Two Cases of Fatal Amlodipine Overdose*

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Two Cases of Fatal Amlodipine Overdose*"

Transcription

1 I Case Report Two Cases of Fatal Amlodipine Overdose* Journal of Analytical Toxicology, Vol. 30, June 2006 Jason H. Sklerovl, ~, Barry Levinel, 2, Kathleen M. Ingwersen 3, Patricia A. Aronica-Pollack 2, and David Fowler 2 I Division of Forensic Toxicology, Office of the Armed Forces Medical Examiner, 1413 Research Blvd., Rockville, Maryland 20850; 20ffice of the Chef Medical Examiner, State of Maryland, 111 Penn St., Baltimore, Maryland 21201; and 3Armed Forces Medical Examiner, Landstuhl Regional Medical Center, Landstuhl, Germany [ Al~stract I Two fatal overdoses of the calcium channel blocker amlodipine are described. Postmortem samples were screened for volatiles and therapeutic and abused drugs. Amlodipine was measured by liquid chromatography-atmospheric pressure photoionization-mass spectrometry. The heart blood amlodipine concentrations for the two cases were 2.4 and 0.95 mg/l, and amlodipine was quantified in all other tissues. In the first case, venlafaxine and norvenlafaxine were also found, and the angiotensin receptor antagonist olmesartan was tentatively identified. The concentrations of amlodipine are compared with previously reported fatal and nonfatal overdoses. The medical examiners ruled in both cases that the manner of death was suicide and the causes of death were mixed drug intoxication and amlodipine intoxication. Introduction Amlodipine, R,S,2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methy]- 1,4-dihydropyridine, is a calcium channel blocker of the dihydropyridine class (Figure 1). Amlodipine is prescribed for the treatment of hypertension and angina pectoris and may have efficacy in the treatment of congestive heart failure (1). Its main site of action is vascular smooth muscle; although it also causes coronary vasodilation. The addition of the amino side A H3 C CH2OCH2CH2NH2 H3C I H 7 NO2 B OOOCH2CH2NCH20~H5 I~ CH3 Figure I. Chemical structure of amlodipine (A) and nicardipine (IS) (B). * Disclaimer: The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of Defense or of the Army, Navy, or Air Force. ~ Author to whom correspondence should be addressed. chain gives amlodipine a basic, hydrophilic nature that is unique to its class. This results in slower absorption (tm~ 6-9 h), a large volume of distribution (21 L/kg), and a longer elimination phase (ht2 = h) compared with other dihydropyridines (1). The metabolism of amlodipine proceeds initially through oxidation to the pyridine form with subsequent oxidative deamination and aliphatic hydroxylation to multiple, inactive metabolites (2,3). Approximately 60% of an oral dose is excreted in the urine as metabolites, with less than 10% excreted unchanged. Doses of amlodipine range from 1.25 to 10 rag/daily, with steady-state concentrations reached in 3-7 days depending on the dose (4). Amlodipine is manufactured as a racemic mixture, but only the S-(-) enantiomer possesses the vasodilative effect (5). Maximum plasma concentrations of amlodipine have been reported at around 4 ]~g/l (6,7) for single 5-rag doses and 5-10 ~g/l (8-10) for single 10-rag doses. In 4 subjects variously taking 5-10-rag daily doses over a 4-8-month period, plasma concentrations measured 1 h after administration were between 8.7 and 13.7 l~g/l (11). In 9 angina pectoris patients treated for 7 days with a 5 rag/day amlodipine regimen, mean serum concentrations on the 7th and 56th days were 8.I ]~g/l and 9.0 Fg/L, respectively (4). The analysis of amlodipine has been reported by various techniques including immunoassay (12), high-performance thinlayer chromatography (8), gas chromatography (GC) with electrochemical detection (11) or mass spectrometry (MS) (3), liquid chromatography (LC) (5,9,13,14), LC-MS (3), or LC-MS-MS (6,15-17). This paper describes two fatal overdoses of amlodipine with tissue concentrations determined by an LC-MS method. Case Report 1 A 44-year-old caucasian male, who had a pre-existing heart condition, was found unresponsive in bed at approximately 10:00 p.m. Medical examination revealed no signs of life and apparent signs of lividity and rigor mortis. No resuscitative efforts were made. The subject was pronounced dead at the scene ap- 346 Reproduction (photocopying) of editorial content of this journal is prohibited without publisher's permission.

2 proximately 30 min after discovery. Five empty bottles of prescription medications were found: two bottles of Benicar (olmesartan medoxomi], 30 tablets per bottle at 40 mg each); one bottle of Norvasc (amlodipine besylate, 30 tablets per bottle at 10 mg each); a second bottle of Norvasc (90 tablets per bottle at 10 mg each); and one bottle of amlodipine (90 tablets at 10 mg each). Two empty bags of prescription medication were also found: one bag was hand-labeled "Amitriptyl', and the other was hand-labeled "Effexn XR". An investigative search of the scene revealed a personal journal with entries implying suicidal risk factors and intent using "pills". Medical records document that the decedent had been prescribed anti-hypertensive medications of differing types. There was no evidence of foul play. An autopsy revealed white foam in the mouth and upper airways, moderate pulmonary congestion and edema, cardiomegaly, moderate to focally severe coronary artery atherosclerosis, and multiple remote contusions with crusted abrasions on the prominent surfaces of the extremities. A large bolus of white tablet residues was recovered from the gastric contents. Case Report 2 A 66-year-old African-American female with a history of depression was found on the floor of her apartment at 11:30 p.m. after a family member had to forcibly enter the residence. Emergency services responded and pronounced the subject dead at 12:15 a.m. Approximately 2 weeks prior, the subject had been prescribed Norvasc for hypertension. The bottle that had originally contained 60 tablets (dose unspecified by investigator) was found empty. A partial autopsy was conducted on the day of the body's discovery. External examination revealed fixed, posterior lividity except for areas exposed to pressure. No evidence of significant recent injury or medical intervention was found. Internal examination of the liver and central nervous system was unremarkable except for the presence of a 2-cm calcified meningioma in the right frontal region of the brain. Methods Materials Amlodipine besylate was supplied by Pfizer (Sandwich Laboratories, Sandwich, U.K.) and had a purity of 99.8%. Nicardipine hydrochloride, ammonium formate, and sodium borate decahydrate were obtained from Sigma-Aldrich (St. Louis, MO). Formic acid was obtained from ICN Biomedicals (Aurora, OH). All solvents were high-performance liquid chromatography (HPLC) grade and purchased from Fisher Scientific (Pittsburgh, PA). Sample preparation Blood, urine, gastric contents, and tissues were collected at autopsy and stored, unpreserved, at -15~ A stock solution of amlodipine was prepared at a concentration of I mg/ml in methanol, and the nicardipine internal standard was prepared at a concentration of 0.01 mg/ml in methanol. Both standards were stored at -15~ in amber bottles. Standard curves were prepared in blood and urine at 0.1, 0.5, 1.0, 2.5, 5.0, and 10.0 mg/l for amlodipine. Two-hundred-microliter volumes of blood, urine, and bile were initially assayed, with the final quantitation of bile based on a dilution. Tissue samples and gastric contents (1.0 g) were homogenized in 25 ml of saturated sodium borate buffer using a Brinkmann (Westbury, NY) PT3000 tissue homogenizer. Twohundred-milligram aliquots of tissue homogenate were extracted. Two-hundred microliters of blood or urine calibrators and 200 IJL of the appropriately diluted specimens were added to clean, labeled 16- x 100-ram tubes, and I ml saturated sodium borate was added. Twenty microliters of the nicardipine internal standard (1.0 mg/l final concentration) were added to each tube along with 2 ml of ethyl acetate. The tubes were capped and mixed for 10 rain on an orbital mixer. After centrifuging the tubes for 5 min at 3000 rpm, the solvent was transferred to 10-mL conical tubes and evaporated to dryness under nitrogen at 40~ The sample residue was reconstituted with 50 IJL of HPLC mobile phase and transferred to autosampler vials. Instrumentation Biological extracts were analyzed using an Agilent 1100 LC-MS system (Palo Alto, CA) consisting of a vacuum degasser (G1379A), quaternary pump (G1311A), autosampler (G 1367A), and thermostatted column compartment (G1316A). The MS (G1956B) was equipped with an atmospheric pressure photoionization (APPI) interface (Syagen, Tustin, CA). Separation was performed using a Zorbax StableBond-C18, highthroughput cartridge column (30 x 2.1 mm, dp = 1.8 ljm, Agilent) held at 30~ The mobile phase consisted of ammonium formate buffer and acetonitrile [20mM, ph 4.5 (adjusted with 10% aqueous formic acid), 65:35 (v/v)]. The flow rate was 0.6 ml/min; the injection volume was 1 tjl The positive ions of amlodipine (rn/z 409, 294, and 238) and nicardipine (m/z 480 and 315) were formed by APPI. Pneumatic-assisted nebulization utilized nitrogen at 60 psi, and 350~ nitrogen drying gas was used at a flow of 6 L/min. The vaporizer temperature was 325~ and the APPI's krypton lamp emitted energy at 10 and 10.6 ev. The use of a dopant chemical for enhanced sensitivity was explored by post-column infusion of either acetone or toluene at 0.06 ml/min from a KDS100 syringe pump (KD Scientific, Holliston, MA) into the HPLC mobile phase stream. Neither dopant resulted in significant enhancement of the response across the range of the standard curve and, therefore, none was added for the analyses. Quantitation was based on multi-point, internal standard linear regression. The peak-area ratio of amlodipine (rn/z 238) to that of the internal standard (m/z 480) was used to calculate the response factor. Identification was based on retention time matching within _+ 2% and ion ratios matching within + 20% to the mean values of all calibrators. 347

3 Results The urine specimen from case 1 was analyzed for drugs of abuse by enzyme-linked immunoassay and for therapeutic and abused drugs by GC-MS, following an alkaline drug extrac- il... ~i Nicarcb'plne(ISTD) ~.,~, ~ Nic,~dpine (ISTD) Time (min) ~ 1,481- Nicardil~ne (ISTD) tion. The heart blood and vitreous were tested for volatile chemicals, including ethanol by headspace GC. No volatile compounds were detected. Venlafaxine and norvenlafaxine were identified in the alkaline urine extract and were confirmed in an alkaline heart blood extract at concentrations of 0.3 mg/l for venlafaxine and 1.0 mg/l for norvenlafaxine. The heart blood for case 2 was tested for volatile substances, and the heart blood and bile specimens were tested for therapeutic and abused drugs. This included volatile testing for methanol, ethanol, acetone, and isopropanol by headspace GC, acid/neutral drug testing by GC-nitrogen-phosphorus detection (NPD), alkaline drug testing by GC-NPD, morphine by immunoassay, and acetaminophen, ethchlorvynol, and salicylate by color test. No volatile substances were detected in the heart blood. The alkaline drug screen identified doxylamine and dextromethorphan in the bile; the presence of each drug was confirmed by 2.5 GC-MS. Neither drug was detected in the heart blood at a limit of quantitation of 0.05 mg/l. Because of the history surrounding these cases, a special assay was developed for amlodipine. The assay was able to accurately quantify amlodipine with a limit - W of quantitation of 0.1 mg/l and limit of detection of mg/l in whole blood. With an increase in both sample size and injection volume, the method could be adapted to measure therapeutic concentrations as well. All specimens were found to contain amlodipine upon confirmation by LC-MS (Figure 2), and the concentrations appear in Table I Time (rain) Figure 2. Extracted ion chromatograms of the liver extract from case 1 (A) and a negative blood sample (g). Discussion Physical symptoms of amlodipine overdose are nonspedfic and may go unreported. These include headache, nausea, Table I. Tissue Distributions for Amlodipine Overdoses Head Peripheral Stomach Blood Blood Bile Brain Kidney Liver Lung Spleen Contents Urine (mg/l) (mg/l) (mg/l) (mg/kg) (mg/kg) (mg/kg) (mg/kg) (mg/kg) (mg/kg) (mg/l) Case NA* Case NA NA 91.1 NA NA NA NA * NA = not available. 348

4 Journal of Analytical Toxicology, VoL 30, lune 2006 fatigue, abdominal pain, and edema. Because of the long halflife of amlodipine, compared with other calcium channel blockers, the onset of action is slower and acute side effects (hypotension, pulmonary edema, and bradycardia) may be delayed. Reports of amlodipine overdose have typically been associated with suicidal intent and have involved doses of between 50 and 500 rag. Koch et al. (18) reported a maximal serum concentration of mg/l in a 63-year-old woman at 11 h after ingesting 70 mg of amlodipine and an unknown amount of oxazepam (serum = 5.25 rag/l). Treatment included gastric lavage, activated charcoal, calcium gluconate, and vasopressors; however, death occurred 26 h after the ingestion. Cosbey and Carson (19) related a postmortem blood concentration of 2.7 mg/l in a 15-year-old female who had intentionally ingested 140 mg of amlodipine and an unspecified dose of mefenamic acid. Death occurred 6 h postingestion, and autopsy found the lungs congested and edematous with the gastric contents containing a little over two 10-rag doses of residual amlodipine. Stanek et al. (20) measured a serum level of mg/l at 2.5 h after the intentional ingestion of mg of amlodipine by a 42-year-old woman, and a similar value of mg/l was measured in the serum of a 76-year-old man by Adams and Browne (21) following the accidental ingestion of 100 mg. Though both of these ingestions were nonfatal, the latter patient died of complications weeks later. A failed suicide attempt was reported by Yuan et al. (22) for a 37-year-old male who ingested amlodipine (6.7 mg/kg, 470 mg estimated dose), atenolol, and alprazolam. A peak serum level of 0.13 mg/l was measured 12 h postingestion and was probably affected by resuscitative efforts, including gastric lavage and activated charcoal. Recently, Johansen and Genner (23) related a fatal amlodipine overdose by a 50-year-old male. The deceased was discovered with moderate decomposition, and his postmortem blood and liver amlodipine levels were 2.2 mg/l and 8.7 mg/kg, respectively. The authors could not definitively assign an acute overdose based on the presence of only 0.1 mg of amlodipine in the stomach contents. In case 1, the significance of two empty bottles of the antihypertensive angiotensin receptor antagonist, olmesartan medoxomil, was considered. Olmesartan medoxomil is the inactive prodrug of the active, de-esterified olmesartan. No reference standard could be obtained for measurement of olmesartan; however, full scan LC-MS analysis of the urine specimen gave tentative identification that matched well with a published mass spectrum (25). The two cases presented herein correlate well with reported postmortem blood concentrations for amlodipine overdoses. Comparisons with fatal and nonfatal serum levels are complicated because of an unknown serum to whole blood ratio; however, the blood values are far in excess of mg/l therapeutic plasma concentrations (24). The residual gastric load of amlodipine calculated from case I corresponds to 47 mg or approximately 5 doses of amlodipine remaining after the removal (at autopsy) of a bolus of undigested medication. The large liver concentrations seen for both cases suggest significant tissue sequestration and, when viewed along with the additional tissue values in case 1, is consistent with the expected large volume of distribution. Evidence for postmortem redis- tribution was unavailable because of the absence of peripheral blood collection in case I and the similarity of central and peripheral blood concentrations in case 2. However, the potential exists for redistribution to have occurred in case I because of the large undigested quantity of drug remaining at autopsy. The medical examiner ruled the cause of death in the first case as mixed drug intoxication with atherosclerotic coronary vascular disease as a possible contributing factor. The manner of death was ruled suicide. The second case was determined to be a suicide, with the cause of death being amlodipine intoxication. Acknowledgments This work was funded in part by the American Registry of Pathology, Washington, D.C References 1. M. Haria and A.J. Wagstaff. Amlodipine: A reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease. Drugs 50: (1995). 2. A.P. Beresford, D. McGibney, MJ. Humphrey, P.V. Macrae, and D.A. Stopher. Metabolism and kinetics of amlodipine in man. Xenobiotica 18" (1988). 3. A.P. Beresford, P.V. Macrae, D. Alker, and R.J. Kobylecki. Biotransformation of amlodipine: Identification and synthesis of metabolites found in rat, dog and human urine--confirmation of structures by gas chromatography-mass spectrometry and liquid chromatography-mass spectrometry. Arzneimittelforschung 39: (1989). 4. K. Watanabe, Y. Ochiai, T. Washizuka, T. Inomata, Y. Miyakita, M. Shiba, T. Izumi, A. Shibata, Y.L. Qu, and T. Nagatomo. Clinical evaluation of serum amlodipine level in patients with angina pectoris. Gen. Pharmacol. 27" (1996). 5. J. Luksa, D. Josic, M. Kremser, Z. Kopitar, and S. Milutinovic. Pharmacokinetic behaviour of R-(+)- and S-(-)-amlodipine after single enantiomer administration. ]. Chromatogr. B 703: (1997). 6. M. Carvalho, C.H. Oliveira, G.D. Mendes, M. Sucupira, M.E.A. Moraes, and G. De Nucci. Amlodipine bioequivalence study: Quantification by liquid chromatography coupled to tandem mass spectrometry. Biopharm. Drug Dispos. 22: (2001). 7. J.Y. Park, K.A. Kim, G.S. Lee, P.W. Park, S.L. Kim, Y.S. Lee, Y.W. Lee, and E.K. Shin. Randomized, open-label, two-period crossover comparison of the pharmacokinetic and pharmacodynamic properties of two amlodipine formulations in healthy adult male Korean subjects. Clin. Ther. 26" (2004). 8. K.K. M. Satia, T.P. Gandhi, I.A. Modi, R.I. Modi, and B.K. Chakravarthy. Detection and determination of total am- Iodipine by high-performance thin-layer chromatography: a useful technique for pharmacokinetic studies. J. Chromatogr. B 667: (1995). 9. G. Bahrami and S. Mirzaeei. Simple and rapid HPLC method for determination of amlodipine in human serum with fluorescence detection and its use in pharmacokinetic studies. J. Pharm. Biomed. Anal. 36: (2004). 10. F. Abad-Santos, J. Novalbos, M.A. Galvez-Mugica, S. Gallego- Sandin, S. Almedia, F. Vallee, and A.G. Garcia. Assessment of sex differences in pharmacokinetics and pharmacodynamics of am- Iodipine in a bioequivalence study. PharmacoL Res. 51: (2005). 11. S.C. Monkman, J.S. Ellis, S. Cholerton, J.M. Thomason, R.A. Sey- 349

5 mour, and J.R. Idle. Automated gas chromatographic assay for amlodipine in plasma and gingival crevicular fluid. J. Chromatogr. B 678: (1996). 12. K. Matalka, T. EI-Thaher, M. Saleem, T. Arafat, A. Jehanli, and A. Badwan. Enzyme linked immunosorbent assay for determination of amlodipine in plasma. ]. Clin. Lab. Anal. 15:47-53 (2001). 13. S. Tatar and S. Atmaca. Determination of amlodipine in human plasma by high-performance liquid chromatography with fluorescence detection. J. Chromatogr. B 758: (2001). 14. K. Shimooka, Y. Sawada, and H. Takematsu. Analysis of am- Iodipine in serum by a sensitive high-performance liquid chromatographic method with amperometric detection. J. Pharm. Biomed. Anal. 7: (1989). 15. A. Marzo, L. Dal Bo, P. Mazzucchelli, N.C. Monti, F. Crivelli, S. Ismaili, M.R. Uhr, and P. La Commare. Amlodipine bioequivalence achieved with a very sensitive liquid chromatography tandem mass spectrometric bioassay. Arzneimittelforschung 50' (2000). 16. B. Streel, C. Laine, C. Zimmer, R. Sibenaler, and A. Ceccato. Enantiomeric determination of amlodipine in human plasma by liquid chromatography coupled to tandem mass spectrometry. J. Biochem. Biophys. Methods 54: (2002). 17. A.B. Baranda, C.A. Mueller, R.M. Alonso, R.M. Jimenez, and W. Weinmann. Quantitative determination of the calcium channel antagonists amlodipine, lercanidipine, nitrendipine, felodipine, and lacidipine in human plasma using liquid chromatography- tandem mass spectrometry. Ther. DrugMoniL 27:44-52 (2004). 18. A.R. Koch, D.P. Vogelaers, J.M. Decruyenaere, B. Callens, A. Verstraete, and W.A. Buylaert. Fatal intoxication with am- Iodipine. J. ToxicoL Clin. ToxicoL 33: (1995). 19. S.H. Crosbey and D.J.L. Carson. A fatal case of amlodipine poisoning. J. Anal. Toxicol. 21: (1997). 20. E.J. Stanek, C.E. Nelson, and D. DeNofrio. Amlodipine overdose. Ann. Pharmacother. 31: (1997). 21. B.D. Adams and W.T. Browne. Amlodipine overdose causes prolonged calcium channel blocker toxicity. Am. ]. Emerg. Med. 16: (1998). 22. T.H. Yuan, W.P. Kems, C.A. Tomaszewski, M.D. Ford, and J.A. Kline. Insulin-glucose as adjunctive therapy for severe calcium channel antagonist poisoning. Clin. ToxicoL 37: (1999). 23. S.S. Johansen and J. Genner. A fatal case of amlodipine poisoning. ]. Clin. Forensic Med. 10: (2003). 24. R.C. Baselt. Disposition of Toxic Drugs and Chemicals in Man, 7th ed. Biomedical Publications, Foster City, CA, 2004, pp N. Kobayashi, I. Fujimori, M. Watanabe, and T. Ikeda. Real-time monitoring of metabolic reactions by microdialysis in combination with tandem mass spectrometry: hydrolysis of CS-866 in vitro in human and rat plasma, livers, and small intestines. Anal Biochem. 287: (2000). Manuscript received January 6, 2006; revision received February 14, 2006, 350

Chandra Mohan Rao Kota et al INTERNATIONAL JOURNAL OF RESEARCH AND REVIEWS IN PHARMACY AND APPLIED SCIENCES

Chandra Mohan Rao Kota et al INTERNATIONAL JOURNAL OF RESEARCH AND REVIEWS IN PHARMACY AND APPLIED SCIENCES Research Article Chandra Mohan Rao Kota et al I S S N 2249-1236 VOL 1, ISSUE (2) INTERNATIONAL JOURNAL OF RESEARCH AND REVIEWS IN PHARMACY AND APPLIED SCIENCES A SIMPLE GRADIENT RP-HPLC METHOD FOR THE

More information

Determination of Amlodipine in Human Plasma by LC-MS/MS and Its Bioequivalence Study in Healthy Chinese Subjects *

Determination of Amlodipine in Human Plasma by LC-MS/MS and Its Bioequivalence Study in Healthy Chinese Subjects * Pharmacology & Pharmacy, 2013, 4, 191-200 http://dx.doi.org/10.4236/pp.2013.42027 Published Online April 2013 (http://www.scirp.org/journal/pp) 191 Determination of Amlodipine in Human Plasma by LC-MS/MS

More information

Rapid LC-MS/MS Method for the Analysis of Fipronil and Amitraz Insecticides and Associated Metabolites in Egg and Other Poultry Products

Rapid LC-MS/MS Method for the Analysis of Fipronil and Amitraz Insecticides and Associated Metabolites in Egg and Other Poultry Products Rapid LC-MS/MS Method for the Analysis of Fipronil and Amitraz Insecticides and Associated Metabolites in Egg and Other Poultry Products Ashley Sage 1, Jianru Stahl-Zeng 2, Jason Causon 1, Mike Whitmore

More information

Isocratic Reverse Phase High Performance Liquid Chromatographic Estimation of Ramipril and Amlodipine in Pharmaceutical Dosage Form

Isocratic Reverse Phase High Performance Liquid Chromatographic Estimation of Ramipril and Amlodipine in Pharmaceutical Dosage Form Isocratic Reverse Phase High Performance Liquid Chromatographic Estimation of Ramipril and Amlodipine in Pharmaceutical Dosage Form Manikanta Kumar. A, P. Vijay Kumar *, Mahesh Nasare, Venkateswar Rao,

More information

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets . Table Interim Revision Announcement Official November 1, 2017 Amlodipine 1 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 2 (Continued) Tablet Strength Nominal Amlodipine/ Nominal Concentra-

More information

Detection of residues of quinolones in milk

Detection of residues of quinolones in milk Food Safety and Monitoring of Safety Aspects 77 Detection of residues of quinolones in milk Gertraud Suhren and P. Hammer Federal Dairy Research Centre, Institute for Hygiene, Hermann-Weigmann-Str. 1,

More information

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ALISKIREN AND AMLODIPINE IN TABLET DOSAGE FORM

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ALISKIREN AND AMLODIPINE IN TABLET DOSAGE FORM Page288 Research Article Pharmaceutical Sciences DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ALISKIREN AND AMLODIPINE IN TABLET DOSAGE FORM Divya P, Aleti P, Venisetty

More information

Public Assessment Report Scientific discussion. Perindopril tert-butylamine/amlodipine Stada (perindopril and amlodipine) SE/H/1500/01-04/DC

Public Assessment Report Scientific discussion. Perindopril tert-butylamine/amlodipine Stada (perindopril and amlodipine) SE/H/1500/01-04/DC Public Assessment Report Scientific discussion Perindopril tert-butylamine/amlodipine Stada (perindopril and amlodipine) SE/H/1500/01-04/DC This module reflects the scientific discussion for the approval

More information

LUPIN LIMITED SAFETY DATA SHEET. Section 1: Identification

LUPIN LIMITED SAFETY DATA SHEET. Section 1: Identification LUPIN LIMITED SAFETY DATA SHEET Section 1: Identification Section 1, Identification Material Manufacturer Distributor Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5 mg/10 mg, 5 mg/10 mg,

More information

Concentration of Enrofloxacin Residue from Tilapia (Oreochromis niloticus) Muscular That Infected by Aeromonas salmonicida

Concentration of Enrofloxacin Residue from Tilapia (Oreochromis niloticus) Muscular That Infected by Aeromonas salmonicida Journal of Agricultural Science and Technology A 4 (2014) 750-754 Earlier title: Journal of Agricultural Science and Technology, ISSN 1939-1250 doi: 10.17265/2161-6256/2014.09.005 D DAVID PUBLISHING Concentration

More information

New Stability Indicating Method for Quantification of Impurities in Amlodipine and Benazepril Capsules by Validated HPLC

New Stability Indicating Method for Quantification of Impurities in Amlodipine and Benazepril Capsules by Validated HPLC American Journal of Analytical Chemistry, 2013, 4, 715-724 Published Online December 2013 (http://www.scirp.org/journal/ajac) http://dx.doi.org/10.4236/ajac.2013.412086 New Stability Indicating Method

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cardalis 2.5 mg/20 mg tablets for dogs Cardalis 5 mg/40 mg tablets for dogs Cardalis 10 mg/80 mg tablets for dogs

More information

Determination of ofloxacin in bulk drug and pharmaceutical dosage form by high performance liquid chromatography method

Determination of ofloxacin in bulk drug and pharmaceutical dosage form by high performance liquid chromatography method Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2015, 7 (10):188-192 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

PBPK/PD Modeling and Simulations to Guide Dose Recommendation of Amlodipine with Viekirax or Viekira Pak

PBPK/PD Modeling and Simulations to Guide Dose Recommendation of Amlodipine with Viekirax or Viekira Pak PBPK/PD Modeling and Simulations to Guide Dose Recommendation of Amlodipine with Viekirax or Viekira Pak Dwaipayan Mukherjee, Ph.D. Jiuhong Zha, Ph.D. Rajeev Menon, Ph.D. Mohamad Shebley, Ph.D. Clinical

More information

Please refer to Table 1 Dosage and Treatment Schedule TABLE 1 Species Product Number of Tubes Cats. Rabbits or Advantage 40 for Cats

Please refer to Table 1 Dosage and Treatment Schedule TABLE 1 Species Product Number of Tubes Cats. Rabbits or Advantage 40 for Cats Advantage Introduction Company name: Bayer plc Address: Animal Health Division Bayer House, Strawberry Hill, Newbury Berkshire RG14 1JA Telephone: 01635 563000 Fax: 01635 563622 Email: animal.health@bayerhealthcare.com

More information

C 22 H 28 FNa 2 O 8 Pıı516.4

C 22 H 28 FNa 2 O 8 Pıı516.4 SIMULTANEOUS DETERMINATION OF DEXAMETHASONE SODIUM PHOSPHATE AND CHLORAMPHENICOL IN OPHTHALMIC SOLUTIONS W.A. Shadoul, E.A. Gad Kariem, M.E. Adam, K.E.E. Ibrahim* Department of Pharmaceutical Chemistry,

More information

Screening 36 Veterinary Drugs in Animal Origin Food by LC/MS/MS Combined with Modified QuEChERS Method

Screening 36 Veterinary Drugs in Animal Origin Food by LC/MS/MS Combined with Modified QuEChERS Method Screening 36 Veterinary Drugs in Animal Origin Food by LC/MS/MS Combined with Modified QuEChERS Method Application Note Food Testing and Agriculture Authors Jin-Lan Sun, Chang Liu, Yue Song Agilent Technologies

More information

Detection and Identification of Flunixin After Multiple Intravenous and Intramuscular Doses to Horses

Detection and Identification of Flunixin After Multiple Intravenous and Intramuscular Doses to Horses Detection and Identification of Flunixin After Multiple Intravenous and Intramuscular Doses to Horses R.A. Sams 1,*, D.F. Gerken 2, and S.M. Ashcraft 1 1Department of Veterinary Clinical Sciences, College

More information

New Zealand Data Sheet. Apo-Amlodipine

New Zealand Data Sheet. Apo-Amlodipine New Zealand Data Sheet Apo-Amlodipine Presentation APO-AMLODIPINE 2.5mg are white to off-white, round unscored tablets, engraved APO on one side and AML over 2.5 on the other side. Each tablet typically

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DOXYPRIM 40% soluble powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Doxycycline hyclate 400.0 mg Excipients:

More information

Stability Indicating Spectrophotometric Method of Amlodipine and Telmisartan in Bulk and Pharmaceutical Dosage Form

Stability Indicating Spectrophotometric Method of Amlodipine and Telmisartan in Bulk and Pharmaceutical Dosage Form Research Article Shinde Prasad S.* 1, Patil Pallavi M. 1 P.E.S s Modern College of Pharmacy, Sector 21, Yamunanagar, igdi, Pune-411044, Maharashtra, India. *Corresponding author s E-mail: pallavipatil_2007@yahoo.com

More information

RENT THERAPEUTIC RESEARC~ VOLUME 66, NUMBER 2, MARcH/APRIL 2005

RENT THERAPEUTIC RESEARC~ VOLUME 66, NUMBER 2, MARcH/APRIL 2005 RENT THERAPEUTIC RESEARC~ VOLUME 66, NUMBER 2, MARcH/APRIL 2005 Bioavailability Study of Fixed-Dose Tablet Versus Capsule Formulation of Amlodipine Plus Benazepril: A Randomized, Single-Dose, Two-Sequence,

More information

One Amlodipine KRKA 5 mg or 10 mg tablet contains amlodipine maleate equivalent to either 5 mg or 10 mg amlodipine per tablet.

One Amlodipine KRKA 5 mg or 10 mg tablet contains amlodipine maleate equivalent to either 5 mg or 10 mg amlodipine per tablet. 1. NAME OF THE MEDICINAL PRODUCT Amlodipine KRKA 5 mg tablets Amlodipine KRKA 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One Amlodipine KRKA 5 mg or 10 mg tablet contains amlodipine maleate

More information

SUMMARY OF PRODUCT CHARACTERISTICS. Euthasol vet. 400 mg/ml, solution for injection (AT, BE, DK, EE, EL, FI, IE, IS, LT, LU, LV, NO, PL, RO SE, UK)

SUMMARY OF PRODUCT CHARACTERISTICS. Euthasol vet. 400 mg/ml, solution for injection (AT, BE, DK, EE, EL, FI, IE, IS, LT, LU, LV, NO, PL, RO SE, UK) SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Euthasol vet. 400 mg/ml, solution for injection (AT, BE, DK, EE, EL, FI, IE, IS, LT, LU, LV, NO, PL, RO SE, UK) Euthasol 400

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/611/99-FINAL-corrigendum 1 June 1999 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS XYLAZINE HYDROCHLORIDE

More information

BIOTRANSFORMATION, A NEW APPROACH TO AMINOGLYCOSIDE BIOSYNTHESIS : II GENTAMICIN. R.T. TESTA and B.C. TILLEY

BIOTRANSFORMATION, A NEW APPROACH TO AMINOGLYCOSIDE BIOSYNTHESIS : II GENTAMICIN. R.T. TESTA and B.C. TILLEY 140 THE JOURNAL OF ANTIBIOTICS FEB. 1976 BIOTRANSFORMATION, A NEW APPROACH TO AMINOGLYCOSIDE BIOSYNTHESIS : II GENTAMICIN R.T. TESTA and B.C. TILLEY Schering Corporation, Bloomfield, New Jersey 07003,

More information

Only for Intravenous Use in Beef and Dairy Cattle. Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous or Intramuscular Use in Horses.

Only for Intravenous Use in Beef and Dairy Cattle. Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous or Intramuscular Use in Horses. INTERVET INC., MERCK ANIMAL HEALTH USA Product Label http://www.vetdepot.com 556 MORRIS AVE., SUMMIT, NJ, 07901 Telephone: 862-245-4321 Order Desk: 800-648-2118 Fax: 862-245-4935 Customer Service: 800-521-5767

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Orafluke 5% w/v Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of suspension contains: Active Substances

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products EMEA/MRL/571/99-FINAL February 1999 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS MELOXICAM SUMMARY REPORT (2) 1. Meloxicam (4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Orafluke 10% w/v Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substances per ml Fenbendazole 100 mg Rafoxanide

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs > 4-10 kg NexGard 68 mg chewable

More information

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF OFLOXACIN AND ORNIDAZOLE IN TABLET DOSAGE FORM BY RP-HPLC

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF OFLOXACIN AND ORNIDAZOLE IN TABLET DOSAGE FORM BY RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF OFLOXACIN AND ORNIDAZOLE IN TABLET DOSAGE FORM BY RP-HPLC B.Dhandapani *1, N.Thirumoorthy 2, Shaik Harun Rasheed 3, M.Rama kotaiah 3

More information

A simple and easy method for determination of meloxicam in rat muscle and plasma

A simple and easy method for determination of meloxicam in rat muscle and plasma Original A simple and easy method for determination of meloxicam in rat muscle and plasma Hidenori Sawada, Kazuko Korenaga, Naohisa Kawamura, Hideo Mizu and Hitoshi Yamauchi Research and Development Department,

More information

PROPYLENE GLYCOL FREE MINOXIDIL TOPICAL FORMULATION FOR HAIR LOSS BASED ON PATENTED TECHNOLOGY

PROPYLENE GLYCOL FREE MINOXIDIL TOPICAL FORMULATION FOR HAIR LOSS BASED ON PATENTED TECHNOLOGY Page 1 of 7 LICENSING OPPORTUNITY PROPYLENE GLYCOL FREE MINOXIDIL TOPICAL FORMULATION FOR HAIR LOSS BASED ON PATENTED TECHNOLOGY NO PROPYLENE GLYCOL NO SCALP IRRITATION, NO GREASY HAIR BIOEQUIVALENT ABSORPTION

More information

Providing Constant Analgesia with OROS Ò Hydromorphone

Providing Constant Analgesia with OROS Ò Hydromorphone Vol. 33 No. 2S February 2007 Journal of Pain and Symptom Management S19 Advances in the Long-Term Management of Chronic Pain: Recent Evidence with OROS Ò Hydromorphone, a Novel, Once-Daily, Long-Acting

More information

NEW ZEALAND DATA SHEET

NEW ZEALAND DATA SHEET NEW ZEALAND DATA SHEET 1. PRODUCT NAME NORVASC 5 mg and 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg coated tablet contains amlodipine besilate equivalent to 5 mg amlodipine. Each

More information

Dexmedetomidine. Dr.G.K.Kumar,M.D.,D.A., Assistant Professor, Madras medical college,chennai. History

Dexmedetomidine. Dr.G.K.Kumar,M.D.,D.A., Assistant Professor, Madras medical college,chennai. History Dexmedetomidine Dr.G.K.Kumar,M.D.,D.A., Assistant Professor, Madras medical college,chennai Dexmedetomidine is the most recently released IV anesthetic. It is a highly selective α 2 -adrenergic agonist

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS Issued March 2017 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Recicort 1.77 mg/ml + 17.7 mg/ml ear drops, solution for dogs and cats Recicort vet 1.77 mg/ml + 17.7 mg/ml

More information

RP-HPLC Method for Simultaneous Estimation of Enalapril Maleate and Chlorthalidone in Synthetic Mixture

RP-HPLC Method for Simultaneous Estimation of Enalapril Maleate and Chlorthalidone in Synthetic Mixture RP-HPLC Method for Simultaneous Estimation of Enalapril Maleate and in Synthetic Mixture VISHWA M. DAVE 1, Dr. DILIP G. MAHESHWARI *. *Head of Department, Department of Quality Assurance, L. J. Institute

More information

EMEDOG 1mg/ml Solution for injection for dogs. Part I ADMINISTRATIVE DATA AND SUMMARY OF THE DOSSIER

EMEDOG 1mg/ml Solution for injection for dogs. Part I ADMINISTRATIVE DATA AND SUMMARY OF THE DOSSIER 57 rue des Bardines 63370 LEMPDES FRANCE EMEDOG 1mg/ml Decentralised Procedure Volume 2/5 Part I ADMINISTRATIVE DATA AND SUMMARY OF THE DOSSIER Part 1b: SPC, label D195 Applicant response Final comments

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amlotan 5 and 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amlotan 5 mg tablets: Each tablet contains 5 mg amlodipine (as

More information

Antihypertensive efficacy of amlodipine in children with chronic kidney diseases

Antihypertensive efficacy of amlodipine in children with chronic kidney diseases (2001) 15, 387 391 2001 Nature Publishing Group All rights reserved 0950-9240/01 $15.00 www.nature.com/jhh ORIGINAL ARTICLE Antihypertensive efficacy of amlodipine in children with chronic kidney diseases

More information

Antimicrobial therapy in critical care

Antimicrobial therapy in critical care Antimicrobial therapy in critical care KARLEE JOHNSTON LEAD PHARMACIST DIVISION OF CRITICAL CARE CANBERRA HOSPITAL AND HEALTH SERVICE Outline 1. Let s talk about sepsis 2. PK/PD considerations 3. Selecting

More information

MARBOCYL FD SUMMARY OF PRODUCT CHARACTERISTICS

MARBOCYL FD SUMMARY OF PRODUCT CHARACTERISTICS MARBOCYL FD SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MARBOCYL FD 1 %, powder and solvent for solution for injection, for cats and dogs. 2. QUALITATIVE AND QUANTITATIVE

More information

Pharmacokinetics of the Bovine Formulation of Enrofloxacin (Baytril 100) in Horses

Pharmacokinetics of the Bovine Formulation of Enrofloxacin (Baytril 100) in Horses C. Boeckh, C. Buchanan, A. Boeckh, S. Wilkie, C. Davis, T. Buchanan, and D. Boothe Pharmacokinetics of the Bovine Formulation of Enrofloxacin (Baytril 100) in Horses Christine Boeckh, DVM, MS a Charles

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Amlodipine Bluefish 5 mg tablets Amlodipine Bluefish 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flukiver 50 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Closantel (as Closantel

More information

USA Product Label LINCOCIN. brand of lincomycin hydrochloride tablets. brand of lincomycin hydrochloride injection, USP. For Use in Animals Only

USA Product Label LINCOCIN. brand of lincomycin hydrochloride tablets. brand of lincomycin hydrochloride injection, USP. For Use in Animals Only USA Product Label http://www.vetdepot.com PHARMACIA & UPJOHN COMPANY Division of Pfizer Inc. Distributed by PFIZER INC. 235 E. 42ND ST., NEW YORK, NY, 10017 Telephone: 269-833-4000 Fax: 616-833-4077 Customer

More information

BIOEQUIVALENCE STUDY OF TWO BRANDS OF MELOXICAM TABLETS IN HEALTHY HUMAN PAKISTANI MALE SUBJECTS

BIOEQUIVALENCE STUDY OF TWO BRANDS OF MELOXICAM TABLETS IN HEALTHY HUMAN PAKISTANI MALE SUBJECTS Acta Poloniae Pharmaceutica ñ Drug Research, Vol. 68 No. 1 pp. 115ñ119, 2011 ISSN 0001-6837 Polish Pharmaceutical Society BIOEQUIVALENCE STUDY OF TWO BRANDS OF MELOXICAM TABLETS IN HEALTHY HUMAN PAKISTANI

More information

Public Assessment Report. Scientific discussion. Xiflodrop 5 mg/ml eye drops, solution. Moxifloxacin hydrochloride DK/H/2221/001/DC

Public Assessment Report. Scientific discussion. Xiflodrop 5 mg/ml eye drops, solution. Moxifloxacin hydrochloride DK/H/2221/001/DC Public Assessment Report Scientific discussion Xiflodrop 5 mg/ml eye drops, solution Moxifloxacin hydrochloride DK/H/2221/001/DC This module reflects the scientific discussion for the approval of Xiflodrop.

More information

Comparative efficacy of DRAXXIN or Nuflor for the treatment of undifferentiated bovine respiratory disease in feeder cattle

Comparative efficacy of DRAXXIN or Nuflor for the treatment of undifferentiated bovine respiratory disease in feeder cattle Treatment Study DRAXXIN vs. Nuflor July 2005 Comparative efficacy of DRAXXIN or Nuflor for the treatment of undifferentiated bovine respiratory disease in feeder cattle Pfizer Animal Health, New York,

More information

Don t let arthritis slow down your dog!

Don t let arthritis slow down your dog! Don t let arthritis slow down your dog! abcd DOG CAT ACUTE CHRONIC PERIOPERATIVE INJECTABLE ORAL SUSPENSION CHEWABLE Keeping your dog in the prime of life Is your dog at risk of developing arthritis? As

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products EMEA/MRL/236/97-FINAL June 1997 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS MELOXICAM SUMMARY REPORT (1) 1. Meloxicam (4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide

More information

Mouse Formulary. The maximum recommended volume of a drug given depends on the route of administration (Formulary for Laboratory Animals, 3 rd ed.

Mouse Formulary. The maximum recommended volume of a drug given depends on the route of administration (Formulary for Laboratory Animals, 3 rd ed. Mouse Formulary The maximum recommended volume of a drug given depends on the route of administration (Formulary for Laboratory Animals, 3 rd ed.): Intraperitoneal (IP) doses should not exceed 80 ml/kg

More information

Treatment of Respiratory Tract Infections Prof. Mohammad Alhumayyd Dr. Aliah Alshanwani

Treatment of Respiratory Tract Infections Prof. Mohammad Alhumayyd Dr. Aliah Alshanwani Treatment of Respiratory Tract Infections Prof. Mohammad Alhumayyd Dr. Aliah Alshanwani 30-1-2018 1 Objectives of the lecture At the end of lecture, the students should be able to understand the following:

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metacam 5 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:

More information

Scientific Discussion post-authorisation update for Rheumocam extension X/007

Scientific Discussion post-authorisation update for Rheumocam extension X/007 5 May 2011 EMA/170257/2011 Veterinary Medicines and Product Data Management Scientific Discussion post-authorisation update for Rheumocam extension X/007 Scope of extension: addition of 20 mg/ml solution

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/803/01-FINAL November 2001 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS GENTAMICIN SUMMARY REPORT

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Anaestamine 100 mg/ml solution for injection Aniketam, 100 mg/ml solution for injection (EE/LT/LV) Aniketam vet., 100 mg/ml

More information

1 INDICATIONS AND USAGE. 1.1 Hypertension FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE. 1.1 Hypertension FULL PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AMLODIPINE besylate tablets USP safely and effectively. See full prescribing information for AMLODIPINE

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flukiver 5% w/v Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Closantel (as Clostanel sodium)

More information

SPECTROPHOTOMETRIC ESTIMATION OF MELOXICAM IN BULK AND ITS PHARMACEUTICAL FORMULATIONS

SPECTROPHOTOMETRIC ESTIMATION OF MELOXICAM IN BULK AND ITS PHARMACEUTICAL FORMULATIONS SPECTROPHOTOMETRIC ESTIMATION OF MELOXICAM IN BULK AND ITS PHARMACEUTICAL FORMULATIONS B.DHANDAPANI, S.ESWARA MURALI, N. SUSRUTHA, RAMA SWETHA, S K. SONIA RANI, T. SARATH BABU, G.V. SEETHARAMANJANEYULU,

More information

Stability of Tylosin in Honey Impact on Residue Analysis Don Noot, Tom Thompson

Stability of Tylosin in Honey Impact on Residue Analysis Don Noot, Tom Thompson Stability of Tylosin in Honey Impact on Residue Analysis Don Noot, Tom Thompson Background Information collaboration with Agriculture and Agri-Food Canada project leader: Dr. Steve Pernal (Beaverlodge,

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. Amikacin 250 mg/ml Injection

PACKAGE LEAFLET: INFORMATION FOR THE USER. Amikacin 250 mg/ml Injection PACKAGE LEAFLET: INFORMATION FOR THE USER Amikacin 250 mg/ml Injection Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you

More information

Amlodipine 5 Mg Tab Cam

Amlodipine 5 Mg Tab Cam Amlodipine 5 Mg Tab Cam what is amlodipine 10 mg used for thuoc amlodipine besylate tablets 5 mg amlodipine 5 mg plus atenolol 50 mg amlodipine 5 mg cost amlodipine besylate 10 mg per tablet amlodipine

More information

BIOLACTAM. Product Description. An innovative in vitro diagnostic for the rapid quantitative determination of ß-lactamase activity

BIOLACTAM. Product Description.  An innovative in vitro diagnostic for the rapid quantitative determination of ß-lactamase activity BIOLACTAM www.biolactam.eu An innovative in vitro diagnostic for the rapid quantitative determination of ß-lactamase activity 1.5-3h 20 Copyright 2014 VL-Diagnostics GmbH. All rights reserved. Product

More information

Proposed Programme for Master of Veterinary Pharmacology and Toxicology by Course and Research

Proposed Programme for Master of Veterinary Pharmacology and Toxicology by Course and Research DEPARTMENT OF PHARMACOLOGY AND TOXICOLOGY FACULTY OF VETERINARY MEDICINE UNIVERSITY OF KHARTOUM Proposed Programme for Master of Veterinary Pharmacology and Toxicology by Course and Research May 2012 Proposed

More information

Maximum antihypertensive effects are attained within 2 weeks after a change in dose. AZOR may be administered with other antihypertensive agents.

Maximum antihypertensive effects are attained within 2 weeks after a change in dose. AZOR may be administered with other antihypertensive agents. Page 4 FULL PRESCRIBING INFORMATION AZOR (amlodipine and olmesartan medoxomil) tablets USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin

More information

POPULATION PHARMACOKINETICS AND PHARMACODYNAMICS OF OFLOXACIN IN SOUTH AFRICAN PATIENTS WITH DRUG- RESISTANT TUBERCULOSIS

POPULATION PHARMACOKINETICS AND PHARMACODYNAMICS OF OFLOXACIN IN SOUTH AFRICAN PATIENTS WITH DRUG- RESISTANT TUBERCULOSIS POPULATION PHARMACOKINETICS AND PHARMACODYNAMICS OF OFLOXACIN IN SOUTH AFRICAN PATIENTS WITH DRUG- RESISTANT TUBERCULOSIS Emmanuel Chigutsa 1, Sandra Meredith 1, Lubbe Wiesner 1, Nesri Padayatchi 2, Joe

More information

The pharmacological and microbiological basis of PK/PD : why did we need to invent PK/PD in the first place? Paul M. Tulkens

The pharmacological and microbiological basis of PK/PD : why did we need to invent PK/PD in the first place? Paul M. Tulkens The pharmacological and microbiological basis of PK/PD : why did we need to invent PK/PD in the first place? Paul M. Tulkens Cellular and Molecular Pharmacology Unit Catholic University of Louvain, Brussels,

More information

ZENTEL (Albendazole) PRODUCT INFORMATION

ZENTEL (Albendazole) PRODUCT INFORMATION ZENTEL (Albendazole) PRODUCT INFORMATION DESCRIPTION ZENTEL contains albendazole, which is methyl [5-(propylthio)-1H-benzimidazol-2-yl] carbamate. It is a member of the benzimidazole group of anthelmintic

More information

Recommended for Implementation at Step 7 of the VICH Process on 15 December 2004 by the VICH Steering Committee

Recommended for Implementation at Step 7 of the VICH Process on 15 December 2004 by the VICH Steering Committee VICH GL27 (ANTIMICROBIAL RESISTANCE: PRE-APPROVAL) December 2003 For implementation at Step 7 - Final GUIDANCE ON PRE-APPROVAL INFORMATION FOR REGISTRATION OF NEW VETERINARY MEDICINAL PRODUCTS FOR FOOD

More information

CHEMMART AMLODIPINE 2.5 mg, 5 mg, 10 mg TABLETS

CHEMMART AMLODIPINE 2.5 mg, 5 mg, 10 mg TABLETS CHEMMART AMLODIPINE 2.5 mg, 5 mg, 10 mg TABLETS Product Information Australia NAME OF THE MEDICINE Amlodipine besylate. DESCRIPTION Amlodipine besylate is a dihydropyridine derivative. Chemical Name: 3-ethyl

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/661/99-FINAL August 1999 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS FLUNIXIN SUMMARY REPORT (1)

More information

Australian College of Veterinary Scientists Fellowship Examination. Veterinary Anaesthesia and Critical Care Paper 1

Australian College of Veterinary Scientists Fellowship Examination. Veterinary Anaesthesia and Critical Care Paper 1 Australian College of Veterinary Scientists Fellowship Examination June 2011 Veterinary Anaesthesia and Critical Care Paper 1 Perusal time: Twenty (20) minutes Time allowed: Three (3) hours after perusal

More information

Synthesis and establishment of Amlodipine impurity G reference standard

Synthesis and establishment of Amlodipine impurity G reference standard Journal of Applied Pharmaceutical Science Vol. 7 (10), pp. 105-110, October, 2017 Available online at http://www.japsonline.com DOI: 10.7324/JAPS.2017.71015 ISSN 2231-3354 Synthesis and establishment of

More information

A. Effect upon human culture 1. Control of malaria has contributed to world=s population explosion 2. Africans brought to U.S.

A. Effect upon human culture 1. Control of malaria has contributed to world=s population explosion 2. Africans brought to U.S. VI. Malaria A. Effect upon human culture 1. Control of malaria has contributed to world=s population explosion 2. Africans brought to U.S. because they were resistant to malaria & other diseases 3. Many

More information

New Insecticide Modes of Action: Whence Selectivity?

New Insecticide Modes of Action: Whence Selectivity? New Insecticide Modes of Action: Whence Selectivity? Joel Coats Professor of Entomology and Toxicology Iowa State University Ames, Iowa utline Selectivity New Insecticide asses Neonictinoids Fipronil Chlorphenapyr

More information

Staphylex Flucloxacillin (sodium)

Staphylex Flucloxacillin (sodium) Staphylex Flucloxacillin (sodium) PRODUCT INFORMATION Name of the Medicine Flucloxacillin sodium is the sodium salt of 3-(2'-chloro-6'-fluorophenyl)-5-methyl-4-isoxazolylpenicillin monohydrate. Structural

More information

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

1. NAME OF THE VETERINARY MEDICINAL PRODUCT Summary of Prodcuct Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrox Max 100 mg/ml Solution for Injection for Cattle and Pigs Enroxal Max 100 mg/ml Solution for Injection for Cattle and

More information

ALBENDAZOLE AND ITS ANALOGUES

ALBENDAZOLE AND ITS ANALOGUES ALBENDAZOLE AND ITS ANALOGUES J. El harti *, M. Ansar, J. Taoufik. Laboratory of Medicinal Chemistry, Faculty of Medicine and Pharmacy, BP 6203, Rabat Institute, University Mohammed V Souissi, Rabat, Morocco.

More information

Pharmacokinetics, safety and effectiveness of high dose rifampicin and moxifloxacin for TB meningitis: a RCT in Indonesia

Pharmacokinetics, safety and effectiveness of high dose rifampicin and moxifloxacin for TB meningitis: a RCT in Indonesia Pharmacokinetics, safety and effectiveness of high dose rifampicin and moxifloxacin for TB meningitis: a RCT in Indonesia Rovina Ruslami, Ahmad Rizal Ganiem, Sofiati Dian, Lika Apriani, Lidya Chaidir,

More information

Proceedings of the World Small Animal Veterinary Association Sydney, Australia 2007

Proceedings of the World Small Animal Veterinary Association Sydney, Australia 2007 Proceedings of the World Small Animal Veterinary Association Sydney, Australia 2007 Hosted by: Australian Small Animal Veterinary Association (ASAVA) Australian Small Animal Veterinary Association (ASAVA)

More information

1 TRADE NAME OF THE MEDICINAL PRODUCT. Gentamicin Paediatric 20mg/2ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 TRADE NAME OF THE MEDICINAL PRODUCT. Gentamicin Paediatric 20mg/2ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 TRADE NAME OF THE MEDICINAL PRODUCT Gentamicin Paediatric 20mg/2ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2ml contains 20mg of Gentamicin as Gentamicin Sulfate Excipient

More information

EPSIPRANTEL Veterinary Oral-Local

EPSIPRANTEL Veterinary Oral-Local EPSIPRANTEL Veterinary Oral-Local A commonly used brand name for a veterinary-labeled product is Cestex. Note: For a listing of dosage forms and brand names by country availability, see the Dosage Forms

More information

Development of Analytical Methods for the Determination of Flunixin and Phenylbutazone Drug Residues in Edible Bovine Tissues

Development of Analytical Methods for the Determination of Flunixin and Phenylbutazone Drug Residues in Edible Bovine Tissues Development of Analytical Methods for the Determination of Flunixin and Phenylbutazone Drug Residues in Edible Bovine Tissues Philip Asea, John Patterson, & Joe Boison CVDR, Health of Animals Laboratory,

More information

Pharmacological Evaluation of Amikacin in Neonates

Pharmacological Evaluation of Amikacin in Neonates ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, JUlY 1975, p. 86-90 Copyright 0 1975 American Society for Microbiology Vol. 8, No. 1 Printed in U.SA. Pharmacological Evaluation of Amikacin in Neonates JORGE B.

More information

Analysis of Hormones & Anabolics

Analysis of Hormones & Anabolics Analysis of Hormones & Anabolics Hormones and anabolics can be used as growth promoters in livestock breeding to enhance average daily weight gain and meat/fat ratio. As a consequence, hormone and anabolic

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Loxicom 0.5 mg/ml oral suspension for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE European Medicines Agency Veterinary Medicines and Inspections EMEA/CVMP/152255/2006-FINAL May 2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE MELOXICAM (Extrapolation to rabbits and goats) SUMMARY

More information

DISSOCIATIVE ANESTHESIA

DISSOCIATIVE ANESTHESIA DISSOCIATIVE ANESTHESIA Adarsh Kumar Dissociative anesthesia implies dissociation from the surrounding with only superficial sleep mediated by interruption of neuronal transmission from unconscious to

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicine and Information Technology Unit EMEA/MRL/719/99-FINAL January 2000 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS PIRLIMYCIN

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE

More information

Article In Vivo Activity of LCB , a Prodrug of LCB , against Staphylococcus aureus

Article In Vivo Activity of LCB , a Prodrug of LCB , against Staphylococcus aureus Article In Vivo Activity of LCB 01-0699, a Prodrug of LCB 01-0648, against Staphylococcus aureus Sang-Hun Oh 1,, Hee-Soo Park 2,, Jun-Hyung Lee 1, Sung-Yun Baek 3, Sang-Eun Chae 3, Kyuman Oh 3, Young Lag

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS Revised: March 2015 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tolracol 50 mg/ml oral suspension for pigs, cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

More information

ZOETIS INC. 333 PORTAGE STREET, KALAMAZOO, MI, Telephone: Customer Service: Website: EXCEDE FOR SWINE

ZOETIS INC. 333 PORTAGE STREET, KALAMAZOO, MI, Telephone: Customer Service: Website:  EXCEDE FOR SWINE ZOETIS INC. 333 PORTAGE STREET, KALAMAZOO, MI, 49007 Telephone: 269-359-4414 Customer Service: 888-963-8471 Website: www.zoetis.com Every effort has been made to ensure the accuracy of the information

More information

Amlodipine and Valsartan Tablets

Amlodipine and Valsartan Tablets . olumn: Inteim Revision Announcement Official Novembe 1, 2017 Amlodipine 1 Amlodipine and Valsatan Tablets DEFINITION Amlodipine and Valsatan Tablets contain NLT 90.0% and NT 110.0% of the labeled amount

More information

LEVOFLOXACIN RESIDUES IN CHICKEN MEAT AND GIBLETS

LEVOFLOXACIN RESIDUES IN CHICKEN MEAT AND GIBLETS Bulgarian Journal of Veterinary Medicine (2013), 16, Suppl. 1, 216 219 LEVOFLOXACIN RESIDUES IN CHICKEN MEAT AND GIBLETS R. KYUCHUKOVA 1, V. URUMOVA 2, M. LYUTSKANOV 2, V. PETROV 2 & A. PAVLOV 1 1 Department

More information

Copper-Storage Liver Disease Basics

Copper-Storage Liver Disease Basics Copper-Storage Liver Disease Basics OVERVIEW Abnormal accumulation of copper in the liver, causing sudden (acute) inflammation of the liver (hepatitis) or long-term (chronic) hepatitis and eventually progressive

More information