Clarithromycin 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. Dosage adjustments may be considered, and when possible, serum concentrations of drugs primarily metabolized by CYP3A should be monitored closely in patients concurrently receiving clarithromycin.
The following drugs or drug classes are known or suspected to be metabolized by the same CYP3A isozyme: Drugs interacting by similar mechanisms through other isozymes within the cytochrome P system include phenytoin, theophylline and valproate.
Antiarrhythmics There have been post marketing reports of torsades de pointes occurring with concurrent use of clarithromycin and quinidine or disopyramide. Electrocardiograms should be monitored for QT prolongation during co-administration of clarithromycin with these drugs. Serum levels of quinidine and disopyramide should be monitored during clarithromycin therapy. There have been post marketing 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. Cyclosporin, tacrolimus and sirolimus Concomitant use of oral clarithromycin and cyclosporin or tacrolimus have resulted in more than a 2-fold increase of the Cmin-levels of both cyclosporin and tacrolimus.
Similar effects are also expected for sirolimus. When initiating treatment with clarithromycin in patients already receiving any of these immunosuppressive agents, cyclosporin, tacrolimus or sirolimus plasma levels must be closely monitored and their doses decreased as necessary.
When clarithromycin is discontinued in these patients, close monitoring of plasma levels of cyclosporin, tacrolimus or sirolimus, is again necessary to guide dose adjustment. Warfarin The use of clarithromycin in patients receiving warfarin may result in potentiation of the effects of warfarin. Prothrombin time should be frequently monitored in these patients see section 4. Careful monitoring of glucose is recommended. Omeprazole Clarithromycin mg every 8 hours was given in combination with omeprazole 40 mg daily to healthy adult subjects.
The mean hour gastric pH value was 5. Sildenafil, tadalafil, and vardenafil Each of these phosphodiesterase inhibitors is metabolized, at least in part, by CYP3A, and CYP3A may be inhibited by concomitantly administered clarithromycin. Co-administration of clarithromycin with sildenafil, tadalafil or vardenafil would likely result in increased phosphodiesterase inhibitor exposure. Reduction of sildenafil, tadalafil and vardenafil dosages should be considered when these drugs are co-administered with clarithromycin.
Dose reduction may need to be considered. In this population subset, inhibition of CYP3A results in significantly higher serum concentrations of tolterodine. A reduction in tolterodine dosage may be necessary in the presence of CYP3A inhibitors, such as clarithromycin in the CYP2D6 poor metabolizer population.
Concomitant administration of oral midazolam and clarithromycin should be avoided. If intravenous midazolam is co-administered with clarithromycin, the patient must be closely monitored to allow dose adjustment. The same precautions should also apply to other benzodiazepines that are metabolised by CYP3A, including triazolam and alprazolam. For benzodiazepines which are not dependent on CYP3A for their elimination temazepam, nitrazepam, lorazepam , a clinically important interaction with clarithromycin is unlikely.
There have been post-marketing reports of drug interactions and central nervous system CNS effects e. Monitoring the patient for increased CNS pharmacological effects is suggested.
Other drug interactions Aminoglycosides Caution is advised regarding concomitant administration of clarithromycin with other ototoxic drugs, especially with aminoglycosides. Digoxin Digoxin is thought to be a substrate for the efflux transporter, P-glycoprotein Pgp. Clarithromycin is known to inhibit Pgp.
When clarithromycin and digoxin are administered together, inhibition of Pgp by clarithromycin may lead to increased exposure to digoxin. Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have also been reported in post marketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Serum digoxin concentrations should be carefully monitored while patients are receiving digoxin and clarithromycin simultaneously.
Zidovudine Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. Because clarithromycin appears to interfere with the absorption of simultaneously administered oral zidovudine, this interaction can be largely avoided by staggering the doses of clarithromycin and zidovudine to allow for a 4-hour interval between each medication.
This interaction does not appear to occur in paediatric HIV-infected patients taking clarithromycin suspension with zidovudine or dideoxyinosine. This interaction is unlikely when clarithromycin is administered via intravenous infusion. Phenytoin and Valproate There have been spontaneous or published reports of interactions of CYP3A inhibitors, including clarithromycin with drugs not thought to be metabolized by CYP3A e. Serum level determinations are recommended for these drugs when administered concomitantly with clarithromycin.
Increased serum levels have been reported. Other ototoxic drugs, especially aminoglycosides In case of concomitant administration of clarithromycin with other ototoxic drugs, especially with aminoglycosides, monitoring of vestibular and auditory function should be carried out during and after treatment see section 4. Bi-directional drug interactions Atazanavir Both clarithromycin and atazanavir are substrates and inhibitors of CYP3A, and there is evidence of a bi-directional drug interaction.
Doses of clarithromycin greater than mg per day should not be co-administered with protease inhibitors. Calcium Channel Blockers Caution is advised regarding the concomitant administration of clarithromycin and calcium channel blockers metabolized by CYP3A4 e. Plasma concentrations of clarithromycin as well as calcium channel blockers may increase due to the interaction. Hypotension, bradyarrhythmias and lactic acidosis have been observed in patients taking clarithromycin and verapamil concomitantly.
Itraconazole Both clarithromycin and itraconazole are substrates and inhibitors of CYP3A, leading to a bidirectional drug interaction. Clarithromycin may increase the plasma levels of itraconazole, while itraconazole may increase the plasma levels of clarithromycin.
Patients taking itraconazole and clarithromycin concomitantly should be monitored closely for signs or symptoms of increased or prolonged pharmacologic effect. Saquinavir Both clarithromycin and saquinavir are substrates and inhibitors of CYP3A, and there is evidence of a bi-directional drug interaction.
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. When saquinavir is co-administered with ritonavir, consideration should be given to the potential effects of ritonavir on clarithromycin. Verapamil Hypotension, bradyarrhythmias and lactic acidosis have been observed in patients taking clarithromycin and verapamil concomitantly.
Data from a limited number of pregnant women exposed in the first trimester indicate a possible increased risk of abortions. To date no other relevant epidemiological data are available.
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Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated, as this may result in ergot lincocin. In one study in 14 healthy volunteers, the concomitant administration of clarithromycin and terfenadine /5ml 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. Co-administration of clarithromycin with sildenafil, tadalafil or vardenafil would likely result in increased phosphodiesterase inhibitor exposure. Turn the bottle upside down. There is limited experience of treatment of children below 6 months of age. Nada, pero cvs, y la, lincocin jarabe 250mg /5ml. A related compound, clindamycin, is derived from lincomycin by. Mejores precios en Colnatur, Epaplus, Lajusticia. Therefore, caution should be exercised in administering clarithromycin to jarabes with impaired hepatic function. Patients with rare hereditary problems of fructose intolerance, lincocin jarabe 250mg /5ml, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take 250mg medicine.
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