Manufacturer: Biogen and Genentech Indications: Rituximab is indicated for relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma and for diffuse, CD20-positive, large B-cell non-Hodgkin’s lymphoma in combination with CHOP (cyclo-phosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
Continue reading " Drug Safety Revisions: Rituximab (Rituxan®) "
Efavirenz (Sustiva generic) Manufacturer: Bristol-Myers Squibb Indication: This prescription-only agent is used in combination with other medications to treat human immunodeficiency virus (HIV) infection. Reason for FDA Intervention: The product’s labeling has been revised to include safety and efficacy data representing 168 weeks of treatment from Study 006 and other available information.
Rosenberg and colleagues conducted a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of a one-time dose of eszopi-clone using the “first-night effect” model of transient insomnia. The first-night effect refers to the insomnia that commonly occurs when someone is assessed in a sleep laboratory.
Continue reading " Eszopiclone (Lunesta): Rosenberg et al. "
Eszopiclone, a non-benzodiazepine hypnotic agent, is a pyrrolopyrazine derivative of the cyclopyrrolone class. It is the (S)-configuration isomer of zopi-clone (Imovane™, Aventis), a hypnotic agent that has been available in Europe since 1987. Eszopiclone is a white to light-yellow crystalline solid. According to the manufacturer, it is very slightly soluble in water, slightly soluble in [...]
Continue reading " Eszopiclone (Lunesta): CHEMICAL AND PHYSICAL PROPERTIES "
Because eszopiclone is metabolized via CYP3A4 and CYP2E1, caution is recommended when a potent CYP3A4 inhibitor (e.g., ketoconazole, itracon-azole, clarithromycin, troleandomycin, nefazodone, ritonavir, nelfinavir) is co-administered. A lower dose, such as 1 mg, should be prescribed when es-zopiclone is used with any of these drugs.
Continue reading " Eszopiclone (Lunesta): DRUG INTERACTIONS "
On the basis of two published clinical trials (see “Clinical Efficacy” on page 389), the most commonly reported adverse drug event (ADE) was an unpleasant taste, with an incidence of 17% to 26%, with no dose-dependent relationship. Somnolence was reported equally at all doses, with an incidence of 4% to 9%. However, headache was reported [...]
Continue reading " Eszopiclone (Lunesta): ADVERSE DRUG EFFECTS "
INTRODUCTION Insomnia is a condition that affects nearly everyone at some point in life. Up to 40% of American adults have intermittent insomnia, and 10% to 15% have a chronic sleep problem. The main presentation of insomnia is difficulty with either falling asleep or maintaining sleep throughout the night.
