AZONE

Pharmacokinetics

• Absorption : Rapidly absorbed from the gastrointestinal tract
• Bioavailability : Approximately 40%
• Peak Plasma Concentration : 2 to 3 hours
• Distribution : Extensively distributed in tissues
• Metabolism : Liver
• Elimination Half-life : Approximately 68 hours
• Excretion : Biliary (major route); urine (6%)

Indications and Dosage

• Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease : One tablet of AZONE 500 mg once on first day then one tablet of AZONE 250 mg once daily for the following 4 days. Alternatively, one tablet of AZONE 500 mg once daily for 3 days
• Uncomplicated Genital Infection caused by Chlamydia trachomatis and for Chancroid : Two tablets of AZONE 500 mg stat
• Uncomplicated Gonorrhea : Four tablets of AZONE 500 mg stat
• Acute Bacterial Sinusitis : One tablet of AZONE 500 mg per day for 3 days or four tablets of AZONE 500 mg stat
• Community-Acquired Pneumonia : One tablet of AZONE 500 mg once on first day then one tablet of AZONE 250 mg once daily for the following 4 days or one tablet of AZONE 500 mg for 3 consecutive days
• Uncomplicated Skin / Soft Tissue Infections : One tablet of AZONE 500 mg once on first day then one tablet of AZONE 250 mg once daily for the following 4 days or one tablet of AZONE 500 mg for 3 consecutive days
• Acute Pelvic Inflammatory Disease : Azithromycin 500 mg IV over 1 hour once daily for 1 day to 2 days then one tablet of AZONE 250 mg once daily for the following 5 days to complete a 7-day therapy
• Acute Otitis Media : one tablet of AZONE 500 mg once on first day then one tablet of AZONE 250 mg once daily for the following 4 days or one tablet of AZONE 500 mg for 3 consecutive days
• Disseminated Mycobacterium Avium Complex Infection:
  Prevention :
  Primary Prophylaxis: AZONE 1.2 g once weekly or AZONE 600 mg twice weekly
  Secondary Prophylaxis : AZONE 500 to 600 mg every day in combination with other antibiotic
  
  Treatment : One tablet of AZONE 250 mg once daily in combination with other antibiotic
• MDR Typhoid Fever (mild or moderate): One tablet of AZONE 500 mg for 7 days
• Cholera :
  Children: Single dose of AZONE 10 mg or AZONE 20 mg per kg.
  Adult : Two tablets of AZONE 500 mg stat
• Trachoma : Two tablets of AZONE 500 mg stat

Side Effects
MOST FREQUENT : Gastrointestinal disorders such as abdominal discomfort and cramp, nausea, vomiting and diarrhoea
RARE : Severe hypersensitivity, thrombocytopenia, mild transient neutropenia

Contraindications
History of cholestatic jaundice/hepatic dysfunction associated with prior use of therapy

Warnings / Precautions

• Discontinue if serious allergic reaction occurs. Allergic symptoms may recur, despite initial successful symptomatic treatment without further therapy exposure.
• Discontinue immediately if abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure occur.
• Consider risk of QT prolongation that can be fatal for at-risk groups, including patients with known QT interval prolongation, history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, uncompensated heart failure, ongoing proarrhythmic conditions (eg., uncorrected hypokalemia / hypomagnesemia), and clinically significant bradycardia.
• May need to discontinue if Clostridium Difficile-Associated Diarrhea is suspected or confirmed.
• Exacerbation of myasthenia gravis symptoms and new onset of myasthenic syndrome has been reported.
• Prolong use may cause bacterial resistance in absence of proven/ suspected bacterial infection.
• Do not use in patients with pneumonia due to moderate to severe illness or risk factors (eg. cystic fibrosis, nosocomial infections, known / suspected bacteremia).
• Should not be relied upon to treat syphilis.

Drug Interactions

• Aluminum- or magnesium-based antacids can reduce the rate of absorption of azithromycin. Azithromycin should be given at least 1 or 2 hours after antacid.
• Azithromycin increases the effect of digoxin by altering intestinal flora.
• Azithromycin increases effects of heparin, warfarin by decreasing metabolism.
• Amitriptyline and azithromycin both increase QTc interval.
• Calcium carbonate decreases the level of azithromycin by inhibition of GI absorption.
• Phenytoin and phenobarbital decrease the effect of azithromycin by P-glycoprotein efflux transporter.

Pregnancy Category : B

Presentations
AZONE 250 mg : A box of 10 blisters, each blister of 10 tablets
AZONE 500 mg : A box of 10 strips, each strip of 3 tablets

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