Indicated for the treatment of community-acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae, (including multidrug resistant S. pneumoniae [MDRSP✓], Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae, for patients 18 years or older.

✓MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are isolates resistant to two or more of the following antibacterials: penicillin, 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

KETEK should only be used to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. Ketek is not an effective treatment for viral infections. 

Acute hepatic failure and severe liver injury, in some cases fatal, have been reported in patients treated with KETEK. These hepatic reactions included fulminant hepatitis and hepatic necrosis leading to  liver transplant, and were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of a few doses of KETEK.

In the presence of severe renal impairment (CLCR less than 30 mL/min), including patients who need dialysis, reduce the dosage of KETEK to 600 mg once daily.

KETEK can prolong the QTc interval of the electrocardiogram in some patients leading to an increased risk for ventricular arrhythmias, including ventricular tachycardia and torsades de pointes with fatal outcomes. Thus, KETEK should be avoided in patients with congenital prolongation of the QTc interval, and in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (e.g., quinidine and procainamide) or Class III (e.g., dofetilide) antiarrhythmic agents.

KETEK may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation. Visual disturbances, some of them severe, included blurred vision, difficulty focusing, and diplopia.

Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with KETEK.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including KETEK, and may range in severity from mild diarrhea to fatal colitis.

KETEK is contraindicated in:

• Patients with myasthenia gravis
• History of hepatitis or jaundice with KETEK or any macrolide
• Concomitant administration of KETEK with cisapride or pimozide
• Concomitant administration of Ketek and colchicine in patients with renal or hepatic impairment

Hypotension, bradyarrhythmia and loss of consciousness have been observed in patients receiving concomitant treatment with calcium channel blockers that are substrates of CYP3A4 (e.g., verapamil, amlodipine, diltiazem).

Serious adverse reactions have been reported in patients taking KETEK concomitantly with CYP 3A4 substrates (colchicine, simvastatin, lovastatin, atorvastatin).

Co-administration of KETEK with ergot alkaloids (such as ergotamine or dihydroergotamine) is not  recommended.

Use with midazolam with caution.

Co-administration of KETEK and metoprolol in patients with heart failure could lead to metoprolol toxicity.

Use with digoxin with caution.

Co-administration of theophylline may worsen gastrointestinal effects such as nausea and vomiting, especially in female patients.

KETEK and oral anticoagulants concomitantly may potentiate the effects of the oral anticoagulants.

Avoid concomitant use with Rifampin.

Avoid concomitant use with other CYP3A4 inducers (phenytoin, carbamazepine, or phenobarbital).

Avoid concomitant use with Itraconazole and Ketoconazole.

There are no adequate and well-controlled studies in pregnant women. Animal studies: delayed fetal maturation.

Telithromycin is excreted in breast milk of rats. Telithromycin may also be excreted in human milk.

GoToSource

• Use in patients under the age of 18. GoToSource

• Scrub typhus. GoToSource

• Lyme disease. GoToSource

• Acute bacterial sinusitis and acute exacerbations of chronic bronchitis. GoToSource

Loss of consciousness, visual disturbances and liver failure. GoToSource  

Exacerbation of myasthenia gravis. GoToSource 

Prolongation of the QTc interval increasing the risk for ventricular arrhythmias, including ventricular tachycardia and torsades de pointes. GoToSource

Pseudomembranous colitis (swelling or inflammation of large intestine (colon). GoToSource

Pill esophagitis (medication-induced inflammation of esophagus). GoToSource

Hypersensitivity reaction. GoToSource

Taste and smell disorders and rhabdomyolysis (destruction of skeletal muscle). GoToSource

Aggravation of pneumonia, convulsions and empyema (accumulation of pus between lungs and inner surface of chest wall). GoToSource

Lawsuits filed for liver failure.