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SIDAZE

Generic Name:                    Serratiopeptidase

Therapeutic Category:     Anti-inflammatory agent

Pharmacological Class:   Proteolytic enzyme

Composition:                      Sidaze 5

Each film coated tablet contains Serratiopeptidase IP 5 mg

Sidaze 10

Each film coated tablet contains Serratiopeptidase IP 10 mg

Pregnancy Category:        D

Presentation:                      Available in the pack size as 10 tablets X 10 blisters

Description

This medication is a proteolytic enzyme (protease), prescribed for inflammation and swelling.

Proteolytic enzymes are specific enzymes that metabolize protein. These enzymes are naturally produced by the human body and other living organisms and help carry out essential functions. Supplementing with these enzymes has shown to have a favorable anti-inflammatory effect on the tissues of the body. A unique enzyme named serratiopeptidase is now emerging as one of the most potent anti-inflammatory supplements.

Serratiopeptidase is an enzyme isolated from non-pathogenic bacteria called enterobacteria Serratia E15. This enzyme makes its inhabitants in the intestine of the silkworm. Silkworms go through a transformational process within a cocoon that turns them into moths. It is this specific enzyme that is used by the silkworm to dissolve the cocoon and reemerge as a moth.

Mechanism of Action

This anti-inflammatory proteolytic enzyme binds to the alpha-2-macroglobulin in the blood, which helps to mask its antigenicity. Then it is slowly transferred to the site of inflammation. Serratiopeptidase hydrolyze bradykinin, histamine, serotonin responsible for edema. It reduces swelling, improves microcirculation and expectoration of sputum. Due to this action Serratiopeptidase has anti-inflammatory, anti-oedemic and fibrinolytic activity and act rapidly on localized inflammation.

Elimination of inflammatory edema and swelling:

Improves the circulation at the inflammatory focus by breaking down abnormal exudates (contains water, blood<proteins, WBC, platelets) which gets deposited in tissue.

Acceleration of liquefaction and elimination of sputum, pus and hematoma: 

Accelerates the elimination of sputum, pus and hematoma*by breaking down and liquefying mucous secretions and fibrin (product of coagulation) clots.

Enhancement of the action of antibiotics:

Increases the concentration of antibiotics in the focus of infection.

Indications

  • Inflammation after operation and traumatic injury.
  • As concomitant therapy for elimination of inflammatory edema and swelling in the following diseases:
    • Otorhinolaryngology: Sinusitis*
    • Gynecology: Engorgement* of the breast.
    • Urology: Cystitis*, epididymitis
    • Dentistry & Oral surgery: Pericoronitis*, Dentoalveolor abscess*
    • Inadequate expectoration of sputum in the following diseases: Bronchitis, bronchial asthma, and concomitant therapy with antitubercular agents in pulmonary tuberculosis. Inadequate expectoration of sputum after anesthesia.

 

Dosage

Route of administration: Oral

Adults: The recommended dose is 5-10 mg 3 times per day.

Children: The drug is not used in children due to the absence of clinical data.

Pharmacokinetics

SIDAZE passes the stomach unchanged and is absorbed in the intestine. The drug is not inactivated by gastric juice. Maximal concentration in plasma is reached in 1 hour. Serratiopeptidase reaches the bloodstream in the enzyme active form; it is also excreted with the bile in active form, and is detected in urine in insignificant quantity

Adverse Effects

Gastro-intestinal disorders: diarrhea, nausea, vomiting, anorexia, and epigastric discomfort, abdominal pain.

Respiratory system disorders: nasal bleeding, streaks of blood in sputum, acute eosinophil pneumonia..

Skin: rash, itching, redness of skin.

Contraindications

SIDAZE is contraindicated in the following populations and situations:

  • Hypersensitivity to Serratiopeptidase or any component of the formulation.

 

Precautions

  • Pregnancy and lactation women take with caution
  • Impairment of blood clotting mechanism and in patients taking anticoagulants.
  • Who have severe hepatic or renal disease take medicine according to practitioner advice

 

Interactions

  • Serratiopeptidase with anti-coagulative agents (Heparin, Warfarin), it may increase anti-coagulative effects.
*Terminologies:

Hematoma: Localized collection of blood outside blood vessel

Sinusitis: Inflammation of sinuses

Engorgement: Occurs in the mammary glands due to expansion and pressure exerted by the synthesis and storage of breast milk, can lead to inflammation

Cystitis: Inflammation of urinary bladder

Pericoronitis: Tissue around the wisdom teeth gets inflamed

Dentoalveolar abscess: Localization of pus in the area surrounding teeth