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Zenith

Zenith

azithromycin

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Azithromycin monohydrate
Indications/Uses
Mild to moderate community-acquired pneumonia caused by Mycoplasma pneumoniae, Chlamydophila psittaci (ornithosis) or Chlamydophila pneumoniae (TWAR). Acute exacerbation of chronic bronchitis. Acute bacterial sinusitis. Tonsillitis, pharyngitis, acute otitis media, & skin & soft tissue infections (eg, furunculosis, pyoderma, impetigo & erysipelas) in patients w/ hypersensitivity to β-lactam antibiotics or when such treatment is not suitable. Uncomplicated genital infections caused by Chlamydia trachomatis or Neisseria gonorrhoeae.
Dosage/Direction for Use
Adult Uncomplicated genital infections due to Chlamydia trachomatis or sensitive Neisseria gonorrhoeae 1,000 mg as single dose. Other indications 500 mg daily for 3 consecutive days. Alternatively, 500 mg on the 1st day then 250 mg on the 2nd-5th day. Childn >45 kg Normal adult dose.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to azithromycin monohydrate, erythromycin, & to any macrolide or ketolide antibiotics.
Special Precautions
Discontinue if an allergic reaction occurs. Fulminant hepatitis potentially leading to life-threatening liver failure in patients w/ preexisting hepatic disease or taking other hepatotoxic medicinal products. Perform LFT in case of signs & symptoms of liver dysfunction eg, rapid developing asthenia associated w/ jaundice, dark urine, bleeding tendency or hepatic encephalopathy. Discontinue immediately if signs & symptoms of hepatitis occur. Infantile hypertrophic pyloric stenosis in neonates (treatment up to 42 days of life). Pseudomembranous colitis. Observe for signs of superinfection w/ non-susceptible organisms, including fungi. Cross-resistance w/ erythromycin-resistant gm +ve strains & methicillin-resistant staphylococci strains. Not intended for severe infections where fast high blood conc of antibiotic have to be achieved. Clostridium difficile-associated diarrhoea. Patients w/ ongoing proarrhythmic conditions (especially women & elderly) eg, w/ congenital or documented QT prolongation; current treatment w/ other active substances that prolong QT interval eg, antiarrhythmics class IA (quinidine & procainamide) & class III (dofetilide, amiodarone, & sotalol), cisapride, terfenadine, antipsychotics (eg, pimozide), antidepressants (eg, citalopram), & fluoroquinolones (eg, moxifloxacin & levofloxacin); electrolyte disturbance, particularly hypokalaemia & hypomagnesaemia; clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency. Exacerbations of the symptoms of myasthenia gravis & new onset of myasthenia syndrome. Long-term use. Neurological & psychiatric disorders. Should not be co-administered w/ ergot derivatives. Visual impairment & blurred vision may have an effect on ability to drive or operate machinery. Significant hepatic disease & severe renal impairment (GFR <10 mL/min). Pregnancy & lactation. Childn <45 kg.
Adverse Reactions
Diarrhoea. Headache; vomiting, abdominal pain, nausea; 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 substrates (eg, digoxin & colchicine). Ergotism w/ ergot alkaloids. Increased conc of phosphorylated zidovudine. Rhabdomyolysis w/ statins. Potentiated anticoagulation w/ coumarin-type oral anticoagulants eg, warfarin. Elevated Cmax & AUC0-5 of cyclosporine. Increased conc w/ nelfinavir. Neutropenia may occur w/ rifabutin. Co-resistance w/ other macrolides. Medicinal products known to prolong QT interval.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Zenith FC tab 500 mg
Packing/Price
30's (P4,135.14/box)
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