Erythromycin Stearate USP

To be submitted at the time of inclusion.

TTablet (Film Coated).
Each tablet contains Erythromycin Stearate USP equivalent to Erythromycin 500 mg.

This product is used as a macrolide antibiotic with a mainly bacteriostatic action against a broad range of bacteria. It acts by inhibition of protein synthesis by binding the 50 S ribosomal subunit of susceptible microorganisms which interfere with bacterial growth & multification. It is active against many gram-positive bacteria, some gram-negative bactaria and against mycoplasma and chlamydia. This product is indicated for the treatment of the following infections caused by susceptible microorganisms :
i) Lower respiratory tract infections e.g. Tracheitis, acute and chronic bronchitis, pneumonia etc.
ii) Upper respiratory tract infections e.g. sinusitis, pharyngitis, tonsillitis etc.
iii) Skin and soft tissue infections.
iv) Ear & Oral infections e.g. Otitis media & Otitis externa, mastoiditis etc.
v) Gastro- intestinal infection e.g. Cholecystitis, staphylococcal enterocolitis.
vi) Veneral infections.

Adults : 500 mg twice daily. This may be increased up to 4 gm according to the severity of the infection.
Children : 30-50 mg per Kg body weight per day in divided dose

The most common side effects nausea, vomiting, flatulence, abdominal discomfort, loose motion, rash, reversible elevations in liver transaminases, transient mild reductions in neutrophil counts etc.

Caution should be taken when administering it ti patients with liver dysfunction or who are currently receiving potentially hepatotoxic drugs.

It is contraindicated to the patient who has a history of previous hypersensitivity reaction to the drug.

Absorption reduced in presence of food, antacid and ergot alkaloids. Increase plasma concentration of digoxin and cyclosporine.

• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.

To be submitted at the time of inclusion.