- ANTI-INFECTIVE DRUGS
- Pharmaceutical Form : Film Coated Tablets
- Composition : Azithromycin (Dihydrate) 500 mg / Ctd. Tab
- Active Substance : Azithromycin
Azithromycin – Medico (Azithromycin) is an azalide, derived from the macrolide class of antibiotics. Following oral administration in humans, Azitromycine – Medico is wildly distributed throughout the body.
Bioavailability is approximately 37 %.
The time taken to peak plasma levels is 2 – 3 hours.
Plasma terminal elimination half-life closely reflects the tissue depletion half-life of 2 to 4 days.
Kinetic studies have shown markedly higher Azitromycine – Medico levels in tissue than in plasma ( up to 50 times the maximum observed concentration in plasma ) indicating that the drug is Highly tissue bound .Concentration in target tissues such as lung , tonsil and prostate exceed the MIC90 for likely pathogens after a single dose of 500 mg.
Azitromycine – Medico demonstrates activity against a wide range Gram-positive and Gram-negative Bacteria including: staphylococcus aureus, streptococcus pneumoniae, streptococcus Pyogenes (Group A and other streptococcal species, haemophilus influenzae and parainfluenzae, moraxella catarrhalis, anaerobes including bacteroides fragilis, E. coli, bordetella parapertussis, Borrelia burgdorferi, haemophilus ducreyi, neisseria gonorrhea and chlamydia trachomatis.
Azitromycine – Medico also demonstrates activity against tegionella pneumophila, mycoplasma pneumoniae and hominis, campylobacter sp, toxoplasma gondii and treponema pallidum
Azithromycin – Medico (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:
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.
NOTE: 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 that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
- 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). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
Azithromycin – Medico is contraindicated in patients with known hypersensitivity to Azitromycine – Medico or any of the macrolide antibiotics.
Azithromycin – Medico is well tolerated . Most side effects observed were mild to moderate in severity The majority of side effects were gastrointestinal in origin with nausea, abdominal discomfort (pain / cramps), vomiting, flatulence, diarrhea and loose stools being occasionally observed .
Allergic reactions such as rash have occurred and there have also been rare reports of serious Hypersensitivity reactions.
Reversible elevations in liver transaminases have been seen with a frequency similar to the Comparative macrolides and penicillin used in clinical trials
Transient mild reductions in neutrophil counts have occasionally been observed.
PRECAUTIONS & WARNINGS :
As with other erythromycin and other macrolide, rare serious allergic reactions, including Angioneurotic oedema and anaphylaxis have been reported As with any antibiotic, observation for signs of super infection with non susceptible organisms, Including fungi is recommended .
Hepatic Impairment: Azitromycine – Medico should not be used in patients with hepatic disease .
Renal Impairment: No dose adjustment is needed in patients with mild renal impairment (Creatinine clearance >40 ml min ). Caution should be exercised in severe renal impairment
Pregnancy, Pregnancy Category B: azithromycin should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.
The recommended dose of Azithromycin – Medico for the treatment of 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.
The recommended dose of Azithromycin – Medico for the treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease is: either 500 mg per day for 3 days or 500 mg as a single dose on the first day followed by 250 mg once daily on Days 2 through 5. Azitromycine – Medico tablets can be taken with or without food.
The recommended dose of Azithromycin – Medico 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 (1000 mg) dose of Azithromycin – Medico
The recommended dose of Azithromycine – Medico for the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae is a single 2 gram (2000 mg) dose of Azithromycine – Medico.
Store Azithromycin – Medico at room temperature, under 30 ºC.
Keep Azithromycin – Medico out of the reach of children
Packing :Box of 3 Coated tablets.