Fuldase Drug Review (Ref. Drug Today, April-June 2004)

INTRODUCTION : The formulation of Serratiopeptidase, Paracetamol and Diclofenac potassium is introduced in India with the brand name of FULDASE. This combination is a potent analgesic, antipyretic, anti-edematous and anti-inflammatory.

COMPOSITION:

Each tablet FULDASE contains:

Serratiopeptidase 10 mg
Paracetamol 500 mg
Diclofenac potassium 50 mg

CLINICAL PHARMACOLOGY:

Serratiopeptidase: Serratiopeptidase is a pro- teolytic enzyme, which binds to alpha-2-mac- roglobulin in the blood, there by, helps to mask us agnogenicity but retains its enzymatic activity and is slowly transferred to site of inflammation. It hydrolyses bradykinin, histamine and serotonin responsible for oedematis status. It reduces swelling and edema, improves microcir-
culation and accelerates the elimination of sputum by breaking down the liquifying mucus se­ cretions and fibrin clots, hence it acts as anti- inflammatory, antiedematous and anti-fibrin- olytic. One of the useful actions of it is that it increases the concentration of antibiotic at the site of infection.

Paracetamol: Paracetamol is a non-steroidal anti- inflammatory drug and is a para-aminophenol derivative. It is centrally acting analgesic and a potent antipyretic, but devoid of a significant antiinflammatory effect which could be due to its weak activity on peripheral prostaglandin synthetase. This drug does not produce acid-base imbalance, electrolyte disturbances, and gastrointestinal irritation nor does it effect blood- clotting factors. It also posses uricosuric prop­ erty to varying degree and are non-addicting. Paracetamol is rapidly absorbed on oral admin­ istration. Peak plasma levels are reached within 1/2 to 1-hour. It is mainly excreted in urine as conjugation products of glucuronic and sulfuric acids. The ability of infant's liver for glucuronidation of paracetamol is poor.

Diclofenac potassium: Diclofenac potassium is anon-steroictal anti-inflammatory, analgesic and anti-pyretic drug, which inhibits prostaglandin synthesis by interfering with the action of pros­ taglandin synthetase. It is ideally suited for patients on sodium free diet, hypertensive pa­ tients and those on diuretic therapy.

INDICATIONS:
Analgesic and antipyretic.
Postoperative and posttraumatic inflammations.
Inflammatory edema and swelling.
Inflammation in sinusitis.
Muscular and skeletal pain co-existing associ­ ated conditions such as spondylitis, rheuma­ toid arthritis and osteoarthritis. Engorgement of breast. Painful inflammatory conditions in gynecology.
Cystitis. Epididymitis.
Pericoronitis of the wisdom tooth-third molar. Alveolar abscess. Inadequate expectoration such as in bronchitis, pulmonary tuberculosis.

CONTRAINDICATIONS: Hypersensitivity to the ingredients. Blood coagulation abnormali­ ties. Peptic ulcer.

SPECIAL PRECAUTIONS: Patient having a history GI ulceration, hematemesis, melena, ulcerative colitis, and Crohn's disease.

Severe cardiac, hepatic and renal impairment or insufficiency.
Patient under going treatment with anti-coagu­ lants.
Use with caution in pedraetricts, pregnancy, lactation and elderly.

ADVERSE EFFECTS: Gastrointestinal dis­ turbances such as anorexia, nausea and gastric discomforts. Rashes. Rarely leucopenia.

DRUG INTERACTIONS: Paracetamol en­ hances oral anticoagulant activity. Its absorp­ tion is increased by meloclopramide and re­ duced by pethidine and propantheline. Chronic use of alcohol potentiates hepatotoxicity by paracetamol.

No drug interaction regarding Serratiopeptidase and diclofenac potassium is reported.

DOSAGE & ADMINISTRATION:
Adult: One tablet of FULDASE should be taken three times in a day orally. It is advised not to take empty stomach.

STORAGE: Keep in a cool and dry place.