Sanbe Farma


Euro Asia Medico
Full Prescribing Info
Each capsule contains: Roxithromycin 150 mg.
Pharmacology: UPLORES is a macrolide antibiotic with actions and uses similar to those of erythromycin.
UPLORES is rapidly absorbed from the gastro-intestinal tract and differs from erythromycin where its bioavailability is not markedly affected by milk or food.
After oral doses, high concentrations of UPLORES are achieved in pulmonary, prostatic and tonsillar tissues, and in tear and pleural fluids. It is not, however, detected in the cerebrospinal fluid of subjects with non-inflamed meninges or in saliva.
UPLORES is indicated for infections caused by susceptible microorganisms, particularly in ears, nose and throat (otorhinolarynx), bronchopulmonary, genital (excluding gonococcal infections) and skin infections.
The antibacterial spectrum of Roxithromycin is as follows: Susceptible bacteria: Streptococcus A; Streptococcus mitis, sanguis, and viridans; Streptococcus agalactiae; Pneumococcus; Meningococcus; Bordatella pertussis; Branhamella catarrhalis; Corynebacterium diptheriae; Listeria monocytogenes; Clostridium; Mycoplasma pneumoniae; Pasteurella multocida; Chlamydia trachomatis and psittaci; Ureaplasma urealyticum; Legionella pneumophila; Campylobacter; Gardnerella vaginalis.
Variable susceptible bacteria: Haemophilus influenzae; Bacteroides fragilis; Vibrio cholera; Staphylococcus aureus; Staphylococcus epidermidis.
Resistant bacteria: Enterobacteriaceae; Pseudomonas.
Dosage/Direction for Use
Adults: 1 capsule, twice daily.
Hypersensitivity to Roxithromycin.
Concomitant administration with ergot derivatives.
Special Precautions
The safety use in pregnant women and nursing mothers has not been established, however, studies in several animals have not revealed any teratogenicity or fetotoxicity.
It is not recommended to be given to those with hepatobiliary disorders, since determination of dosage in those patients is on study.
It should be used with caution in patients with hepatic function impairment.
Inappropriate usage may raise resistant strains.
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, therefore caution is required when treating: Patients with congenital or documented QT prolongation.
Patients currently receiving treatment with other active substances known to prolong QT interval such as antiarrhythmics of classes IA and III; antipsychotic agents; antidepressants; and fluoroquinolones.
Patients with electrolyte disturbance, particularly in cases of hypokalemia and hypomagnesemia.
Patients with clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency.
Elderly patients: Elderly patients may be more susceptible to drug-associated effects on the QT interval.
Use In Pregnancy & Lactation
The safety use in pregnant women and nursing mothers has not been established, however, studies in several animals have not revealed any teratogenicity or fetotoxicity.
Adverse Reactions
Mild gastro-intestinal discomfort such as nausea, vomiting, diarrhea.
Allergic skin reactions.
Transient elevation possibility of alanine aminotransferase (ALT/GPT), aspartate aminotransferase (AST/GOT) and alkaline phosphatase.
Drug Interactions
There is a weak interaction with theophylline.
Concomitant administration of Roxithromycin with: Theophylline, may increase theophylline concentration in plasma; Digoxin, may elevate digoxin absorption; Terfenadine, may increase serum terfenadine concentration.
Store between 15° - 30°C.
MIMS Class
ATC Classification
J01FA06 - roxithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Cap 150 mg x 3 x 10's.
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