4.2 Immunocompromised patients: No data are available for IV use, but oral clarithromycin has been used in HIV patients to treat disseminated or localised infections (M. avium, M. intracellulare, M. chelonae, M. fortuitum, M. kansaii) at 1000mg/day in two divided doses).
4.3 (see section 4.5)
4.4 There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see Section 4.5).
4.5 As with other macrolide antibiotics the use of clarithromycin in patients concurrently taking drugs metabolised by the cytochrome p450 system (e.g. cilostazol, methylprednisolone, oral anticoagulants (eg warfarin), quinidine, sildenafil, ergot alkaloids, alprazolam, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoin, cyclosporin,vinoblastine, valproateand tacrolimus) may be associated with elevations in serum levels of these other drugs. Rhabdomyolysis, co-incident with the co-administration of clarithromycin, and HMG-CoA reductase inhibitors, such as lovastatin and simvastatin has been reported.
There have been post-marketed reports of Torsade de Pointes occurring with the concurrent use of clarithromycin and quinidine or disopyramide. Levels of these medications should be monitored during clarithromycin therapy.
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. When clarithromycin and colchicine are administered together, inhibition of Pgp and/or CYP3A by clarithromycin may lead to increased exposure to colchicine. Patients should be monitored for clinical symptoms of colchicine toxicity (see Section 4.4).
Post-marketing reports indicate that co-administration of clarithromycin with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischaemia of the extremities and other tissues including the central nervous system (see section 4.3 Contra-indications).
4.8 There have been reports of Stevens-Johnson syndrome / toxic epidermal necrolysis with orally administered clarithromycin.
There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see sections 4.4 and 4.5).
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal products and other handling of the product.
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