Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “TROMETHAMINE”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 37 records · Page 2Linked to original sources

Entry of tromethamine into the cerebrospinal fluid of humans after cerebrovascular events.

OBJECTIVE: The intravenous administration of tromethamine (INN, trometamol) lowers the intracranial pressure in patients with brain edema. One postulated mechanism of action is the increase of the pH of the cerebrospinal fluid. METHODS: To study tromethamine kinetics in serum and cerebrospinal fluid, nine patients with external ventriculostomies and normal serum creatinine values received 60 mmol intravenous tromethamine (Tris 36.34%, pH 11) over 30 minutes. Serum and cerebrospinal fluid were drawn repeatedly, and concentrations were determined by HPLC. RESULTS: Maximum serum concentrations (Cmax) ranged from 211 to 426 mg/L (median, 302 mg/L). The volume of distribution was 0.34 to 0.86 L/kg body weight (median, 0.53 L/kg), and the elimination half-life in serum (t1/2beta) 3.22 to 8.44 hours (median, 4.53 hours). Cerebrospinal fluid Cmax values ranging from 0.68 to 34.14 mg/L (median, 3.88 mg/L) were observed 1 to 12 hours after the end of the tromethamine infusion (median, 2 hours). AUC(CSF)/AUC(S) as a measure of overall cerebrospinal fluid penetration was 0.015 to 0.46 (median, 0.068). Cerebrospinal fluid Cmax and AUC(CSF)/AUC(S) depended on the function of the blood-cerebrospinal fluid barrier. Cerebrospinal fluid t1/2 (8.52 to 14.2 hours; median, 11.2 hours) was substantially longer than the t1/2beta in serum. In vitro, cerebrospinal fluid concentrations < or =30 mg/L did not influence cerebrospinal fluid pH. CONCLUSION: Tromethamine cerebrospinal fluid concentrations will be high enough to increase the pH of the cerebrospinal fluid only at large doses and in patients with a pronounced disruption of the blood-cerebrospinal fluid barrier.

Adult↗

Treatment of cyclophosphamide-induced hemorrhagic cystitis with intravesical carboprost tromethamine.

We review our experience with 18 consecutive patients who received intravesical carboprost tromethamine, an F2-alpha prostaglandin, for severe hemorrhagic cystitis following cyclophosphamide chemotherapy. Of the patients 16 were given cyclophosphamide for conditioning before bone marrow transplantation and 2 received the drug as cytotoxic therapy alone (dose range 3.6 to 15.8 gm.). All patients had severe gross hematuria that was refractory to forced diuresis and to continuous saline bladder irrigation. The intravesical prostaglandin therapy was initiated only after significant transfusion requirements (greater than 1 unit packed red blood cells per day) and/or numerous catheter manipulations for relief of clot retention. Eligible patients underwent complete clot evacuation followed by intravesical instillation of 0.4 to 1.0 mg.% carboprost tromethamine for 2 hours 4 times per day, alternating with continuous saline bladder irrigation for 2 hours. Six patients attempted an alternate protocol of 0.8 to 1.0 mg.% carboprost tromethamine given by continuous saline bladder irrigation. Complete resolution of gross hematuria occurred in 9 patients (50%). Eight patients had a partial response, with decreased transfusion requirements noted. However, complete resolution ultimately required an alternative therapy (for example formalin or urinary diversion). One patient (6%) failed to respond and required formalin therapy on day 4 of carboprost tromethamine therapy. Decreased red blood cell transfusion requirements were noted during and after therapy when compared to pretreatment values. No changes in renal or bladder function were noted during the mean followup of 17 weeks (range 1 to 64 weeks). There were 3 cases of recurrent hematuria. Side effects were limited to bladder spasm in 14 of the 18 patients (78%), with no systemic complications. The results suggest that carboprost tromethamine is a useful bedside therapy for hemorrhagic cystitis due to cyclophosphamide, and treatment appears to have minimal toxicity.

Administration, Intravesical↗

A HILIC method for the analysis of tromethamine as the counter ion in an investigational pharmaceutical salt.

A hydrophilic interaction chromatography (HILIC) method using an aminopropyl stationary phase was developed and validated to determine the content of tromethamine as counter ion in an investigational drug substance. Tromethamine was a very polar compound without any chromophores, and could not be readily retained and detected by conventional reserved-phase HPLC-UV methods. Furthermore, the tromethamine salt of the drug compound also had limited solubility in aqueous solution. The method employed simple acetonitrile/water mobile phase (80/20, v/v) to provide sufficient retention for tromethamine. Meanwhile, the high acetonitrile content also helped to dissolve the drug substance sample. Refractive index (RI) was used for the detection of tromethamine. The method was found to be specific without interference from the drug compound and related impurities. The method was also validated for suitable precision, linearity and accuracy for the analysis of drug substance samples. The effects of various parameters, such as acetonitrile content, mobile phase salt concentration, and column temperature on HILIC separation were investigated.

Chromatography, High Pressure Liquid↗

Retrospective case-control evaluation of the use of parenteral ketorolac tromethamine in patients after surgery.

The aim of this study was to assess medication usage and to determine differences in selected outcomes in patients who received either parenteral ketorolac tromethamine or narcotics after surgery. A retrospective case-control study was used in patients on a surgery service who were postoperative. Forty patients who received parenteral ketorolac tromethamine as their primary postoperative pain medication were matched by surgical procedure, age, and sex to 40 patients who did not receive parenteral or oral ketorolac tromethamine. Patient data were collected by chart review, and fiscal information was obtained through hospital computer data bases. Simple t-tests were used to examine between-group differences in outcomes measured by interval scales, and contingency table analyses using the chi-square statistic were used to examine differences in dichotomous and ordinal scale outcomes. Parenteral ketorolac was prescribed in accordance with Food and Drug Administration (FDA)-approved guidelines 55% of the time, but actual patient use was in accordance with FDA guidelines 75% of the time. There were no differences between groups in any measure of analgesia prescription. Significant findings between patients receiving ketorolac tromethamine versus controls included a longer length of hospital stay (14.6 +/- 13.0 v 9.2 +/- 8.3 days), higher pharmacy cost ($69. 57 +/- $87.00 v $5.20 +/- $6.10), and higher use of histamine-2 antagonists (59.0% v 35.0%). Subgroup analysis showed that patients with a principle gastrointestinal diagnosis had the greatest differences in length of stay. Prospective studies are needed to assess patient outcomes when parenteral ketorolac tromethamine is prescribed for postoperative pain.

Anti-Inflammatory Agents, Non-Steroidal↗

Fosfomycin tromethamine: single-dose treatment of acute cystitis.

Fosfomycin tromethamine is an oral antimicrobial indicated for the treatment of uncomplicated lower urinary tract infections (UTIs). This agent is active in the urine against common uropathogens that are associated with cystitis in women, including organisms resistant to other antibiotics. A single dose of fosfomycin tromethamine is well absorbed and produces a therapeutic concentration in the urine for one to three days. Comparative clinical trials suggest that a single 3.0-g dose of fosfomycin tromethamine is as clinically effective as 7- to 10-day treatment regimens of standard agents such as nitrofurantoin, norfloxacin, and trimethoprim/sulfamethoxazole used to treat UTIs. Fosfomycin tromethamine is well tolerated and appears safe for use during pregnancy. Quality-of-life advantages, such as enhanced compliance and convenience, are also important aspects of fosfomycin tromethamine therapy.

Acute Disease↗

Pharmacokinetics of single-dose oral and intramuscular ketorolac tromethamine in the young and elderly.

The elderly are likely candidates to receive analgesics for pain from a variety of etiologies. Ketorolac tromethamine is a nonsteroidal, analgesic, anti-inflammatory, antipyretic investigational drug with anti-prostaglandin synthetase activity. Sixteen healthy, young men (mean age 30 years and mean weight 75 kg) and 13 healthy, elderly subjects (11 men and two women; mean age 72 years and mean weight 75 kg) participated in an open-label, parallel single-dose study. On each day of ketorolac tromethamine administration the subjects fasted overnight and for 2 hours post-dose. A single intramuscular (IM) dose of 30 mg of ketorolac tromethamine was administered followed by an oral dose (PO) of 10 mg after a 1 week washout period for the elderly subjects. Plasma samples were taken from 0 through 48 hours post-dose and analyzed for ketorolac by HPLC. The elimination of ketorolac was decreased slightly in the elderly following both doses, as evidenced by a prolongation in half-life (4.7 to 6.1 hours for PO and 4.5 to 7.0 hours for IM) and a reduced total plasma clearance compared to the young adult subjects. These differences were statistically significant (P less than .001). Considerable overlap frequently was observed when comparing the range of values obtained for the young and elderly for plasma half-life, clearance, AUC, Tmax and Cmax. The absorption of ketorolac tromethamine was not altered substantially in the elderly following either dose route. Ketorolac plasma protein binding was not altered substantially in the elderly. The present results show that the elderly may need slightly less frequent dosing of ketorolac than young adults to maintain similar plasma levels.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗

The efficacy of sublingual hyoscyamine sulfate and intravenous ketorolac tromethamine in the relief of ureteral colic.

A prospective, randomized, open-label, single-dose study was conducted in an emergency department (ED) of a tertiary care teaching hospital to evaluate the efficacy of hyoscyamine sulfate as compared to ketorolac tromethamine for the reduction of pain from ureteral colic in the ED. Patients were included if they were at least 18 years of age and presented to the ED with an initial history and physical examination consistent with ureteral colic. Ureteral calculi were confirmed by ultrasound or intravenous urogram. Consecutive patients were randomized to either a single sublingual dose of 0.125 mg of hyoscyamine sulfate or a single intravenous dose of 30 mg of ketorolac tromethamine given over 1 minute. After 30 minutes, if analgesia was inadequate, patients were given rescue medication. Baseline pain scores were obtained using a horizontal, 100-mm visual analog scale. Additional pain scores were obtained at 10-minute intervals for 30 minutes. Upon completion of the study, both patients and physicians completed a global assessment score questionnaire. Fifty-four evaluable patients were randomized. Demographics and baseline pain scores were similar for each group. Decreasing trends in pain over time were observed for both treatment groups, with significantly greater pain reduction observed with ketorolac tromethamine as compared to hyoscyamine sulfate. Global evaluations of pain relief revealed better results in the ketorolac tromethamine group than in the hyoscyamine sulfate group, although this result was not statistically significant.

Administration, Sublingual↗

Comparative analgesic efficacy and tolerability of ketorolac tromethamine and glafenine in patients with post-operative pain.

In a randomized, single-dose, double-blind, parallel comparative trial of analgesic efficacy, 96 adult patients received either 10 mg ketorolac tromethamine or 400 mg glafenine orally the morning after surgery if they requested pain relief medication. Each patient provided a baseline pain assessment and then received the assigned medication. Patients assessed pain intensity and pain relief and reported any adverse events in interviews held 30 minutes after drug administration and then hourly for 6 hours. The demographic characteristics, baseline pain intensity, and surgical categories of the 47 patients who received ketorolac tromethamine and the 49 who received glafenine were similar. Both drugs provided prompt, sustained pain relief throughout the 6-hour observation period, and there were no statistically significant differences between the two groups in any of the efficacy measures analyzed. The global assessment recorded by patients suggested a slight clinical advantage for ketorolac tromethamine (32.6% of 'excellent' responses) as compared to glafenine (12.5% 'excellent'). The differences in overall response were statistically significant (p = 0.017). Fourteen (30%) patients who received ketorolac tromethamine and 17 (35%) who received glafenine reported adverse experiences that began or seemed to worsen after administration of the study drugs. The most prominent were drowsiness and sleeping, both of which are common in post-surgical patients.

Adolescent↗

Potentiation of antibiotic activity by EDTA-tromethamine against three clinically isolated gram-positive resistant bacteria. An in vitro investigation.

The in vitro synergistic effects of combinations of EDTA-tromethamine and five antimicrobial agents (ampicillin, cephalexin, oxytetracycline, streptomycin and sulphadimethoxine) on three clinically isolated Gram-positive bacteria (Staphylococcus aureus, Staphylococcus hominis and Streptococcus faecium) were investigated. The bacteria had been isolated from three cases of canine otitis resistant to beta-lactam antibiotic therapy. The antimicrobial activity was evaluated by measuring the minimal inhibitory concentration for the antibiotics alone or in combination with EDTA-tromethamine. EDTA-tromethamine potentiated the activity of cefalexin against S. aureus and S. hominis, of oxytetracycline against S. aureus and S. faecium and of streptomycin against S. faecium. No significant effects were noted on the activity of oxytetracycline against S. hominis. The remaining combinations gave a slight synergistic effect. As previously shown for Gram-negative resistant bacteria, these data suggest that the association of EDTA-tromethamine and appropriate antibiotic therapy may be useful to overcome persistent infections of soft tissues in domestic animals.

Animals↗

A randomized, controlled trial to compare ketorolac tromethamine versus placebo after cesarean section to reduce pain and narcotic usage.

OBJECTIVE: The purpose of this study was to determine whether postcesarean section administration of ketorolac tromethamine reduces pain and narcotic usage. STUDY DESIGN: A double-blinded randomized, placebo-controlled trial of ketorolac tromethamine was performed. Patients were randomly assigned to receive either ketorolac tromethamine or placebo. Patient-controlled analgesia (PCA) was used for pain control. Visual analog scales (VAS) were administered postoperatively to assess pain levels. Morphine equivalents and attempts were recorded. RESULTS: There were 22 patients in each arm of the study. There was no significant difference between patient demographics, blood loss, and type of anesthesia. Pain scores were significantly different at 2, 3, 4, 6, 12, and 24 hours by analysis of variance (ANOVA) (P=.033). There was a significant decrease in pain medication usage (P=.008) in the study group. CONCLUSION: Ketorolac tromethamine is efficacious in reducing postoperative pain and narcotics usage after cesarean section.

Adult↗

Lodoxamide tromethamine treatment for superior limbic keratoconjunctivitis.

PURPOSE: We studied the efficacy of topically applied lodoxamide tromethamine 0.1% in the treatment of superior limbic keratoconjunctivitis. METHODS: Three patients with clinical findings of bilateral superior limbic keratoconjunctivitis. were treated with topical lodoxamide tromethamine four times daily in both eyes. RESULTS: While the patients were taking lodoxamide tromethamine, symptoms and objective findings resolved. CONCLUSIONS: Topically applied lodoxamide tromethamine 0.1% is useful in the treatment of superior limbic keratoconjunctivitis. There may be a role for mast cell stabilizers in the treatment of this disorder.

Administration, Topical↗

Comparison of ketorolac tromethamine 0.5% and rimexolone 1% to control inflammation after cataract extraction. Prospective randomized double-masked study.

PURPOSE: To compare the efficacy of a topical nonsteroidal anti-inflammatory agent (ketorolac tromethamine 0.5%) with that of a topical steroid (rimexolone 1%) to control inflammation after cataract surgery. SETTING: Storm Eye Institute, Department of Ophthalmology, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: Thirty-six patients were prospectively and randomly assigned to receive topical treatment with either ketorolac tromethamine 0.5% or rimexolone 1% starting the day after routine cataract extraction. Treatment was masked to both patient and investigator. Each patient had uneventful small incision phacoemulsification with placement of a foldable posterior chamber intraocular lens. Patients used 1 of the 2 antiinflammatory agents 4 times each day starting 24 hours after surgery. No antiinflammatory medications were used preoperatively, intraoperatively, or for 24 hours postoperatively. Signs and symptoms of inflammation, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated 1, 4, 7, and 30 days postoperatively. RESULTS: There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements. In addition, there was no difference in IOP measurements between groups. CONCLUSIONS: Ketorolac tromethamine 0.5% was as effective as rimexolone 1% in reducing inflammation after cataract surgery. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.

Aged↗

Comparison of ketorolac tromethamine 0.5% and loteprednol etabonate 0.5% for inflammation after phacoemulsification: prospective randomized double-masked study.

PURPOSE: To compare the efficacy of a topical nonsteroidal antiinflammatory agent (ketorolac tromethamine ophthalmic solution 0.5%) and a topical steroid (loteprednol etabonate ophthalmic suspension 0.5%) in controlling inflammation after cataract surgery. SETTING: Magill Research Center for Vision Correction, Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: Sixty patients were prospectively and randomly assigned to receive topical treatment with ketorolac tromethamine ophthalmic solution 0.5% or loteprednol etabonate ophthalmic suspension 0.5% starting the day after routine phacoemulsification for cataract extraction. Both patient and investigator were masked to treatment. All patients had uneventful small-incision phacoemulsification with placement of a foldable posterior chamber intraocular lens (IOL). Patients used 1 of the 2 antiinflammatory agents 4 times a day starting 24 hours after surgery. Signs and symptoms of inflammation as documented by external slitlamp examination, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated on postoperative days 1, 4, 7, and 30. RESULTS: There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements or in IOP between groups. No patient in either group was removed from the study for lack of treatment efficiency. CONCLUSIONS: Ketorolac tromethamine ophthalmic solution 0.5% was as effective as loteprednol etabonate ophthalmic suspension 0.5% in reducing inflammation after routine phacoemulsification and IOL implantation. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.

Aged↗

Effect of freezing, long-term storage, and microwave thawing on the stability of ketorolac tromethamine.

BACKGROUND: Ketorolac tromethamine is a nonsteroidal agent with potent analgesic and moderate antiinflammatory activity. Advance preparation of intravenous solution could be useful to improve quality assurance, time management, and cost-savings of drug delivery. OBJECTIVE: To investigate the effect of freezing, long-term storage, and microwave thawing on the stability of ketorolac tromethamine in dextrose 5% infusion. METHODS: Five polyolefin bags of solution containing ketorolac tromethamine 20 mg per 100 mL of dextrose 5% were frozen for 3 months at -20 degrees C, thawed in a microwave oven with a validated cycle, and stored at 4 degrees C. The concentration of ketorolac was measured by HPLC. Visual inspection and pH measurement were also carried out. RESULTS: No color change or precipitation was observed. Ketorolac was stable for at least 60 days under refrigeration after freeze-thaw. Throughout this period, the lower confidence limit of the estimated regression line of the concentration-time profile remained >90% of the initial concentration, and the pH value decreased slightly without affecting chromatographic parameters. CONCLUSIONS: Within these limits, ketorolac tromethamine in dextrose 5% infusion may be prepared and frozen in advance by a centralized intravenous admixture service, then thawed before use in clinical units.

Anti-Inflammatory Agents, Non-Steroidal↗

Experimental brain injury: successful therapy with the weak base, tromethamine. With an overview of CNS acidosis.

The presence of lactic acidosis in the cerebrospinal fluid of patients suffering brain injury as the result of trauma, subarachnoid hemorrhage, neoplasia, or ischemia has been well documented. The authors theorized that this acidosis becomes harmful in itself, and that treatment with an alkalinizing agent (tris(hydroxymethyl)aminomethane: tromethamine) capable of penetrating the blood-brain barrier would be efficacious. Fifteen pairs of mongrel cats were subjected to a 2.85-atmosphere fluid-percussion injury (LD80), and were supported by respirators for up to 72 hours prior to being placed in cages for an additional 4 days of observation. Experimental cats underwent continuous infusion of tromethamine (begun 10 minutes after injury); control animals were infused with an equal volume of lactated Ringer's solution. Twenty percent of the control group survived until sacrificed on Day 7 post-injury. Survival in the tromethamine group was 60% (p less than 0.05), and morbidity also appeared to be reduced in the treated cats. Intracranial pressure (ICP) in treated cats was 60% (p less than 0.05) of that in the control cats after respirator support for 3 days. Tromethamine infusion was associated with improved survival, decreased morbidity, and decreased ICP when compared with results in control animals. The literature with regard to central nervous system acidosis has been reviewed in an attempt to clarify and define this problem.

Acidosis↗

Second trimester pregnancy termination in primigravidas by double application of dinoprostone gel and intramuscular administration of carboprost tromethamine.

A randomized study of legal pregnancy termination in the second trimester has been performed in primigravidas by endocervical application of Prepidil gel (dinoprostone gel) in combination with intramuscular application of Prostin 15 M (carboprost tromethamine). The study comprised 97 patients. The control group (N = 35) included patients in whom pharmacologic preparation of the cervix was performed by a singleton endocervical application of 0.5 mg dinoprostone gel and intramuscular administration of Prostin 15 M (Carboprost Tromethamine) (1 ml/2 h) 10 h later and until abortion. The investigated group A (N = 31) underwent pharmacologic preparation of the cervix by endocervical application of 0.5 dinoprostone gel, 2 times during an interval of 4 hours. Intramuscular injection of Prostin 15 M (Carboprost Tromethamine) (1 ml/h) was administered 6 hours after the second application of gel and until abortion. The investigated group B (N = 31) underwent pharmacologic preparation of the cervix by a singleton double-dose endocervical application of 0.5 mg dinoprostone gel and intramuscular treatment by 1 ml/2 h of Prostin 15 M (Carboprost Tromethamine) applied 10 hours later and until abortion. On the basis of obtained results, a conclusion was made that the NEW combination of endocervical and intramuscular application of prostaglandins gives statistically significantly shortened abortion interval (the control group x = 9.97; SD = 5.22 versus investigation group: A-x = 6.80; SD = 4.31 and investigation group: B-x = 5.55; SD = 3.48). Better pharmacologic preparation of the uterine cervix resulted in shorter abortion interval and decreased amount of systemically applied prostaglandins. A shortened abortion interval significantly decreases the rate of immediate, early and late complications. A decreased amount of systemically applied prostaglandins results in significantly lower rate of unwanted side-effects caused by prostaglandins, making this method of pregnancy termination significantly cheaper.

Abortion, Induced↗

[Chemolysis of cystine calculi incarcerated in the ureter by the alkaline organic amine, tromethamine-E].

We dissolved the cystine calculi incarcerated in the ureter by irrigation with tromethamine-E via percutaneous nephrostomy. Case 1: A 25-year-old man with a past history of cystinuria and staghorn calculi in the right kidney, suffered from obstructive renal failure caused by the incarceration of a stone (18 x 15 mm) in the left middle ureter. After recovering promptly from renal failure by left percutaneous nephrostomy, he received continuous irrigation with tromethamine-E through an angiographic catheter percutaneously placed in the ureter. The ureteral calculus was reduced by 70% in size after the irrigation for 35 days, and then extracted percutaneously. Case 2: A 3-year-old child had multiple cystine calculi in the right renal pelvis and ureter. Although a calculus in the renal pelvis was extracted by the percutaneous ultrasound lithotripsy, two calculi incarcerated in the middle ureter were impossible to remove by a percutaneous approach. The irrigation with tromethamine-E was initiated through the catheter placed percutaneously in the right ureter. Both calculi completely dissolved 47 days later. The chemolysis by irrigation with tromethamine-E was greatly valuable in the treatment of cystine calculi. This dissolution could be an alternative to surgery especially in the treatment of ureteral cystine calculi, which might be difficult to be extracted by the percutaneous or transurethral approach.

Adult↗

In vitro action of combinations of antimicrobial agents and EDTA-tromethamine on Pseudomonas aeruginosa.

Combinations of EDTA-tromethamine and 7 antimicrobial agents (chloramphenicol, nalidixic acid, oxytetracycline, penicillin, polymyxin-B, streptomycin, and triple sulfa) were tested for synergistic activities against Pseudomonas aeruginosa. Three in vitro tests were used, including minimal inhibitory concentrations of the drugs, a 2-dimensional Microtiter checkerboard technique, and bacterial inhibition studies. A synergistic inhibitory action was observed with combinations of EDTA-tromethamine plus penicillin and EDTA-tromethamine plus oxytetracycline. When chloramphenicol, streptomycin, nalidixic acid, polymyxin-B, or triple sulfa was mixed with EDTA-tromethamine, synergistic action did not occur.

Animals↗