Telithromycin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Community-acquired pneumonia caused by S.pneumoniae, H.influenzae, H.parainfluenzae, M.catarrhalis, C.pneumoniae, M.pneumoniae and L.pneumopila
• Acute exacerbations of chronic bronchitis caused by H.influenzae, H.parainfluenzae, S.pneumoniae, M.catarrhalis and S.aureus
• Acute sinusitis caused by S.pneumoniae, H.influenzae, S.aureus  and M.catarrhalis 
• Tonsilitis/ Pharyngitis causes by S.pyogenes

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other macrolide antibiotics
• Porphyria
• Myasthenia gravis
• Family or personal history of QT prolongation
• Previous history of hepatitis or jaundice associated with telithromycin or other macrolide use
• Coadministration with ergot alkaloids
• Coadministration with cisapride
• Coadministration with pimozide
• Coadministration with astemizole
• Coadministration with terfenadine
• Coadministration with simvastatin
• Coadministration with lovastatin
• Coadministration with atorvastatin
• Coadministration with cerivastatin
• Coadministration with midazolam

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Hepatic impairment
• Risk factors for QT prolongation
• May impair ability to drive and operate machinery 

Forms avail. in SA and covered in this monograph: tab

Infections caused by: Most Gram-positive aerobic cocci (including multi-drug resistant S. pneumoniae); Fastidious Gram-negative bacilli; Other, including: M. pneumoniae, Chlamydia spp. and P. acnes

General dosing range

• Oral (tab): 800mg, dly

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Community acquired pneumonia

• Oral (tab): 800mg, dly; Treatment duration: 7-10 days (Manufacturer recommendation)

Acute exacerbation of chronic bronchitis
Acute sinusitis
Tonsilitis
Pharyngitis

• Oral (tab): 800mg, dly; Treatment duration: 5 days (Manufacturer recommendation)

This drug should only be used for definitive therapy (administration of antibiotics based on known results of culture and sensitivities); Not recommended for use as empiric therapy (administration of antibiotics based on the assumption of a causative organism), except as an alternative in beta-lactam allergic patients

Not established for use in children below 12 years

Pregnancy

• Caution
• In animal studies, undesirable events have been observed. Use should only be considered after assessment of the benefit-risk profile, where the benefits outweigh any potential risks to the mother or foetus

Breastfeeding

• Caution
• The secretion of telithromycin into breast milk is unknown. Caution is recommended when considering use in breastfeeding mothers

Renal Impairment

• Mild to moderate: No dose adjustment recommended 
• Severe: Caution; dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably porphyrinogenic (PRP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Somnolence
• Insomnia
• Vertigo
• Nervousness
• Paresthesia
• Transient loss of consciousness

Cardiovascular Disorders

• Flushing
• Atrial dysrhythmia
• Hypotension
• Bradycarida
• Palpitations
• Prolonged QT interval

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Abdominal pain
• Flatulence
• Constipation
• Anorexia
• Oral moniliasis
• Stomatitis
• Pseudomembranous colitis
• Pancreatitis

Hepatobiliary Disorders

• Increased hepatic enzymes
• Hepatitis
• Cholestatic jaundice
• Severe hepatic failure

Genitourinary Disorders

• Vaginal moniliasis

Musculoskeletal Disorders

• Muscle cramps

Skin and Subcutaneous Tissue Disorders

• Eczema
• Erythema multiforme
• Rash
• Urticaria
• Pruritis
• Facial oedema
• Angioedema
• Anaphylaxis

Immune, Blood and Lymphatic System Disorders

• Eosinophilia

Sensory Disorders

• Disturbance of taste
• Visual disturbances
• Parosmia

• Ergot alkaloids
• Cisapride
• Pimozide
• Asthemizole
• Terfenadine
• Statins
• Midazolam
• QT prolonging agents
• CYP3A4 inducers
• CYP3A4 substrates
• Digoxin
• Benzodiazepines
• Sotalol

Specific cases may require

• Hepatic function
• Ophthalmic examination

Telithromycin is an erythromycin-A semi-synthetic derivative that binds to two sites (domains II and V) on the 50S ribosomal subunit which results in inhibition of protein synthesis. By binding at domain II, telithromycin retains activity against gram-positive cocci that have developed resistance via methylases (erm genes) that alter the binding site at domain V.

Spectrum of activity: Most Gram-positive aerobic cocci (including multi-drug resistant S. pneumoniae); Fastidious Gram-negative bacilli; Other, including: M. pneumoniae, Chlamydia spp. and P. acnes

Tablet 400mg

• Ketek (Sanofi) originator