Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
clarithromycin, Quantity: 500 mg
Arrotex Pharmaceuticals Pty Ltd
Clarithromycin
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; hypromellose; titanium dioxide; iron oxide yellow; magnesium stearate; macrogol 8000; microcrystalline cellulose
Oral
20's, 42's, 100's, 28's, 14's
(S4) Prescription Only Medicine
Clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1. Acute streptococcal pharyngitis 2. Community acquired pneumonia due to Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophilia and Streptococcus pneumoniae 3. Uncomplicated skin and skin structure infections due to Staphylococcus aureus or Streptococcus pyogenes 4. Disseminated or localised mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare and skin and skin structure infections due to Mycobacterium chelonae. Clarithromycin should be used in combination with other antimycobacterial agents. 5. Prevention of disseminated Mycobacterium avium complex infection in HIV-infected adults with CD4 lymphocyte counts < 75 cells/mm3 (see PRECAUTIONS). Disseminated infection due to Mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis 6. Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. 7. Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. Clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1. Acute streptococcal pharyngitis and tonsillitis caused by Streptococcus pyogenes 2. Community acquired pneumonia including infections due to Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila 3. Skin and skin structure infections (e.g. impetigo) 4. Disseminated or localised infections due to Mycobacterium avium or Mycobacterium intracellulare in immunocompromised children, including those with HIV Infection or AIDS. 5. Acute otitis media. Note: 1. Penicillins are the drug of first choice in the treatment of acute otitis media. 2. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. Clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3 There is insufficient evidence of efficacy to support the use of clarithromycin in acute bronchitis in young children. 4. The data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.
Visual Identification: pale yellow, capsule-shaped, film-coated tablets engraved "CLA500" on one side, "APO" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2007-11-22
1 AUSTRALIAN PRODUCT INFORMATION APO- CLARITHROMYCIN (CLARITHROMYCIN) TABLETS 1 NAME OF THE MEDICINE Clarithromycin. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg or 500 mg of clarithromycin as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM 250 MG TABLETS Pale yellow, oval, film-coated tablets engraved “CLA250” on one side, “APO” on the other side. 500 MG TABLETS Pale yellow, capsule-shaped, film-coated tablets engraved “CLA500” on one side, “APO” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Acute streptococcal pharyngitis; Community acquired pneumonia due to _Chlamydia _ _pneumoniae, _ _Mycoplasma _ _pneumoniae, Legionella pneumophila _and _Streptococcus pneumoniae_; (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Uncomplicated skin and skin structure infections due to _ Staphylococcus aureus _ or _Streptococcus pyogenes_; (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Disseminated or localised mycobacterial infections due to _ Mycobacterium avium _ or _Mycobacterium _ _intracellulare _ and skin and skin structure infections due to _Mycobacterium chelonae_. Clarithromycin should be used in combination with other antimycobacterial agents; Prevention of disseminated _Mycobacterium avium _complex infection in HIV-infected adults with CD 4 lymphocyte counts < 75 cells/mm 3 (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Disseminated infection due to _ Mycobacterium avium _ complex should be excluded by a negative blood culture prior to commencement of 2 prophylaxis; Acute bacterial exacerbation of chronic bronchitis due to _ Haemophilus influenzae, _ _Moraxella catarrhalis _or _Streptococcus pneumoni Soma hati kamili