Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Pinewood Laboratories Ltd,
250 Milligram
Coated Tablets
2006-05-19
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Claryl 250mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Film-coated tablet contains 250 mg of clarithromycin For excipients, see 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, oval, biconvex marked with `250` on one side and ‘CL’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin is indicated for the treatment of infections due to susceptible organisms. Such infections include:- 1. Lower respiratory tract infections (e.g. bronchitis, pneumonia). 2. Upper respiratory tract infections (e.g. pharyngitis, sinusitis). 3. Skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipalis). 4. Disseminated or localised mycobacterial infections due to _Mycobacterium avium _or _Mycobacterium_ _intracellulare_. Localised infections due to _Mycobacterium chelonae_, _Mycobacterium fortuitum _or _Mycobacterium kansasii_. 5. Clarithromycin is indicated for the prevention of disseminated _Mycobacterium avium complex _infection in HIV - infected patients with CD4 lymphocyte counts less than or equal to 100/mm³. 6. Clarithromycin in the presence of acid suppression is indicated for the eradication of _H. pylori_, resulting in decreased recurrence of duodenal ulcer. (See further information). As with other antibiotics, it is recommended that guidelines on the prevalence of local resistance, and associated medical practice regarding the prescription of antibiotics, be consulted before prescribing clarithromycin. Further Information: _H. pylori _is strongly associated with peptic ulcer disease. 90 to 100% of patients with duodenal ulcers are infected with this agent. Eradication of _H. pylori _has been shown to markedly reduce the rate of duodenal ulcer recurrence, there Read the complete document