CLARITHROMYCIN Coated Tablets 250mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
CLARITHROMYCIN
Available from:
Pliva Pharma Limited
Dosage:
250mg Milligram
Pharmaceutical form:
Coated Tablets
Authorization date:
2006-03-31
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin 250mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg Clarithromycin
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Clarithromycin 250mg tablets are white, oblong, biconvex film-coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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, erysipelas).
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.
The prevention of disseminated _Mycobacterium avium _complex infection in HIV infected patients with CD4
lymphocyte counts less than or equal to 100/mm
3
.
6.
Clarithromycin in the presence of acid suppression is indicated for the eradication of _Helicobacter 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: Helicobacter pylori _is strongly associated with peptic ulcer disease. Ninety to 100% of patients
with duodenal ulcers are infected with this agent. Eradication of _Helicobacter pylori _has been shown to markedly
reduce the need for maintenance anti-secretory therapy.
In a well controlled double-blind study
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