SEPLIX-D

(Serratiopeptidase 10mg+ Diclofenac Pottassium 50mg)

COMPOSITION :

Diclofenac Potassium BP 50 mg. Serratiopeptidase (as enteric coated tablet) 10 mg. (20,000 Serratiopeptidase units)

Diclofenac potassium is a Non Steroidal Anti Inflammatory Drug (NSAID). The chemical name is [o-(2, 6-dichloroanilino) phenyl] acetate. The molecular weight is 334.2 and its molecular formula is C14H10Cl2KNO2.

Serratiopeptidase is a proteolytic (protease) acid-labile enzyme having molecular weight 52kDa. It shows very strong proteolytic activity and has been widely used in therapy as an anti-inflammatory drug because of its ability to enhance the penetration of antibiotics in infected sites.

PHARMACOLOGY

Mechanism of Action

Diclofenac has analgesic, antipyretic and anti-inflammatory activities. It is a potent inhibitor of cycloxygenase activity (COX 1 & 2), which causes a sharp reduction in the formation of prostaglandin, prostacyclin and thromboxane products, all of which are mediators of inflammation. Its potency against COX 2 is substantially greater than other NSAIDs.

Serratiopeptidase binds to alpha-2-macroglobulin in the blood in the ratio of 1:1, which helps to mask its antigenicity but retains its enzymatic activity and is slowly transferred to site of inflammation. It hydrolyses bradykinin, histamine and serotonin responsible for edematous conditions. It reduces swelling improves microcirculation and expectoration of sputum etc. Thus it has anti-inflammatory, anti-oedemic and fibrinolytic activity and acts rapidly on localized inflammation.

Pharmacokinetics

Diclofenac is almost completely absorbed orally. It is subjected to first-pass metabolism and about 50% of unchanged form reaches the systemic circulation. Diclofenac at therapeutic concentration is more than 99% plasma protein bound. It is metabolized to 4?-hydroxydiclofenac and 4?,5-dihydroxydiclofenac. It is excreted in the form of glucoronide and sulphate conjugates, mainly in the urine (60%), bile (35%) and < 1% as unchanged diclofenac. The terminal plasma half life is about 1-2 hours.Serratiopeptidase is absorbed through intestines into the blood stream. The oral bioavailability is generally low, owing to the acidic conditions of the stomach and poor permeability across intestinal mucosa. Enteric coated form enables the enzyme to pass through the stomach unchanged, and be absorbed in the intestine. In vivo studies suggest that maximum concentration is reached within 1 hour after administration in both the blood and lymph and the concentration was higher in the latter.

INDICATIONS

In musculoskeletal and joint disorders such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis; peri articular disorders like bursitis and tendonitis; soft tissue disorders such as sprains and strains; and other painful conditions like renal colic, acute gout, dysmenorrheal, migraine, post operative oedema; inflammation and oedama associated with trauma, infection, respiratory tract congestion, chronic venous insufficiency; actinic keratoses and fever.

ADVERSE EFFECTS

Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes and tinnitus.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation and as an analgesic reducing pain in conditions such as arthritis or acute injury. It can also be used to reduce menstrual pain, dysmenorrhea. Diclofenac is used for musculoskeletal complaints, especially arthritis, rheumatoid arthritis, polymyositis, dermatomyositis, osteoarthritis, dental pain, TMJ, spondylarthritis, ankylosing spondylitis, gout attacks, and pain management in cases of kidney stones and gallstones. An additional indication is the treatment of acute migraines. Diclofenac is used commonly to treat mild to moderate post-operative or post-traumatic pain, particularly when inflammation is also present, and is effective against menstrual pain and endometriosis.

SEPLIX D INDICATIONS

In musculoskeletal and joint disorders such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis; peri articular disorders like bursitis and tendonitis; soft tissue disorders such as sprains and strains; and other painful conditions like renal colic, acute gout, dysmenorrheal, migraine, post operative oedema; inflammation and oedama associated with trauma, infection, respiratory tract congestion, chronic venous insufficiency; actinic keratoses and fever.

ADVERSE EFFECTS :

Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes and tinnitus.

DOSAGE:

1 TABLET TWICE A DAY.