ZITROMAXINE 250 mg
Capsules

Other antibacterial drugs

  • Chemical Composition

    Azitromicine Base 250 mg

  • Packing

    6Capsules

  • Medical Id

    CA-02

  • License Number

    338/2003

  • License date

    29/12/2003

Mechanism Of Action Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the: 1-Gram-Positive Aerobes: Staphylococcus aureus. Streptococcus agalactiae. Streptococcus pneumoniae. Streptococcus pyogenes. NOTE: Azithromycin demonstrates cross-resistance with erythromycin-resistant gram-positive strains. Most strains of Enterococcus faecalis and methicillin-resistant staphylococci are resistant to azithromycin. Gram-Negative Aerobes: Haemophilus ducreyi. Haemophilus influenzae. Moraxella catarrhalis. Neisseria gonorrhoeae. “Other” Microorganisms: Chlamydia pneumoniae. Chlamydia trachomatis. Mycoplasma pneumoniae. NOTE: Beta-lactamase production should have no effect on azithromycin activity.
INDICATIONS Zitromaxine (Azithromycin) is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Adults: Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease: Due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Community-Acquired Pneumonia: Due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. Uncomplicated Skin and Skin Structure Infections: Due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage. Urethritis and Cervicitis: Due to Chlamydia trachomatis or Neisseria gonorrhoeae. Genital Ulcer Disease: In men due to Haemophilus ducreyi (chancroid). Pediatric Patients: Acute Otitis Media: Caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Community-Acquired Pneumonia: Due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
CONTRAINDICATIONS Zitromaxine (Azithromycin) is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic.
Side EFFECTS The most common side effects are related to the gastrointestinal tract, such as nausea, vomiting, diarrhea, or abdominal pain. Allergic reactions, headache, dizziness, palpitations, and chest pain may also occur. Potentially serious side effects of angioedema and cholestatic jaundice are very rare.
WARNINGS Serious allergic reactions have been reported rarely in patients on azithromycin therapy. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. In the treatment of pneumonia, azithromycin has only been shown to be safe and effective in the treatment of community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems including immunodeficiency or functional asplenia. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.” Because azithromycin is principally eliminated via the liver, caution should be exercised when azithromycin is administered to patients with impaired hepatic function. Caution should also be exercised when prescribing azithromycin in patients with renal impairment.The following adverse events have not been reported in clinical trials with azithromycin, an azalide; however, they have been reported with macrolide products: ventricular arrhythmias, including ventricular tachycardia in individuals with prolonged QT intervals. pataint should be cutioned to take azithromycin suspensionat least one hour prior to a meal or at least two hours after a meal these medication should not be taken with food however ,azithromycin tablets can be taken with or without food .
DRUG INTERACTIONS Aluminum and magnesium containing antacids reduce the peak serum levels (rate) but not the AUC (extent) of azithromycin absorption. Concurrent use of macrolides and theophylline has been associated with increases in the serum concentrations of theophylline. Concurrent use of macrolides and warfarin in may be associated with increased anticoagulant effects. Careful monitoring of patients is advised when the following drugs used with Azithromycin concomitantly: Digoxin: Elevated digoxin levels. Ergotamine or Dihydroergotamine: Acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia. Triazolam: Decrease the clearance of triazolam and thus may increase the pharmacologic effect of triazolam. Drugs Metabolized by the Cytochrome P450System: Elevations of serum carbamazepine, terfenadine, cyclosporine, hexobarbital, and phenytoin levels. Drug \ Clinical Laboratory Test Interactions: Reversible elevated serum creatine phosphokinase, potassium, ALT (SGPT), GGT, and AST (SGOT); with an incidence of less than 1%, leukopenia, neutropenia, decreased platelet count, elevated serum alkaline phosphatase, bilirubin, BUN, creatinine, blood glucose, LDH, and phosphate. In pediatric use no laboratory tests interactions were reported.
Pregnancy And lactations azithromycin should be used during pregnancy only if clearly needed ,caution should be exercised when azitromycin to a nursing woman .
Dosage And Administration Adults: The recommended dose of azithromycin for the treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease, community-acquired pneumonia of mild severity, pharyngitis/tonsillitis (as second-line therapy), and uncomplicated skin and skin structure infections due to the indicated organisms is: 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5. Azithromycin capsules should be given at least 1 hour before or 2 hours after a meal. Azithromycin capsules should not be taken with food. The recommended dose of azithromycin for the treatment of genital ulcer disease due to Haemophilus ducreyi (chancroid), non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram dose of azithromycin (4 of Zitromaxine-250 mg capsules). The recommended dose of azithromycin for the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae is a single 2 gram (2000 mg) dose of azithromycin (8 of Zitromaxine-250 mg capsules). Pediatric Patients: Acute Otitis Media and Community Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of children with acute otitis media and community-acquired pneumonia is 10 mg/kg as a single dose on the first day (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day). Azithromycin for oral suspension should not be taken with food. Pharyngitis/Tonsillitis: The recommended dose for children with pharyngitis/tonsillitis is 12 mg/kg once a day for 5 days (not to exceed 500 mg/day). Constituting instructions for azithromycin oral suspension, 300, 600, 900, 1200 mg bottles.
Storage Conditions Zitromaxine tablets and capsules should be stored below 30° C