KLACID MR TABLET 500 MG

AESICA QUEENBOROUGH LIMITED - UNITED KINGDOMABBVIE S.R.L. (ITALY)🇸🇬 Health Sciences Authority

Approval Date: Jul 9, 1998
Approval ID: aa08938429df3729
Company: AESICA QUEENBOROUGH LIMITED - UNITED KINGDOMABBVIE S.R.L. (ITALY)
Type: Therapeutic

Approval Details

Approval Id: aa08938429df3729
Drug Name: KLACID MR TABLET 500 MG
Product Name: KLACID MR TABLET 500 MG
Approval Number: SIN09884P
Approval Date: 1998-07-09
Registrant: ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Licence Holder: ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, EXTENDED RELEASE
Dosage: 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/min), as appropriate clarithromycin dosage reduction is not possible when administering this product. Clarithromycin immediate release tablets may be utilized in this patient population (see section 4.3). Refer the dosing for immediate release formulation.
Route Of Administration: ORAL
Indication Info: 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Contraindications: 4.3. Contraindications <ul class="bullet"> <li>Hypersensitivity to macrolide antibiotic drugs or any of its excipients (see section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Concomitant administration of clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide, terfenadine as this may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, and torsades de pointes (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Concomitant administration of clarithromycin and ergot alkaloids (e.g., ergotamine or dihydroergotamine) is contraindicated, as this may result in ergot toxicity (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Concomitant administration of clarithromycin and oral midazolam is contraindicated (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)</li> <li>Clarithromycin should not be given to patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Clarithromycin should not be given to patients with electrolyte disturbances (hypokalemia or hypomagnesaemia, due to the risk of prolongation of the QT-interval).</li> <li>Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment.</li> <li>Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Clarithromycin (and other strong CYP3A4 inhibitors) should not be used concomitantly with colchicine (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>As the dose cannot be reduced from 500 mg once-daily, clarithromycin modified release is contraindicated in patients with creatinine clearance less than 30 mL/min. Clarithromycin immediate release tablets may be utilized in this patient population.</li> <li>Concomitant administration with ticagrelor, ivabradine or ranolazine is contraindicated.</li> <li>Concomitant administration of clarithromycin and lomitapide is contraindicated (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul>
Atc Code: J01FA09
Atc Item Name: clarithromycin
Pharma Manufacturer Name: ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Company Detail Path: /organization/abbott-laboratories-singapore-private-limited

Active Ingredients

Clarithromycin

500 mg

Clarithromycin

500 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jul 9, 1998

Approval ID

aa08938429df3729

Type

Therapeutic

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