ZITROMAXINE 200 mg
Syrup

Other antibacterial drugs

  • Chemical Composition

    Azitromycin (Dihydrate) 200 mg / 5 ml

  • Packing

    15ml-22,5ml-30ml

  • Medical Id

    SY-08

  • License Number

    116/2004

  • License date

    1/3/2004

Mechanism Of Action Azithromycin acts by binding to the S50 ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acidsynthesis 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. 2-Gram-Negative Aerobes: Haemophilusducreyi. Haemophilusinfluenzae. 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 Haemophilusinfluenzae, Moraxella catarrhalis, or Streptococcuspneumoniae. Community-Acquired Pneumonia: Due to Chlamydiapneumoniae, Haemophilusinfluenzae, Mycoplasmapneumoniae, or Streptococcuspneumoniae in patients appropriate for oral therapy. Pharyngitis/Tonsillitis: Caused by Streptococcuspyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. Uncomplicated Skin and Skin Structure Infections: Due to Staphylococcusaureus, Streptococcuspyogenes, or Streptococcusagalactiae. Abscesses usually require surgical drainage. Urethritis and Cervicitis: Due to Chlamydia trachomatis or Neisseriagonorrhoeae. Genital Ulcer Disease: In men due to Haemophilusducreyi (chancroid). Pediatric Patients: Acute Otitis Media: Caused by Haemophilusinfluenzae, Moraxella catarrhalis, or Streptococcuspneumoniae. Community-Acquired Pneumonia: Due to Chlamydiapneumoniae, Haemophilusinfluenzae, Mycoplasmapneumoniae, or Streptococcuspneumoniae in patients appropriate for oral therapy Pharyngitis/Tonsillitis: Caused by Streptococcuspyogenes 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 reactionshave been reported rarely in patients on azithromycin therapy. If an allergicreaction 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 Chlamydiapneumoniae, Haemophilusinfluenzae, Mycoplasmapneumoniae, or Streptococcuspneumoniae 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 nosocomiallyacquired 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 normalflora 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 ventriculartachycardia in individuals with prolonged QT intervals.
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 is 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 peripheralvasospasm 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 serumcreatine phosphokinase, potassium, ALT (SGPT), GGT, and AST (SGOT); with an incidence of less than 1%, leukopenia, neutropenia, decreased platelet count, elevated serumalkaline phosphatase, bilirubin, BUN, creatinine, blood glucose, LDH, and phosphate. In pediatric use no laboratory tests interactions were reported.
Pregnancy And lactations Pregnancy:there are no adequate data from the use of azithromycin in pregnant women. the safety of azithromycin has not been confirmed during pregnancy. therefore azithromycin should only be used during pregnancy if the benefit outweighs the risk. Lactation:it is not known whether azithromycin is excreted in breast milk , there are no adequate and well- controlled clinical studies in nursing women therefor azithromycin should only be used in lactating women where adequatealternatives are not available and with caution.
Dosage And Administration 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 25 mg /day). Azithromycine for oral suspension is taken with or without 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).
Storage Conditions Store before constitution below 25° C in dry place. after reconstitution : Store 5-30 ° C& should be used within 5 days.& discard any unused portion after 5 days