Telithromycin

DEA Class;  Rx

Common Brand Names; Ketek

KETEK is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of KETEK. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression.

KETEK is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibacterial

KETEK is contraindicated in patients with a history of hypersensitivity to telithromycin, any components of KETEK tablets, or any macrolide antibacterial.

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

• Myasthenia gravis 
• Hepatotoxicity 
• QTc prolongation 
• Visual disturbances and loss of consciousness 
• Clostridium difficile-associated diarrhea 

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.

Physicians and patients should monitor for the appearance of signs or symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, alcoholic stools, liver tenderness, or hepatomegaly. Patients with signs or symptoms of hepatitis must be advised to discontinue KETEK and immediately seek medical evaluation, which should include liver function tests. If clinical hepatitis or transaminase elevations combined with other systemic symptoms occur, KETEK should be permanently discontinued.

Telithromycin is classified in FDA pregnancy risk category C.

risedronate sodium

Ketek Oral Tab: 300mg, 400mg