STALWAR-DX

Serratiopeptidase With Diclofenace Free Acid

INTRODUCTION:-

In our day to day clinical practice we come across a large number of painful
inflammatory conditions which are associated with swelling and oedema. Same is
the case with post operative surgical pain. The management of such condition
requires a comprehensive approach that not only provides relief from pain but also
reduces swelling and oedema. Hence to ensure optimal relieg a more efficacious
approach would be to use a combination of a NSAID and proteolytic enzyme.
Diclofenaac is a NSAID with potent analgesic action while serratiopleptidase is a
proteolytic enzyme which has greater caseinolytic and fibrinolytic activity than other
known alkaline or neutral proteases. A combination of the two drugs which contains
enteric coated serratiopeptidase is now available in the Indian market.

THE RATIONALE:-

Given orally, serratiopeptidase suppresses vascular permeability associated

inflammation by inhibiting substances such as carrageenan, bradykinin and
serotonin. This results in reduction in swelling and oedema. It also aids in better
tissue penetration of diclofenac at the oedematous site thus resulting in enhanced
anti-inflammatory acton. Moreover. Since serratiopeptidase is enteric coated it
passes through the stomach unchanged and is an absorbed in the intestine. The
release time of individual drugs is different thus avoiding interaction with each other.
Also, the preparations available so far contain only 10mg of serratiopeptidase and
50mg of diclofenac while this formulation contains 15mg of serratiopeptidase and
69.75mg diclofenac sodium. The therapeutic daily doses of serratiopeptidase and
diclofenac are 30mg and 150mg respectively. Hence the optimal dosage of both the
drugs are available with a reduced dosage frequency that is when the formulation is
given twice daily. This ensures better patient compliance.

THE DRUGS
Serratiopeptidase Machanise of action :

Serratiopeptidase indirectly reduces dilatation of blood capillaries and controls

permeability by hydrolyzing bradydinin, histamine and serotonin. It blocks plasmin
inhibitors thus helping the fibribolytic activity of plasmin degradation of ‘extra-fibrin’
to small fragments prevents clogging of microcapillaries, helps clearance of
exudate, reduces swelling and improves microcirculation.

PHARMACOKINETICS:

Serratiopeptidase when consumed in unprotected form is destroyed by acid in the

stomach. However, enteric coated granules, enable the enzyme to pass through the
stomach unchanged, and be absorbed in the intestine. It is found negligibly in urine
suggesting that it is transported directly from the intestine into the blood stream.

Diclofenac free acid:

G.I. friendly NSAID, which is non-uncerogenic, therefore, is well tolerated with

75mg BD dosage.

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Mechanism of action:

Diclofenac is an inhibitor of cycloxygenase. It also appears to reduce intracellular

concentrations of free arechidonate in leukocytes.

Pharmacokinetics:

After oral administration it is rapidly and completely absorbed. It shows substantial

first pass effect and is highly protein bound. It is metabolised, excreted in urine and
bile.

INDICATIONS
Orthopaedics:

Reduces pain, suppresses and eliminates post-operative bleeding, reduces pain

and swelling associated with sprain of the ankle.

Obstetrics & Gynaecology:

Pain and swelling associated with perianal laceration and lateral eposiotomy.

Ordintal conditions:

Pericoronitis of wisdom tooth, acute alveolar abscess, periodontitis, traumatic

alveolar fracture etc.

Repiratory disease:

Chronic bronchitis, sinusitis.

CONTRAINDICATIONS:

Moderate to severe hepatic impairment, active peptic ulcer disease.

ADVERSE EFFECTS:

GI disturbances such as anorexia, gastric discomfort and nausea.

PRECAUTIONS:

Use with caution in-patients with blood coagulation abnormalities, hepatic and renal
impairment, or under treatment with anticoagulant.

Pregnancy & lactation:

Contraindicated.

AMINISTRATION:

One capsule twice daily.

COMPOSITION:

Each capsule contains 15mg enteric coated serratiopeptidase and 69.75mg

diclofenac free acid equiv. to 75mg. Diclofenac sodium.

PRESENTATION:

Strip of 10 Caps.