MACROLIDE-  Antibacterial (systemic)

Treatment of Bronchitis, Otitis media acute,Cervicitis and urethritis gonococcal, Cervicitis and urethritis nongonococcal, Chancroid,

Mycobacterium avium complex (MAC) disease, Pelvic inflammatory disease, pharyngitis, Tonsillitis,Pneumonia community-acquired

Skin and soft tissue infections, Sinusitis acute, bacterial.

FDA Pregnancy Category B

Breast-feeding: It is not known if Azithromycin is distributed into breast milk.

Pediatrics, appropriate studies on the relationship of age to the effects oral azithromycin have not been performed in children up to 16 years of age.

Geriatrics Pharmacokinetic data in healthy elderly subjects (65 to 85 years old) were similar to those for younger volunteers (18 to 40 years old). A higher peak concentration (by 30 to 50%) was found in elderly women; however, no significant accumulation occurred. Dosage adjustment does not appear to be necessary in older patients with normal renal and hepatic function.

Contraindications

Except under special circumstances, this medication should not be used when the following medical problem exists:

Hypersensitivity to azithromycin, erythromycins, or other macrolides

Risk-benefit should be considered when the following medical problem exists:

Hepatic function impairment.

(because biliary excretion is the major route of elimination, caution should be used in patients with hepatic function impairment)

Drug Interactions

Antacids, aluminum- and magnesium-containing, Cyclosporine, Digoxin, Hexobarbital, Phenytoin, Terfenadine, Dihydroergotamine, Ergotamine, Nelfinavir, Wafarin.

Bronchitis, bacterial exacerbations or Pharyngitis, streptococcal or Pneumonia, due to Streptococcus pneumoniae or Haemophilus influenzae, or Skin and soft tissue infections, uncomplicated, due to Staphylococcus aureus, Streptococcus agalactiae, or Streptococcus pyogenes or Tonsillitis, streptococcal:

Adults and adolescents 16 years of age and older:

Oral, 500 mg as a single dose on the first day, then 250 mg once a day on days two through five.

Adolescents up to 16 years of age:

Safety and efficacy have not been established.

Cervicitis, nongonococcal or Urethritis, nongonococcal-

Adults and adolescents 16 years of age and older:

Oral, 1000 mg as a single dose.

Adolescents up to 16 years of age:

Safety and efficacy have not been established.

Children up to 16 years of age - Safety and efficacy have not been established.

Those indicating need for medical attention:

Incidence rare

Acute interstitial nephritis, allergic reactions,pseudomembranous colitis

Those indicating need for medical attention only if they continue or are bothersome

Incidence less frequent

Gastrointestinal disturbances, Dizziness, headache.

Store below 30°C (86°F), protect from light and moisture.

Keep the medicine in the box.

Each box contains 1 blister of 6 capsules, Azithromycin 250 mg.