Single Intravenous Loading Dose Research Articles

Ibalizumab for the treatment of multidrug-resistant HIV-1 infection.

Ibalizumab, a humanized monoclonal antibody to CD4, was recently approved by the United States Food and Drug Administration (FDA) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen. Ibalizumab is the first in a new class of antiretroviral drugs designated as post-attachment inhibitors. It exerts its antiviral effect by noncompetitive binding of CD4, thereby blocking conformational changes in the CD4-gp120 complex that are essential for viral entry. Clinical studies have demonstrated ibalizumab's significant antiviral activity in patients with advanced HIV disease and extensive treatment experience, who had limited treatment options. Ibalizumab is administered intravenously at a dose of 800 mg every 2 weeks following a single intravenous loading dose of 2000 mg. The most common adverse reactions reported with the use of ibalizumab are diarrhea, dizziness, nausea and rash.

Use of aspirin as sole oral antiplatelet therapy in acute flow diversion for ruptured dissecting aneurysms

Subarachnoid hemorrhage secondary to rupture of a circumferential dissecting aneurysm continues to be a treatment dilemma. Vessel sacrifice, when possible, continues to be the safest option but in certain cases...

Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide‐naive patients with partial‐onset seizures

To examine the safety and tolerability of rapidly initiating adjunctive lacosamide via a single intravenous loading dose followed by twice-daily oral lacosamide in lacosamide-naive adults with partial-onset seizures. This open-label, multicenter trial, enrolled patients with epilepsy who were taking 1-2 antiepileptic drugs (AEDs) in one of four sequential cohorts containing 25 subjects each. An intravenous lacosamide loading dose (200, 300, or 400 mg) was administered over 15 min followed 12 h later by initiation of oral dosing consisting of one-half of the loading dose administered twice daily for 6.5 days. The first cohort was administered lacosamide 200 mg/day, followed by a cohort at 300 mg/day, and then a cohort at 400 mg/day. The results from each cohort were evaluated before enrolling the next highest dose level. The fourth cohort enrolled patients at the highest dose with clinically acceptable safety and tolerability results. Safety evaluations included treatment-emergent adverse events (TEAEs), patient withdrawals due to TEAEs, and changes in vital signs, 12-lead electrocardiography (ECG) studies, laboratory parameters, and clinical examinations. Postinfusion lacosamide plasma concentrations were also evaluated. A total of 100 patients were enrolled, 25 in each cohort. The loading dose for the repeat cohort was 300 mg; therefore, 25 patients were enrolled at 200 mg/day, 50 at 300 mg/day, and 25 at 400 mg/day. Most TEAEs occurred within the first 4 h following infusion; dose-related TEAEs (incidence ≥10%) during this timeframe included dizziness, somnolence, and nausea. Seven patients withdrew, all due to TEAEs: three (6%) from the combined 300 mg group and four (16%) from the 400 mg group; four of these patients discontinued within 4 h following infusion. The most common TEAEs leading to discontinuation (overall incidence >1%) were dizziness (6%), nausea (5%), and vomiting (3%). No clinically relevant pattern of changes from baseline ECG, clinical laboratory parameters, or vital signs were observed. Trough plasma concentrations suggested that near steady-state lacosamide concentrations were achieved with a single intravenous loading dose. Intravenous loading doses of 200 and 300 mg lacosamide administered over 15 min followed by oral lacosamide were well tolerated in lacosamide-naive patients. The 400-mg loading dose was less well tolerated due to a higher frequency of dose-related TEAEs. These results support the feasibility of rapid initiation of adjunctive lacosamide treatment.

96: A Multicenter, Open-Label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Maintenance as Adjunctive Therapy In Patients With Partial-Onset Seizures

96: A Multicenter, Open-Label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Maintenance as Adjunctive Therapy In Patients With Partial-Onset Seizures

Sequential Levels of Ceftriaxone in Intervertebral Disc Removed As Part of Scoliosis Surgery

A single intravenous loading dose of 1 g ceftriaxone was injected at different intervals before surgery for correction of spinal scoliosis. Serum and concomitant disc samples were obtained and assay was performed using high-pressure liquid chromatography. Data showed that the antibiotic levels in intervertebral disc space reached 3.5 mcg/mg, which is above the minimum inhibitory concentration for most of the relevant pathogens, as early as 1 hour after intravenous administration. These therapeutic levels were maintained for more than 5 hours, an accepted period for most spinal surgical procedures.