1 vial

$#0

Klacid, Klamycin, Clarac

  • Treatment of infections caused by susceptible organisms

PO:
Clarac 250mg tablets (yellow), Klacid 250mg tablets (yellow), Klamycin 250mg tablets (yellow), Klacid suspension 125mg/5ml

IV:
For initial reconstitution add 10ml of Water for Injection ONLY to a 500mg vial. Dilute the reconstituted solution (500mg/10ml) in at least 250ml of compatible IV fluid. Infuse over 60 minutes.
The initial reconstituted solution is stable for 24 hours when stored at room temperature or refrigerated. The final diluted solution should be used within 6 hours when stored at room temperature or with 24 hours if refrigerated.
Compatible with the following IV fluids:
Normal saline 5% Dextrose Glucose and sodium chloride
Hartmann’s
Do not mix with other medications or IV fluids


ADULT DOSE
PO:
250mg-500mg 12hrly

IV:
500mg 12hrly

PAEDIATRIC DOSE
PO/IV:
7.5-15mg/kg 12 hourly

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY
Dose in renal impairment [GFR (ml/min)]
<10 Oral: 250mg every 12 hours; IV: 250mg every 12 hours
10-20 Oral: 250mg every 12 hrs; IV: 250-500mg every 12 hrs
>20-50 Dose as in normal renal function

Dose in renal replacement therapy
CAPD Oral: 250mg every 12-24 hours; IV: 250mg every 12 hours
HD Oral: 250mg every 12-24 hours; IV: 250mg every 12 hours
CVVHDF Oral: 250mg every 12 hrs; IV: 250-500mg every 12 hrs

Clarithromycin is a semi-synthetic macrolide antibiotic. Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis.

Clarithromycin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections:
Aerobic Gram-Positive Microorganisms:
Staphylococcus aureus
Streptococcus pneumoniae
Streptococcus pyogenes

Aerobic Gram-Negative Microorganisms:
Haemophilus influenzae
Haemophilus parainfluenzae
Moraxella catarrhalis

Other Microorganisms:
Mycoplasma pneumoniae
Chlamydia pneumoniae (TWAR)
Mycobacterium avium complex (MAC) consisting of:
Mycobacterium avium
Mycobacterium intracellulare

CONTRAINDICATIONS:

  • Hypersensitivity to clarithromycin


WARNINGS
Pseudomembranous colitis
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.

PRECAUTIONS
General
Prescribing clarithromycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Laboratory Tests:
No tests in addition to routine ICU tests are required

Drug/Laboratory Test Interactions:
None of note

Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations. Monitoring of serum theophylline concentrations should be considered for patients receiving high doses of theophylline or with baseline concentrations in the upper therapeutic range.


Spontaneous reports in the postmarketing period suggest that concomitant administration of clarithromycin and oral anticoagulants may potentiate the effects of warfarin.

Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have also been reported in postmarketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Serum digoxin concentrations should be carefully monitored while patients are receiving digoxin and clarithromycin simultaneously.

There have been postmarketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency.

As with other macrolides, clarithromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly.
Erythromycin has been reported to increase the systemic exposure (AUC) of sildenafil. A similar interaction may occur with clarithromycin; reduction of sildenafil dosage should be considered.

Body as a whole:
Anaphylaxis
Gastrointestinal system:
Diarrhoea, nausea, abnormal taste, dyspepsia, abdominal pain/discomfort, cholestasis, hepatitis
Haematological system:
Thrombocytopaenia, leukopaenia, neutropaenia

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