- Approval Id
- 3869ca92e86e3b06
- Drug Name
- KLACID IV FOR INJECTION 500 MG/VIAL
- Product Name
- KLACID IV FOR INJECTION 500 MG/VIAL
- Approval Number
- SIN09119P
- Approval Date
- 1997-01-06
- Registrant
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
- Licence Holder
- ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
<strong>Dosage and Administration</strong><br>
Intravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin therapy when appropriate. Klacid® IV should be administered into one of the larger proximal veins as an IV infusion over 60 minutes using a solution concentration of about 2 mg/ml. Clarithromycin should be given as a bolus or an intramuscular injection.</p>
<p><strong>Adults:</strong> The recommended dosage of Klacid® IV in adults 18 years of age or older is 1.0 g daily divided into two 500 mg doses, appropriately diluted as described below.<br>
<strong>Pediatric: </strong>There are insufficient data to recommend a dosage regimen for use of the Klacid® IV formulation in patients less than 18 years of age (see Pediatric Suspension).<br>
<strong>Elderly:</strong> As for adults.</p>
<p><em><strong>Renal Impairment</strong></em><br>
In patients with renal impairment who have creatinine clearance less than 30 ml/min, the dosage of clarithromycin should be reduced to one half of the normal recommended dose.</p>
<p><u>Preparation for Use</u><br>
See <strong>section 6.6</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic Indications</strong><br>
Klacid® I.V. is indicated whenever parenteral therapy is required for treatment of sensitive microorganisms in adults 18 years and older in the following conditions:</p>
<ol>
<li>Upper respiratory tract infections</li>
<li>Lower respiratory tract infections (see <strong>section 4.4 and 5.1</strong> regarding Sensitivity Testing – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Skin and soft tissue infections (see <strong>section 4.4 and 5.1</strong> regarding Sensitivity Testing – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii.</li>
</ol>
<p>Consideration should be given to national official guidance on the appropriate use of antibacterial agents.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong></p>
<ul>
<li>Hypersensitivity to macrolide antibiotic drugs or any of its excipients (see <strong>section 6.1</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</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 <em>torsades de pointes</em> (see <strong>section 4.5</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Concomitant administration of clarithromycin and ergot alkaloids (e.g., ergotamine or dihydroergotamine) is contraindicated, as this may result in ergot toxicity (see <strong>section 4.5</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Concomitant administration of clarithromycin and oral midazolam is contraindicated (see <strong>section 4.5</strong>)</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 <em>torsades de pointes</em> (see <strong>sections 4.4 and 4.5</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</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 <strong>section 4.4</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Clarithromycin (and other strong CYP3A4 inhibitors) should not be used concomitantly with colchicine (see <strong>sections 4.4 and 4.5</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Concomitant administration with ticagrelor or ranolazine is contraindicated.</li>
<li>Concomitant administration of clarithromycin and lomitapide is contraindicated (see <strong>section 4.5</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
- Atc Code
- J01FA09
- Atc Item Name
- clarithromycin
- Pharma Manufacturer Name
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
