Development of electrochemical methods for determination of Tramadol ( Generic Ultram )--analytical application to pharmaceutical dosage forms.

OBJECTIVE: To assess the analgesic effect and side effects of PCA with lornoxicam compared with morphine and Tramadol ( Generic Ultram ). METHODS: 89 patients, scheduled for elective hysterectomy or hysteromyomectomy, were randomly divided into Group L, Group M and Group T. Three drugs administered i.v. via a patient-controlled analgesia for up to 24 h postoperatively. RESULTS: Efficacy was assessed by comparing total pain relief (TOTPAR) and sum of pain intensity difference (SPID) over 24 h. Statistically significant equivalence of lornoxicam, morphine and Tramadol ( Generic Ultram ) was shown by TOTPAR values 15.2 +/- 3.9, 16.4 +/- 3.5 and 15.9 +/- 4.4, by SPID values 10.3 +/- 3.1, 9.0 +/- 2.0 and 9.2 +/- 4.7, respectively (P > 0.05). Lornoxicam caused fewer adverse events than morphine and Tramadol ( Generic Ultram ) (10.0%, 26.7% and 17.2% of patients, respectively). CONCLUSION: The study suggests that lornoxicam provides an alternative to morphine or tramadaol for the treatment of postoperative pain.

Tramadol ( Generic Ultram ) in the treatment of pain

A novel, multidimensional SPE sample-processing platform for complex fluids, which relies on the combination of small LC columns packed with restricted access materials (RAM) and molecular imprinted polymers (MIP) is described. It is called the Six-S ProcEdure (Six-SPE). Six-SPE involves a size-selective sample-separation step followed by a solvent-switch. Six-SPE efficiently removes interfering matrix components of complex aqueous samples and creates optimal conditions for selective recognition, i.e. binding of the imprinted target analyte(s). A Six-SPE analysis cycle consists of four distinct steps: 1. separation of a given sample (e.g. plasma, urine, saliva, milk, etc.) by adsorptive extraction (e.g. reversed-phase partitioning) of low molecular weight components on to the stationary phase of a RAM column and simultaneous size-exclusion, i.e. quantitative disposal of macromolecular matrix constituents to waste; 2. desorption and transfer of the extract from the RAM column on to a series-connected MIP column using a pure organic mobile phase (e.g. acetonitrile) [solvent switch]; 3. molecular recognition, i.e. selective binding of the target analyte(s) by a tailor-made MIP column; and 4. desorption and transfer of the analyte fraction on to a series-connected separation (e.g. HPLC) and/or detection system (e.g. UV, FD, MS). As a first application we coupled the Six-SPE platform to a conventional HPLC system for on-line analysis of the analgesic drug Tramadol ( Generic Ultram ) in human plasma using LiChrospher ADS RP-18 as a RAM precolumn for the fractionation step in the first and second chromatographic dimension and a Tramadol ( Generic Ultram ) imprinted polymer for the molecular recognition step, i.e. third chromatographic dimension.


Tramadol ( Generic Ultram ): new preparation. Capsules: central analgesic; step 2 on the WHO scale.

Tramadol ( Generic Ultram ) HCl, marketed as Ultram in the USA, was introduced as a non-scheduled drug in April 1995 based on the assumption that the risk of abuse was sufficiently low to warrant a non-scheduled status. However, approval was contingent upon the development of an innovative proactive surveillance program, to be overseen by an independent steering committee, which would detect unexpectedly high levels of abuse. The postmarketing surveillance program consisted of systematic collection and scientific evaluation of reports of suspected abuse in high-risk populations surveyed through an extensive key informant network of drug abuse specialists and all spontaneous reports of abuse received through the FDA MedWatch system. Methods to estimate the number of patients prescribed Tramadol ( Generic Ultram ) were also developed. Monthly rates of abuse were calculated as an index of the risk-benefit ratio (i.e., abuse cases per 100,000 patients prescribed the drug). The data for the 3 years since the drug was introduced show that the reported rate of abuse has been low. Although a period of experimentation seemed to occur in the first 18 months after its introduction--which reached a peak rate of approximately two cases per 100,000 patients exposed--during the 2 year period prior to June 1998, the reported rate of abuse has significantly (P = 0.011) declined, reaching levels of less than one case per 100,000 patients in the last 18 months. The overwhelming majority of abuse cases (97%) have been found to occur among individuals with a history of substance abuse and the abuse has been confined to isolated pockets around the country-notably none of which have significant populations of street drug abusers. Thus, the data support the decision not to schedule Tramadol ( Generic Ultram ) and, furthermore, suggest that a proactive post-marketing surveillance program can be successfully developed to effectively monitor abuse of new medications.

Analgesia at the department of intensive care.

Analgesia at the Department of intensive care can be distributed into three groups, with respect to the patient's respiratory status: 1) analgesia in a patient on controlled ventilation; 2) analgesia in a patient who is being weaned from a respirator; 3) analgesia in a patient breathing spontaneously. In patients of group 1, analgesia, respiratory depression and sedation are achieved with morphine applied parenterally or epidurally. While patients on assisted ventilation (group 2) require good analgesia and sedation, they should remain cooperative; this is achieved with Tramadol ( Generic Ultram ) or ketamine. Spontaneously breathing patients are maintained on Tramadol ( Generic Ultram ) in combination with NSAID. In all patients the dosage needs to be adjusted with respect to the type of pain, age, nutrition status, and previous use of analgesics.

Analgesic efficacy and safety of Tramadol ( Generic Ultram )/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial.Peloso PM, Fortin L, Beaulieu A, Kamin M, Rosenthal N; Protocol TRP-CAN-1 Study Group.Division of Rheumatology, Roy and Lucille Carver College of Medicine, University of Iowa Health Care E330 GH, 200 Hawkins Drive, Iowa City, IA 52242, USA. OBJECTIVE: To evaluate the analgesic efficacy and safety of Tramadol ( Generic Ultram ) 37.5 mg/acetaminophen 325 mg (Tramadol ( Generic Ultram )/APAP) combination tablets for treatment of chronic low back pain (LBP). METHODS: This 91 day, multicenter, outpatient, randomized, double blind, placebo controlled study enrolled 338 patients with chronic LBP requiring daily medication for > or = 3 months. Patients with at least moderate pain [pain visual analog scale (VAS) with scores > or = 40/100 mm] after washout were randomized to Tramadol ( Generic Ultram )/APAP or placebo. After a 10 day titration, patients received 1 or 2 tablets QID. Primary outcome measure was final pain VAS score. Secondary measures included pain relief, quality of life and physical functioning, efficacy failure, and overall medication assessments. RESULTS: In total, 336 intent-to-treat patients received Tramadol ( Generic Ultram )/APAP (n = 167) or placebo (n = 169). Mean baseline pain VAS score was 67.8. Intent-to-treat analysis showed significantly better mean final pain VAS scores (47.4 vs 62.9; p < 0.001) and mean final pain relief scores (1.8 vs 0.7; p < 0.001) for Tramadol ( Generic Ultram )/APAP than for placebo. Roland Disability Questionnaire scores and physical-related subcategories of the McGill Pain Questionnaire and the Medical Outcome Study Short Form-36 Health Survey were significantly better for Tramadol ( Generic Ultram )/APAP patients. More patients rated Tramadol ( Generic Ultram )/APAP as "very good" or "good" than placebo (63.6 vs 25.2%; p < 0.001). Kaplan-Meier estimates of cumulative discontinuation rates due to efficacy failures were 22.9% (Tramadol ( Generic Ultram )/APAP) vs 54.7% (placebo; p < 0.001). The most common treatment related adverse events with Tramadol ( Generic Ultram )/APAP were nausea (12.0%), dizziness (10.8%), and constipation (10.2%). Average daily dose of Tramadol ( Generic Ultram )/APAP was 4.2 tablets (Tramadol ( Generic Ultram ) 158 mg/APAP 1369 mg). CONCLUSION: Tramadol ( Generic Ultram ) 37.5 mg/APAP 325 mg combination tablets show efficacy in pain reduction, in measures of physical functioning and quality of life, and in overall medication assessments, with a tolerability profile comparable with other opioids used for the treatment of chronic LBP.

Ketoprofen (ketonal): a drug for preventing and treating postoperative pain

An inert matrix to control the release of Tramadol ( Generic Ultram ) HCl was prepared using glyceryl behenate as a matrix-forming agent. The matrices were prepared by either direct compression of a physical mixture of the drug and the matrix-forming agent or by compression of granules prepared by hot fusion of the drug and the matrix-forming agent. The hot fusion method was found to be more effective than compression of physical mixtures in retarding the release of the drug from the matrix. Drug release was adjusted by using release enhancers, such as microcrystalline cellulose and lactose, and the results showed that higher release rates were obtained using lactose. However, the release of the drug was independent of the compression force and the pH of the dissolution medium. This study showed that glyceryl behenate is an appropriate waxy material that can be used as a matrix-forming agent to control the release of a water-soluble drug such as Tramadol ( Generic Ultram ) HCl.