Telithromycin Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Pneumonia

Mild to moderate community-acquired pneumonia: 800 mg orally once a day for 7 to 10 days

Usual Adult Dose for Sinusitis

800 mg orally once a day for 5 days

Because the risks outweigh the benefits, telithromycin is no longer approved by the FDA for the treatment of acute bacterial sinusitis.

Usual Adult Dose for Bronchitis

800 mg orally once a day for 5 days

Because the risks outweigh the benefits, telithromycin is no longer approved by the FDA for the treatment of acute bacterial exacerbation of chronic bronchitis.

Usual Adult Dose for Tonsillitis/Pharyngitis

800 mg orally once a day for 5 days

The use of telithromycin for the treatment of tonsillitis/pharyngitis is not approved by the FDA.

Usual Pediatric Dose for Tonsillitis/Pharyngitis

13 years or older: 800 mg orally once a day for 5 days

The use of telithromycin for the treatment of tonsillitis/pharyngitis is not approved by the FDA.

Renal Dose Adjustments

CrCl 29 mL/min or less: 600 mg orally once a day

Liver Dose Adjustments

No dose adjustments are necessary unless severe renal impairment (CrCl 29 mL/min or less) is also present, in which case a dose of 400 mg orally once a day is recommended.

Precautions

Telithromycin is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis, including fatal and life-threatening acute respiratory failure, have been reported; in some cases the onset occurred within a few hours after the first dose of telithromycin.

Coadministration of telithromycin with pimozide or cisapride is contraindicated. Coadministration of telithromycin with colchicine is contraindicated in patients with renal or hepatic impairment.

The concurrent use of certain CYP450 3A4 substrates and inducers is considered contraindicated or not recommended. Close clinical and laboratory monitoring for altered efficacy and safety of the patient's other drugs is recommended whenever telithromycin is added to or discontinued from a drug regimen.

Telithromycin is contraindicated in patients with a history of hepatitis and/or jaundice associated with the use of telithromycin or other macrolide antibiotics. Acute hepatic failure and severe liver injury, in some cases fatal have been reported in patients treated with telithromycin. Physicians and patients should monitor for the appearance of signs or symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness, and hepatomegaly. Patients with signs or symptoms of hepatitis must be advised to discontinue telithromycin and immediately seek medical evaluation, which should include liver function tests.

Due to its potential to prolong the QTc interval, telithromycin should be avoided in patients with ongoing proarrhythmic conditions including known prolonged QTc interval, hypokalemia, hypomagnesemia, significant bradycardia, congestive heart failure, myocardial ischemia, and atrial fibrillation, or who are receiving antiarrhythmic agents which prolong the QT interval.

Serious and occasionally fatal hypersensitivity reactions have been reported with antibiotics. The drug should be discontinued immediately at the first appearance of a skin rash or other signs of hypersensitivity. Severe, acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures including oxygen, intravenous fluids, antihistamines, corticosteroids, cardiovascular support and airway management as clinically indicated.

Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibiotics and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following telithromycin therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against C difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy.

Caution is recommended in patients with a history of colitis or other gastrointestinal disorders.

Safety and efficacy have not been established in pediatric patients (less than 18 years of age).

Dialysis

Hemodialysis: 600 mg orally once a day
Since telithromycin may be partially removed by hemodialysis, it is recommended that it be administered after dialysis sessions on hemodialysis days.

Other Comments

Telithromycin may be given without regard to meals.

Patients should be cautioned about potential visual difficulties, loss of consciousness, confusion, or hallucinations with regard to driving or engaging in other potentially hazardous activities.

To reduce the risk of development of drug resistant organisms, antibiotics should only be used to treat or prevent proven or suspected infections caused by bacteria. Culture and susceptibility information should be considered when selecting treatment or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy. Patients should be advised to avoid missing doses and to complete the entire course of therapy.

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