ZHEJIANG MEDICINES&HEALTH PRODUCTS I/E CO.,LTD
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Place of Origin: | Guangdong, China (Mainland) |
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Azithromycin Tablets 250MG 500MG Antibiotic 3*1's / Box 10*1's / Box
Azithromycin Tablets 500MG
COMPOSITION.
Each Azithromycin Tablets contains azithromycin 500mg.
PHARMACOLOGICAL ACTION:
Based on animal models of infection, the antibacterial activity of azithromycin appears to correlate with the ratio of area under the concentration- time curve to minimum inhibitory concentration (AUC/MIC) for certain pathogens (S. pneumoniae and S. aureus). The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials with azithromycin.
INDICATIONS:
Zithromax is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
Acute bacterial exacerbations of chronic bronchitis in adults
Acute bacterial sinusitis in adults
Uncomplicated skin and skin structure infections in adults
Urethritis and cervicitis in adults
Genital ulcer disease in men
Acute otitis media in pediatric patients
Community-acquired pneumonia in adults and pediatric patients
CONTRA-INDICATIONS:
Patients with known hypersensitivity to azithromycin,erythromycin,any other macrolide or ketolide antibiotic,or to any component of the product.
WARNINGS:
Serious (including fatal) allergic and skin reactions: Discontinue azithromycin if reaction occurs.
Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported, Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval.
Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs.
Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis.
Azithromycin has been reported to be excreted in human breast milk in small amounts. Caution should be exercised when azithromycin is administered to a nursing woman.
DOSAGE AND DIRECTIONS FOR USE:
Adult Patients
Infection |
Recommended Dose/Duration of Therapy |
Community- acquired pneumonia (mild severity) Pharyngitis/ tonsillitis (second-line therapy) Skin/skin structure(uncomplicated) |
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. |
Acute bacterial exacerbations of chronic bronchitis (mild to moderate) |
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days. |
Acute bacterial sinusitis |
500 mg once daily for 3 days. |
Genital ulcer disease (chancroid) Non-gonococcal urethritis and cervicitis |
One single 1 gram dose. |
Gonococcal urethritis and cervicitis |
One single 2 gram dose. |
Pediatric Patients
Infection |
Recommended Dose/Duration of Therapy |
Acute otitis media |
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on days 2 through 5. |
Acute bacterial sinusitis |
10 mg/kg once daily for 3 days. |
Community-acquired pneumonia |
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. |
Pharyngitis/tonsillitis |
12 mg/kg once daily for 5 days. |
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastrointestinal system with diarrhea/loose stools (4 to 5%), nausea (3%), and abdominal pain (2 to 3%) being the most frequently reported.
Adverse reactions 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.
STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light. Keep out of reach of children.