Usage
Diclofenac + Paracetamol + Serratiopeptidase is prescribed for the relief of pain and inflammation associated with various conditions, including:
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Post-operative pain
- Dental pain
- Musculoskeletal pain
- Soft tissue injuries
- Other painful inflammatory conditions
Pharmacological Classification:
This combination drug includes:
- Diclofenac: Nonsteroidal anti-inflammatory drug (NSAID)
- Paracetamol: Analgesic and antipyretic
- Serratiopeptidase: Proteolytic enzyme
Alternate Names
While the generic name is Diclofenac + Paracetamol + Serratiopeptidase, it’s marketed under various brand names, some of which are listed in the Drug Profile Summary section below. Regional variations may exist.
How It Works
Pharmacodynamics:
- Diclofenac: Inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, thereby decreasing pain and inflammation.
- Paracetamol: Believed to inhibit COX in the central nervous system, providing analgesic and antipyretic effects. The exact mechanism is not fully understood.
- Serratiopeptidase: Breaks down proteins like fibrin, bradykinin, and histamine at the site of inflammation, reducing swelling and edema.
Pharmacokinetics:
- Diclofenac: Well-absorbed orally. Metabolized in the liver, primarily by CYP2C9. Excreted via kidneys and bile.
- Paracetamol: Rapidly absorbed from the gastrointestinal tract. Metabolized in the liver and excreted in urine, primarily as glucuronide and sulfate conjugates.
- Serratiopeptidase: Absorbed in the intestines. Mechanism of absorption and metabolism is not fully elucidated.
Elimination Pathways:
- Diclofenac: Renal and hepatic excretion
- Paracetamol: Renal excretion
- Serratiopeptidase: Unknown
Dosage
Standard Dosage
Adults:
One tablet (containing Diclofenac 50mg, Paracetamol 325mg, and Serratiopeptidase 10mg) two to three times daily, preferably after meals. Maximum daily dose is Diclofenac 150mg, Paracetamol 4g, and Serratiopeptidase 60mg.
Children:
Not recommended for children under 10 years of age as safety and efficacy have not been established. If used, pediatric dosing should be carefully determined and monitored by a physician.
Special Cases:
- Elderly Patients: Start with the lowest effective dose and monitor closely for adverse effects.
- Patients with Renal Impairment: Dose reduction may be necessary. Monitor renal function.
- Patients with Hepatic Dysfunction: Dose reduction may be necessary. Monitor liver function.
- Patients with Comorbid Conditions: Careful evaluation and dose adjustment may be required, particularly for patients with cardiovascular disease, gastrointestinal disorders, or bleeding disorders.
Clinical Use Cases
The provided sources do not include dose recommendations for specific medical settings such as Intubation, Surgical Procedures, Mechanical Ventilation, Intensive Care Unit (ICU) Use, or Emergency Situations. Dosage in these settings must be under direct medical supervision and adjusted per patient requirements.
Dosage Adjustments
Dose adjustments are necessary for patients with renal/hepatic impairment and other relevant comorbidities. Consult the Special Cases section above. Genetic polymorphisms affecting drug metabolism are not widely studied for this specific combination.
Side Effects
Common Side Effects
- Nausea
- Vomiting
- Stomach pain
- Heartburn
- Diarrhea
- Headache
- Dizziness
Rare but Serious Side Effects
- Allergic reactions (skin rash, itching, swelling of face, tongue, or throat, difficulty breathing)
- Gastrointestinal bleeding
- Peptic ulcers
- Liver damage
- Kidney damage
- Cardiovascular events (heart attack, stroke)
Long-Term Effects
Chronic complications from prolonged use may include kidney damage, gastrointestinal issues, and cardiovascular risks, especially with high doses or pre-existing conditions.
Adverse Drug Reactions (ADR)
Clinically significant ADRs include severe allergic reactions, gastrointestinal bleeding, liver or kidney damage, and cardiovascular events. Any such reaction necessitates immediate medical intervention.
Contraindications
- Hypersensitivity to any component of the drug.
- Active peptic ulcer or gastrointestinal bleeding.
- Severe hepatic, renal, or cardiac failure.
- Last trimester of pregnancy.
- Aspirin-induced asthma, urticaria, or acute rhinitis.
Drug Interactions
- NSAIDs (aspirin, ibuprofen)
- Anticoagulants (warfarin)
- Antihypertensives
- Diuretics
- Lithium
- Methotrexate
- Cyclosporine
- Digoxin
- Corticosteroids
- Antifungals (ketoconazole, fluconazole)
- Antibiotics (chloramphenicol)
Pregnancy and Breastfeeding
Pregnancy Safety Category: Diclofenac is contraindicated in the third trimester. Use in the first and second trimesters is not recommended unless potential benefits outweigh risks. Paracetamol is generally considered safe during pregnancy. Serratiopeptidase safety during pregnancy is not well-established.
This combination should be avoided during pregnancy, especially in the third trimester.
Breastfeeding: Diclofenac and Paracetamol are present in breast milk in low concentrations. Serratiopeptidase excretion in breast milk is not known. Exercise caution and consult a physician before using during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Diclofenac: COX inhibitor, reduces prostaglandins. Paracetamol: Analgesic and antipyretic. Serratiopeptidase: Proteolytic enzyme, reduces inflammation.
- Side Effects: Nausea, vomiting, stomach pain, heartburn, diarrhea, headache, dizziness. Rarely: allergic reactions, gastrointestinal bleeding, liver/kidney damage, cardiovascular events.
- Contraindications: Hypersensitivity, active peptic ulcer, severe hepatic/renal/cardiac failure, last trimester of pregnancy, aspirin-induced asthma/urticaria/rhinitis.
- Drug Interactions: NSAIDs, anticoagulants, antihypertensives, and others. (See Drug Interactions Section for the full list)
- Pregnancy & Breastfeeding: Not recommended during pregnancy, especially the third trimester. Use with caution during breastfeeding.
- Dosage: Adults: One tablet two to three times daily after meals. Max: Diclofenac 150mg, Paracetamol 4g, Serratiopeptidase 60mg/day. Not recommended for children under 10.
- Monitoring Parameters: Liver and kidney function tests, blood pressure, signs of gastrointestinal bleeding. Monitor patients with pre-existing heart conditions.
Popular Combinations
The combination of Diclofenac, Paracetamol, and Serratiopeptidase is itself a popular combination aiming for synergistic pain and inflammation relief.
Precautions
- General Precautions: Evaluate patients for allergies, hepatic/renal function, gastrointestinal issues, and cardiovascular risks before initiating treatment.
- Pregnant Women: Avoid, especially in the third trimester.
- Breastfeeding Mothers: Use cautiously after consulting a doctor.
- Children & Elderly: Not recommended for children under 10. Start with the lowest effective dose in the elderly and monitor carefully.
- Lifestyle Considerations: Avoid alcohol. Driving may be impaired due to dizziness or drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Diclofenac + Paracetamol + Serratiopeptidase?
A: Adults: One tablet (Diclofenac 50mg + Paracetamol 325mg + Serratiopeptidase 10mg) two to three times daily after meals. Not recommended for children under 10.
Q2: Can I take this medicine on an empty stomach?
A: It is recommended to take it after meals to minimize the risk of gastrointestinal upset.
Q3: What are the common side effects?
A: Common side effects include nausea, vomiting, stomach pain, heartburn, diarrhea, headache, and dizziness.
Q4: What are the serious side effects I should watch for?
A: Serious side effects that require immediate medical attention include allergic reactions, gastrointestinal bleeding, signs of liver or kidney damage, and cardiovascular issues such as chest pain or shortness of breath.
Q5: Can I drink alcohol while taking this medicine?
A: Alcohol should be avoided while taking this medication, as it can increase the risk of stomach bleeding and liver damage, particularly with Diclofenac and Paracetamol.
Q6: Is it safe to take this medicine during pregnancy?
A: It’s generally not recommended during pregnancy, especially in the third trimester. Consult a doctor before use if you are pregnant or planning to become pregnant.
Q7: Can I take this medicine while breastfeeding?
A: Limited data are available about the safety of this combination during breastfeeding. Consult your physician to weigh the potential benefits against the possible risks to the infant.
Q8: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember, unless it’s close to the time for your next dose. Do not double the dose to catch up.
Q9: Can I drive while taking this medicine?
A: This medicine can cause dizziness and drowsiness. Do not drive or operate heavy machinery if these effects are experienced.
Q10: How long should I take this medicine?
A: Take this medication only for the duration prescribed by your doctor. Even if you feel better, do not discontinue use without consulting your physician. Prolonged use, especially at high doses, carries increased risks of side effects.
