Section 4.3 Contra-indications
The paragraph:
Klaricid Paediatric Suspension 250mg/5ml or Clarithromycin 250mg/5ml Granules for Oral Suspension and ergot derivatives should not be co-administered.
has been changed to
Klaricid Paediatric Suspension 250mg/5ml or Clarithromycin 250mg/5ml Granules for Oral Suspension and ergot derivatives should not be co-administered (see section 4.5).
4.4 Special warnings and special precautions for use
The following statements have been included in this section:
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).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of Interaction
The following drugs have been added to the section “As with other macrolide antibiotics the use of clarithromycin in patients concurrently taking drugs metabolised by the cytochrome P450 system.
Cilostazol, methylprednisolone, quinidine, alprazolam, vinblastine, valproate
“Warfarin” has been changed to “oral anticoagulants (e.g warfarin)”
The following paragraphs have been included in this section:
There have been postmarketed reports of Torsade de Points occurring with the
concurrent use of clarithrtomycin 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 ischemia of the extremeties and other tissues
including the central nervous system (see section 4.3, Contraindications).
4.8 Undesirable effects
The following statement has been changed from:
“Other side-effects including headache, arthralgia, myalgia and allergic reactions ranging from urticaria, mild skin eruptions and angioedema to anaphylaxis and rarely Stevens-Johnson syndrome / toxic epidermal necrolysis.”
To
“Other side-effects including headache, arthralgia, myalgia and allergic reactions ranging from urticaria, mild skin eruptions and angioedema to anaphylaxis have been reported. There have been reports of and rarely Stevens-Johnson syndrome / toxic epidermal necrolysis with orally administered clarithromycin.”
The following statement has been added to this section:
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).
10. DATE OF REVISION OF THE TEXT
The date of revision of the text has been changed from February 2005 to
14 September 2006
|
