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CLARITHROMYCIN is a brand name for Clarithromycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Clarithromycin film-coated tablets is indicated in adults and adolescents 12 years and older for the treatment of the following bacterial infections, when caused by clarithromycin-susceptible bacteria (see section 4.4 and 5.1). • Acute bacterial exacerbation of chronic bronchitis • Mild to moderate community acquired…
Verbatim from this product's MHRA label. Tap a section to expand.
The dosage of Clarithromycin film-coated Tablets depends on the clinical condition of the patient and has to be defined in any case by the physician.
Children older than 12 years and adults: • 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. • 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).
Elimination of Helicobacter pylori in adults:
In patients with gastro-duodenal ulcers due to H. pylori infection clarithromycin can be used in a dose of 500 mg twice daily during the eradication therapy in combination with amoxicillin 1000 mg twice daily and omeprazole 20 mg twice daily*.
Dosage in patients with renal impairment:
The maximum recommended dosages should be reduced proportionately to renal impairment. e. 250 mg once daily, or 250 mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients.
Duration of therapy:
The duration of therapy with Clarithromycin film-coated Tablets 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 is 6 to 14 days.
• 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 (two 250 mg tablets or one 500 mg tablet) twice daily in combination with amoxicillin 1000 mg twice daily and omeprazole 20 mg twice daily should be continued for 7 days*.
Method of administration:
Clarithromycin film-coated tablets 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 and formation of the 14- hydroxy metabolite.
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 table displays adverse reactions reported in clinical trials and from post-marketing experience with clarithromycin immediate-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.
Infections and infestations Uncommon:
Cellulitis1, candidiasis, gastroenteritis2, infection3, vaginal infection Not known: Pseudomembranous colitis, erysipelas Blood and the lymphatic system disorders Uncommon: Leukopenia, neutropenia4, eosinophilia4 Not known: Agranulocytosis, thrombocytopenia Immune system disorders* Uncommon: Anaphylactoid reaction1, hypersensitivity Not known: Anaphylactic reaction, angioedema Metabolism and nutrition disorders Uncommon: Anorexia, decreased appetite Psychiatric disorders Common: Insomnia Uncommon: Anxiety, nervousness3 Not known: Psychotic disorder, confusional state5, depersonalisation, depression, disorientation, hallucination, abnormal dreams, mania Nervous system disorders Common: Dysgeusia, headache, taste perversion Uncommon: Loss of consciousness1, dyskinesia1, dizziness, somnolence5, tremor Not known*: Convulsion, ageusia, parosmia, anosmia , paraesthesia Ear and labyrinth disorders Uncommon: Vertigo, impaired hearing, tinnitus Not known*: deafness Cardiac disorders Uncommon: Cardiac arrest1, atrial fibrillation1, electrocardiogram QT prolonged Not known: Torsade de Pointes*, ventricular tachycardia*, ventricular fibrillation Vascular disorders Common: Vasodilation1 Not known*: Hemorrhage# Respiratory, thoracic and mediastinal disorders Uncommon: Asthma1, epistaxis2, pulmonary embolism1 Gastrointestinal disorders Common: Diarrhea*, vomiting, abdominal pain, nausea, dyspepsia, Uncommon: Oesophagitis1, gastroesophageal reflux disease2, gastritis, stomatitis, glossitis, abdominal distension4, abdominal distension, constipation, dry mouth, eructation, flatulence, Not known*: Pancreatitis, tongue discolouration, tooth discoloration Hepato-biliary disorders Common: Liver function test abnormal Uncommon: Cholestasis4, hepatitis4, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased4 Not known: Hepatic failure*, jaundice hepatocellular Skin and subcutaneous tissue disorders Common: Rash, hyperhidrosis Uncommon: Dermatitis bullous1, pruritus, urticaria, rash maculo-papular3 Not known: Stevens-Johnson syndrome*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS), acne, severe cutaneous adverse reactions (SCAR) (eg: acute generalised exanthematous pustulosis (AGEP) 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 Not known: International normalised ratio increased#, prolongation of prothrombin time#, urine color abnormal 1 ADRs reported only for the powder for solution for injection formulation 2 ADRs reported only for the extended-release tablets formulation 3 ADRs reported only for the granules for oral suspension formulation 4 ADRs reported only for the immediate-release tablets 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.
6). 2). Clarithromycin is principally excreted by the liver. Therefore, caution should be exercised in administering the antibiotic 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.
In some instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications. Discontinue clarithromycin immediately if signs and symptoms of hepatitis occur, such as anorexia, jaundice, dark urine, pruritus, or tender abdomen.
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.
1. * according the publication in Gastroenterology. 5). Concomitant administration with ticagrelor, ivabradine or ranolazine is contraindicated. g. ergotamine or dihydroergotamine is contraindicated, as this may result in ergot toxicity.
5). 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.
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.
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Patient exposure is estimated to be greater than 1 billion patient treatment days for clarithromycin. c. Description of selected adverse reactions Injection site phlebitis, injection site pain, vessel puncture site pain, and injection site inflammation are specific to the clarithromycin intravenous formulation.
4). g. somnolence and confusion) with the concomitant use of clarithromycin and triazolam. 5). There have been rare reports of clarithromycin ER tablets in the stool, many of which have occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times.
In several reports, tablet residues have occurred in the context of diarrhea. It is […]
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.
5). 3). 5). 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.
Clarithromycin should be used with caution when administered concurrently with medications that induce the […]