aceclofenac, paracetamol and serratiopeptidase

Action and Spectrum

Actions and spectrum: 

• aceclofenac: It is a NSAID with analgesic and anti-inflammatory properties. aceclofenac works by inhibiting prostaglandins production, which are responsible for pain and inflammation. 
• paracetamol: paracetamol is a pain reliever and fever reducer. It works by increasing the pain threshold and reducing fever through an unknown mechanism. It is effective for mild to moderate pain and fever. 
• serratiopeptidase: serratiopeptidase is an enzyme with anti-inflammatory and fibrinolytic properties. It helps reduce inflammation by breaking down and clearing away damaged or dead tissue. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Hypersensitivity

Gastric discomfort

Vomiting

Diarrhoea 

Dyspepsia

Vertigo 

Diarrhoea

Flatulence

Gastritis

Constipation 

Ulcerative stomatitis 

Anorexia 

Nausea 

Epistaxis

Skin rash 

Abdominal pain 

Dizziness 

Pruritis 

Allergic reactions 

Black Box Warning

Black Box Warning: 

There was no specific black box warning associated with aceclofenac, paracetamol, and serratiopeptidase. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity: This combination should not be used if a person has a known hypersensitivity or allergy to any of its components, including aceclofenac, paracetamol, or serratiopeptidase. 
• Severe Liver Disease: It should be avoided or used with extreme caution in individuals with severe liver disease, as both aceclofenac and paracetamol can affect liver function. 
• Severe Kidney Disease: People with severe kidney disease should use this combination cautiously or avoid it altogether because it may further impair kidney function. 
• Gastrointestinal Ulcers or Bleeding: If someone has a history of gastrointestinal ulcers, bleeding, or perforation, the use of aceclofenac should be avoided due to its potential to worsen these conditions.

Caution: 

• Kidney Function: Caution is necessary in individuals with impaired kidney function. Adequate monitoring of renal function and dose adjustments may be needed in such cases. 
• Gastrointestinal Issues: Patients with a history of gastrointestinal ulcers, bleeding, or other digestive system disorders should use this combination with caution, especially the aceclofenac component, as it can potentially irritate the stomach lining. 
• Asthma: aceclofenac can exacerbate asthma symptoms in some individuals. Caution should be exercised in patients with a history of asthma or other respiratory conditions. 
• Pregnancy and Breastfeeding: Depending on the specific formulation, this combination may have different recommendations regarding use during pregnancy and lactation. paracetamol is considered safer during pregnancy, but aceclofenac should be avoided, especially in the later stages of pregnancy. Consult a healthcare provider for guidance if pregnant or breastfeeding.

Comorbidities: 

• Arthritis: This combination is often prescribed for patients with arthritis, like osteoarthritis or rheumatoid arthritis. Arthritis is a common comorbidity, and pain and inflammation management are a primary goal of treatment. 
• Infections: serratiopeptidase, an enzyme in this combination, has anti-inflammatory and anti-infective properties. It may be used in cases where infections or inflammatory conditions are comorbid with pain. 
• Fever: paracetamol is included in this combination to reduce fever. Patients with fever due to various infections or illnesses may be prescribed this medication. 
• Gastrointestinal Conditions: Patients with comorbid gastrointestinal conditions like gastritis, acid reflux, or peptic ulcers should use this combination with caution, particularly the aceclofenac component, which can irritate the stomach lining. 
• Hepatic Disorders: Liver disorders are comorbidities that can affect the metabolism of medications like paracetamol, which is metabolized by the liver. 

Pregnancy / Lactation

Pregnancy consideration: pregnancy category: not assigned 

Lactation: excreted into human milk: unknown   

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• <b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

aceclofenac, paracetamol, and serratiopeptidase combination medication harnesses the pharmacological properties of its individual components to provide a multifaceted therapeutic approach. aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that reduces pain and inflammation by inhibiting production of inflammatory substances called prostaglandins.

paracetamol acts as an analgesic and antipyretic, relieving pain and reducing fever by affecting the brain’s temperature-regulating center. serratiopeptidase, an enzyme, contributes to the medication’s anti-inflammatory effects by breaking down and removing damaged or dead tissue, facilitating the body’s natural healing processes. Together, these components offer pain relief, reduce inflammation, and address associated symptoms, making this combination useful for a range of conditions involving pain and inflammation.  

Pharmacodynamics: 

• aceclofenac: As a nonsteroidal anti-inflammatory drug (NSAID), aceclofenac exerts its pharmacological effects primarily by inhibiting the enzyme cyclooxygenase (COX). This inhibition reduces the synthesis of prostaglandins, which are signalling molecules involved in inflammation, pain, and fever.  
• paracetamol: paracetamol is an analgesic and antipyretic. While its exact mechanism of action is not fully understood, it is believed to work primarily in the central nervous system. paracetamol is thought to inhibit an enzyme called COX in the brain, which helps reduce the perception of pain and lower fever by affecting the temperature-regulating center. 
• serratiopeptidase: serratiopeptidase is an enzyme derived from the bacterium Serratia marcescens. It has proteolytic (protein-dissolving) properties and is known for its anti-inflammatory and fibrinolytic (clot-dissolving) effects. serratiopeptidase works by breaking down and digesting non-living tissue, such as damaged or dead proteins, fibrin clots, and cellular debris. This action helps reduce swelling, inflammation, and pain by facilitating the removal of these substances from the affected area. 

Pharmacokinetics: 

aceclofenac: 

• Absorption: aceclofenac is well absorbed from the gastrointestinal tract after oral administration. It reaches peak plasma concentrations within a few hours. 
• Distribution: It is extensively bound to plasma proteins, primarily albumin. It has a large volume of distribution, meaning it can distribute widely throughout the body. 
• Metabolism: aceclofenac is metabolized in the liver to its active metabolite, diclofenac. Diclofenac further undergoes glucuronidation and sulfation. 
• Excretion: The metabolites are eliminated primarily through the kidneys, both in their free and conjugated forms. 

paracetamol: 

• Absorption: paracetamol is rapidly and completely absorbed from the gastrointestinal tract. It is absorbed in the stomach and small intestine. 
• Distribution: It has a small volume of distribution, indicating limited tissue penetration. paracetamol is primarily distributed in the extracellular fluid. 
• Metabolism: paracetamol is metabolized in the liver. The majority of it undergoes glucuronidation and sulfation, forming non-toxic metabolites that are excreted in the urine. A small portion is metabolized by the cytochrome P450 system to a reactive metabolite called N-acetyl-p-benzoquinoneimine (NAPQI), which is normally detoxified by conjugation with glutathione. 
• Excretion: The majority of paracetamol and its metabolites gets excreted in the urine as glucuronide & sulfate conjugates. A small amount is excreted unchanged. 

serratiopeptidase: 

• Absorption: serratiopeptidase is absorbed from the gastrointestinal tract after oral administration. 
• Distribution: It is distributed to various tissues, including areas of inflammation, where it exerts its proteolytic effects. 
• Metabolism: serratiopeptidase is primarily metabolized in the liver. 
• Excretion: Metabolites are excreted in the urine and feces. 

Adminstartion

Administration: 

• Dosage: The specific dosage and dosing schedule should be based on your medical condition. It is essential to follow their instructions carefully. 
• Formulation: This combination medication is available in various formulations, such as tablets or capsules. The formulation you receive will depend on your doctor’s prescription. 
• Duration: The duration depends on the condition being treated. It is important to complete the prescribed course of medication even if you start feeling better before it is finished. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: aceclofenac, paracetamol and serratiopeptidase 

Pronounced: (Uh-sek-loh-feh-nak, Par-uh-set-uh-mawl and Suh-ray-tee-oh-pep-tuh-days)  

Why do we use aceclofenac, paracetamol and serratiopeptidase? 

• Pain Management: This combination is often prescribed for pain relief, particularly in conditions where inflammation and pain are present.  
• Fever Reduction: The paracetamol component of this combination is an antipyretic, meaning it helps reduce fever. It is often used to manage fever associated with various illnesses. 
• Anti-Inflammatory: aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID), is included to reduce inflammation. It can be helpful in conditions characterized by inflammation, such as arthritis. 
• Enzymatic Action: serratiopeptidase is an enzyme that may assist in reducing swelling and inflammation. It is sometimes used to support recovery after surgery or in conditions with excessive tissue swelling. 
• Infections: serratiopeptidase’s enzymatic action might help reduce swelling and pain associated with infections, particularly those involving the respiratory or ENT systems.