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PubMed2000

Development of model aqueous ophthalmic solution of indomethacin.

A new model aqueous solution of indomethacin was developed on the basis of Pluronic F68 (15%) and F127 (10%). They showed some practical advantages over the models prepared with polyols and polysorbate 80, which were used for comparison. It was found that both Pluronics acted very similarly and were more effective as solubilizers, created an appropriate viscosity, and formed reversible gels at higher temperatures, ensured the indomethacin chemical stability and prolonged in vitro drug diffusion, and showed high physiological tolerance on rabbit eyes. Moreover, indomethacin stability and solution viscosity in the presence of Pluronics did not change after heat sterilization (i.e., the samples can bear heat sterilization).

Excipients↗
PubMed2001

Effects of adhesives and permeation enhancers on the skin permeation of captopril.

To formulate a transdermal drug delivery system of captopril, monolithic adhesive matrix type patches containing 20% captopril, different pressure-sensitive adhesives, and various permeation enhancers were prepared using a labcoater. The effects of the adhesives and permeation enhancers on skin permeation of captopril from the prepared patches were evaluated using Franz diffusion cells fitted with excised rat skins. The permeation rate of the drug through the excised skin was dependent on the type of polyacrylate copolymers studied. Fatty alcohols resulted in a pronounced enhancing effect on the skin permeation of captopril, while dimethyl sulfoxide, N-methyl-2-pyrrolidone, oleic acid, Transcutol, and polysorbate 20 showed no significant enhancing effect. The permeation-enhancing effect of the fatty alcohols reached the maximum at the level of 100%. Based on these results, a captopril patch may be developed with further optimization.

Acrylates↗
PubMed2002

Development of a topical suspension containing three active ingredients.

The objective of this study was to develop a topical suspension that contains sarafloxacin hydrochloride (1 mg/mL), triamcinolone acetonide (1 mg/mL), and clotrimazole (10 mg/mL), and is stable at room temperature (15-28 degrees C) for clinical usage. Due to the difference in the physicochemical properties and chemical stability profiles of these three active ingredients, it is a challenge to develop a stable suspension formulation containing these three drugs. In this study, the stability of these drugs in different buffer solutions was determined under different accelerated isothermal conditions. The Arrhenius equation was subsequently utilized to predict the room-temperature stability of these three drugs in these buffer solutions. By knowing the room-temperature solubility of the drugs in the buffer solution, the stability of the drugs in suspension was predicted. As a result, a 0.02 M phosphate buffer (pH 7.0) containing 0.02% (w/v)polysorbate 20, 1% (w/v) NaCl, and 0.1% (w/v) EDTA was determined to be an acceptable medium. In addition, 0.35% (w/v) high-viscosity carboxymethylcellulose (HV-CMC) was first selected as the suspending agent to enhance the redispersibility of the suspension. Stability data further supported that all three drugs were stable in the suspension containing HV-CMC with less than 5% potency loss for at least 6 months at 40 degrees C and 12 months at 25 degrees C. However, the viscosity drop of this HV-CMC formulation at 25 degrees C and 40 degrees C became a product stability concern. To improve the viscosity stability of the suspension, the medium-viscosity carboxymethylcellulose (MV-CMC) was selected to replace the HV-CMC as the suspending agent. The optimal combination of MV-CMC and sodium chloride in achieving the most desirable dispersion properties for the formulation was determined through the use of a 32 factorial design. The optimal formulation containing 1% MV-CMC and 1% sodium chloride has shown improved viscosity stability during storage and has been used for clinical studies.

Administration, Topical↗
PubMed2002

Gadolinium-loaded nanoparticles engineered from microemulsion templates.

Microemulsions (oil-in-water) have been used as templates to engineer stable emulsifying wax and Brij 72 (polyoxyl 2 stearyl ether) nanoparticles. The technique is simple, reproducible, and amenable to large-scale production of stable nanoparticles having diameters below 100 nm. Investigation of the process variables showed that the amount of surfactant used in the preparation of microemulsion templates had the greatest influence on the microemulsion window, as well as the properties and stability of the cured nanoparticles. Emulsifying wax and Brij 72 nanoparticles (2 mg/mL) made with 3 mM polyoxyl 20 stearyl ether and 2.3mM polysorbate 80, respectively, were the most stable based on retention of nanoparticle size over time. Gadolinium acetylacetonate (GdAcAc), a potential anticancer agent for neutron capture therapy (NCT), was entrapped in stable nanoparticles. The apparent water solubility of GdAcAc was increased more than 2000-fold by entrapment into nanoparticles. The entrapment efficiency of GdAcAc was about 100% for emulsifying wax nanoparticles and 86% for Brij 72 nanoparticles, as determined by gel permeation chromatography (GPC). Elution profiles were obtained with light scattering (counts per second) to detect nanoparticles and ultraviolet (UV) absorption of GdAcAc at 288 nm. Challenges of these cured nanoparticles in biologically relevant media such as 10% fetal bovine serum, 10 mM phosphate-buffered saline, 150 mM NaCl, and 10% lactose at 37 degrees C for 60 min demonstrated that these nanoparticles are stable. The ease of preparation of these very small and stable nanoparticles, and the ability to entrap lipophilic drugs such as GdAcAc with high efficiency, suggested that these systems may have potential in cell targeting, especially for specific delivery to tumor cells for NCT.

Capsules↗
PubMed2003

Effect of excipients on the stability and aerosol performance of nebulized aviscumine.

Pulmonary delivery is an attractive alternative route to deliver protein drugs that are currently delivered by injection. Inhalation therapy via nebulizers is a well accepted way for pulmonary application of proteins considering the formulation difficulties of MDIs or DPIs. This research presents the effect of variable excipients on the stability and aerosol performance of freeze-dried aviscumine after reconstitution and nebulization. Aviscumine formulations containing 100 mmol/L Tris buffer, 0.1% (w/v) Polysorbate 80, 0.01% (w/v) Na(2)-EDTA and 8% (w/v) Hydroxyethyl starch have been lyophilized and reconstituted with a buffered isotonic solution pH 8. The aviscumine activity was determined by a binding assay directly after reconstitution and after nebulization with a PariBoy air-jet nebulizer, a Multisonic and a Systam ultrasonic nebulizer. The stabilization of aviscumine by the addition of variable buffer salts to the reconstitution medium, such as 50, 100, and 200 mmol/L Tris buffer, 20 and 100 mmol/L phosphate buffer, and 20 and 100 mmol/L Tricine buffer, was studied. About 50% of aviscumine activity was lost after 20 min nebulization time without any additives. Nevertheless, higher buffer concentrations confer greater stability. About 70% of the aviscumine activity could be retained by the addition 0.03% octanoyl-N-methylglucamide and 100 mmol/L Tricine to the reconstitution medium.

Administration, Inhalation↗
PubMed1999

Cell injury effect of isopropyl unoprostone, an antiglaucoma agent, on cultured human conjunctival cells.

Corneal epithelial disorders due to isopropyl unoprostone (unoprostone) eye drops, a prostaglandin F2alpha-related substance and antiglaucoma agent, have been reported since the agent became commercially available. The in vitro study was performed to clarify the mechanism of cell injury due to unoprostone. After Chang's human conjunctival cells were cultured and exposed for 2, 4 and 8 min to 0.03, 0.06, and 0.12% unoprostone and its vehicle containing 1% polysorbate 80, a cell growth assay and DNA histogram analysis using a flow cytometer and scanning electron microscopy were performed. The number of living cells was reduced, and the floating cell number increased immediately after exposure to 0.12% unoprostone for 8 min. When the cells were cultured for another 48 hr after exposure to unoprostone, the cell number was reduced dose and time dependently. Exposure for 2 min to 0.12% unoprostone showed no effect on the cell cycle. However, exposure for 2 min to 0.12% unoprostone caused alteration of the cell surface, such as reduction of microvilli and filopodia. The vehicle did not affect the cell surface or cell growth. These results suggest that clinically instilled eye drops ofunoprostone can affect cell structure, inhibit cell growth, and gradually cause corneal epithelial disorders.

Cell Division↗
PubMed1986

Absorption of water-miscible forms of vitamin E in a patient with cholestasis and in thoracic duct-cannulated rats.

Oral administration of vitamin E (100 mg tocopherol X kg-1 X day-1) as tocopheryl polyethylene glycol 1000 succinate (TPGS) to a child with congenital hepatic cholestasis (unresponsive to oral administration of dl-alpha-tocopheryl acetate) promoted an increase of tocopherol in plasma and adipose tissue while tocopheryl acetate emulsified with medium chain triglycerides and polysorbate 80 (MCT-E) did not. alpha-Tocopherol absorption, quantitated in thoracic duct-cannulated rats receiving intraduodenal infusions of soybean oil and saline, was similar for TPGS, MCT-E, and dl-alpha-tocopheryl acetate; gamma-tocopherol absorption from soybean oil was not affected by the presence of the supplemental alpha-tocopherol. Following bile duct ligation in one rat, TPGS promoted the absorption of alpha-tocopherol while absorption of gamma-tocopherol from soybean oil was decreased 30 fold, demonstrating that TPGS, which forms a micellar solution, delivers alpha-tocopherol through the unstirred water layer to enterocytes, while free tocopherol (alpha or gamma) absorption requires the presence of bile salts.

Administration, Oral↗
PubMed2005

Novel formulations of taxanes: a review. Old wine in a new bottle?

Over the past two decades, the taxanes have played a significant role in the treatment of various malignancies. However, the poor solubility of these compounds necessitates the inclusion of surfactant vehicles in their commercial formulations. Cremophor EL and polysorbate 80 have long comprised the standard solvent system for paclitaxel and docetaxel, respectively. A number of pharmacologic and biologic effects related to both of these drug formulations have been described, including clinically relevant acute hypersensitivity reactions and peripheral neuropathy. In addition, these solvents affect the disposition of intravenously administered solubilized drugs and leach plasticizers from polyvinylchloride infusion sets. A number of strategies to develop formulations of surfactant-free taxanes have been developed. They include albumin nanoparticles, polyglutamates, taxane analogs and prodrugs, emulsions, and lipsomes. An overview of these novel formulations of taxanes, their mechanisms of action, pharmacokinetics, dose and administration, adverse effects, and clinical efficacy will be discussed.

Bridged-Ring Compounds↗
PubMed1976

Effect of a topical interferon inducer on rhinovirus infections in volunteers.

Six controlled trials of a topical interferon inducer, N',N'-diotadecyl-N',N'-bis-(2-hydroxyethyl) propanediamine (CP 20961), against rhinovirus infection in volunteers were reviewed. Controls were the drug vehicle (which consisted of a mixture of polysorbate-80 in gylcerol and saline), saline only, and oral lactose. Multiple doses of the inducer given before challenge in any of three regimens reduced the symptomatic response to viral infection. Treatment with three doses of drug the day before challenge enhanced the interferon response to virus; four days of treatment with either the drug or its vehicle before challenge produced a refractoriness to further interferon induction. Both the drug and its vehicle were capable of inducing nasal interferon. When interferon was present at the time of viral inoculation, symptoms were reduced with or without an increase in the interferon response to infection. The rates of infection and illness were increased after a single dose of drug and decreased after a single dose of the vehicle alone.

Administration, Intranasal↗
PubMed2003

Development and evaluation of a thermoreversible ovule formulation of stampidine, a novel nonspermicidal broad-spectrum anti-human immunodeficiency virus microbicide.

Stampidine [2',3'-didehydro-2',3'-dideoxythymidine 5'-[p-bromophenyl methoxyalaninyl phosphate], a prodrug of stavudine (STV/d4T) with improved anti-HIV activity, is undergoing development as a novel nonspermicidal microbicide. Here, we report the stability of stampidine as a function of pH, preparation of a novel thermoreversible ovule formulation for mucosal delivery, its dissolution profile in synthetic vaginal fluid, and its mucosal toxicity potential as well as systemic absorption in the rabbit model. Stampidine was most stable under acidic conditions. Stampidine was solubilized in a thermoreversible ovule formulation composed of polyethylene glycol 400, polyethylene glycol fatty acid esters, and polysorbate 80. Does were exposed intravaginally for 14 days to an ovule formulation with and without 0.5%, 1%, or 2% stampidine corresponding to 1 x 107- to 4 x 107-fold higher than its in vitro anti-HIV IC50 value. Vaginal tissues harvested on Day 15 were evaluated for mucosal toxicity and cellular inflammation. Additionally, does were exposed intravaginally to stampidine, and plasma collected at various time points was assayed by analytical HPLC for the prodrug and its bioactive metabolites. Stampidine did not cause mucosal inflammation. The vaginal irritation scores for 0.5-2% stampidine were within the acceptable range for clinical trials. The prodrug and its major metabolites were undetectable in the blood plasma. The marked stability of stampidine at acidic pH, its rapid spreadability, together with its lack of mucosal toxicity or systemic absorption of stampidine via a thermoreversible ovule may provide the foundation for its clinical development as an easy-to-use, safe, and effective broad-spectrum anti-HIV microbicide without contraceptive activity.

Administration, Intravaginal↗
PubMed1991

Long-lasting epidural sensory blockade by n-butyl-p-aminobenzoate in the terminally ill intractable cancer pain patient.

An aqueous suspension of n-butyl-p-aminobenzoate (BAB), a highly lipid-soluble congener of benzocaine, was applied epidurally in terminally ill cancer patients with intractable pain. The suspension consisted of 10% BAB and 0.025% of the nonionic surfactant polysorbate 80 in 0.9% sodium chloride. Twelve consecutive patients received epidural BAB because pain was uncontrollable either by palliative radiotherapy or oral or epidural administrations of analgesics. The catheter or injecting needle was positioned at the segmental level of the pain. Repeated epidural injections were administered. In all patients, long-lasting sensory blockade (segmental analgesia) occurred, accompanied by a marked reduction or even absence of pain. In all patients, treatment with epidural opioids, alone or combined with local anesthetics, was no longer necessary. Five of the 12 patients did not require further administration of oral opioids. Motor, bowel, and bladder function were well preserved. In 6 patients, extensive necropsy of the spinal cord and spinal nerves did not reveal pathomorphologic changes. The outer aspect of the dura showed signs of focal necrosis on microscopy, yet its collagen structure and thickness were unchanged. Epidurally, focal infiltrative reactions were seen. The epidural use of an extremely lipid-soluble--hence hydrophobic--local anesthetic, with an exceptionally low pKa (2.3), formulated in suspension of the base, is conceptually innovative and needs further investigation. The authors conclude that the epidural administration of a BAB suspension may be an effective alternative to the neurolytic agents alcohol and phenol and may replace procedures such as cordotomy. Further investigation to determine the safety of BAB in this patient group appears warranted.

Adult↗
PubMed2004

Mechanism by which a sustained inflation can worsen oxygenation in acute lung injury.

BACKGROUND: Sustained lung inflations (recruitment maneuvers [RMs]) are occasionally used during mechanical ventilation of patients with acute lung injury to restore aeration to atelectatic alveoli. However, RMs do not improve, and may even worsen, gas exchange in a fraction of these patients. In this study, the authors sought to determine the mechanism by which an RM can impair gas exchange in acute lung injury. METHODS: The authors selected a model of acute lung injury that was unlikely to exhibit sustained recruitment in response to a lung inflation. In five sheep, lung injury was induced by lavage with 0.2% polysorbate 80 in saline. Positron emission tomography and [13N]nitrogen were used to assess regional lung function in dependent, middle, and nondependent lung regions. Physiologic data and positron emission scans were collected before and 5 min after a sustained inflation (continuous positive airway pressure of 50 cm H2O for 30 s). RESULTS: All animals showed greater loss of aeration and higher perfusion and shunting blood flow in the dependent region. After the RM, Pao2 decreased in all animals by 35 +/- 22 mmHg (P < 0.05). This decrease in Pao2 was associated with redistribution of pulmonary blood flow from the middle, more aerated region to the dependent, less aerated region (P < 0.05) and with an increase in the fraction of pulmonary blood flow that was shunted in the dependent region (P < 0.05). Neither respiratory compliance nor aeration of the dependent region improved after the RM. CONCLUSIONS: When a sustained inflation does not restore aeration to atelectatic regions, it can worsen oxygenation by increasing the fraction of pulmonary blood flow that is shunted in nonaerated regions.

Animals↗
PubMed2001

Increased cytotoxicity and stability of Lipiodol-pirarubicin emulsion compared to classical doxorubicin-Lipiodol: potential advantage for chemoembolization of unresectable hepatocellular carcinoma.

There is no well-defined curative treatment for advanced and unresectable hepatocellular carcinoma. The widely used transarterial chemoembolization (TACE) with a doxorubicin-Lipiodol emulsion has not been shown to improve survival in randomized studies. Further, obstruction of the hepatic artery used in the procedure is badly tolerated in patients with cirrhosis. Drugs with a more rapid penetration into the cancer cells are likely to eliminate the need for obstruction of the hepatic artery. We therefore compared the cytotoxicity of another anthracycline pirarubicin with that of the commonly used doxorubicin. In this report, we show that pirarubicin has a greater in vitro cytotoxic effect than doxorubicin on the HepG2 and Hu-H7 human hepatoma cell lines. Pirarubicin emulsion with Lipiodol is more stable at 37 degrees C than doxorubicin-Lipiodol. Moreover, pirarubicin accumulates at a greater extent in the oil phase, permitting Lipiodol to act as a slow-releasing vector for the anthracycline. Further, amiodarone, a multidrug resistance inhibitor, was shown to decrease the intrinsic resistance of HepG2 and Hu-H7 cells to both anthracyclines, and the presence of polysorbate 80 in the amiodarone preparation increased the stability of the anthracycline-Lipiodol emulsions. We therefore conclude that pirarubicin is a better candidate for TACE than doxorubicin. The rapid and increased cytotoxicity of pirarubicin on hepatoma cancer cells and the stability of the pirarubicin-Lipiodol amiodarone emulsion could avoid the complete obstruction of the hepatic artery by Gelfoam sponges, and provide a better tolerated method of TACE in patients with latent liver insufficiency.

Amiodarone↗
PubMed2001

Effects of E047/1, a new antiarrhythmic drug, on experimental atrial fibrillation in anesthetized dogs.

Effects of a new antiarrhythmic drug, E047/1, on atrial fibrillation were studied. Atrial conduction velocity and effective refractory period (ERP), electrocardiogram parameters (RR, PR, QRS, QT, and QTc intervals), systolic and diastolic blood pressure, and plasma concentrations of E047/1 were determined during the first 30 min after sequential administration of 1, 3, and 6 mg/kg of E047/1 in polysorbate 60 (Tween 60) to anesthetized, opened-chest dogs with vagally induced atrial fibrillation. Epicardial mapping (using 224 unipolar electrodes) was used to determine atrial fibrillation cycle length and activation sequence before and after drug administration. E0471, 3 mg/kg, prevented atrial fibrillation reinduction, and 6 mg/kg terminated atrial fibrillation. E047/1, 6 mg/kg, increased atrial ERP from 124 +/- 9 to 168 +/- 14 ms (p < 0.05). Conduction velocity decreased from 103 +/- 4 cm/s to 87 +/- 3 cm/s (p < 0.05). Epicardial mapping showed that under drug influence there was gradual reduction of wavelet number until termination of the reentrant excitation. Atrial fibrillation cycle length increased before atrial fibrillation termination from 93 +/- 4 to 137 +/- 12 ms (p < 0.05). The ability of E047/1 to terminate and prevent reinduction of experimental atrial fibrillation appears associated more with a significant prolongation of the atrial ERP than with a slowing of conduction. E047/1 appears to be a promising antifibrillatory agent.

Animals↗
PubMed2001

Aesthetic comparison of wound closure techniques in a porcine model.

OBJECTIVE: To compare various commonly used closure techniques and their esthetic results. Also to look for differences in cost, time, and ease of use among the methods. DESIGN: A prospective comparison in a porcine skin model with a blinded assessment of outcomes. METHODS: Thirty 6-cm, full-thickness skin incisions were made on the back of two domestic white swine. Undermining was accomplished, and buried simple, interrupted, absorbable, braided (Polysorb, US Surgical) subdermal sutures were placed in a uniform fashion in each wound. The skin was then closed using one of the following five methods: running subcuticular 4-0 nylon, running subcuticular 4-0 absorbable monofilament (Biosyn, US Surgical), tissue glue (Dermabond, Ethicon), adhesive tape, or running subcuticular nylon with intradermal injection of hyaluronic acid. Nonabsorbable sutures and tape were removed on postoperative day 7, and photographs were taken at regular intervals during a 12-week healing period. Biopsies were taken from wounds in each group at 2 weeks and 12 weeks for histologic comparison. Independent observers evaluated the photographs, and an independent histologist evaluated the biopsies to look for differences in inflammation and scar formation. The surgeons who performed the wound closure rated the ease of use and amount of time required for each technique. RESULTS: Adhesive tape closure was faster and easier to perform. There were no significant differences among the adhesive tape, nylon, or absorbable suture groups regarding cosmetic appearance throughout the study period. The tissue glue wounds had more of a tendency to dehisce. Adhesive tape is less expensive than the other methods when material costs and operating room time are considered. CONCLUSION: Adhesive tape closure of surgical wounds is cosmetically acceptable, convenient, and saves both time and material costs. We recommend it as an alternative for closure of neck incisions.

Absorbable Implants↗
PubMed1986

Use of absorbable staples for closure of proximal end of ileal loops.

The use of the GIA stapler has reduced dramatically the operative time for the creation of urinary division ileal and colonic loops. It is widely known that steel staples in the urinary tract prompt stone formation around a foreign body. A case of stone formation around a GIA stainless steel staple is presented. A possible solution to this potential problem by the use of the new Polysorb-Lactimer absorbable TA55 stapler is presented.

Female↗
PubMedDate not supplied

Pharmacology and toxicology of a new aqueous formulation of intravenous amiodarone (Amio-Aqueous) compared with Cordarone IV.

Hypotension is the most frequent adverse event reported with intravenous amiodarone (Cordarone IV). The hypotension has been attributed to the vasoactive solvents of the formulation, polysorbate 80 and benzyl alcohol, both known to exhibit negative inotropy and hypotensive effect. A new aqueous formulation of intravenous amiodarone (Amio-Aqueous) does not contain vasoactive excipients and may be less toxic and cause less hypotension than Cordarone IV. This hypothesis was tested in a series of animal studies with direct comparison of Amio-Aqueous and Cordarone IV. All studies were performed on Sprague-Dawley rats. The acute toxicology study showed that both LD50 and LD100 were 30% greater for Amio-Aqueous than for Cordarone. At the dose at which all animals expired on Cordarone, 50% of animals were still alive on Amio-Aqueous. The study on myocardial contractility showed that Amio-Aqueous was a far less negative inotropic than Cordarone IV (P < 0.001). Amio Aqueous did not have an effect on contractility at 5- and 10-mg/kg dose levels while Cordarone resulted in a 25% (P < 0.01) and 29% (P < 0.002) decrease, respectively. The study on arterial blood pressure showed that Cordarone caused a significant decrease in blood pressure at each of the 3, 5, 10, and 20 mg/kg doses (P < 0.05 to P < 0.001) while Amio-Aqueous did not. The study on the antiarrhythmic effects showed comparable efficacy for both formulations. In conclusion, Cordarone IV was more toxic and caused significant hypotension and negative inotropy while Amio-Aqueous lacked the hypotensive and cardiotoxic properties of Cordarone. Therefore, Amio-Aqueous is a safer alternative than the standard formulation.

Amiodarone↗
PubMed2005

Hepatotoxicity during rapid intravenous loading with amiodarone: Description of three cases and review of the literature.

OBJECTIVE: Atrial fibrillation is the most common arrhythmia after cardiac surgery. Amiodarone can effectively prevent and control postoperative atrial and ventricular fibrillation. Acute hepatic damage after intravenous amiodarone, which can be fatal, is not well recognized. We describe three cases of acute hepatocellular injury after intravenous amiodarone administration in critically ill patients. Another 25 published cases and six cases reported to the Swiss Pharmacovigilance Center (Swissmedic) are discussed. DESIGN: This study consisted of a series of three case reports and review of the literature. SETTING: : This study was conducted at an operative critical care unit at the University Hospital Basel, Switzerland. PATIENTS: Three hemodynamically compromised patients after open heart surgery developed significant increases of transaminases (up to more than 100-fold of the upper limit of normal) shortly after the introduction of intravenous amiodarone. INTERVENTIONS AND MEASUREMENT: Cessation of intravenous amiodarone and of other potentially hepatotoxic drugs. RESULTS: Liver parameters significantly improved or returned to normal in all three patients, even after start of oral amiodarone in two patients. CONCLUSIONS: Amiodarone is a highly effective antiarrhythmic agent for the treatment and prevention of atrial and ventricular arrhythmias. Acute liver damage after intravenous amiodarone, possibly induced by the solubilizer polysorbate 80, is rare but potentially harmful. Amiodarone loading should therefore be adapted to the necessity of an immediate effect of the drug, and liver function should be monitored closely in critically ill patients. Oral maintenance therapy with amiodarone is possible, even in patients who developed liver disease during intravenous loading.

Aged↗