However, the addition of clofazimine to the regimen added no additional microbiologic or clinical benefit. Tolerability of both multidrug regimens was comparable with the most common adverse events being gastrointestinal in nature. Patients receiving the clofazimine-containing regimen had reduced survival rates; however, their baseline mycobacterial colony counts were higher.
The results of this trial support the addition of ethambutol to clarithromycin for the treatment of initial dMAC infections but do not support adding clofazimine as a third agent. Oral Cephalosporin. In a controlled clinical trial of pediatric patients with acute otitis media performed in the United States, where significant rates of beta-lactamase producing organisms were found, BIAXIN was compared to an oral cephalosporin.
In this trial, strict evaluability criteria were used to determine clinical response. For the patients who were evaluated for clinical efficacy, the clinical success rate i. In a smaller number of patients, microbiologic determinations were made at the pre-treatment visit. In two other controlled clinical trials of acute otitis media performed in the United States, where significant rates of beta-lactamase producing organisms were found, BIAXIN was compared to an oral antimicrobial agent that contained a specific beta-lactamase inhibitor.
In these trials, strict evaluability criteria were used to determine the clinical responses. In the patients who were evaluated for clinical efficacy, the combined clinical success rate i. Two U. Eradication of H.
A randomized, double-blind clinical trial trial 8 performed in the U. This trial established that the day triple therapy was equivalent to the day triple therapy in eradicating H. Three U. Two trials trials 9 and 10 were conducted in patients with an active duodenal ulcer, and the third trial trial 11 was conducted in patients with a duodenal ulcer in the past 5 years, but without an ulcer present at the time of enrollment.
The dosage regimen in the trials was BIAXIN mg twice a day plus omeprazole 20 mg twice a day plus amoxicillin 1 gram twice a day for 10 days. In trials 9 and 10, patients who took the omeprazole regimen also received an additional 18 days of omeprazole 20 mg once a day. Endpoints studied were eradication of H. For a given patient, H. Four randomized, double-blind, multi-center trials trials 12, 13, 14, and 15 evaluated BIAXIN mg three times a day plus omeprazole 40 mg once a day for 14 days, followed by omeprazole 20 mg once a day trials 12, 13, and 15 or by omeprazole 40 mg once a day trial 14 for an additional 14 days in patients with active duodenal ulcer associated with H.
Trials 12 and 13 were conducted in the U. Trials 14 and 15were conducted in Europe and enrolled and patients, respectively. These trials compared the combination regimen to omeprazole monotherapy. The results for the efficacy analyses for these trials are described in Tables 20, 21, and In the per-protocol analysis, the following patients were excluded: dropouts, patients with major protocol violations, patients with missing H.
Ulcer recurrence at 6-months and at 12 months following the end of treatment was assessed for patients in whom ulcers were healed post-treatment see the results in Table Thus, in patients with duodenal ulcer associated with H.
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Approval: See full prescribing information FPI for additional information. Regimens which contain BIAXIN Filmtab as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. Table 1. For H. Pediatric Patients For treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.
Table 2. Add the remainder of water to the bottle and shake. Table 3. Avoid BIAXIN in the following patients: patients with known prolongation of the QT interval, ventricular cardiac arrhythmia, including torsades de pointes patients receiving drugs known to prolong the QT interval [see also Contraindications 4.
Table 4. Table 5. Table 6. Table 7. All-Cause Mortality in Patients with Coronary Artery Disease 1 to 10 Years Following BIAXIN Exposure In one clinical trial evaluating treatment with clarithromycin on outcomes in patients with coronary artery disease, an increase in risk of all-cause mortality was observed in patients randomized to clarithromycin. Blood and Lymphatic System: Thrombocytopenia, agranulocytosis Cardiac: Ventricular arrhythmia, ventricular tachycardia, torsades de pointes Ear and Labyrinth: Deafness was reported chiefly in elderly women and was usually reversible.
Nervous System: Parosmia, anosmia, ageusia, paresthesia and convulsions Psychiatric : Abnormal behavior, confusional state, depersonalization, disorientation, hallucination, depression, manic behavior, abnormal dream, psychotic disorder. Renal and Urinary: Nephritis interstitial, renal failure Skin and Subcutaneous Tissue: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms DRESS , Henoch-Schonlein purpura, acne, acute generalized exanthematous pustulosis Vascular: Hemorrhage.
Electrocardiograms should be monitored for QTc prolongation during coadministration of clarithromycin with these drugs [see Warnings and Precautions 5.
Serum concentrations of these medications should also be monitored. There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with disopyramide and quinidine. There have been postmarketing reports of hypoglycemia with the concomitant administration of clarithromycin and disopyramide.
Therefore, blood glucose levels should be monitored during concomitant administration of clarithromycin and disopyramide. When clarithromycin and digoxin are co-administered, inhibition of Pgp by clarithromycin may lead to increased exposure of digoxin.
Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have been reported in postmarketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Monitoring of serum digoxin concentrations should be considered, especially for patients with digoxin concentrations in the upper therapeutic range.
Oral Anticoagulants: Warfarin Use With Caution Oral anticoagulants: Spontaneous reports in the postmarketing period suggest that concomitant administration of clarithromycin and oral anticoagulants may potentiate the effects of the oral anticoagulants.
Prothrombin times should be carefully monitored while patients are receiving clarithromycin and oral anticoagulants simultaneously [see Warnings and Precautions 5.
Antiepileptics: Carbamazepine Use With Caution Carbamazepine: Concomitant administration of single doses of clarithromycin and carbamazepine has been shown to result in increased plasma concentrations of carbamazepine.
Blood level monitoring of carbamazepine may be considered. Increased serum concentrations of carbamazepine were observed in clinical trials with clarithromycin. There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with carbamazepine.
Clarithromycin may increase the plasma concentrations of itraconazole. Patients taking itraconazole and clarithromycin concomitantly should be monitored closely for signs or symptoms of increased or prolonged adverse reactions. The dose of colchicine should be reduced when co-administered with clarithromycin in patients with normal renal and hepatic function [see Contraindications 4.
Co-administration with clarithromycin could result in increased quetiapine exposure and possible quetiapine related toxicities. There have been postmarketing reports of somnolence, orthostatic hypotension, altered state of consciousness, neuroleptic malignant syndrome, and QT prolongation during concomitant administration.
Refer to quetiapine prescribing information for recommendations on dose reduction if co-administered with CYP3A4 inhibitors such as clarithromycin. In this population subset, inhibition of CYP3A results in significantly higher serum concentrations of tolterodine. Tolterodine 1 mg twice daily is recommended in patients deficient in CYP2D6 activity poor metabolizers when co-administered with clarithromycin. Boceprevir in patients with normal renal function Didanosine No Dose Adjustment Boceprevir: Both clarithromycin and boceprevir are substrates and inhibitors of CYP3A, potentially leading to a bi-directional drug interaction when co-administered.
Zidovudine Zidovudine: Simultaneous oral administration of clarithromycin immediate-release tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. Administration of clarithromycin and zidovudine should be separated by at least two hours [see Pharmacokinetics The impact of co-administration of clarithromycin extended-release tablets or granules and zidovudine has not been evaluated. Calcium Channel Blockers: Verapamil Use With Caution Verapamil: Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil, [see Warnings and Precautions 5.
Clarithromycin and other macrolides are known to inhibit CYP3A. There is potential of CYP3A-mediated interaction between nifedipine and clarithromycin. Hypotension and peripheral edema were observed when clarithromycin was taken concomitantly with nifedipine [see Warnings and Precautions 5.
Ergot Alkaloids: Ergotamine Dihydroergotamine Contraindicated Ergotamine, Dihydroergotamine: Postmarketing reports indicate that coadministration of clarithromycin with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system [see Contraindications 4.
Tacrolimus Tacrolimus: There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with tacrolimus. Co-administration of clarithromycin with sildenafil, tadalafil, or vardenafil will result in increased exposure of these phosphodiesterase inhibitors. Co-administration of these phosphodiesterase inhibitors with clarithromycin is not recommended. Increased systemic exposure of these drugs may occur with clarithromycin; reduction of dosage for phosphodiesterase inhibitors should be considered see their respective prescribing information.
Xanthine Derivatives: Theophylline Use With Caution Theophylline: Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations [see Pharmacokinetics Monitoring of serum theophylline concentrations should be considered for patients receiving high doses of theophylline or with baseline concentrations in the upper therapeutic range.
Triazolobenzodiazepines and Other Related Benzodiazepines: Midazolam Use With Caution Midazolam: When oral midazolam is co-administered with clarithromycin, dose adjustments may be necessary and possible prolongation and intensity of effect should be anticipated [see Warnings and Precautions 5. Alprazolam Triazolam Triazolam, Alprazolam: Caution and appropriate dose adjustments should be considered when triazolam or alprazolam is co-administered with clarithromycin.
There have been postmarketing reports of drug interactions and central nervous system CNS effects e. Monitoring the patient for increased CNS pharmacological effects is suggested.
In postmarketing experience, erythromycin has been reported to decrease the clearance of triazolam and midazolam, and thus, may increase the pharmacologic effect of these benzodiazepines. Since concentrations of OH clarithromycin are significantly reduced when clarithromycin is co-administered with atazanavir, alternative antibacterial therapy should be considered for indications other than infections due to Mycobacterium avium complex.
Doses of clarithromycin greater than mg per day should not be co-administered with protease inhibitors. Ritonavir in patients with decreased renal function Ritonavir: Since concentrations of OH clarithromycin are significantly reduced when clarithromycin is co-administered with ritonavir, alternative antibacterial therapy should be considered for indications other than infections due to Mycobacterium avium [see Pharmacokinetics Saquinavir in patients with decreased renal function Saquinavir: When saquinavir is co-administered with ritonavir, consideration should be given to the potential effects of ritonavir on clarithromycin refer to ritonavir above [see Pharmacokinetics Etravirine Etravirine: Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, OH-clarithromycin, were increased.
Because OH-clarithromycin has reduced activity against Mycobacterium avium complex MAC , overall activity against this pathogen may be altered; therefore alternatives to clarithromycin should be considered for the treatment of MAC. Saquinavir in patients with normal renal function No Dose Adjustment Ritonavir in patients with normal renal function Proton Pump Inhibitors: Omeprazole Use With Caution Omeprazole: Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of omeprazole [see Pharmacokinetics Miscellaneous Cytochrome P Inducers: Efavirenz Nevirapine Rifampicin Rifabutin Rifapentine Use With Caution Inducers of CYP3A enzymes, such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine will increase the metabolism of clarithromycin, thus decreasing plasma concentrations of clarithromycin, while increasing those of OH-clarithromycin.
Since the microbiological activities of clarithromycin and OH-clarithromycin are different for different bacteria, the intended therapeutic effect could be impaired during concomitant administration of clarithromycin and enzyme inducers. Alternative antibacterial treatment should be considered when treating patients receiving inducers of CYP3A. Resistance The major routes of resistance are modification of the 23S rRNA in the 50S ribosomal subunit to insensitivity or drug efflux pumps.
Antimicrobial Activity Clarithromycin has been shown to be active against most of the isolates of the following microorganisms both in vitro and in clinical infections [see Indications and Usage 1 ]. Gram-Negative Bacteria Legionella pneumophila Pasteurella multocida. Anaerobic Bacteria Clostridium perfringens Peptococcus niger Prevotella melaninogenica Propionibacterium acnes Susceptibility Testing Methods Excluding Mycobacteria and Helicobacter When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens.
Dilution Techniques Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations MICs. Diffusion Techniques Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. Susceptibility Testing for Mycobacterium avium Complex MAC The reference methodology for susceptibility testing of Mycobacterium avium complex MAC is broth dilution either microdilution or macrodilution method.
Susceptibility Testing for Helicobacter pylori The reference methodology for susceptibility testing of H. Table Note: When testing Streptococcus pyogenes and Streptococcus pneumoniae , susceptibility and resistance to clarithromycin can be predicted using erythromycin. Quality Control Standardized susceptibility test procedures require the use of laboratory control bacteria to monitor and ensure the accuracy and precision of supplies and reagents in the assay, and the techniques of the individual performing the test.
Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here. Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor.
Do not stop taking this medication without consulting your doctor. Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
You may be at higher risk than you think from bacteria that can lead to pneumonia, bacteremia, and meningitis. Each oval, yellow, film-coated, extended-release tablet debossed with the Abbott logo and "LC" on one side, contains mg of clarithromycin. Nonmedicinal ingredients: cellulosic polymers, lactose monohydrate, magnesium stearate, propylene glycol, Quinoline Yellow Lake E, sorbitan monooleate, talc, titanium dioxide, and vanillin.
This medication does not contain tartrazine. There are important differences between the two pneumococcal vaccines for adults available in Canada. Adults: The recommended adult dose of clarithromycin tablets is mg to mg twice daily every 12 hours for 7 to 14 days, depending on the condition being treated. The recommended adult dose of the extended-release form of clarithromycin is 1, mg 2 tablets once daily for 5 to 14 days, depending on the condition being treated.
For the treatment and prevention of MAC, the usual dose of clarithromycin is mg twice daily. When used with other medications to kill H.
Children: The recommended total daily dose for children is 15 mg per kilogram of body weight to a maximum of 1, mg per day. This total daily dose should be divided in 2 equal doses given 12 hours apart. Total treatment duration is usually 5 to 10 days, depending on the condition being treated. For the treatment and prevention of MAC, the usual dose of clarithromycin is 7. If the child is receiving an oral suspension of clarithromycin, use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.
Clarithromycin tablets and clarithromycin suspension given twice daily may be taken with or without food. Taking this medication with food may cause less stomach upset. The extended-release tablets of clarithromycin must be taken with food.
The tablets must be swallowed whole and not crushed or broken. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule.
You may notice Biaxin XL tablet coatings in your stool, but this does not mean the medicine was not absorbed by your body. Biaxin XL should always be taken with food, while regular Biaxin can be taken with or without.
Biaxin is also available as Biaxin Granules, a liquid oral suspension. Continue Learning about Macrolides Can azithromycin cause side effects?
Affecting two to three million Americans each year, CAP results in approximately 10 million physician visits annually. The most common symptoms of CAP include malaise, shaking chills, chest pain, weakness, fever, and a cough that produces rust or greenish-colored mucus. According to recent treatment guidelines for CAP issued by a working group from the Centers for Disease Control and Prevention CDC , macrolides, including clarithromycin, are recommended as first-line treatment options for outpatients with CAP.
Abbott Laboratories has a long history of leadership in anti-infectives dating back to the s. Abbott was one of the five pioneers in the United States to start commercial production of penicillin.
Years later, in conjunction with the research efforts of two other pharmaceutical companies, Abbott developed an early macrolide antibiotic.
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