Clarithromycin 250mg/5ml Oral Suspension
Each 5 ml of the constituted suspension contains clarithromycin 250 mg
Excipients with known effect
Each 5ml constituted suspension contains:
2508.00mg of sucrose
20mg of aspartame
For the full list of excipients, see section 6.1
Granules for oral suspension
White to off-white granular powder forming white to off-white suspension on reconstitution with water.
Clarithromycin 125mg/5ml Oral Suspension is indicated in children, 6 months to 12 years.
Clarithromycin 125mg/5ml Oral Suspension is indicated for treatment of the following infections in children when caused by clarithromycin-susceptible organisms:
- Lower respiratory tract infections.
- Upper respiratory tract infections.
- Skin and skin structure infections.
- Acute otitis media.
Clarithromycin 125mg/5ml Oral Suspension is usually active against the following organisms in vitro:
Gram-positive Bacteria: Staphylococcus aureus (methicillin susceptible); Streptococcus pyogenes (Group A beta-haemolytic streptococci); alpha-haemolytic streptococci (viridans group); Streptococcus (Diplococcus) pneumoniae; Streptococcus agalactiae; Listeria monocytogenes.
Gram-negative Bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae; Legionella pneumophila, Bordetella pertussis, Helicobacter pylori; Campylobacter jejuni.
Mycoplasma: Mycoplasma pneumoniae; Ureaplasma urealyticum.
Other Organisms: Chlamydia trachomatis; Mycobacterium avium; Mycobacterium leprae; Chlamydia pneumoniae.
Anaerobes: Macrolide-susceptible Bacteroides fragilis; Clostridium perfringens; Peptococcus species; Peptostreptococcus species; Propionibacterium acnes.
Clarithromycin 125mg/5ml Oral Suspension has bactericidal activity against several bacterial strains. These organisms include H. influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, Helicobacter pylori and Campylobacter species.
The activity of clarithromycin against H. pylori is greater at neutral pH than at acid pH.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
The dosage of clarithromycin depends on the clinical condition of the patient and has to be defined in any case by the physician.
Clinical trials have been conducted using clarithromycin pediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin pediatric suspension (Clarithromycin granules for oral suspension). The use of clarithromycin (tablet/I.V) is not recommended for children under 12 years of age.
Clarithromycin 250mg/5ml Oral Suspension
The usual duration of treatment is 5 to 10 days depending on the pathogen involved and the severity of the condition.
The recommended daily dose of Clarithromycin 250mg/ 5ml Oral Suspension in children is given in the following table and is based on an approximate 7.5mg/ kg twice daily dosing regimen. Doses up to 500 mg twice daily have been used in the treatment of severe infections.
For some children, depending on body weight, it may be more appropriate to administer the 250mg/ 5ml oral suspension.
Clarithromycin 250mg/ 5ml Oral Suspension dosage in children
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Dosage based on body weight (kg)
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Weight (kg)*
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Approximate age in years
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Dose in mg of clarithromycin to be given twice daily
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Dose in ml of 125 mg/ 5 ml oral suspension to be given twice daily by pipette***
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Dosage per 5ml teaspoonful twice daily
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|
8 - 11
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1 - 2
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62.5
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1.25**
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1/4
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12 - 19
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3 - 6
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125
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2.5
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1/2
|
|
20 - 29
|
7 - 9
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187.5
|
3.75**
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3/4**
|
|
30 - 40
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10 - 12
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250
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5.0
|
1
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*children < 8 kg should be dosed based on a per kg basis (approx. 7.5 mg/ kg twice daily)
**in order to avoid the need to estimate quarter teaspoonfuls, it is recommended that the 125mg/ 5ml oral suspension is used for children in these weight bands (please consult the prescribing information for the 125mg/ 5ml oral suspension for details).
*** A graduated syringe is provided with the bottle for use as a pipette. This enables more accurate dosing than the 5 ml spoon (also provided with the bottle) when fractions of a spoonful are needed to achieve the right dose
Patients with renal and hepatic insufficiency
Clarithromycin should not be administered to paediatric patients with severe hepatic or renal insufficiency. Caution is required when administering clarithromycin to children with lesser degrees of renal or hepatic insufficiency.
Method of Administration
Clarithromycin 250mg/5 ml Oral Suspension may be given without regard to meals, as food does not affect the extent of bioavailability.
Clarithromycin 250mg/5 ml Oral Suspension should be administered twice daily as recommended in the table above. The doses should be given at 12-hour intervals.
Clarithromycin oral suspension can cause a bitter after-taste. This can be avoided by drinking juice or water soon after intake of the suspension.
Clarithromycin is contraindicated in patients with known hypersensitivity to clarithromycin, to other macrolide antibiotic drugs or to any of its excipients (see section 6.1).
Concomitant administration of Clarithromycin and ergot derivatives (ergotamine or dihydroergotamine) is contraindicated, as this may result in ergot toxicity (see section 4.5).
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 pointe (see section 4.5).
Clarithromycin should not be given in patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia including torsades de pointe (see sections 4.4 and 4.5).
Concomitant administration with ticagrelor or ranolazine is contraindicated
Clarithromycin should not be given to patients with hypokalaemia (risk of prolongation of QT-time).
Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin) or atorvastatin, due to the increased risk of myopathy, including rhabdomyolysis.
Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment.
As with other strong CYP3A4 inhibitors, Clarithromycin should not be used in patients taking colchicine.
The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy (see section 4.6).
Clarithromycin is mainly excreted by the liver. Therefore, caution should be taken in administering clarithromycin to patients with impaired hepatic function. Caution should also be exercised when administering clarithromycin to patients with moderate to severe renal impairment.
Cases of fatal hepatic failure (see section 4.8) have been reported. Some patients may have had pre-existing hepatic disea
