Binozyt

Binozyt

azithromycin

Manufacturer:

Sandoz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Azithromycin
Indications/Uses
Mild to moderately severe community-acquired pneumonia; acute exacerbation of chronic bronchitis; acute bacterial sinusitis; pharyngitis/tonsillitis; acute bacterial otitis media; skin & soft tissue infections; uncomplicated Chlamydia trachomatis urethritis & cervicitis.
Dosage/Direction for Use
Adult 500 mg daily for 3 consecutive days, or 500 mg on day 1 then 250 mg on days 2-5. Uncomplicated Chlamydia trachomatis urethritis & cervicitis 1,000 mg as single dose. Childn & adolescents <18 yr 30 mg/kg administered as 10 mg/kg once daily for 3 days, or 10 mg/kg on day 1 followed by 5 mg/kg/day for the following 4 days. Childn Pharyngitis caused by Streptococcus pyogenes 10 mg/kg or 20 mg/kg single dose for 3 days. Max daily dose: 500 mg.
Administration
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity to azirthromycin, erythromycin, any macrolide or ketolide antibiotics.
Special Precautions
Angioedema & anaphylaxis. Observe for signs of superinfection. Caution in patients w/ neurological & psychiatric disorders; diabetic patients. Drugs known to prolong QT interval. Clostridium difficile-associated diarrhea (CDAD); QT prolongation; myasthenia gravis; dermatologic reactions eg, Drug Reaction w/ Eosinophilia & Systemic symptoms (DRESS). Exclude concomitant infection by T. palladium. Not the 1st choice for treatment of pharyngitis & tonsilitis caused by Streptococcus pyogenes; sinusitis; acute otitis media. Not indicated for infected burn wounds. Rare hereditary galactose intolerance, lactose deficiency or glucose-galactose malabsorption. Use for Mycobacterium Avium Complex in childn has not been established. Co-administration of ergot derivatives. Significant hepatic disease. Stop if liver dysfunction has emerged. Severe renal impairment (GFR <10 mL/min). Pregnancy & lactation.
Adverse Reactions
Diarrhea. Headache; vomiting, abdominal pain, nausea; inj site pain; decreased lymphocyte count & blood bicarbonate, increased eosinophil count, basophils, monocytes & neutrophils.
Drug Interactions
Reduced peak serum conc w/ antacids. Increased serum levels of P-gp substrate eg, digoxin. Increased conc of phosphorylated zidovudine. Theoretical possibility of ergotism w/ ergot derivatives. Enhanced effect w/ astemizole & alfentanil. Increased QT interval prolongation, ventricular arrhythmia & torsades de pointes w/ cisapride. Monitor prothrombin time w/ coumarin-type oral anticoagulants. Elevated Cmax & AUC0-5 of ciclosporin. Do not concurrently use w/ other active substances that prolong the QT interval.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Binozyt powd for susp 200 mg/5 mL
Packing/Price
1's
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