TELITHROMYCIN

Indications & Dose:

To treat mild to moderate community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae

•   BY MOUTH

Adults. 800 mg once daily P.O. for 7 to 10 days.

DOSAGE ADJUSTMENT For patients with severe renal impairment, including patients on dialysis, dosage reduced to 600 mg once daily for 7 to 10 days. For patients with severe renal impairment and coexisting hepatic impairment, dosage reduced to 400 mg once daily for 7 to 10 days.

Contraindications:

Cisapride or pimozide therapy; history of hepatitis or jaundice associated with use of telithromycin or any macrolide antibiotic; hypersensitivity to telithromycin, macrolide antibiotics, or their components; myasthenia gravis 

Side Effects:

Cautions:

Precautions:

hepatic impairment; renal impairment; pregnancy; coronary heart disease, ventricular arrhythmias, bradycardia, hypokalaemia, hypomagnesaemia–risk of QT interval prolongation; concomitant administration of drugs that prolong QT-interval; myasthenia gravis (risk of exacerbation–use only if no other alternative). 

Interaction:

DRUGS

atorvastatin, lovastatin, midazolam, pimozide,

simvastatin: Possibly increased blood levels of these drugs cisapride, dofetilide, procainamide,

quinidine: Increased risk of prolonged QT interval

colchicine: Increased blood colchicine levels with risk of colchicine toxicity itraconazole,

ketoconazole: Increased blood level of telithromycin oral anticoagulants: Possibly potentiated effects of oral anticoagulants rifampin:

Decreased blood level of telithromycin sotalol:

Decreased sotalol absorption theophylline: Increased risk of adverse GI reactions

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Dizziness, fatigue, headache, insomnia, somnolence, transient loss of consciousness, vertigo

CV: Atrial arrhythmias, prolonged QT interval, torsades de pointes

EENT: Blurred vision, difficulty focusing eyes, diplopia, dry mouth, glossitis, oral candidiasis, stomatitis

GI: Abdominal distention or pain, anorexia, constipation, diarrhea, elevated liver function test results, flatulence, fulminant hepatitis, gastroenteritis, gastritis, hepatic failure or necrosis, hepatitis, nausea, pseudomembranous colitis, taste perversion, vomiting

GU: Vaginal candidiasis, vaginitis, vaginosis (fungal)

HEME: Increased platelet count

MS: Exacerbated myasthenia gravis, muscle cramps

RESP: Acute respiratory failure

SKIN: Diaphoresis, rash Other: Angioedema, anaphylaxis

Patient And Carer Advice: