aceclofenac and serratiopeptidase

Action and Spectrum

Actions and spectrum: 

• aceclofenac: It is a non-steroidal anti-inflammatory drug with analgesic and anti-inflammatory properties. aceclofenac works by inhibiting the enzymes responsible for pain and inflammation, making it useful in conditions like arthritis, musculoskeletal disorders, and post-operative pain. 
• serratiopeptidase: This is an enzyme derived from bacteria. serratiopeptidase has anti-inflammatory and anti-edema properties. It is believed to work by breaking down and thinning the fluid or mucus that can accumulate during the inflammatory process, which helps reduce swelling and pain. 

The combination of aceclofenac and serratiopeptidase is often used to manage pain, inflammation, and swelling associated with conditions like osteoarthritis, rheumatoid arthritis, and acute injuries. It offers both pain relief and anti-inflammatory effects, making it suitable for a range of musculoskeletal issues. 

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 

Black Box Warning

Black Box Warning: 

There were no specific black box warnings associated with aceclofenac/serratiopeptidase. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity: Individuals who have a known hypersensitivity or allergy to aceclofenac, serratiopeptidase, or any other ingredients in the medication should avoid its use. 
• Asthma, Nasal Polyps, and Aspirin Sensitivity: aceclofenac can cause bronchospasm and worsen asthma symptoms. Individuals with a history of asthma, nasal polyps, or aspirin sensitivity should avoid aceclofenac. 
• Active Peptic Ulcers: This combination may increase the risk of gastrointestinal bleeding and ulceration. It is contraindicated in individuals with active peptic ulcers. 
• Severe Liver or Kidney Dysfunction: People with severe liver or kidney impairment should avoid aceclofenac/serratiopeptidase because it can further worsen these conditions.

Caution: 

• Gastrointestinal Effects: aceclofenac can increase the risk of gastrointestinal irritation, bleeding, and ulcers. It should be used cautiously in individuals with a history of gastrointestinal problems, such as peptic ulcers, gastritis, or gastrointestinal bleeding. If you experience symptoms like abdominal pain, black stools, or vomiting blood while taking this medication, seek medical attention immediately. 
• Pregnancy and Lactation: aceclofenac should be avoided during pregnancy, especially in the third trimester, as it may harm the fetus. It is also not recommended during breastfeeding. 
• Children: The use of aceclofenac/serratiopeptidase in children, particularly those under a certain age, may not be recommended or may require specific dosage adjustments. Consult a pediatrician for guidance. 
• History of Gastrointestinal Bleeding: Individuals with a history of gastrointestinal bleeding should avoid aceclofenac/serratiopeptidase due to the increased risk of bleeding. 
• Coronary Artery Bypass Graft (CABG) Surgery: aceclofenac is contraindicated in the perioperative period of CABG surgery.

Comorbidities: 

• Cardiovascular Diseases: Cardiovascular comorbidities, including hypertension, coronary artery disease, and heart failure, should be considered. Close monitoring and caution are required when using this medication in individuals with heart-related comorbidities 
• Renal Dysfunction: Comorbid kidney conditions, such as chronic kidney disease, may be worsened by aceclofenac. This medication can affect kidney function and lead to reduced renal blood flow. Individuals with kidney issues should use this medication cautiously and have their kidney function monitored regularly. 
• Asthma: Asthma is a comorbidity that needs attention due to the potential for aceclofenac to exacerbate asthma symptoms or cause bronchospasm, especially in individuals with a history of asthma. It should be used with caution, and any breathing difficulties should be reported immediately. 
• Liver Disorders: Individuals with liver comorbidities or elevated liver enzymes should exercise caution when using aceclofenac/serratiopeptidase, as it may affect liver function. Regular liver function tests may be necessary. 
• Hypertension: Individuals with hypertension need careful monitoring when using aceclofenac/serratiopeptidase because NSAIDs can raise blood pressure. 

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/serratiopeptidase is a combination medication with a dual pharmacological profile. aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID), exerts anti-inflammatory and analgesic effects by inhibiting cyclooxygenase (COX), thereby reducing the production of inflammatory prostaglandins. This action alleviates pain and inflammation associated with various conditions.

serratiopeptidase, on the other hand, is an enzyme derived from the bacterium Serratia that possesses fibrinolytic and anti-inflammatory properties. It aids in reducing tissue swelling, promoting the breakdown of fibrin deposits, and facilitating the resolution of inflammatory processes.

Together, these pharmacological actions make aceclofenac/serratiopeptidase a valuable therapeutic option for managing pain and inflammation in conditions like osteoarthritis and post-surgical recovery. However, its use should be cautious and monitored, especially in individuals with comorbidities like gastrointestinal, cardiovascular, or renal disorders.  

Pharmacodynamics: 

aceclofenac: 

• Anti-Inflammatory Action: aceclofenac acts as a nonsteroidal anti-inflammatory drug (NSAID) by inhibiting the enzyme cyclooxygenase (COX). This inhibition reduces the production of prostaglandins, which are inflammatory mediators.  
• Analgesic Effect: By reducing prostaglandin levels, aceclofenac also provides pain relief, making it effective in managing pain symptoms in various musculoskeletal and inflammatory disorders. 

serratiopeptidase: 

• Anti-Inflammatory Properties: serratiopeptidase is an enzyme with fibrinolytic properties. It helps break down fibrin, a protein involved in the formation of scar tissue and inflammation. By reducing fibrin deposits and promoting the dissolution of inflammatory products, serratiopeptidase contributes to the resolution of inflammation and swelling. 
• Mucolytic Activity: serratiopeptidase has also shown mucolytic activity, which means it can help break down and thin mucus, potentially improving conditions involving excessive mucus production and congestion. 

When combined, aceclofenac and serratiopeptidase offer a synergistic effect in managing pain, inflammation, and associated symptoms.  

Pharmacokinetics: 

aceclofenac: 

• Absorption: aceclofenac is absorbed from the gastrointestinal tract after oral administration. It is well absorbed, with a peak plasma concentration reached within 1 to 3 hours. 
• Distribution: aceclofenac is widely distributed throughout the body, including joint tissues. It binds to plasma proteins, primarily albumin. 
• Metabolism: aceclofenac undergoes metabolism in the liver, primarily through CYP2C9 enzymes, to form its active metabolite, diclofenac. This metabolite is responsible for most of its anti-inflammatory and analgesic effects. 
• Excretion: Both aceclofenac and its metabolites are excreted in the urine and, to a very lesser extent, in feces. 

serratiopeptidase: 

• Absorption: serratiopeptidase is absorbed from the gastrointestinal tract after oral administration. It is known for its bioavailability when taken orally. 
• Distribution: After absorption, serratiopeptidase is distributed throughout the body and can exert its enzymatic action systemically. 
• Metabolism: serratiopeptidase is not significantly metabolized in the body. It functions as an enzyme to break down proteins. 
• Excretion: serratiopeptidase is excreted from the body primarily through urine. 

Adminstartion

Administration: 

• Dosage: The dosage may vary based on the specific product and the condition being treated.  
• Frequency: Usually, aceclofenac/serratiopeptidase tablets are taken orally with water. The frequency of administration may also depend on the condition but is commonly taken once or twice daily. 
• Duration: The duration of treatment will be determined by healthcare provider based on the nature and severity of your condition. It’s important not to stop the medication prematurely, even if you start feeling better, unless advised by your healthcare provider. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: aceclofenac and serratiopeptidase 

Pronounced: (ay-sek-loh-fen-ak and sehr-ay-tee-oh-pep-tih-days)  

Why do we use aceclofenac and serratiopeptidase? 

• Pain and Inflammation: It is often prescribed to reduce pain and inflammation in conditions such as arthritis, osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. 
• Postoperative Inflammation: After surgical procedures, it may be used to manage pain and inflammation. 
• Muscle and Joint Disorders: This combination can help relieve pain and discomfort with muscle and joint disorders. 
• Swelling and Edema: serratiopeptidase, an enzyme, is known for its anti-inflammatory properties and may be used to reduce swelling and edema.