Concise Prescribing Info
Azithromycin dihydrate
Lower resp tract infection including bronchitis & pneumonia; acute otitis media; sinusitis; pharyngitis/tonsillitis. Skin & skin structure infections. Chancroid in men; uncomplicated genital infections due to Chlamydia trachomatis & non-multiresistant Neisseria gonorrhoea. Odontostomatological infections.
Dosage/Direction for Use
Cap/Powd for oral susp Geriatric & adult Mild to moderate resp tract, skin & soft tissue infections, pharyngitis/tonsillitis 500 mg as single loading dose on day 1 followed by 250 mg daily as single dose on days 2-5. Acute bacterial sinusitis, odontostomatological infections 500 mg daily for total of 3 days. Chancroid, Chlamydia trachomatis & non-multiresistant Neisseria gonorrhoea infections 1 g as single dose. Powd for oral susp Childn Days 1-3: Weighing >45 kg Adult dose, 36-45 kg 400 mg once daily, 26-35 kg 300 mg once daily, 15-25 kg 200 mg once daily, <15 kg 10 mg/kg once daily. Acute otitis media 30 mg/kg as single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as single dose on day 1 followed by 5 mg/kg daily on days 2-5. Pharyngitis/tonsillitis Adolescent & childn ≥2 yr 12 mg/kg once daily for 5 days. 
Should be taken on an empty stomach.
Hypersensitivity to azithromycin, erythromycin, other macrolides eg, azalide or ketolide. History of cholestatic jaundice/hepatic dysfunction associated w/ prior azithromycin use.
Special Precautions
Not to be used in hypersensitive patients. Discontinue if symptoms of hepatitis occur eg, malaise, nausea, vomiting, abdominal colic, fever. Pre-existing liver disease; hepatocellular &/or cholestatic hepatitis w/ or w/o jaundice; hepatic necrosis. Fungal or bacterial superinfection including C. difficile-associated diarrhea (>2 mth post-antibiotic treatment) in prolonged use. QTc prolongation & ventricular arrhythmias including Torsades de pointes. May mask or delay symptoms of incubating gonorrhea or syphilis. Liver damage. Renal impairment (GFR <10 mL/min). Pregnancy & lactation.
Adverse Reactions
Abdominal pain, diarrhea, flatulence, nausea, vomiting; increased liver enzymes; headache; abnormal vision. Prolonged QT interval, Torsades de pointes; generalized exanthematous pustulosis, SJS, TEN; congenital hypertrophic pyloric stenosis; hepatic necrosis, hepatitis, liver failure; DRESS, hypersensitivity reaction; Eaton-Lambert syndrome, exacerbation of myasthenia gravis, myasthenic crisis.
Drug Interactions
Increased risk of acute ergotism w/ ergot derivative & macrolides. Increased risk of bleeding w/ warfarin. Increased risk of rhabdomyolysis w/ simvastatin, lovastatin, or atorvastatin. Increased risk of QT interval prolongation w/ imipramine, lopinavir, apomorphine, nilotinib, vardenafil, citalopram, paliperidone, alfuzosin, lumefantrine, trazodone, granisetron, ranolazine, solifenacin, sunitinib, promethazine, mifepristone, arsenic trioxide, salmeterol, nortriptyline, norfloxacin, clozapine, sorafenib, chloroquine, propafenone, haloperidol, posaconazole, ciprofloxacin, gemifloxacin, ondansetron, pentamidine, ofloxacin, amitriptyline, voriconazole, clomipramine, fluconazole, ketoconazole, quinine, lapatinib, trimipramine, flecainide, octreotide, prochlorperazine, chlorpromazine, pazopanib, mefloquine, domperidone, sodium phosphate. Increased risk of QT interval prolongation & serious cardiac events w/ procainamide. Increased risk of cardiotoxicity w/ class III antiarrhythmic. Increase serum of theophylline; phenytoin; cyclosporine; carbamazepine. Decreased plasma conc w/ Al- or Mg-containing products.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Floctil cap 250 mg
1 × 6's;10 × 6's
Floctil powd for oral susp 100 mg/5 mL
15 mL x 1's
Floctil powd for oral susp 200 mg/5 mL
15 mL x 1's
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