacy data.

Special Cases:

• Elderly Patients: Start with the lowest effective dose and monitor closely for adverse effects.
• Patients with Renal Impairment: Dose adjustment may be necessary depending on the degree of impairment.
• Patients with Hepatic Dysfunction: Dose reduction may be required. Close monitoring is essential.
• Patients with Comorbid Conditions: Use with caution in patients with cardiovascular disease, gastrointestinal disorders, or bleeding tendencies.

Clinical Use Cases

• Intubation: Not typically used.
• Surgical Procedures: Commonly used for post-operative pain management.
• Mechanical Ventilation: Not indicated.
• Intensive Care Unit (ICU) Use: May be used for pain management, but with caution.
• Emergency Situations: Not the preferred choice for acute emergency situations.

Dosage Adjustments

• Adjust dosage based on patient’s age, renal and hepatic function, and other medical conditions. Individualized dosing is crucial.

Side Effects

Common Side Effects:

Nausea, vomiting, diarrhea, stomach pain, headache, dizziness, indigestion, flatulence.

Rare but Serious Side Effects:

Allergic reactions (rash, itching, swelling), gastrointestinal bleeding, peptic ulcers, liver damage, kidney dysfunction.

Long-Term Effects:

Potential for gastrointestinal complications with chronic use.

Adverse Drug Reactions (ADR):

Stevens-Johnson syndrome, toxic epidermal necrolysis (rare).

Contraindications

• Hypersensitivity to diclofenac, serratiopeptidase, or any component of the formulation.
• Active peptic ulcer or gastrointestinal bleeding.
• Severe heart failure, coronary artery disease, recent bypass surgery.
• Severe hepatic or renal impairment.
• Third trimester of pregnancy.

Drug Interactions

• Other NSAIDs, anticoagulants (warfarin), antihypertensives, lithium, methotrexate, digoxin, cyclosporine, tacrolimus, quinolone antibiotics, phenytoin, alcohol.

Pregnancy and Breastfeeding

• Pregnancy Safety Category: Contraindicated in the third trimester. Use with caution in the first and second trimesters only if potential benefits outweigh risks.
• Breastfeeding: Not recommended as it may pass into breast milk.

Drug Profile Summary

• Mechanism of Action: Diclofenac inhibits COX enzymes; Serratiopeptidase breaks down fibrin and other inflammatory mediators.
• Side Effects: Nausea, vomiting, GI upset, headache, dizziness; rarely, allergic reactions, GI bleeding, liver/kidney dysfunction.
• Contraindications: Hypersensitivity, peptic ulcer, severe heart/liver/kidney disease, pregnancy (third trimester).
• Drug Interactions: Other NSAIDs, anticoagulants, antihypertensives, lithium, methotrexate.
• Pregnancy & Breastfeeding: Contraindicated in the third trimester of pregnancy; not recommended during breastfeeding.
• Dosage: Adults: 50 mg Diclofenac + 10 mg Serratiopeptidase, 2-3 times/day after meals.
• Monitoring Parameters: Renal and hepatic function, blood pressure, signs of GI bleeding.

Popular Combinations

• Sometimes combined with Paracetamol for enhanced analgesic and antipyretic effects.

Precautions

• General Precautions: Assess for allergies, renal/hepatic function, cardiovascular disease, and GI disorders.
• Specific Populations: Use with caution in pregnancy, breastfeeding, elderly, and patients with renal/hepatic impairment.
• Lifestyle Considerations: Avoid alcohol, driving restrictions if dizziness occurs.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Diclofenac + Serratiopeptidase?

A: The standard adult dose is 50 mg Diclofenac + 10 mg Serratiopeptidase, taken two to three times daily, preferably after meals.

Q2: What are the common side effects?

A: Common side effects include nausea, vomiting, stomach upset, headache, and dizziness.

Q3: Is it safe during pregnancy?

A: It is contraindicated in the third trimester of pregnancy. Use in the first and second trimesters only if absolutely necessary and under strict medical supervision.

Q4: Can I take it with alcohol?

A: Alcohol should be avoided as it can increase the risk of gastrointestinal side effects.

Q5: What if I have kidney problems?

A: Dose adjustment may be necessary. Consult a nephrologist for guidance.

Q6: What are the serious side effects to watch out for?

A: Allergic reactions, gastrointestinal bleeding, liver damage, and kidney dysfunction are rare but serious side effects. Seek immediate medical attention if these occur.

Q7: How does Diclofenac + Serratiopeptidase work differently from Diclofenac alone?

A: Serratiopeptidase adds anti-inflammatory and anti-edemic properties, offering synergistic benefits with Diclofenac.

Q8: What should I do if I miss a dose?

A: Take the missed dose as soon as you remember unless it is close to the next scheduled dose. Do not double the dose to catch up.

Q9: Can it be used for long-term pain management?

A: Long-term use should be carefully considered and monitored due to the potential for gastrointestinal complications.

Q10: Are there any drug interactions I should be aware of?

A: It can interact with other NSAIDs, anticoagulants (warfarin), antihypertensives, and certain other medications. Inform your doctor about all medications you are taking.