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DESCRIPTION:
Roxithromycin is a semi-synthetic macrolide. Serratiopeptidase is a proteolytic enzyme derived from serratia spp. It enhances the action of Roxithromycin in focus infection and helps in breaking down the thick sputum.
MECHANISM OF ACTION:
Roxithromycin acts by binding to 50S ribosomal sub-unit of bacteria and inhibits the protein synthesis. Serratiopeptidase binds to alpha-2-macroglobulin in the blood in the ratio of 1:1 which helps to mask its antigenicity but retain its enzymatic activity. Levels of serratiopeptidase are slowly transferred to the exudate at the site of inflammation and gradually the blood level decline.
PHARMACOKINETICS:
Serratiopeptidase by hydrolysing bradykinin, histamine and serotonin it indirectly reduces dilatation of blood capillaries and controls permeability. Serratiopeptidase blocks plasmin inhibitors thus helping the fibrinolytic activity of plasmin. Degradation of 'extra fibrin' to small fragments prevents clogging of microcapillaries helps clearance of exudate, reduces swelling and improves microcirculation.
Onset of Action: 1-2 hours.
Duration of Action: 8 to 12 hours
ADVERSE EFFECTS:
Nausea, vomiting, diarrhea, skin rash and transient rise in liver transaminase
CONTRAINDICATIONS:Concomitant use of ergotamine type compounds. Hypersensitivity to Serratiopeptidase.
SPECIAL PRECAUTIONS:Hepatic dysfunction. Serratiopeptidase for impairment of blood clotting mechanism and in patients taking anticoagulants.
PREGNANCY :Safety not established
LACTATION:Use with caution
ELDERLY: May be used with caution
INTERACTION:Terfenadine: Serum levels elevated leading to ventricular arrhythmias.
Digoxin: Increases absorption.
Midazolam: Increases its half-life.
Disopyramide: Displaced from its protein bound sites.
INDICATIONS:
Pneumonia, acute bronchitis pharyngitis, sinusitis, tonsillitis, genital infections. Infective Asthma & Otitis. In serious Otitis media ROXYDASE helps in minimizing the incidence of recurrence of fluid in the ear and reduces the viscosity of effusion.
DOSAGE AND ADMINISTRATION:
Adults: 1 tablet twice daily.
Children:5-8 mg/kg/day into 2 divided doses for not more than 10 days.
INSTRUCTIONS:
Tablet is not to be crushed or chewed. It is to be swallowed as whole along with water. |
