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Clarithromycin 500mg Tablets(Accord Healthcare Limited)
2017-02-20 10:50:43 来源: 作者: 【 】 浏览:555次 评论:0
1. Name of the medicinal product

Clarithromycin 500mg Film-coated Tablets

2. Qualitative and quantitative composition

Each tablet contains Clarithromycin 500 mg.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated Tablets

Clarithromycin tablets 500 mg are Light yellow coloured, oval shaped, biconvex, film-coated tablets, with 'C' and '2' debossed on either side of breakline on one side.

4. Clinical particulars
 
4.1 Therapeutic indications

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Clarithromycin tablets are indicated in adults and children 12 years and older. (Adult only formulations, e.g. tablets, IV)

Clarithromycin Tablets are indicated for treatment of the following infections caused by susceptible organisms Indication include:

Lower respiratory tract infections for example: acute and chronic bronchitis, and pneumonia.

Upper respiratory tract infections for example: sinusitis and pharyngitis.

Clarithromycin is appropriate for initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens as listed in the microbiology section.

Clarithromycin is also indicated in skin and soft tissue infections of mild to moderate severity.

Clarithromycin in the presence of acid suppression effected by omeprazole or lansoprazole is also indicated for the eradication of H. pylori in patients with duodenal ulcers. See Dosage and Administration section.

Clarithromycin is usually active against the following organisms in vitro:

Gram-positive Bacteria: Staphylococcus aureus (methicillin susceptible); Streptococcus pyogenes (Group A beta-hemolytic streptococci); alpha-hemolytic streptococci (viridans group); Streptococcus (Diplococcus) pneumoniae; Streptococcus agalactiae; Listeria monocytogenes.

Gram-negative Bacteria: Haemophilus influenzae; Haemophilus parainfluenzae; Moraxella (Branhamella) catarrhalis; Neisseria gonorrhoeae; Legionella pneumophila; Bordetella pertussis; Helicobacter pylori; Campylobacter jejuni.

Mycoplasma: Mycoplasma pneumoniae; Ureaplasma urealyticum.

Other Organisms: Chlamydia trachomatis; Mycobacterium avium; Mycobacterium leprae

Anaerobes: Macrolide-susceptible Bacteroides fragilis; Clostridium perfringens; Peptococcus sp

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