Overview

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti- inflammatory, analgesic, and antipyretic activities.
Paracetamol, also known as Acetaminophen, is commonly used for its analgesic and antipyretic effects.
Serratiopeptidase is a proteolytic enzyme (protease) produced by Enterobacterium Serratia sp. E-15 used in the prevention of pain and swelling.

Indications

Diclofenac Potassium

• For treatment of primary dysmenorrhea
• For relief of mild to moderate pain
• For relief of the signs and symptoms of osteoarthritis
• For relief of the signs and symptoms of rheumatoid arthritis

Paracetamol

• For mild to moderate pain (from headaches, menstrual periods, toothaches,
  backaches, osteoarthritis, or cold/flu aches and pains)
• To reduce fever

Serratiopeptidase

• Anti-inflammatory properties
• post-traumatic swelling
• fibrocystic breast disease
• bronchitis

Rationale of Combination

Diclofenac potassium is used as an anti-inflammatory agent to pacify mild to moderate pain and inflammation. Common conditions associated with pain and inflammation includes arthritis, trauma, surgery and fibermyalgia whereas paracetamol is used for temporary relief of fever, minor aches, and pains. Additionally, serratiopeptidase helps to reduce fluid retention in affected areas, which contributes to proper drainage and a quicker recovery.

Contraindications

Contraindicated in patients with severe ulcer gastrointestinal bleeding, and hypersensitivity. Diclofenac sodium and Serratiopeptidase is contraindicated in patients with asthma, renal or hepatic disorders, hypertension, porphyria, peri- operative pain in CABG surgery patients and bleeding disorders.

Side Effects

Skin rash

Diarrhea

Gastrointestinal disturbance/Abdominal pain (or stomach pain)/Heartburn or

Nose bleed

Nausea

Allergic reactions

Dizziness

Pharmacology

Diclofenac Potassium
Diclofenac is an acetic acid non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Diclofenac inhibits the production of prostaglandins by inhibiting COX-1 and COX-2 pathways thereby exhibiting anti- inflammatory effects.
Absorption: Well absorbed following oral administration.
Distribution: widely distributed in animals. Plasma protein binding exhibited is >99%
Elimination: Hepatic metabolism leads to elimination through urine.

Paracetamol
• For mild to moderate pain (from headaches, menstrual periods, toothaches,
backaches, osteoarthritis, or cold/flu aches and pains)
• To reduce fever

Serratiopeptidase
Serratiopeptidase is an enzyme isolated from a non-pathogenic bacteria called Enterobacteria Serratia E15. Serratiopeptidase has powerful anti-inflammatory properties and is particularly useful for post-traumatic swelling, fibrocystic breast disease and bronchitis.It is able to digest dead tissue, blood clots, cysts, and arterial plaques.
Absorption: On oral administration, serratiopeptidase is absorbed in GI tract.
Distribution: Distributed throughout the body tissues, unchanged via systemic circulation. It reaches in higher concentration in inflamed tissues. Serratiopeptidase levels in inflammatory exudates rises gradually with decline in blood levels indicating that serratiopeptidase is quite rapidly transferred to the site of inflammation.

Interactions

Diclofenac potassium, Serratiopeptidase should not be taken concomitantly with other NSAIDs, anticoagulants including low-dose/LMW heparin, sucralfate, triamterene, cyclosporine, cholestyramine, colestipol, digoxin, aspirin, methotrexate and lithium whereas Paracetamol reduces the absorption of cholestyramine within 1 hour of administration whereas it accelerates the absorption with metoclopramide.