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 ...
Jul 16, 2019 · Most discontinuations in the KETEK group were due to adverse reactions in the gastrointestinal body system, primarily diarrhea (0.9% for KETEK vs. 0.7% for comparators), and nausea (0.7% for KETEK vs. 0.5% for comparators). Adverse reactions (ARs) occurring in clinical studies in 2% or more of KETEK patients are included below.
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A nurse is caring for a patient who has an acute bacterial exacerbation of chronic bronchitis and who has been prescribed telithromycin (Ketek). Before therapy begins, the nurse will assess the patient for a history of which of the following? Select one: a. Hepatic insufficiency b. Infection of the eye c. Ulcerative colitis d. Hearing loss
Telithromycin has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias, including torsades de pointes. Thus, telithromycin 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.
Telithromycin is excreted in breast milk of rats. Telithromycin may also be excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when KETEK is administered to a nursing mother.
Concomitant administration of telithromycin with intravenous or oral midazolam resulted in 2- and 6-fold increases, respectively, in the AUC of midazolam due to inhibition of CYP 3A4-dependent metabolism of midazolam. (See PRECAUTIONS)
When metoprolol was co-administered with telithromycin, there was an increase of approximately 38% on the C max and AUC of metoprolol, however, there was no effect on the elimination half-life of metoprolol. Telithromycin exposure is not modified with concomitant single-dose administration of metoprolol. (See PRECAUTIONS, Drug interactions)
The plasma peak and trough levels of digoxin were increased by 73% and 21%, respectively, in healthy volunteers when co-administered with telithromycin. However, trough plasma concentrations of digoxin (when equilibrium between plasma and tissue concentrations has been achieved) ranged from 0.74 to 2.17 ng/mL. There were no significant changes in ECG parameters and no signs of digoxin toxicity. (See PRECAUTIONS)
Telithromycin belongs to the ketolide class of antibacterials and is structurally related to the macrolide family of antibiotics. Telithromycin concentrates in phagocytes where it exhibits activity against intracellular respiratory pathogens. In vitro, telithromycin has been shown to demonstrate concentration-dependent bactericidal activity against isolates of Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP 1 ]).
Telithromycin blocks protein synthesis by binding to domains II and V of 23S rRNA of the 50S ribosomal subunit. By binding at domain II, telithromycin retains activity against gram-positive cocci (e.g., Streptococcus pneumoniae) in the presence of resistance mediated by methylases ( erm genes) that alter the domain V binding site of telithromycin. Telithromycin may also inhibit the assembly of nascent ribosomal units.
Telithromycin, a ketolide, differs chemically from the macrolide group of antibacterials by the lack of α-L-cladinose at position 3 of the erythronolide A ring, resulting in a 3-keto function. It is further characterized by a C11-12 carbamate substituted by an imidazolyl and pyridyl ring through a butyl chain.
Telithromycin belongs to the ketolide class of antibacterials and is structurally related to the macrolides. Telithromycin blocks protein synthesis by binding to domains II and V of 23S rRNA of the 50S ribosomal subunit. Telithromycin may also inhibit the assembly of nascent ribosomal units.
Midazolam (CYP3A4 Substrate) Use with Caution (Plasma exposure likely to be increased) Monitor for benzodiazepine-related adverse reactions and adjust midazolam dosage if necessary. Use caution with other benzodiazepines, which are metabolized by CYP3A4 and undergo a high first-pass effect (e.g., triazolam).
Other drugs metabolized by CYP3A4, such as carbamazepine, cyclosporine, tacrolimus, sirolimus, hexobarbital, and phenytoin (CYP3A4 Substrates) Use with Caution (Plasma exposure likely to be increased) No specific drug interaction studies have been performed to evaluate these drug-drug interactions with KETEK.
Co-administration of theophylline may worsen gastrointestinal effects such as nausea and vomiting, especially in female patients. Administer theophylline and KETEK 1 hour apart to decrease the likelihood of gastrointestinal side effects. Oral Anticoagulants.
KETEK is a strong CYP3A4 inhibitor and this interaction may occur while using both drugs at their recommended dosages. If co-administration of KETEK and colchicine is necessary in patients with normal renal and hepatic function, reduce the dosage of colchicine.
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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
Mechanism of Action. Telithromycin belongs to the ketolide class of antibacterials and is structurally related to the macrolides. Telithromycin blocks protein synthesis by binding to domains II and V of 23S rRNA of the 50S ribosomal subunit. Telithromycin may also inhibit the assembly of nascent ribosomal units.
Of the total number of patients in Phase 3 clinical trials (n=4,780), Ketek was administered to 694 patients who were 65 years and older, including 231 patients who were 75 years and older. Efficacy and safety in patients 65 years and older were generally similar to that observed in younger patients; however, greater sensitivity of some older individuals cannot be ruled out. [see Clinical Pharmacology (12.3)]
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.
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.
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. [see Adverse Reactions (6.1)]
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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
Telithromycin is a strong inhibitor of CYP3A4 and also a CYP3A4 substrate. Co-administration of Ketek and drugs that induce or inhibit the cytochrome P450 3A4 enzyme system may affect Ketek plasma concentrations resulting in diminished efficacy or an increase or prolongation of both the therapeutic and adverse effects; therefore, appropriate dosage adjustments may be necessary for drugs co-administered with telithromycin.
An immunocompromised patient in a critical care setting has developed a respiratory infection that has been attributed to methicillin-resistant Staphylococcus aureus (MRSA). The nurse should anticipate that the patient will require treatment with. answer.
Dexmethylphenidate will improve Scott’s attention span so that he will be able to complete a task. A 10-year-old boy is taking dextroamphetamine (Dexedrine) daily for ADHD. At each clinic visit, the nurse’s priority assessment would be. height and weight.
Opioid receptors are highly concentrated in some regions of the central nervous system , including the ascending and descending pain pathways and portions of the brain essential to the endogenous analgesia system.