Zenith Suspension

Zenith Suspension

azithromycin

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Azithromycin monohydrate
Indications/Uses
Treatment of mild to moderate infections caused by susceptible microorganisms including upper & lower resp tract infections eg, acute bacterial bronchitis & sinusitis, community-acquired pneumonia, acute otitis media, acute streptococcal pharyngitis or tonsillitis; uncomplicated skin & skin structure infections; Chlamydia trachomatis conjunctivitis & trachoma.
Dosage/Direction for Use
Childn Total dose: 30 mg/kg in a 3-day or 5-day regimen. 3-day regimen: 10 mg/kg once daily for 3 days. 5-day regimen: 10 mg/kg on Day 1 followed by 5 mg/kg once daily for Days 2-5. 3-day (Days 1-3) & 5-day (Day 1) therapy (10 mg/kg/day): >45 kg 12.5 mL, 36-45 kg 10 mL, 26-35 kg 7.5 mL, 17-25 kg 5 mL, 16 kg 4 mL, 14 kg 3.5 mL, 12 kg 3 mL, 10 kg 2.5 mL. 5-day therapy (Days 2-5) therapy (5 mg/kg/day): >45 kg 6.25 mL, 36-45 kg 5 mL, 26-35 kg 3.75 mL, 17-25 kg 2.5 mL, 16 kg 2 mL, 14 kg 1.75 mL, 12 kg 1.5 mL, 10 kg 1.25 mL. Streptococcal pharyngitis 10 or 20 mg/kg once daily for 3 days. Max: 500 mg/day. Conjunctivitis & trachoma Childn ≥12 mth 20 mg/kg as a single dose or once a wk for up to 3 wk.
Administration
May be taken with or without food: Drink fruit juice immediately after swallowing to avoid bitter after-taste.
Contraindications
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. History of cholestatic jaundice or hepatic dysfunction. Co-administration w/ pimozide.
Special Precautions
Hypersensitivity reactions; hepatotoxicity; pneumonia inappropriate for oral treatment due to moderate to severe illness or risk factors; myasthenia gravis; ventricular arrhythmias associated w/ prolonged QT interval including ventricular tachycardia & Torsades de pointes. Severe renal impairment &/or significant liver disease. Consider diagnosis of pseudomembranous colitis in patients who develop diarrhea. Avoid long-term or repeated use. Neurological or psychiatric disorders. Not for infected burn wounds & systemic severe infections. Perform serologic test for syphilis & appropriate cultures for gonorrhea. Co-administration w/ ergot derivatives. Lysosomal lipid storage diseases eg, Tay-Sachs disease, Niemann-Pick disease. Fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn <6 mth (community-acquired pneumonia, acute otitis media or bacterial sinusitis) or <2 yr (pharyngitis & tonsillitis).
Adverse Reactions
Nausea, vomiting, diarrhea or loose stools, abdominal discomfort (pain, cramps), headache & rash.
Drug Interactions
Decreased rate of absorption w/ Al & Mg hydroxide containing antacids. Additive synergistic effects w/ antimalarial agents in vitro. Enhances risk of cardiotoxicity of astemizole & significant inhibition of alfentanil clearance. Potentiates the anticoagulant effect of coumarin-type anticoagulants eg, warfarin. Increased Cmax & AUC of ciclosporin. Elevated digoxin levels. Increases pharmacological effects of disopyramide. Ergotism w/ ergot derivatives. Increased conc w/ nelfinavir. Increased serum conc of phenytoin, hexobarbital & theophylline. Inhibit pimozide metabolism. Cardiac repolarization (QTc) interval w/ terfenadine.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Zenith Suspension powd for oral susp 200 mg/5 mL
Packing/Price
20 mL x 1's (P366.43/bottle)
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