Gatifloxacin. gatifloxacin GFLX GFLX GFLX

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1 GFLX Gatifloxacin gatifloxacingflx GFLX GFLX Key words: gatifloxacinhypoglycemiahyperglycemiadiabeticrenal dysfunction GatifloxacinGFLX PRSP GFLX mg GFLXTequin 5 GFLX 5 GFLX 89 I GFLX mgdl 5

2 Table. Number of cases classified by gender and complication Male Female Table. Blood glucose of hypoglycemia Table. Blood glucose of hyperglycemia Glucose levelmg/dl No. of patients% Glucose levelmg/dl No. of patients% mgdl GFLX Ccr Ccr Scr Ccr Ccr Cockcroft-Gault 75 mlmin 5 Ccr Scr BUN II Table Table mgdl 7. mgdl 5 mgdl 9 mgdl 9 mgdl 9 mgdl 9 mg dl 99 mgdl

of patients% 7 9..7 8.7 8..7.. -9-9 -9-9 5- -99-99 -99-99 -99 9-... 5 5.7 7.. 7. 75 mgdl GFLX Ccr Ccr Scr Ccr Ccr Cockcroft-Gault 75 mlmin 5 Ccr Scr BUN II Table 89.

3 GFLX Fig Table GFLX Table 5 Fig.. Number of cases classified by side effect onset day mg mg Table glibenclamidegliclazide sulfonylureasu SU insulin.acarbose.voglibose.pioglitazone hydrochloride.metformin hydrochloride.9nateglinide SU SU voglibose 7.metformin hydrochloride 8. nateglinide 9. Table. Number of cases classified by age and complication Age Table 5. Number of cases classified by daily dose of gatifloxacin and complication Dose mg/day

.7 SU voglibose 7.metformin hydrochloride 8. nateglinide 9. Table. Number of cases classified by age and complication Age 5-5-5 55-7 7.9 5-7 8. 75-8 9 7 5 5. 85-9 5 8.

4 Treated SU SU Insulin SU Other Insulin Insulin Other Other Not treated Table. Type of antidiabetes in diabetics No. of patients% SU: sulfonylurea antidiabetes Other: acarbose, voglibose, pioglitazone hydrochloride, metformin hydrochloride, nateglinide Table 7. Dose of sulfonylurea antidiabetes Dose Maximum Intermediate Low No. of patients% Table Cockcroft-Gault Ccr Table 9 Ccr Ccr 9.Ccr Ccr. Ccr Ccr.. 7. Ccr GFLX Ccr Fig. mg. mg 9 9. mg.5 mg 7.7 mg. mg 85.7 Ccr 5 Ccr 75 mlmin mg 7 GFLX Table GFLX µ gml GFLX mg..7 µ gml GFLX Ccr..9. mlmin III 89 GFLX

Dose of sulfonylurea antidiabetes Dose Maximum Intermediate Low No. of patients% 5. 8.7 5. 8. 9 5 8..7 5 Table 8 75 9 5. 7 5. 55 9 89. 8 7 87.5 75. 7.75 8.

5 GFLX Table 8. Number of cases classified by complication n=75 No. of complications% n= No. of complications% YES NO YES NO Renal dysfunction Hepatic dysfunction Cardiovascular disease Non Renal dysfunction 8..7 Hepatic dysfunction 7.. Cardiovascular disease 7.. Renal dysfunction Hepatic dysfunction Cardiovascular disease Table 9. Number of cases classified by renal functionccr % % % % SevereCcr Moderate Ccr Mild Ccr NormalCcr Renal dysfunction% Fig.. Correlation between daily dose and estimated Ccr. GFLX GFLX Tequin GFLX mg

Cardiovascular disease 8. 57.9 Table 9. Number of cases classified by renal functionccr % % % % SevereCcr 5 5.9 9 5.9. 8... Moderate Ccr 9..5 5. 8... Mild Ccr 75.9 5.9 5.7 NormalCcr 75.

6 Table. Serum concentration of gatifloxain in patients No Adverse effect Gender Age Primary disease Complication Concentration g/ml Time after dosinghr g/ml Estimated Ccr ml/min Female 8 UTI Diabetic male 8 UTI Acute renal dysfunction.. Female 8 Acute RTI Cardiac disease 5.59 male 9 Infection Hypertension 5.8. Dose: mg Table. Drug list of hypoglycemia in serious side effects in Japanese package inserts Antimicrobials gatifloxacin levofloxacin ciprofloxacin sparfloxacin ofloxacin lomefloxacin enoxacin sulphametoxazol/trimetoprim Antiarrhythmics disopyramide phosphate cibenzoline succinate Aminolevan Indomethacin injection Antineoplastics mitotane SU SU SU SU 7 Table GFLX disopyramide phosphatecibenzoline succinate 7,8 GFLX Ccr 9 mlmin GFR 75 mlmin Ccr 75 mlmin Ccr lomefloxacinlflx ofloxacinoflx OFLX 9.8 µ gml 78 5 GFLX GFLX µ gml mg.7 µ gml GFLX glucose 75 8.

Drug list of hypoglycemia in serious side effects in Japanese package inserts Antimicrobials gatifloxacin levofloxacin ciprofloxacin sparfloxacin ofloxacin lomefloxacin enoxacin

7 GFLX GFLX GFLX Ccr GFLX 9,,7 insulin insulin insulin glycogen GFLX Maeda 8 LFLXenoxacinsparfloxacintosufloxacin mm glucose insulin insulin verapamilca channel blockerdiazoxidek -ATP channel opener K -ATP channel Ca insulin Gajjar 9 GFLX mg ciprofloxacincpfx5 mg insulin GFLX AUC 75 CPFX insulin AUC GFLX CPFX 85 Gajjar GFLXCPFX insulin 8 GFLX, mgkg glucose, mgkg p.5 GFLX 8 mgkg Cmax µ gml mg 8 µ gml Maeda 8 in vitro LFLX Gajjar 9 GFLX insulin GFLX insulin insulin glycogen GFLX insulin GFLX GFLX β insulin SU HbAc8. insulin SU GFLX insulin β HIT-T5 GFLX glucose insulin.5 µ gml insulin

channel blockerdiazoxidek -ATP channel opener K -ATP channel Ca insulin Gajjar 9 GFLX mg ciprofloxacincpfx5 mg insulin GFLX AUC 75 CPFX insulin AUC

8 GFLX β insulin 5 g 5 ml 5 5 ml ml Menzies 7 GFLX glucose glucose glucose GFLX GFLX GFLX GFLX GFLX Bristol-Myers SquibbTequin Cockcroft D W, Gault M H: Prediction of creatinine clearance from serum creatinine. Nephron :, 97 5 S7S77, GFLX I I 7Suppl : 757, Disopyramide Progress in Medicine 9: 88, : 995, 9 LFLX :, : 58, Willmore L J: The effect of age on pharmacokinetics of antiepileptic drugs. Epilepsia : SS, 995 GFLX 7Suppl : 89, 999 GFLX 7Suppl : 7, 999 : 7988, 99 5 : 9595, 99 Baker S E, Hangii M C: Possible GFLX-induced hypoglycemia. Ann Pharmacother : 77, 7 Menzies D J, Dorsainvil P A, Cunha B A, et al: Severe and persistent hypoglycemia due to GFLX interaction

Nephron :, 97 5 S7S77, GFLX I I 7Suppl : 757, 999 7 Disopyramide Progress in Medicine 9: 88, 999 8 : 995, 9 LFLX :, : 58, Willmore L J: The effect of age on

9 GFLX with oral hypoglycemic agents. Am J Med 5: :, 8 Maeda N, Tamagawa T, Niki I, et al: Increase in insulin release from rat pancreatic islets by quinolone antibiotics. British Journal of Pharmacology 7: 7 7, 99 9 Gajjar D A, Pharm B, et al: Effect of multiple-dose GFLX or ciprofloxacin on glucose homeostasis and insulin production in patients with noninsulindependent diabetes mellitus maintained with diet and exercise. Pharmacotherapy : 7S8S, Gatifloxacin : 8787, 998 mgp. 8 mgp. p. Analysis of patients with hypoglycemia andor hyperglycemia induced by gatifloxacin Risk factors and patient profiles Toshiyuki Tamayama, Yasushi Tanaka and Atsushi Saito Drug Information Department, Kyorin Pharmaceutical Co., Ltd., 5 Kanda Surugadai, Chiyoda-ku, Tokyo, Japan Department of Medicine, Metabolism and Endocrinology, Juntendo University School of Medicine The Jikei University School of Medicine GATIFLO Tablets, containing gatifloxacingflx, a synthetic fluoroquinolone antibacterial agent, were launched in Japan in June. For several months after GFLX were marketed, cases of hypoglycemia andor hyperglycemia were reported as adverse drug reactions. Thus, Emergency Safety Information statement was issued in March, stipulating the contraindication of GFLX in patients with diabetes mellitus. Risk factors for inducing blood glucose change were estimated by analyzing data collected from 89 cases with severe blood glucose change reported by March. The results were as follows:. Of 89 cases, hypoglycemia was noted in 7589 and hyperglycemia in Patients with diabeties accounted for 5877.of hypoglycemia and 78.of hyperglycemia.. Patients 5 years or older accounted for 8 cases9.7of hypoglycemia and 7.of hyperglycemia.. Among cases with records on renal function, dysfunction was found in 989.of 55 cases of hypoglycemia, and 787.5out of 8 cases of hyperglycemia. Based on the above findings,diabetes mellitus,aged person,andrenal dysfunctionare estimated as major risk factors for blood glucose change induced by GFLX. To prevent adverse reactions related to blood glucose change, it is essential to recognize these risk factors and to administer GFLX appropriately based on statements in labeling on the package inserts.

noninsulindependent diabetes mellitus maintained with diet and exercise. Pharmacotherapy : 7S8S, Gatifloxacin : 8787, 998 mgp. 8 mgp. p.

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