Usage
- Paracetamol + Serratiopeptidase is prescribed for reducing pain, inflammation, and swelling associated with various conditions, including post-surgical recovery, trauma, infections, and musculoskeletal disorders like osteoarthritis and rheumatoid arthritis. It also finds use in managing conditions like back pain, toothaches, and sinusitis.
- Pharmacological Classification: Analgesic (Paracetamol), Antipyretic (Paracetamol), Anti-inflammatory (Serratiopeptidase), Proteolytic enzyme (Serratiopeptidase).
- Mechanism of Action: Paracetamol acts centrally to reduce pain and fever. Its exact mechanism is not fully understood, but it is thought to inhibit cyclooxygenase (COX) enzymes in the central nervous system, affecting prostaglandin synthesis, which plays a role in pain and fever. Serratiopeptidase is a proteolytic enzyme that breaks down proteins, reducing inflammation and swelling by thinning fluids around the injured area and facilitating drainage.
Alternate Names
- No widely recognized alternate generic names exist.
- Brand Names: Numerous brand names exist depending on the manufacturer and region, including Lysoflam, Signoflam, and Dolostat-SP, amongst others.
How It Works
- Pharmacodynamics: Paracetamol primarily exerts analgesic and antipyretic effects. Serratiopeptidase exerts anti-inflammatory and anti-edemic effects.
- Pharmacokinetics:
- Paracetamol: Rapidly absorbed after oral administration, reaching peak plasma concentrations within 30-60 minutes. Metabolized primarily in the liver and excreted in the urine, with a half-life of approximately 1-4 hours.
- Serratiopeptidase: Absorbed in the intestines. It binds to alpha-2-macroglobulin in the blood, masking its antigenicity while retaining enzymatic activity. The molecular weight ranges from 45 kDa to 60 kDa. It is a metalloprotease containing three zinc atoms as ligands and one active site.
- Mode of Action: Paracetamol’s precise mode of action is not entirely clear, but it is thought to involve inhibition of COX enzymes and modulation of the endocannabinoid system. Serratiopeptidase acts by breaking down proteins like bradykinin, fibrin, and histamine, which contribute to inflammation and swelling.
- Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation: Paracetamol may interact with the serotonergic and cannabinoid systems. Serratiopeptidase functions via enzymatic action, directly targeting proteins associated with inflammation.
- Elimination Pathways: Paracetamol is primarily eliminated via hepatic metabolism and renal excretion. Serratiopeptidase elimination pathways are not fully elucidated.
Dosage
Standard Dosage
Adults:
- One tablet of Paracetamol (500mg/625mg) + Serratiopeptidase (10mg/15mg) twice daily. Alternatively, formulations with Paracetamol 325mg and Serratiopeptidase 15mg are given twice daily.
- Maximum daily dose of Paracetamol should not exceed 4000mg. Maximum daily dose of Serratiopeptidase is generally up to 60 mg.
- Administer preferably after meals.
Children:
- Consult a physician for pediatric dosing as it varies by weight and age.
Special Cases:
- Elderly Patients: May require dose adjustments based on renal and hepatic function.
- Patients with Renal Impairment: Dose adjustments are necessary for patients with creatinine clearance less than 30 mL/min; increase the dosing interval to a minimum of 6 hours.
- Patients with Hepatic Dysfunction: Dose reduction is often recommended in patients with severe liver disease.
- Patients with Comorbid Conditions: Requires careful consideration based on specific conditions.
Clinical Use Cases
- Intubation: Data specific to paracetamol + serratiopeptidase use during intubation is limited. Paracetamol may be used for post-intubation pain management.
- Surgical Procedures: Can be used pre- and post-operatively for pain and inflammation management. Serratiopeptidase should be stopped at least two weeks before elective surgery.
- Mechanical Ventilation: No specific dosage guidelines exist for this combination in mechanically ventilated patients. Paracetamol may be used for pain and fever.
- Intensive Care Unit (ICU) Use: Paracetamol is frequently used in ICUs for analgesia and antipyresis. Monitor for potential drug interactions.
- Emergency Situations: Primarily, paracetamol may be considered for emergency pain or fever management.
Dosage Adjustments
- Modify doses based on individual patient factors, including renal/hepatic impairment.
Side Effects
Common Side Effects
- Nausea, vomiting, stomach pain, indigestion, diarrhea, loss of appetite, headache, and dizziness.
Rare but Serious Side Effects
- Allergic reactions (skin rash, itching, swelling), hepatotoxicity (with paracetamol overdose), blood coagulation disorders (with serratiopeptidase).
Long-Term Effects
- Potential for hepatotoxicity with chronic excessive paracetamol use.
Adverse Drug Reactions (ADR)
- Severe allergic reactions, severe liver damage (paracetamol overdose), Stevens-Johnson syndrome.
Contraindications
- Hypersensitivity to any component of the formulation.
- Severe hepatic or renal impairment.
- Active peptic ulcer or bleeding disorders.
- Last trimester of pregnancy.
Drug Interactions
- Alcohol (increased risk of hepatotoxicity with paracetamol).
- Anticoagulants (serratiopeptidase may increase bleeding risk).
- Other NSAIDs (increased risk of gastrointestinal adverse effects).
- Antihypertensives and diuretics (may reduce their effectiveness).
Pregnancy and Breastfeeding
- Pregnancy: Paracetamol is generally considered safe during pregnancy, especially in the first two trimesters. Serratiopeptidase use is not recommended during pregnancy due to limited safety data.
- Breastfeeding: Paracetamol is considered safe during breastfeeding. Serratiopeptidase should be avoided due to the lack of safety information.
Drug Profile Summary
- Mechanism of Action: Paracetamol: Analgesic and antipyretic, exact mechanism unclear. Serratiopeptidase: Anti-inflammatory and anti-edemic through proteolytic action.
- Side Effects: Nausea, vomiting, stomach upset, allergic reactions, hepatotoxicity (paracetamol overdose), bleeding risk (serratiopeptidase).
- Contraindications: Hypersensitivity, severe liver/kidney disease, active peptic ulcer, last trimester of pregnancy.
- Drug Interactions: Alcohol, anticoagulants, NSAIDs.
- Pregnancy & Breastfeeding: Paracetamol generally safe; serratiopeptidase avoid.
- Dosage: Adults: One tablet (Paracetamol 500mg/625mg + Serratiopeptidase 10mg/15mg or other combinations) twice daily.
- Monitoring Parameters: Liver function tests (especially with long-term use or high doses of paracetamol), renal function, signs of bleeding (with serratiopeptidase).
Popular Combinations
- Often combined with other NSAIDs or analgesics for enhanced pain relief, although caution is advised due to increased risk of side effects.
Precautions
- Assess for allergies, hepatic and renal function before initiating therapy.
- Caution in patients with a history of gastrointestinal disorders.
- Avoid alcohol during treatment.
- Advise patients to report any unusual symptoms.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Paracetamol + Serratiopeptidase?
A: Adults: One tablet (combination strength varies, typically Paracetamol 500mg/625mg + Serratiopeptidase 10/15mg or other combinations) twice daily after food. Pediatric and special population dosing should be determined by a physician.
Q2: Can I take this combination if I am pregnant or breastfeeding?
A: Paracetamol is generally considered safe during pregnancy and breastfeeding. Serratiopeptidase should be avoided due to insufficient safety data.
Q3: What are the common side effects?
A: Nausea, vomiting, indigestion, stomach pain, diarrhea, and headache.
Q4: What are the serious side effects I should be aware of?
A: Allergic reactions, liver damage (paracetamol overdose), and bleeding problems (serratiopeptidase).
Q5: Are there any drug interactions I should know about?
A: Yes, avoid alcohol while taking this medication. It can interact with blood thinners, other NSAIDs, some blood pressure medications, and certain antibiotics. Consult your physician before taking any other medication.
Q6: Can patients with kidney or liver problems take this medicine?
A: Patients with severe kidney or liver problems should generally avoid this combination. Dose adjustments may be necessary for those with mild to moderate impairment.
Q7: How long can I take Paracetamol + Serratiopeptidase?
A: Follow your doctor’s recommendations. For short-term pain relief, a course of 7 days is common. Long-term use requires regular monitoring.
Q8: Can this drug be crushed or chewed?
A: No. Swallow the tablets whole with water. Do not crush, chew, or break them.
Q9: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is almost time for the next dose. Do not double the dose to catch up.
Q10: Can I drive after taking this medicine?
A: This medication can cause dizziness in some people. Avoid driving or operating heavy machinery until you know how this medication affects you.
