Loading…
CLARITHROMYCIN is a brand name for Clarithromycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Clarithromycin 250 mg/5 ml suspension is indicated in adults, adolescents and children, 6 months to 12 years, for the treatment of the following acute and chronic infections, when caused by clarithromycin susceptible organisms. • Infections of the upper respiratory tract such as tonsillitis/pharyngitis, as an…
Verbatim from this product's MHRA label. Tap a section to expand.
2. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 2 Posology and method of administration The dosage of Clarithromycin 250 mg/5 ml suspension depends on the clinical condition of the patient and has to be defined in any case by the physician.
Adults and adolescents:
Standard dosage: The usual dose is 250 mg twice daily.
High dosage treatment (severe infections):
The usual dose may be increased to 500 mg twice daily in severe infections.
Elimination of Helicobacter pylori in adults:
In patients with gastro-duodenal ulcers due to H. pylori infection clarithromycin as part of the first line triple therapy is given in a dosage of 500 mg twice daily. The national recommendations for Helicobacter pylori eradication have to be considered.
Dosage in patients with renal impairment:
The maximum recommended dosages should be reduced proportionately to renal impairment. At creatinine clearance rate of less than 30 ml/min, the dosage should be halved to 250 mg daily or in the most severe infections to 250 mg twice daily.
The duration of treatment should not exceed 14 days in these patients. 5 mg/kg twice a day. 75 ml twice daily 30 – 40 kg 8 – 12 years 5 ml twice daily Children weighing less than 8 kg should be treated based on their bodyweight. 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 (granules for oral suspension). There is limited experience of treatment of children below 6 months of age. For the indication community acquired pneumonia effect in children under 3 years of age is not documented.
e. 5 mg/kg once a day, and the duration of treatment should not exceed 14 days.
Duration of therapy:
The duration of therapy with Clarithromycin 250 mg/5 ml suspension depends on the clinical condition of the patient. The duration of therapy has in any case to be determined by the physician. • The usual duration of treatment of children up to 12 years of age is 5 to 10 days.
a. Summary of the safety profile The most frequent and common adverse reactions related to clarithromycin therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting and taste perversion. 8). There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without preexisting mycobacterial infections.
b. Tabulated summary of adverse reactions The following section displays adverse reactions reported in clinical trials and from post- marketing experience with all clarithromycin formulations (granules for oral suspension, film- coated tablets and prolonged release tablets).
The reactions considered at least possibly related to clarithromycin are displayed by system organ class and frequency using the following convention: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100) and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness when the seriousness could be assessed. g. acute generalised exanthematous pustulosis (AGEP))Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), acne, Musculoskeletal, connective tissue and bone disorders Uncommon:Muscle spasms3, musculoskeletal stiffness1, myalgia2 Not known*: Rhabdomyolysis2,6, myopathy Renal and urinary disorders Uncommon: Blood creatinine increased1, blood urea increased1 Not known*: Renal failure, interstitial nephritis.
General disorders and administration site conditions Very common:
Injection site phlebitis1 Common: Injection site pain1, injection site inflammation1 Uncommon: Malaise4, pyrexia3, asthenia, chest pain4, chills4, fatigue4 Investigations Uncommon: Albumin globulin ratio abnormal1, blood alkaline phosphatase increased4, blood lactate dehydrogenase increased4.
6). 2). Clarithromycin is principally metabolized by the liver. Therefore, caution should be exercised 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.
Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible.
8) have been reported. Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products. Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop, such as anorexia, jaundice, dark urine, pruritus, or tender abdomen.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. Clostridium difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents including clarithromycin, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon, which may lead to overgrowth of C. difficile. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Therefore, discontinuation of clarithromycin therapy should be considered regardless of the indication. Microbial testing should be performed and adequate treatment initiated. Drugs inhibiting peristalsis should be avoided. There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency.
1. 5). Concomitant administration with ticagrelor, ivabradine or ranolazine is contraindicated. g. 5). 5). 5). 5). Clarithromycin should not be given to patients with electrolyte disturbances (hypokalaemia or hypomagnesaemia, due to the risk of prolongation of the QT interval) 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. 5). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Clarithromycin in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
• The usual duration of treatment of adults and adolescents is 6 to 14 days. • Therapy should be continued at least for 2 days after symptoms have subsided. • In streptococcus pyogenes (as a beta-haemolytic streptococcal) infections the duration of therapy should be at least 10 days.
• Combination therapy for the eradication of H. g. clarithromycin 500 mg twice daily in combination with amoxicillin 1000 mg twice daily and omeprazole 20 mg twice daily should be continued for 7 days. 6. For administration after reconstitution an oral PE/PP-measuring syringe or a PP-measuring spoon are used.
Granules of the oral suspension can cause a bitter aftertaste when remaining in the mouth. This can be avoided by eating or drinking something immediately after the intake of the suspension Clarithromycin may be given irrespective of food intake.
Food does not affect the extent of bioavailability. Food does only slightly delay the onset of absorption of clarithromycin.
Not known*:
International normalised ratio increased#, prothrombin time prolonged#, urine colour abnormal 1 ADRs reported only for the powder for solution for injection formulation 2 ADRs reported only for the extended release tablet formulation 3 ADRs reported only for the granules for oral suspension formulation 4 ADRs reported only for the immediate-release tablet formulation 5,6 See description of selected adverse reactions * Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to medicinal product exposure.
Patient exposure is estimated to be greater than 1 billion patient treatment days for clarithromycin. c. 4). g. somnolence and confusion) with the concomitant use of clarithromycin and triazolam. 5).
Special population:
Adverse Reactions in Immunocompromised Patients (see section e) d. Paediatric populations Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric suspension.
Frequency, type and […]
5). 3). 5). Caution is advised regarding concomitant administration of clarithromycin with other ototoxic drugs, especially with aminoglycosides. Monitoring of vestibular and auditory function should be carried out during and after treatment.
8). Therefore as the following situations may lead to an increased risk for ventricular arrhythmias (including torsade de pointes), clarithromycin should be used with caution in the following patients: • Patients with coronary artery disease, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia • Patients with electrolyte disturbances.
3). 5). 3). 3). Epidemiological studies investigating the risk of adverse cardiovascular outcomes with macrolides have shown variable results. Some observational studies have identified a rare short term risk of arrhythmia, myocardial infarction and cardiovascular mortality associated with macrolides including clarithromycin.
Consideration of these findings should be balanced with treatment benefits when prescribing clarithromycin.
Pneumonia:
In view of the emerging resistance of Streptococcus pneumoniae to macrolides, it is important that sensitivity testing be performed when prescribing clarithromycin for community-acquired pneumonia. In hospital-acquired pneumonia, clarithromycin should be used in combination with additional appropriate antibiotics.
Skin and soft tissue infections of mild to moderate severity:
These infections are most often caused by Staphylococcus aureus and Streptococcus pyogenes, both of which may be resistant to macrolides. Therefore, it is important that sensitivity testing be performed. g. allergy), other antibiotics, such as clindamycin, may be the drug of first choice.
Currently, macrolides are only considered to play a role in some skin and soft tissue infections, such as those caused by Corynebacterium minutissimum, acne vulgaris, and erysipelas and in situations where penicillin treatment cannot be used.
g. Acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome, toxic epidermal necrolysis and drug rash with eosinophilia and systemic symptoms (DRESS)), clarithromycin therapy should be discontinued immediately and appropriate treatment should be urgently initiated.
5). HMG-CoA Reductase Inhibitors (statins): […]