AZIMAGBRO Tablet

For the treatment of respiratory-tract infections (including otitis media), in skin and soft-tissue infections and in uncomplicated genital infections. Also used for the prophylaxis and as component of regimens in the treatment of Mycobacterium avium complex (MAC) infections.

Adults

- Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis, Community-acquired pneumonia, patients with cystic fibrosis, patients with nosocomial infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). Pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, Genital ulcer disease in men, Pediatric patients, Community-acquired pneumonia, patients with cystic fibrosis, patients with nosocomial infections, patients with known or suspected bacteremia, patients requiring hospitalization, or patients with significant underlying health problems that may, compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). Pharyngitis/tonsillitis.

Dosage and Administration

The usual oral adult dose is 500mg as a single dose daily for 3 days.

Alternatively, an initial dose of 500mg may be followed by 250mg daily for a further 4 days.

For Uncomplicated genital infections caused by Chlamydia trachomatis and for chancroid, 1g of azithromycin is given as a single dose. A single dose of 2g has been given for uncomplicated gonorrhea. Followed by 500mg daily may be given, or 1g may be given once a week for at least 3 weeks until all lesions have completely healed.

For prophylaxis of disseminated MAC infections, azithromycin 1.2g may be given once weekly. For treatment or secondary prophylaxis, 500mg once daily should be given with other antimycobacterials.

For mild to moderate typhoid caused by multidrug resistant strains, 500mg once daily may be given for 7 days.

In patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. Azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

(See the package insert about the details.)

Most of the adverse effects leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain.

Adults

Multiple-dose regimens

Overall, the most common treatment-related adverse effects in adult patients receiving multiple-dose regimens of azithromycin were related to the gastrointestinal system with diarrhea/loose stools, nausea and abdominal pain being the most frequently reported.

No other treatment-related adverse effects occurred in patients on the multiple dose regimens of azithromycin with a frequency greater than 1%. Adverse effects that occurred with a frequency of 1% or less included the following:

Cardiovascular: Palpitations, chest pain.

Gastrointestinal: Dyspepsia, flatulence, vomiting, melena and cholestatic, jaundice.

Genitourinary: Monilia, vaginitis and nephritis.

Nervous System: Dizziness, headache, vertigo and somnolence.

General: Fatigue.

Allergic: Rash, pruritus, photosensitivity and angioedema.

Co-administration of nelfinavir at steady-state with a single oral dose or azithromycin resulted in increased azithromycin serum concentrations.

Although a dose adjustment of azithromycin is not recommended when administered in combination with Nelfinavir, close monitoring for known side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted.

Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported. Despite initially successful symptomatic tract and of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown at present. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

Precautions

Because azithromycin is principally eliminated via the liver, caution should be exercised when azithromycin is administered to patients with impaired hepatic function. Due to the limited data in subjects with GFR<10mL/min, caution should be exercised when prescribing azithromycin in these patients.

Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de points, have been seen in treatment with other macrolides. A similar effect with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization.

Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.

Prescribing azithromycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.

Information for Patients Azithromycin tablets can be taken with or without food.

Azithromycin dehydrate, a macrolide antibiotic of the azalide subclass, exerts its antibacterial action by binding to the 50s ribosomal subunit of susceptible bacteria and suppressing protein synthesis.