Clarithromycin
Clarithromycin Prescribing Information
Contraindications (
- Hypersensitivity to clarithromycin or any macrolide drug
- Cisapride and pimozide
- History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin
- Colchicine in renal or hepatic impairment
- Lomitapide, lovastatin, and simvastatin
- Ergot alkaloids (ergotamine or dihydroergotamine)
- Lurasidone
Clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs
Concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated
There have been postmarketing reports of drug interactions when clarithromycin is co-administered with cisapride or pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and
Clarithromycin tablets are contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin.
Concomitant administration of clarithromycin tablets and colchicine is contraindicated in patients with renal or hepatic impairment.
Concomitant administration of clarithromycin tablets with lomitapide is contraindicated due to potential for markedly increased transaminases
Concomitant administration of clarithromycin tablets with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis
Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated
Concomitant
For information about contraindications of other drugs indicated in combination with clarithromycin tablets, refer to their full prescribing information (contraindications section).
Drug Interactions (
Clarithromycin tablets should be used with caution in patients receiving treatment with other drugs known to be CYP3A enzyme substrates, especially if the CYP3A substrate has a narrow safety margin (e.g., carbamazepine) and/or the substrate is extensively metabolized by this enzyme. Adjust dosage when appropriate and monitor serum concentrations of drugs primarily metabolized by CYP3A closely in patients concurrently receiving clarithromycin.
Drugs That Are Affected By Clarithromycin Tablets | ||
Drug(s) with Pharmacokinetics Affected by clarithromycin tablets | Recommendation | Comments |
| Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Digoxin | Not Recommended Use With Caution | Disopyramide, Quinidine : There have been postmarketing reports of torsades de pointes occurring with concurrent use of clarithromycin and quinidineor disopyramide. Electrocardiograms should be monitored for QTc prolongation during coadministration of clarithromycin with these drugs[see Warnings and Precautions ]. |
| 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. |
| Antifungals: Itraconazole Fluconazole | Use With Caution No Dose Adjustment | Itraconazole : Both clarithromycin and itraconazole are substrates and inhibitors of CYP3A, potentially leading to a bi-directional drug interaction when administered concomitantly (see also Itraconazole under “Drugs That Affect Clarithromycin tablets” in the table below). 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.Fluconazole :[see Pharmacokinetics ] |
| Anti-Gout Agents: Colchicine (in patients with renal or hepatic impairment) Colchicine (In patients with normal renal and hepatic function) | Contraindicated Use With Caution | Colchicine : Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (Pgp). Clarithromycin and other macrolides are known to inhibit CYP3A and Pgp. The dose of colchicine should be reduced when co-administered with clarithromycin in patients with normal renal and hepatic function[see Contraindication and Warnings and Precautions ]. |
| Antipsychotics: Pimozide Quetiapine Lurasidone | Contraindicated | Pimozide: [See Contraindication ] |
| Antispasmodics: Tolterodine (patient deficient in CYP2D6 activity) | Use With Caution | Tolterodine : The primary route of metabolism for tolterodine is via CYP2D6. However, in a subset of the population devoid of CYP2D6, the identified pathway of metabolism is via CYP3A. 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. |
| Antivirals: Atazanavir Saquinavir (in patients with decreased renal function) Ritonavir Etravirine Maraviroc Boceprevir (in patients with normal renal function) Didanosine Zidovudine | Use With Caution No Dose Adjustment | Atazanavir : Both clarithromycin and atazanavir are substrates and inhibitors of CYP3A, and there is evidence of a bi-directional drug interaction (see Atazanavir under “Drugs That Affect Clarithromycin tablets” in the table below)[see Pharmacokinetics ]. Saquinavir : Both clarithromycin and saquinavir are substrates and inhibitors of CYP3A and there is evidence of a bi-directional drug interaction (seeSaquinavir under “Drugs That Affect Clarithromycin tablets” in the table below) [see Pharmacokinetics ]. Ritonavir, Etravirine : (see Ritonavir and Etravirine under “Drugs That Affect Clarithromycin tablets” in the table below)[see Pharmacokinetics ]. Maraviroc : Clarithromycin may result in increases in maraviroc exposures by inhibition of CYP3A metabolism. See Selzentry®prescribing information for dose recommendation when given with strong CYP3A inhibitors such as clarithromycin.Boceprevir : Both clarithromycin and boceprevir are substrates and inhibitors of CYP3A, potentially leading to a bi-directional drug interaction when co-administered. No dose adjustments are necessary for patients with normal renal function (see Victrelis®prescribing information).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 Amlodipine Diltiazem Nifedipine | Use With Caution | Verapamil : Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil,[see Warnings and Precautions ] Nifedipine: Nifedipine is a substrate for CYP3A. 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 ] . |
| 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 ] . |
| Gastroprokinetic Agents: Cisapride | Contraindicated | Cisapride :[See Contraindications ] |
| Lipid-lowering agents: Lomitapide Lovastatin Simvastatin Atorvastatin Pravastatin Fluvastatin | Contraindicated Use With Caution No Dose Adjustment | Lomitapide, Lovastatin, Simvastatin : Clarithromycin may increase the exposure of these drugs by inhibition of CYP3A metabolism, thereby increasing the risk of toxicities from these drugs[see Contraindications and Warnings and Precautions ] Atorvastatin, Pravastatin, Fluvastatin :[See Warnings and Precautions ] |
| Hypoglycemic Agents: Nateglinide Pioglitazone Repaglinide Rosiglitazone Insulin | Use With Caution | Nateglinide, Pioglitazone, Repaglinide, Rosiglitazone :[See Warnings and Precautions and Adverse Reactions ] Insulin :[See Warnings and Precautions and Adverse Reactions ] |
| Immunosuppressants: Cyclosporine Tacrolimus | Use With Caution | Cyclosporine : There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with cyclosporine.Tacrolimus : There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with tacrolimus. |
| Phosphodiesterase inhibitors: Sildenafil Tadalafil Vardenafil | Use With Caution | Sildenafil, Tadalafil, Vardenafil : Each of these phosphodiesterase inhibitors is primarily metabolized by CYP3A, and CYP3A will be inhibited by concomitant administration of clarithromycin. 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). |
| Proton Pump Inhibitors: Omeprazole | No Dose Adjustment | Omeprazole: The mean 24-hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when coadministered with clarithromycin as a result of increased omeprazole exposures[see Pharmacokinetics ] (see also Omeprazole under “Drugs That Affect Clarithromycin tablets” in the table below). |
| 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 Alprazolam Triazolam Temazepam Nitrazepam Lorazepam | Use With Caution No Dose Adjustment | 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 and Pharmacokinetics ] .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.g., somnolence and confusion) with the concomitant use of clarithromycin and triazolam. 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. Temazepam, Nitrazepam, Lorazepam : For benzodiazepines which are not metabolized by CYP3A (e.g., temazepam, nitrazepam, lorazepam), a clinically important interaction with clarithromycin is unlikely. |
| Cytochrome P450 Inducers: Rifabutin | Use With Caution | Rifabutin : Concomitant administration of rifabutin and clarithromycin resulted in an increase in rifabutin, and decrease in clarithromycin serum levels together with an increased risk of uveitis (see Rifabutin under “Drugs That Affect Clarithromycin tablets” in the table below). |
| Other Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisole Vinblastine Phenobarbital St. John’s Wort | Use With Caution | There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with alfentanil, methylprednisolone, cilostazol, bromocriptine, vinblastine, phenobarbital, and St. John’s Wort. |
| Other Drugs Metabolized by CYP450 Isoforms Other than CYP3A: Hexobarbital Phenytoin Valproate | Use With Caution | There have been postmarketing reports of interactions of clarithromycin with drugs not thought to be metabolized by CYP3A, including hexobarbital, phenytoin, and valproate. |
Drugs that Affect Clarithromycin tablets | ||
Drug(s) that Affect the Pharmacokinetics of Clarithromycin tablets | Recommendation | Comments |
Antifungals: Itraconazole | Use With Caution | Itraconazole: Itraconazole may increase the plasma concentrations of clarithromycin. Patients taking itraconazole and clarithromycin concomitantly should be monitored closely for signs or symptoms of increased or prolonged adverse reactions (see also Itraconazole under “Drugs That Are Affected By Clarithromycin tablets” in the table above). |
| Antivirals: Atazanavir Ritonavir (in patients with decreased renal function) Saquinavir (in patients with decreased renal function) Etravirine Saquinavir (in patients with normal renal function) Ritonavir (in patients with normal renal function) | Use With Caution No Dose Adjustment | Atazanavir : When clarithromycin is co-administered with atazanavir, the dose of clarithromycin should be decreased by 50%[see Clinical Pharmacology ]. Since concentrations of 14-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 1,000 mg per day should not be co-administered with protease inhibitors.Ritonavir : Since concentrations of 14-OH clarithromycin are significantly reduced when clarithromycin is co-administered with ritonavir, alternative antibacterial therapy should be considered for indications other than infections due toMycobacterium avium [see Pharmacokinetics ] .Doses of clarithromycin greater than 1,000 mg per day should not be co-administered with protease inhibitors. 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 : Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, 14-OH-clarithromycin, were increased. Because 14-OH-clarithromycin has reduced activity againstMycobacterium avium complex (MAC), overall activity against this pathogen may be altered; therefore alternatives to clarithromycin should be considered for the treatment of MAC. |
| 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 P450 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 14-OH-clarithromycin. Since the microbiological activities of clarithromycin and 14-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. There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with rifabutin (see Rifabutin under “Drugs That Are Affected By Clarithromycin tablets” in the table above). |
Co-administration of clarithromycin tablets can alter the concentrations of other drugs. The potential for drug-drug interactions must be considered prior to and during therapy.
Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following:
- Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ()
1.1 Acute Bacterial Exacerbation of Chronic BronchitisClarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae,Haemophilus parainfluenzae,Moraxella catarrhalis, orStreptococcus pneumoniae [see Indications andUsage ]. - Acute Maxillary Sinusitis ()
1.2 Acute Maxillary SinusitisClarithromycin tablets (in adults) are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae,Moraxella catarrhalis, orStreptococcus pneumoniae [see Indications and Usage ]. - Community-Acquired Pneumonia ()
1.3 Community-Acquired PneumoniaClarithromycin tablets are indicated
[see Indications and Usage ]for the treatment of mild to moderate infections caused by susceptible isolates due to:- Haemophilus influenzae(in adults)
- Mycoplasma pneumoniae,Streptococcus pneumoniae,Chlamydophilapneumoniae(Clarithromycin tablets [in adults and pediatric patients])
- Pharyngitis/Tonsillitis ()
1.4 Pharyngitis/TonsillitisClarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Streptococcus pyogenesas an alternative in individuals who cannot use first line therapy. - Uncomplicated Skin and Skin Structure Infections ()
1.5 Uncomplicated Skin and Skin Structure InfectionsClarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Staphylococcus aureus, orStreptococcus pyogenes. - Acute Otitis Media in Pediatric Patients ()
1.6 Acute Otitis MediaClarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae,Moraxella catarrhalis, orStreptococcus pneumoniae [see Clinical Studies ]. - Treatment and Prophylaxis of Disseminated Mycobacterial Infections ()
1.7 Treatment and Prophylaxis of Disseminated Mycobacterial InfectionsClarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Mycobacterium aviumorMycobacterium intracellularein patients with advanced HIV infection[see Clinical Studies ]. - Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults ()
1.8Helicobacter pyloriInfection and Duodenal Ulcer DiseaseClarithromycin tablets are given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of
H. pylorihas been demonstrated to reduce the risk of duodenal ulcer recurrence[see Clinical Studies ].- Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients withH. pyloriinfection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicateH. pylori.
- Clarithromycin tablets in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated withH. pyloriinfection. Regimens which contain clarithromycin tablets 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.
- Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
There is resistance to macrolides in certain bacterial infections caused by
- Adults: Clarithromycin tablets 250 mg or 500 mg every 12 hours for 7–14 days ()
2.2 Adult DosageThe recommended dosages of clarithromycin tablets for the treatment of mild to moderate infections in adults are listed in Table 1.
Table 1. Adult Dosage Guidelines Clarithromycin tabletsInfectionDosage(every 12 hours)Duration(days)Acute bacterial exacerbation of chronic bronchitis 250 to 500 mga 7b-14 Acute maxillary sinusitis 500 mg 14 Community-acquired pneumonia 250 mg 7c-14 Pharyngitis/Tonsillitis 250 mg 10 Uncomplicated skin and skin structure infections 250 mg 7-14 Treatment and prophylaxis of disseminated Mycobacterium aviumdisease[see Dosage and Administration ]500 mgd - H.pylorieradication to reduce the risk of duodenal ulcer recurrence with amoxicillin and omeprazole or lansoprazole[see Dosage and Administration ]500 mg 10-14 H.pylorieradication to reduce the risk of duodenal ulcer recurrence with omeprazole[see Dosage and Administration ]500 mg every 8 hours 14 aFor M. catarrhalisandS. pneumoniaeuse 250 mg. ForH. influenzaeandH. parainfluenzae, use 500 mg.
bForH parainfluenzae, the duration of therapy is 7 days.
cForH. influenzae, the duration of therapy is 7 days.
dClarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection. - H.pylorieradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): Clarithromycin tablets 500 mg every 8 or 12 hours for 10–14 days. See full prescribing information (FPI) for additional information. ()
2.3 Combination Dosing Regimens forH. pyloriInfection- Triple therapy: Clarithromycin tablets/lansoprazole/amoxicillin
The recommended adult dosage is 500 mg clarithromycin tablets, 30 mg lansoprazole, and 1 gram amoxicillin, all given every 12 hours for 10 or 14 days
[see Indications and Usage and Clinical Studies ].- Triple therapy: Clarithromycin tablets /omeprazole/amoxicillin
The recommended adult dosage is 500 mg clarithromycin tablets, 20 mg omeprazole, and 1 gram amoxicillin; all given every 12 hours for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief
[see Indications and Usage and Clinical Studies ].- Dual therapy: Clarithromycin tablets /omeprazole
The recommended adult dosage is 500 mg clarithromycin tablets given every 8 hours and 40 mg omeprazole given once every morning for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief
[see Indications and Usage and Clinical Studies ]. - Pediatric Patients: Clarithromycin 15 mg/kg/day divided every 12 hours for 10 days ()
2.4 Pediatric DosageThe recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose). Refer to dosage regimens for mycobacterial infections in pediatric patients for additional dosage information
[see Dosage and Administration ]. - Mycobacterial Infections: Clarithromycin tablets 500 mg every 12 hours; Clarithromycin tablets 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients ()
2.5 Dosage Regimens for Mycobacterial InfectionsFor the treatment of disseminated infection due to
Mycobacterium aviumcomplex (MAC), clarithromycin tablets are recommended as the primary agents. Clarithromycin tablets should be used in combination with other antimycobacterial drugs (e.g. ethambutol) that have shownin vitroactivity against MAC or clinical benefit in MAC treatment[see Clinical Studies ].Adult PatientsFor treatment and prophylaxis of mycobacterial infections in adults, the recommended dose of clarithromycin tablets is 500 mg every 12 hours.
Pediatric PatientsFor treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg every 12 hours.
[See Use in Specific Populations and Clinical Studies ].Clarithromycin tablets therapy should continue if clinical response is observed. Clarithromycin tablets can be discontinued when the patient is considered at low risk of disseminated infection.
- Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment ()
2.6 Dosage Adjustment in Patients with Renal ImpairmentSee Table 2 for dosage adjustment in patients with moderate or severe renal impairment with or without concomitant atazanavir or ritonavir-containing regimens
[see Drug Interactions ].Table 2. Clarithromycin Tablets Dosage Adjustments in Patients with Renal Impairment Recommended Clarithromycin Tablets Dosage ReductionPatients with severe renal impairment (CLcrof <30 mL/min) Reduce the dosage of clarithromycin tablets by 50% Patients with moderate renal impairment (CLcrof 30 to 60 mL/min) taking concomitant atazanavir or ritonavir-containing regimens Reduce the dosage of clarithromycin tablets by 50% Patients with severe renal impairment (CLcrof <30 mL/min) taking concomitant atazanavir or ritonavir-containing regimens Reduce the dosage of clarithromycin tablets by 75%
Clarithromycin is available as:
- Clarithromycin tablets, USP (yellow oval film-coated tablet):
- 250 mg: debossed with ‘CL1’ on one side and plain on other side
- 500 mg: debossed with ‘CL2’ on one side and plain on other side
In a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin tablets every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-OH clarithromycin were increased compared to those achieved in healthy young adults. These changes in pharmacokinetics parallel known age-related decreases in renal function. In clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients. Consider dosage adjustment in elderly patients with severe renal impairment. Elderly patients may be more susceptible to development of
Most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older
Especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, some of which occurred in patients with renal insufficiency. Deaths have been reported in some patients
- Hypersensitivity to clarithromycin or any macrolide drug ()
4.1 HypersensitivityClarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs
[see Warnings and Precautions ]. - Cisapride and pimozide ()
4.2 Cisapride and PimozideConcomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated
[see Drug Interactions ].There have been postmarketing reports of drug interactions when clarithromycin is co-administered with cisapride or pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and
torsades de pointes) most likely due to inhibition of metabolism of these drugs by clarithromycin tablets. Fatalities have been reported. - History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin ()
4.3 Cholestatic Jaundice/Hepatic DysfunctionClarithromycin tablets are contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin.
- Colchicine in renal or hepatic impairment ()
4.4 ColchicineConcomitant administration of clarithromycin tablets and colchicine is contraindicated in patients with renal or hepatic impairment.
- Lomitapide, lovastatin, and simvastatin ()
4.5 Lomitapide, Lovastatin, and SimvastatinConcomitant administration of clarithromycin tablets with lomitapide is contraindicated due to potential for markedly increased transaminases
[see Warnings and Precautions and Drug Interactions ].Concomitant administration of clarithromycin tablets with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis
[see Warnings and Precautions and Drug Interactions ]. - Ergot alkaloids (ergotamine or dihydroergotamine) ()
4.6 Ergot AlkaloidsConcomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated
[see Drug Interactions ]. - Lurasidone ()
4.7 LurasidoneConcomitant
administrationof clarithromycin and lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions[see Drug Interactions ].