Zithrolic

Zithrolic

azithromycin

Manufacturer:

Berlico Mulia Farma
Concise Prescribing Info
Contents
Azithromycin
Indications/Uses
Mild to moderate infections: Lower resp tract (acute bacterial exacerbations of COPD due to H. influenzae, Moraxella catarrhalis or Streptococcus pneumoniae; mild pneumonia due to Streptococcus pneumoniae or H. influenzae in outpatients appropriate for oral therapy); upper resp tract (alternative to 1st line therapy of acute pharyngitis/tonsilitis due to Streptococcus pyogenes in individuals who cannot use 1st line therapy); uncomplicated skin & skin structure infections due to Staph aureus, Streptococcus pyogenes, or Streptococcus agalactiae; non-gonococcal urethritis & cervicitis due to Chlamydia trachomatis.
Dosage/Direction for Use
Adult STD caused by susceptible Chlamydia trachomatis, Haemophilus ducreyi, or Neisseria gonorrhoeae 1,000 mg as a single dose. All other indications 500 mg daily for 3 days. Total dose: 1,500 mg. Alternative dose for 5 days administration: 500 mg on the 1st day then 250 mg daily on 2nd to 5th day. Childn 10 mg/kg daily for 3 days. Total dose: 30 mg/kg. Alternative dose for 5 days administration: 10 mg/kg on the 1st day then 5 mg/kg daily on 2nd to 5th day.
Administration
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotics.
Special Precautions
Discontinue if an allergic reaction, signs & symptoms of hepatitis occurs. Clinicians should be aware that the recurrent allergy symptoms may occur when symptomatic therapy is discontinued. Abnormal liver function, hepatitis, cholestatic jaundice, liver necrosis, & liver failure; Clostridium difficile-associated diarrhea (CDAD), & the severity can range from mild diarrhea to fatal colitis; prolongation of cardiac repolarization & QT interval, risk of cardiac arrhythmias & Torsades de pointes. Should not be used together w/ ergot derivatives due to possible ergotism. Discontinue ongoing use of antibiotics which are not directed against C. difficile if CDAD is suspected or confirmed. Perform susceptibility testing during treatment. Should not be used in patients w/ pneumonia who are deemed inappropriate for outpatient receiving oral therapy due to moderate to severe disease or risk factors eg, patients w/ nosocomial acquired infections; w/ or suspected bacteremia; requiring hospitalization; elderly or physically weak, or who have significant underlying health problems that may impair their ability to fight off their disease (including immunodeficiency or functional asplenia). Patients w/ congenital or history of QT interval prolongation; who are receiving treatment w/ other active substances known to prolong the QT interval eg, class 1A & III arrhythmias, antipsychotics, antidepressants, & fluoroquinolones; electrolyte disturbances, especially in cases of hypokalemia & hypomagnesaemia; clinically relevant bradycardia, cardiac arrhythmias or cardiac insufficiency. Monitoring of clinical signs & serum digoxin levels are required during & after treatment; prothrombin time when used in patients receiving coumarin-type oral anticoagulants. Monitor cyclosporine levels & adjust dose if co-administration is required. Increased systemic exposure in patients w/ severe renal impairment (GFR 10 mL/min). Patients w/ significant liver disease. Childn <6 mth. Elderly may be more sensitive to the development of Torsades de pointes, arrhythmias.
Drug Interactions
Should not be taken concomitantly w/ antacids. Possible increased serum levels of P-gp substrates eg, digoxin. Increased conc of the active metabolite phosphorylated zidovudine in peripheral blood mononuclear cells. Concomitant use w/ ergot derivatives is not recommended. Post-marketing rhabdomyolysis cases w/ statins. Potentiation of anticoagulants following co-administration of azithromycin & coumarin type oral anticoagulant. Increased Cmax & AUC0-5 of cyclosporine. Co-administration w/ nelfinavir at steady state may increase azithromycin level. Neutropenia was observed in subjects receiving concurrent treatment w/ rifabutin.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Zithrolic FC caplet 500 mg
Packing/Price
5 × 6's (Rp242,000/boks)
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