Drug Interaction:
Drug interactions- summary-
Azole antifungals + Telithromycin
Coadministration with itraconazole resulted in increase in Cmax and AUC of telithromycin
CYP3A4 eg carbamazepine, phenobarbital, phenytion, rifampin + Telithromycin
Coadminstratioon is likely to result in subtherapeutic levels of telithromycin.
Avoid coadministration
Telithromycin + antiarrhythmic agents eg amiodarone, bretylium, disopyramide, dofetilide
procainamide, quinidine, salotol
Risk of life threatening cardiac arrhythmias. Avoid coadministration
Telithromycin + benzodiapines eg midazolam
Coadministration resulted an increase in AUC of midazolam,
Monitor closely and adjust midazolam dose as needed
Telithromycin + Carbamazepine-eg cyclospoine, hexobarbital, phenytoin, sirolimus
tacrolymus
Elevation in serum levels of these drugs
Telithromycin + Cisapride
Coadministration is contraindicated
Telithromycin + Colchicine
Increased serum colchine levels with toxicity
Telithromycin + Digoxin
Monitor digoxin levels and adverse reactions when used with telithromycin
Telithromycin + Ergot alkaloids
Coadministration not recommended
Indication:
Community acquired pneumonia ( CAP )
Revised XXXXXX 2010 KETEK® (telithromycin) Tablets
Ketek is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of Ketek. (See CONTRAINDICATIONS.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KETEK and other antibacterial drugs, KETEK should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
Adverse Reaction:
Adverse reactions-
CNS - dry mouth, fatigue, increased sweating, insomnia, somnolence vertigo
Dermatologic - rash
GI - abdominal distention,abdominal pain, anorexia, constipation,dyspepsia, flatulance,
gastritis, gastroenteritis, GI upset, glossitis, stomatitis, watery stools
GU - vaginal candidiasis, vaginitis, vaginosis fungal
Haematogical - hepatitis with or without jaundice,
Special senses- blurred vision, diplopia, or difficulty in focusing
Lab test abnormalities- abnormal liver function tests, including increased liver enzymes
Contra-Indications:
Hypersensitivity reactions-
Special Precautions-
Hepatotoxicity - acute hepatic failure and severe liver injury in some cases fatal reported.
Patients with signs and symptoms of hepatitis must be adviced to discontinue telithromycin
annd imediately seek medical attention.
Myasthenia gravis- telithromycin contraindicated in patients with patients with myasthenia gravis
Excaberation of myasthenia gravis reported and some reports included fatal and life-threatening
acute respiratory failure.
Cardiac effects- telithromycin has the potential to prolong the QTC interval of electrocardogram,
and in some cases may lead to increased risk of ventricular arrhthmias
Visual disturbances- telithromycin may cause visual disturbances particularly of slowing
the ability to accomodate and ability to release accomodation
Renal /hepatic function impairment -in the case of severe renal function impairment,
Reduced dosage of telithromycin is recommended
Hazardous tasks- advice patients not to drive or operate machinery in cases where they
experience visual disturbances or loss of consciousness while taking telithromycin
Pregnancy- administer during pregnancy only if the benefits outweigh the potetial risks to
the fetus.
Lactation- excercise caution when telithromycin is administered to breast-feeding mother
Children- safety and efficacy for use in children not established
Dosages/ Overdosage Etc:
Indication-
Community acquired pneumonia ( CAP )
Dosage-
800mg orally once every 24 hours for 7 to 10 days
Patient Information:
1. Advice patients of liver injury associated with telithromycin which in some cases may be severe.
Symtoms of liver injury - nausea, fatigue, anorexia, jaundice, dark urine, light colored stools,
tender abdomen
2. Antibiotics drugs including telithromycin should be used to treat bacterial infections. They
do not treat viral infections eg, common cold
3. Avoid taking telithromycin if receiving class 1A antiarrhythmics agents eg, quinidine,
procainamide or class III eg dofetilide,
4. Inform your doctor of any family history of QTc prologationor clinically significant bradycardia
5. Telithromycin is contraindicated in patients with myasthenia gravis
6. Avoid simvastatin, Lovastatin, or atorvastatin if receiving telithromycin. If telithromycin is
prescribed stop therapy with atorvastatin, simvastatin, lovastatin
7. Telithromycin tablets can be taken with or without food
8. Minimise activites such as driving , operating machinery during the period of treatment
with telithromycin
Pharmacology/ Pharmacokinetics:
Pharmacology-
Telithromycin belongs to to the ketolide class of antibacterials and is structurally related
to macrolide family of antibiotics
Interaction with Food:
Can be taken with or without food
Pregnancy and lactation:
Pregnancy-
Administer during pregnancy only if the benefits outweigh the potential risks to
the fetus.
Lactation-
Excercise caution when telthromycin is administered to breast-feeding mother
Children-
Safety and efficacy for use in children not established