Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
Clarithromycin
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
J01FA09
500 mg
TABLET, EXTENDED RELEASE
Clarithromycin 500 mg
ORAL
Prescription Only
Aesica Queenborough Limited
ACTIVE
1998-07-09
KLACID ® MR 1. NAME OF THE MEDICINAL PRODUCT Clarithromycin 500 mg, Modified-Release Tablets (MR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clarithromycin 500 mg, Modified-Release Tablets: One tablet contains 500 mg Clarithromycin. Excipient: Lactose 115 mg per tablet Tablet sodium content: 15.3 mg per tablet For the full list of excipients, see PHARMACEUTICAL PARTICULARS, LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM FORMULATION PHARMACEUTICAL FORM Clarithromycin MR Tablets Yellow, ovaloid film-coated tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Klacid MR is indicated for treatment of infections caused by susceptible organisms. Indications include: Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia. Upper respiratory tract infections for example, sinusitus and pharyngitis. Klacid MR is also indicated in skin and soft tissue infections of mild to moderate severity, for example folliculitis, cellulitis and erysipelas. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE AND ADMINISTRATION ADULTS: The usual recommended dosage of Klacid MR in adults is one 500mg modified-release tablet daily to be taken with food. In more severe infections, the dosage can be increased to two 500mg modified-release tablets daily. The usual duration of treatment is 7 to 14 days. CHILDREN OLDER THAN 12 YEARS: As for adults. CHILDREN YOUNGER THAN 12 YEARS: Use Klacid Paediatric Suspension. The use of Klacid MR has not been studied in children less than 12 years of age. Klacid MR should not be used in patients with renal impairment (creatinine clearance less than 30 mL/min). Klacid immediate release tablets may be used in this patient population (see SECTION 4.3). Do not crush or Đọc toàn bộ tài liệu
KLACID ® MR 1. NAME OF THE MEDICINAL PRODUCT Clarithromycin 500 mg, Modified-Release Tablets (MR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clarithromycin 500 mg, Modified-Release Tablets: One tablet contains 500 mg Clarithromycin. Excipient: Lactose 115 mg per tablet Tablet sodium content: 15.3 mg per tablet For the full list of excipients, see PHARMACEUTICAL PARTICULARS, List of excipients. 3. PHARMACEUTICAL FORM Formulation Pharmaceutical Form Clarithromycin MR Tablets Yellow, ovaloid film-coated tablet 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Klacid ® MR is indicated for treatment of infections caused by susceptible organisms. Indications include: Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia (see section 4.4 and 5.1 regarding Sensitivity Testing) Upper respiratory tract infections for example, sinusitis and pharyngitis. Klacid ® MR is also indicated in skin and soft tissue infections of mild to moderate severity, for example folliculitis, cellulitis and erysipelas (see section 4.4 and 5.1 regarding Sensitivity Testing). 4.2 Posology and method of administration Dosage and Administration Adults: The usual recommended dosage of Klacid ® MR in adults is one 500mg modified-release tablet daily to be taken with food. In more severe infections, the dosage can be increased to two 500mg modified-release tablets daily. The usual duration of treatment is 7 to 14 days. Children older than 12 years: As for adults. Children younger than 12 years: Use Klacid ® Paediatric Suspension. The use of Klacid ® MR has not been studied in children less than 12 years of age. Klacid ® MR should not be used in patients with renal impairment (creatinine clearance less than 30 mL/min). Klacid ® immediate release tablets may be used in this patient population (see section 4.3). Do not crush or chew Klacid ® MR tablets. Renal Impairment Clarithromycin modified release should not be used in patients with significant renal impairment (creatinine clearance less than 30 ml/mi Đọc toàn bộ tài liệu