KLACID LA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
CLARITHROMYCIN
Available from:
Abbott Laboratories Ireland Ltd
Dosage:
500 Milligram
Pharmaceutical form:
Modified-release Tablets
Authorization date:
1997-03-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid LA 500mg Modified release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Clarithromycin 500 mg
Each tablet contains 115 mg lactose
Each tablet contains 15.3 mg sodium
_For full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Modified release tablet.
Yellow, ovaloid modified-release tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Klacid LA is indicated for treatment of infections caused by susceptible organisms.
Indications include:
Lower respiratory tract infections for example bronchitis and pneumonia.
Upper respiratory tract infections for example sinusitis and pharyngitis.
Skin and soft tissue infections for example folliculitis, cellulitis and erysipelas.
As with other antibiotics, it is recommended that guidelines on the prevalence of local
resistance, and associated medical practice regarding theprescription of antibiotics, be
consulted before prescribing Klacid LA. Klacid LA is indicated in adults and children 12 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: The usual recommended dosage of Klacid LA in adults is one 500 mg modified
-release tablet
daily to be taken with
food.
In more severe infections, the dosage can be increased to two 500 mg modified-release tablets taken as one dose daily.
Dose must be taken at the same time every day.
Tablets must be swallowed whole.
The usual duration of treatment is 6 to 14 days.
CHILDREN OLDER THAN 12 YEARS: As for adults.
CHILDREN YOUNGER THAN 12 YEARS: Clinical trials have been conducted using clarithromycin pediatric suspension in
children 6 months to 12 years of age. Use of Klacid LA is not recommended for children younger than 12 years.
Therefore children under 12 years of age should u
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