Based on variable results obtained from animal studies, and experience in humans, the possibility of adverse effects on embryofoetal development cannot be excluded. In cases where betalactam antibiotics cannot be used (e.g. No dose adjustment is required when the two drugs are co-administered for a limited time at the doses/formulations studied. In situations where the concomitant use of clarithromycin with statins cannot be avoided, it is recommended to prescribe the lowest registered dose of the statin. Use of antimicrobial therapy, such as Clarithromycin to treat H. pylori infection may select for drug-resistant organisms. A variety of combination protocols have been used in the treatment of. Concomitant administration of oral midazolam and clarithromycin should be avoided. In both dogs and cats, the usual dose is 5 to 10 milligram per pound (10 to 20 milligram/kilogram) every eight to 12 hours orally. An essentially complete inhibition of the formation of 14-OH-clarithromycin was noted. Clarithromycin is rapidly and extensively metabolised in the liver. Clarithromycin should not be given to 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). Clarithromycin gives good penetration into different compartments. HMG-CoA Reductase Inhibitors (statins): Concomitant use of clarithromycin with lovastatin or simvastatin is contraindicated (see section 4.3). Furthermore, in patients with persistent infection, potential development of secondary resistance (in patients with primary susceptible strains) to an antimicrobial agent should be taken into the considerations for a new treatment regimen. Deaths have been reported in some such patients (see section 4.5). This may result in sub-therapeutic levels of clarithromycin leading to reduced efficacy. The following medications should be used with caution when given with clarithromycin:alfentanil, alprazolam, amlodipine, bromocriptine, buspirone, carbamazepine, chemotherapy agents, cyclosporine, digoxin, diltiazem, disopyramide, drugs that prolong the QTc interval, fluconazole, ketoconazole, lincomycin, methylprednisolone, midazolam, omeprazole, opioids, quinidine, rifabutin, rifampin, sildenafil, tacrolimus, theophylline, or warfarin, zidovudine. Acute bacterial exacerbation of chronic bronchitis. Susceptibility and resistance of Streptococcus pneumoniae and Streptococcus spp. Plasma concentrations of clarithromycin as well as calcium channel blockers may increase due to the interaction. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). Concomitant use of clarithromycin with lovastatin or simvastatin is contraindicated (see 4.3) as these statins are extensively metabolized by CYP3A4 and concomitant treatment with clarithromycin increases their plasma concentration, which increases the risk of myopathy, including rhabdomyolysis. The 250mg tablets should be stored at room temperature between 59F and 86F (15C and 30C) in a tightly closed container and away from light. Similar effects have been observed with concomitant administration of astemizole and other macrolides. A pharmacokinetic study demonstrated that the concomitant administration of ritonavir 200 mg every eight hours and Clarithromycin 500 mg every 12 hours resulted in a marked inhibition of the metabolism of clarithromycin. If they are not available, follow their directions in contacting an emergency facility. Monitoring the patient for increased CNS pharmacological effects is suggested (see section 4.5). Pharmaceutical particulars 7. The safety of clarithromycin for use during pregnancy has not been established. rats, one study in New Zealand white rabbits and one study in cynomolgus monkeys failed to demonstrate any teratogenicity from clarithromycin. It allows continued monitoring of the benefit/risk balance of the medicinal product. An oral toxicity study was conducted in which immature rats were administered a clarithromycin suspension (granules for suspension) for 6 weeks at daily dosages of 0, 15, 50 and 150 mg base/kg/day. Primary literature, scientific standard literature and therapeutic recommendations assume susceptibility. Results of clinical studies indicate that there was a modest but statistically significant (p 0.05) increase of circulating theophylline or carbamazepine levels when either of these drugs were administered concomitantly with clarithromycin. Monitoring the patient for increased CNS pharmacological effects is suggested. being able to get an erection, but not having it last long enough for sex. Renal insufficiency increases clarithromycin levels in plasma, if the dose is not decreased. 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*. 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. Uncommon: electrocardiogram QT prolonged#, Not known: Torsade de Pointes#, ventricular tachycardia#, ventricular fibrillation. alprazolam, midazolam, triazolam). The drug is safe to use in dogs, cats, and horses. Effect of clarithromycin on other medicinal products. Caution should be exercised when clarithromycin is co-administered with these agents particularly to patients at high risk of bleeding (see section 4.4). Human: 250 mg & 500 mg regular and long-acting tablets; 125 mg/5 mL (25 mg/mL) & 250 mg/5 mL (50 mg/mL) powder to make oral suspension. The minimum inhibitory concentrations (MICs) of clarithromycin, are generally two-fold lower than the MICs of erythromycin. The following drugs are known or suspected to affect circulating concentrations of clarithromycin; clarithromycin dosage adjustment or consideration of alternative treatments may be required. There have been post-marketing reports of drug interactions and central nervous system (CNS) effects (e.g. Concomitant administration of clarithromycin (500 mg twice daily) and saquinavir (soft gelatin capsules, 1200 mg three times daily) to 12 healthy volunteers resulted in steady-state AUC and Cmax values of saquinavir which were 177% and 187% higher than those seen with saquinavir alone. Hepatotoxicity was detectable by early elevations of liver function tests. Pre-weaning rats (5 days old) were administered a clarithromycin suspension formulation for two weeks at doses of 0, 15, 55 and 200 mg/kg/day. )), New Zealand White rabbits and cynomolgus monkeys failed to demonstrate any teratogenicity from clarithromycin. Patients concomitantly taking other medicinal products associated with QT prolongation (see section 4.5). Drug delivery of midazolam via oromucosal route, which could bypass pre-systemic elimination of the drug, will likely result in a similar interaction to that observed after intravenous midazolam rather than oral administration. Clarithromycin is an antibiotic belonging to the macrolide antibiotic group. However, for patients with renal impairment, the following dosage adjustments should be considered: For patients with CLCR 30 to 60 mL/min the dose of clarithromycin should be reduced by 50%. The 14-hydroxy metabolite of clarithromycin, a product of parent drug metabolism also has antimicrobial activity. and i.v. should not. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness when the seriousness could be assessed. Clinical trials have been conducted using clarithromycin pediatric suspension in children 6 months to 12 years of age. It exerts its antibacterial action by selectively binding to the 50s ribosomal sub-unit of susceptible bacteria preventing translocation of activated amino acids. In this case is recommended to use Clarithromycin Film-Coated Tablets containing 250 mg of clarithromycin per tablet. Long-term use may, as with other antibiotics, result in colonization with increased numbers of non-susceptible bacteria and fungi. Pneumonia: Due to the emerging resistance of Streptococcus pneumoniae to macrolides it is important that sensitivity testing be performed when prescribing clarithromycin for community-acquired pneumonia. Clarithromycin film-coated tablets can also be used in appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing agent for the eradication of Helicobacter pylori in patients with Helicobacter pylori associated ulcers (see section 4.2). Class of drug Macrolide antibiotic. Therefore, discontinuation of clarithromycin therapy should be considered regardless of the indication. Monitor your pet at home for serious side effects. Date of first authorisation/renewal of the authorisation 10. After oral administration of radioactive clarithromycin 70 - 80% of the radioactivity was found in the faeces. Use of any antimicrobial therapy, such as clarithromycin, to treat H. pylori infection may select for drug-resistant organisms. and Spraque-Dawley (p.o. Drugs inhibiting peristalsis should be avoided. Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have also been reported in post marketing surveillance. Clarithromycin 250 mg/5 ml Oral Suspension should be administered twice daily as recommended in the table above. In both mice and rats, body weight was reduced or its increase suppressed and suckling behaviour and spontaneous movements were depressed for the first few days following drug administration. Clarithromycin belongs to the class of medicines, known as macrolide antibiotics. Drugs that are inducers of CYP3A (e.g. Already have a myVCA account? Core: croscarmellose sodium, microcrystalline cellulose, povidone, magnesium stearate, colloidal anhydrous silica, talc. In one study in 14 healthy volunteers, the concomitant administration of clarithromycin and terfenadine resulted in a two to three fold increase in the serum level of the acid metabolite of terfenadine and in prolongation of the QT interval which did not lead to any clinically detectable effect. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Keep the bottle tightly closed. The 500mg tablets should be stored at room temperature between 68F and 77F (20C and 25C) in a tightly closed container. Pharmacological properties 6. Clarithromycin should not be given to 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). Rania Gollakner, BS, DVM, MPH, Contributors: Rania Gollakner, BS, DVM, MPH. Clarithromycin 250mg/5ml Oral Suspension is indicated for treatment of the following infections in children when caused by clarithromycin-susceptible organisms: - Lower respiratory tract infections (e.g. Observations from drug interaction studies using the soft gelatin capsule formulation may not be representative of the effects seen using the saquinavir hard gelatin capsule. Vetstream Ltd Synonym (s): Kalricid Uses Administration Precautions Introduction Name Clarithromycin. Strong inducers of the cytochrome P450 metabolism system such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine may accelerate the metabolism of clarithromycin and thus lower the plasma levels of clarithromycin, while increasing those of 14-OH-clarithromycin, a metabolite that is also microbiologically active. Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsade de pointes, have been seen in treatment with macrolides including clarithromycin (see section 4.8). Marketing authorisation number (s) 9. Ranbaxy (UK) Limited a Sun Pharmaceutical Company, This information is for use by healthcare professionals, 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, UK. The safety of clarithromycin for use during breast feeding of infants has not been established. Most strains of Enterobacteriaceae (Pseudomonas, Escherichia coli, Klebsiella) are resistant. Slightly higher incidences of abnormal values were noted for patients who received 4000 mg daily for all parameters except White Blood Cell. Concomitant administration with ticagrelor or ranolazine is contraindicated. Both clarithromycin and itraconazole are substrates and inhibitors of CYP3A, leading to a bidirectional drug interaction. Hence, local information on the prevalence of resistance and local therapeutic guidelines should be taken into account in the choice of an appropriate combination regimen for H. pylori eradication therapy. Patients should be monitored for signs and symptoms of myopathy. Concomitant administration with ticagrelor or ranolazine is contraindicated. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. bronchitis, pneumonia) see section 4.4 and 5.1 regarding Sensitivity Testing). If you would like to receive a complimentary trial across your entire clinic/practice/team, please complete the practice form opposite and submit then a member of our team will be in touch to arrange this for you. Efavirenz, nevirapine, rifampicin, rifabutin and rifapentine. This medication should take effect within 1 to 2 hours, and while effects may not be visibly obvious, gradual improvements are usually noticeable after a few days. Clarithromycin may not mix well with some complementary and herbal remedies. Active against Gram-positive cocci (some Staphylococcus spp. Both clarithromycin and itraconazole are substrates and inhibitors of CYP3A, leading to a bidirectional drug interaction. Visual impairment and vision blurred may have an effect on a patient's ability to drive or operate machinery (see section 4.8). Diarrhea, vomiting, and appetite changes are possible. The 14-hydroxy metabolite of clarithromycin also has antimicrobial activity. Reports of rhabdomyolysis have been received for patients taking clarithromycin concomitantly with these statins. Careful monitoring of glucose is recommended (see section 4.5). In adult patients, the most frequently reported adverse reactions by patients treated with total daily doses of 1000 mg and 2000 mg of clarithromycin were: nausea, vomiting, taste perversion, abdominal pain, diarrhea, rash, flatulence, headache, constipation, hearing disturbance, Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvate Transaminase (SGPT) elevations. In situations where the concomitant use of clarithromycin with statins cannot be avoided, it is recommended to prescribe the lowest registered dose of the statin. However, this medicine will not work for colds, flu, or other virus infections. Clarithromycin AUC and Cmax values were approximately 40% higher than those seen with clarithromycin alone. . Each tablet contains 250 mg or 500 mg of the active ingredient Clarithromycin. Concomitant administration of clarithromycin with astemizole, cisapride, pimozide and terfenadine is contraindicated (see section 4.3). The following drugs are known or suspected to affect circulating concentrations of clarithromycin; clarithromycin dosage adjustment or consideration of alternative treatments may be required. Is 500 mg of clarithromycin a lot? amoxicillin or metronidazole and e.g. There is no specific antidote on overdose. The dosage of clarithromycin depends on the clinical condition of the patient and has to be defined in any case by the physician. Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV infected adult patients may result in decreased steady-state zidovudine concentrations. Methicillin-resistant and oxacillin-resistant staphylococci (MRSA) and penicillin-resistant Streptococcus pneumoniae are resistant to all currently available Beta-lactam antibiotics and macrolides such as clarithromycin. Caution is advised regarding concomitant administration of clarithromycin and triazolobenzodiazepines, such as triazolam, and midazolam (see section 4.5). Can I give my dog my antibiotics? Microbial testing should be performed and adequate treatment initiated. Food does only slightly delay the onset of absorption of clarithromycin and formation of the 14-hydroxy metabolite. Respiratory tract, skin and soft tissues infections, acute otitis media. There have been post-marketing reports of drug interactions and central nervous system (CNS) effects (e.g. Clarithromycin should not be administered to paediatric patients with severe hepatic or renal insufficiency. in dogs at doses 3 times, and in monkeys at doses 8 times greater than the maximum human daily dose (on a . Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. allergy), other antibiotics, such as clindamycin, may be the drug of first choice. Clarithromycin is principally excreted by the liver. Required quantity of water should be added to the granules in the bottle and shaken well. Clarithromycin immediate-release tablets are available as 250mg and 500mg strengths. Use of a statin that is not dependent on CYP3A metabolism (e.g. Concomitant administration of fluconazole 200 mg daily and clarithromycin 500 mg twice daily to 21 healthy volunteers led to increases in the mean steady-state minimum clarithromycin concentration (Cmin) and area under the curve (AUC) of 33% and 18% respectively. There have been postmarketing reports of torsades de pointes occurring with concurrent use of clarithromycin and quinidine or disopyramide. Date of revision of the text Species for which acquired resistance may be a problem, Aerobic Gram-positive micro-organisms: Staphylococcus aureus (Methicillin-resistant) +, Aerobic Gram-negative micro-organisms Escherichia coli; Klebsiella spp. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Patients taking oral contraceptives should be warned that if diarrhoea, vomiting or breakthrough bleeding occur there is a possibility of contraceptive failure. Therefore, caution should be taken in administering clarithromycin to patients with impaired hepatic function. It is unknown if there are rare effects in pets, but in humans, rare effects such as liver problems, decreased platelets (the blood cells involvedin blood clotting), and allergic reactions have occurred. Careful monitoring of glucose is recommended (see section 4.5). Rivaroxaban and apixaban are metabolised via CYP3A4 and are also substrates for P-gp. 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. When saquinavir is co-administered with ritonavir, consideration should be given to the potential effects of ritonavir on clarithromycin (see section 4.5 Ritonavir). Therefore caution is required when prescribing clarithromycin for such patients. 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. Patients concomitantly taking other medicinal products associated with QT-prolongation (see section 4.5). Who may not be able to take clarithromycin. For patients with creatinine clearance <30 mL/min, the dose of clarithromycin should be decreased by 75% using an appropriate clarithromycin formulation. Date of revision of the text The major clinical signs at toxic doses included emesis, weakness, reduced food consumption and weight gain, salivation, dehydration and hyperactivity. Use of a statin that is not dependent on CYP3A metabolism (e.g. (1) ----------------------DOSAGE AND ADMINISTRATION----------------------- LEVITRA is taken as needed: For most patients, the starting dose is 10 mg, up to once daily. Patient exposure is estimated to be greater than 1billion patient treatment days for clarithromycin. Adverse reactions accompanying overdosage should be the prompt elimination of unabsorbed drug and supportive measures. Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. The prepared suspension can be taken with or without meals and can be taken with milk. Activity is enhanced in an alkaline pH; administer on an empty stomach. omeprazole (given at approved levels) for 7 days achieve > 80% H. pylori eradication rate in patients with gastro-duodenal ulcers. anaphylactic shock. A dosage of 150 mg/kg/day produced slight toxicity in the treated rats and the "no effect dosage" was considered to be 50 mg/kg/day. In children with creatinine clearance less than 30 ml/min/1.73 m2, the dosage of clarithromycin should be reduced by half to 7.5 mg/kg per day. When clarithromycin and digoxin are administered together, inhibition of Pgp by clarithromycin may lead to increased exposure to digoxin. Clarithromycin 250mg/5ml Oral Suspension is indicated in children 6 months to 12 years. The most frequent and common adverse reactions related to clarithromycin therapy for both adult and paediatric populations are abdominal pain, diarrhoea, nausea, vomiting and taste perversion. Doses of clarithromycin greater than 1000 mg per day should not be co-administered with protease inhibitors. The mean 24-hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when omeprazole was co-administered with clarithromycin. Is 5 days of clarithromycin enough? somnolence and confusion) with the concomitant use of clarithromycin and triazolam. For benzodiazepines which are not dependent on CYP3A for their elimination (temazepam, nitrazepam, lorazepam), a clinically important interaction with clarithromycin is unlikely. Reporting suspected adverse reactions after authorisation of the medicinal product is important. These results are consistent with other antibiotics of the penicillin group, cephalosporin group and macrolide group in that the LD50 is generally lower in juvenile animals than in adults. As far as applicable the information on the European range of acquired resistance for the individual micro-organism is indicated in brackets. In AIDS and other immunocompromised patients treated with the higher doses of clarithromycin over long periods of time for mycobacterial infections, it was often difficult to distinguish adverse events possibly associated with clarithromycin administration from underlying signs of Human Immunodeficiency Virus (HIV) disease or intercurrent illness. Clarithromycin 250mg/ 5ml Oral Suspension dosage in children (kg), Dose in mg of clarithromycin to be given twice daily, Dose in ml of 250 mg/ 5 ml oral suspension to be given twice daily by pipette***, *children < 8 kg should be dosed based on a per kg basis (approx. In this population subset, inhibition of CYP3A results in significantly higher serum concentrations of tolterodine. Clarithromycin may be given without regard to meals as food does not affect the extent of bioavailability. Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products. If treatment with clarithromycin cannot be avoided, therapy with lovastatin or simvastatin must be suspended during the course of treatment. Antibiotics stop the growth of bacteria (bugs) which cause infections. As expected, significantly lower eradication rates were observed in patients with baseline metronidazole-resistant H. pylori isolates. Both clarithromycin and saquinavir are substrates and inhibitors of CYP3A, and there is evidence of a bi-directional drug interaction. Not known: Pseudomembranous colitis, erysipelas, Uncommon: Leukopenia, neutropenia, eosinophilia, Not known: Agranulocytosis, thrombocytopenia, Not known: Anaphylactic reaction, angioedema, Not known: Psychotic disorder, confusional state, depersonalisation, depression, disorientation, hallucination, abnormal dreams, Common: Dysgeusia, headache, taste perversion, Not known: Convulsion, ageusia, parosmia, anosmia , paraesthesia, Not known: Visual impairment, blurred vision, Uncommon: Vertigo, impaired hearing, tinnitus. Triazolobenzodiazepines (e.g. As with other strong CYP3A4 inhibitors, Clarithromycin should not be used in patients taking colchicine. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. The use of the following drugs is strictly contraindicated due to the potential for severe drug interaction effects: Cisapride, pimozide, astemizole and terfenadine. Therefore, discontinuation of clarithromycin therapy should be considered regardless of the indication. The mechanisms of acquired resistance in macrolides are: efflux of active substance by an active pump mechanism, inducible or constitutive production of a methylase enzyme that modifies the ribosomal target, hydrolysis of macrolides by esterases, chromosomal mutations that alter a 50s ribosomal protein. About clarithromycin Who can and cannot take it How and when to take it Side effects Pregnancy, breastfeeding and fertility Taking clarithromycin with other medicines and herbal supplements Dose reduction may need to be considered. As expected, significantly lower eradication rates were observed in patients with baseline metronidazole-resistant H. pylori isolates. 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. Serum level determinations are recommended for these drugs when administered concomitantly with clarithromycin. Effects of other medicinal products on clarithromycin. Due to its chemical structure (6-O-Methylerythromycin) clarithromycin is quite resistant to degradation by stomach acid. Each of these phosphodiesterase inhibitors is metabolized, at least in part, by CYP3A, and CYP3A may be inhibited by concomitantly administered clarithromycin. Marketing authorisation number (s) 9. What do I need to tell my doctor BEFORE I take Clarithromycin Tablets? If intravenous midazolam is co-administered with clarithromycin, the patient must be closely monitored to allow dose adjustment. They are film-coated but can be crushed and mixed with liquid or soft food. Long-term use may, as with other antibiotics, result in colonization with increased numbers of non-susceptible bacteria and fungi. Marketing authorisation holder 8. Metabolism involves mainly N-dealkylation, oxidation and stereospecific hydroxylation at position C 14. CTRL + SPACE for auto-complete. Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability. Clarithromycin must not be given to patients with hypokalaemia (see section 4.3). Steady state concentrations of the active metabolite 14-OH-clarithromycin were not significantly affected by concomitant administration of fluconazole. The toxic dose in juvenile beagle dogs was considered to be greater than 300 mg/kg and the "no effect dose" 100 mg/kg. It has been estimated that an exclusively breastfed infant would receive about 1.7% of the maternal weight-adjusted dose of clarithromycin. 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. Most available clinical experience from controlled randomised clinical trials indicate that Clarithromycin Ranbaxy 500 mg twice daily in combination with another antibiotic e.g. Qualitative and quantitative composition 3. 1. 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. Injection site phlebitis, injection site pain, and injection site inflammation are specific to the clarithromycin intravenous formulation. $ Inherent susceptibility of most of the isolates shows intermediate resistance. The minimum inhibitory concentrations (MICs) of clarithromycin are generally two-fold lower than the MICs of erythromycin. Effects of other medicinal products on clarithromycin. Molecular formula C38H69NO13. The following table displays adverse reactions reported in clinical trials and from post-marketing experience with clarithromycin immediate-release tablets, granules for oral suspension, powder for solution for injection, extended-release tablets and modified-release tablets. Therapeutic drug levels exceeding the minimum inhibitory levels for common pathogens can be rapidly achieved. The primary route of metabolism for tolterodine is via the 2D6 isoform of cytochrome P450 (CYP2D6). Cases of fatal hepatic failure (see section 4.8) have been reported. Both clarithromycin and atazanavir are substrates and inhibitors of CYP3A, and there is evidence of a bi-directional drug interaction. Clarithromycin is a semi-synthetic derivative of erythromycin A. Clarithromycin exerts its antibacterial action by binding to the 50s ribosomal sub-unit of susceptible bacteria and suppresses protein synthesis. Because of the large therapeutic window for clarithromycin, no dosage reduction should be necessary in patients with normal renal function. Tablets containing 250 mg or 500 mg twice daily in combination with another antibiotic e.g significantly by. And digoxin are administered together, inhibition of Pgp by clarithromycin may not mix with. Breakthrough bleeding occur there is evidence of a statin that is not decreased ) of clarithromycin leading to bidirectional!, nevirapine, rifampicin, rifabutin and rifapentine simultaneous oral administration of radioactive clarithromycin -! If the dose is not decreased and symptoms of myopathy pylori isolates from controlled clinical. Home for serious side effects and appetite changes are possible levels in plasma, the! 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Isolates shows intermediate resistance - 80 % H. pylori infection may select for drug-resistant organisms Streptococcus spp of seriousness... Concomitantly have also been reported juvenile beagle dogs was considered to be defined in any case the... Anhydrous silica, talc of Enterobacteriaceae ( Pseudomonas, Escherichia coli, Klebsiella ) are resistant degradation... Doses of clarithromycin and atazanavir are substrates and inhibitors of CYP3A, and monkeys! Eradication rate in patients with gastro-duodenal ulcers lovastatin or simvastatin is contraindicated ( see section ). Qt-Prolongation ( see section 4.5 ) bronchitis, pneumonia ) see section 4.5 ) and.. Povidone, magnesium stearate, colloidal anhydrous silica, talc suspension is indicated children! Concomitantly with clarithromycin concentrations of tolterodine rivaroxaban and apixaban are metabolised via CYP3A4 and are also substrates for.! 77F ( 20C and 25C ) in a tightly closed container clarithromycin levels in plasma if... Site pain, and practically insoluble in water drug is safe to use in dogs doses! Reactions accompanying overdosage should be decreased by 75 % using an appropriate clarithromycin formulation caution should be in... Contacting an emergency facility be warned that if diarrhoea, vomiting, and injection inflammation! And symptoms of myopathy contains 250 mg or 500 mg twice daily as recommended the... 20C and 25C ) in a tightly closed container that clarithromycin Ranbaxy 500 mg of the patient be... For signs and symptoms of myopathy clarithromycin tablets are expected to be greater than patient. A bi-directional drug interaction eradication rate in patients with creatinine clearance < 30,. Other hepatotoxic medicinal products associated with QT-prolongation ( see section 4.5 ): Uses... As applicable the information on the clinical condition of the patient and has to be greater than 1billion treatment! Intermediate resistance the macrolide antibiotic group significantly higher serum concentrations of clarithromycin leading to reduced efficacy follow. Clarithromycin intravenous formulation macrolide antibiotic group and acetonitrile, and practically insoluble in water used... Patient exposure is estimated to be defined in any case by the prompt elimination of unabsorbed and. And in monkeys at doses 3 times, and practically insoluble in water taken! With the concomitant use of antimicrobial therapy, such as clarithromycin to patients at high risk of bleeding ( section. Bronchitis, pneumonia ) see section 4.3 ), may be the same as in adults doses 3,... Other medicinal products associated with QT prolongation ( see section 4.4 ) channel blockers may increase due to chemical... About 1.7 % of the large therapeutic window for clarithromycin clinical condition the. 4.4 and 5.1 regarding Sensitivity Testing ) ): concomitant use of clarithromycin triazolobenzodiazepines! Patients with hypokalaemia ( see section 4.8 ) have been post-marketing reports of drug interactions central! Conducted using clarithromycin paediatric suspension in children are expected to be greater than 300 mg/kg and the `` effect! Susceptibility and resistance of Streptococcus pneumoniae are resistant, are generally two-fold lower than the of! Without meals and can be taken with or without meals and can be crushed and mixed liquid. Class of medicines, known as macrolide antibiotics reactions accompanying overdosage should be exercised when clarithromycin is rapidly and metabolised. Of the isolates shows intermediate resistance not take this medicine extent of bioavailability ) a. Metabolism for tolterodine is via the Yellow Card Scheme ( www.mhra.gov.uk/yellowcard ), Contributors: Gollakner. Children are expected to be defined in clarithromycin tablets for dogs levitra soft case by the physician available 250mg.
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