ROBERT F. REILLY AND DAVID H. ELLISON nephron segments in superficial cortex of the rat kidney. J. Ultrastruct. Res. 99: 169 187, DORUP, J., P. MORSING, AND R. RASCH. Tubule-tubule and tubulearteriole contacts in rat kidney distal nephrons: a morphologic study based on computer-assisted three-dimensional reconstructions. Lab. Invest. 67: 761769, 1992. DOUCET, A. Function and control of Na-K-ATPase in single nephron segments of the mammalian kidney. Kidney Int. 34: 749 760, DOUCET, A., AND A. I. KATZ. Mineralocorticoid receptors along the nephron: [3H]aldosterone binding in rabbit tubules. Am. J. Physiol. 241 Renal Fluid Electrolyte Physiol. 10 ; : F605F611, 1981. DUC, C., N. FARMAN, C. M. CANESSA, J.-P. BONVALET, AND B. C. ROSSIER. Cell-specific expression of epithelial sodium channel and subunits in aldosterone-responsive epithelia from the rat: localization by in situ hybridization and immunocytochemistry. J. Cell Biol. 127: 19071921, 1994. DURKIN, J. T., D. C. AHRENS, Y. C. PAN, AND J. P. REEVES. Purification and amino-terminal sequence of the bovine cardiac sodium-calcium exchanger: evidence for the presence of a signal sequence. Arch. Biochem. Biophys. 290: 369 375, EDELSTEIN, C. L., Y. SHI, J. BERKMAN, AND D. H. ELLISON. Renal ischemia decreases thiazide-sensitive Na-Cl cotransporter expression Abstract ; . J. Am. Soc. Nephrol. 9: 34A, 1998. ELALOUF, J. M., N. ROINEL, AND C. DE ROUFFIGNAC. Stimulation by human calcitonin of electrolyte transport in distal tubules of rat kidney. Pflugers Arch. 399: 111118, 1983. ELLISON, D. H. Adaptation to Diuretic Drugs. Diuretic Agents: Clinical Physiology and Pharmacology. San Diego, CA: Academic, 1997, p. 209 232. ELLISON, D. H., R. F. REILLY, N. OBERMULLER, C. CANESSA, AND S. BACHMANN. Molecular localization of Na and Ca transport pathways along the renal distal tubule Abstract ; . J. Am. Soc. Nephrol. 6: 947, 1995. ELLISON, D. H., AND H. VELAZQUEZ. Cultured rabbit distal convoluted tubule cells transport sodium and potassium Abstract ; . Kidney Int. 35: 479, 1989. ELLISON, D. H., H. VELAZQUEZ, AND F. S. WRIGHT. Thiazide sensitive sodium chloride cotransport in the early distal tubule. Am. J. Physiol. 253 Renal Fluid Electrolyte Physiol. 22 ; : F546 F554, 1987. ELLISON, D. H., H. VELAZQUEZ, AND F. S. WRIGHT. Adaptation of the distal convoluted tubule of the rat: structural and functional effects of dietary salt intake and chronic diuretic infusion. J. Clin. Invest. 83: 113126, 1989. EL MERNISSI, G., AND A. DOUCET. Specific activity of Na-KATPase after adrenalectomy and hormone replacement along the rabbit nephron. Pflugers Arch. 402: 258 263, ETTINGER, B., J. T. CITRON, B. LIVERMORE, AND L. I. DOLMAN. Chlorthalidone reduces calcium oxalate calculous recurrence but magnesium hydroxide does not. J. Urol. 139: 679 684, FANESTIL, D. D., D. A. VAUGHN, AND P. BLAKELY. Dietary NaCl and KCl do not regulate renal density of the thiazide diuretic receptor. Am. J. Physiol. 273 Regulatory Integrative Comp. Physiol. 42 ; : R1241R1245, 1997. FANESTIL, D. D., D. A. VAUGHN, AND P. BLAKELY. Metabolic acid-base influences on renal thiazide receptor density. Am. J. Physiol. 272 Regulatory Integrative Comp. Physiol. 41 ; : R2004 R2008, 1997. FARMAN, N. Steroid receptors: distribution along the nephron. Semin. Nephrol. 12: 1217, 1992. FARMAN, N., AND J. P. BONVALET. Aldosterone binding in isolated tubules. III. Autoradiography along the rat nephron. Am. J. Physiol. 245 Renal Fluid Electrolyte Physiol. 14 ; : F606 F614, 1983. FARMAN, N., P. PRADELLES, AND J. P. BONVALET. Binding of aldosterone metabolites in isolated tubular segments. Am. J. Physiol. 249 Renal Fluid Electrolyte Physiol. 18 ; : F923F932, 1985. FARMAN, N., C. R. TALBOT, R. BOUCHER, M. FAY, C. CANESSA, B. ROSSIER, AND J. P. BONVALET. Noncoordinated expression of alpha-, beta-, and gamma-subunit mRNAs of epithelial Na channel along rat respiratory tract. Am. J. Physiol. 272 Cell Physiol. 41 ; : C131C141, 1997.

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BRIEF SUMMARY NIMOTOP * nimodipine Miles ; CAPSULES For Oral Use INDICATIONS A N D USAGE Nimotol * nimixiipine ; is indicated for the improvement if neurologic at deficits due to spasm following subarachnoid hemorrhage from ruptured congenital intracranial aneurysms in patients who are in gi d neurological condition post-ictus e.g. Hunt and Hess Grades l-lll ; . Oral Nimot0p * therapy should begin within 96 hour; , of the subarachnoid hemorrhage and continue for 21 days. CONTRAINDICATIONS None known. PRECAUTIONS General: Blood Pressure: Nimodipine has the hemodynamic effects expected of a calcium channel blocker, although they are generally not marked. In patients with subarachnoid hemorrhage given Nimotpo * in clinical studies, about 5% were reported to have had lowering of the blood pressure and about 1% left the study because of this not all could be attributed to nimodipine ; . Nevertheless, blood pressure shxi!d be carefully monitored during treatment with Jimotop * based on its known pharmacology and the known effects of calcium channel blockers. Hepatic Disease: The metabolism of Nim0top * is decreased in patients with impaired hepatic function. Such patients should have their blood pressure and pulse rate monitored closely and should be given a lower dose see Dcwage and Administration ; . Laboratory Test Interactions: None known. Drug Interaction: It is possible that the cardiovascular action of other calcium channel blockers could be enhanced by the addition of Nimotop * . In Europe, Nimotop was observed ro occasionally intensify the effect of antihypertensive compounds taken concomit.inrly by patients suffering from hypertension: this phenomenon was not observed in North American clinical trials. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a two-year study, higher incidences of adenocarcinoma of the uterus and Leydig-cell adenoma of the testes were observed in rats given a diet containing 1800 ppm nimodipine equivalent to 91 to 121 mg kg day nimodipine ; than in placebo controls. The differences were not statistically significant; however, the higher rates were well within historical control range for these tumors in the Wist ar strain. Nimodipine was found not to be carcinogenic in a 91-week mouse study but the high dose of 1800 ppm nimodipine-in-feed 546 to 774 mg kg day ; shortened the life expectancy of the animals. Mutagenic studies, including the Ames, micronucleus and dominant lethal tests were negative. Nimodipine did not impair rhe fertility and general reprcKiuctive performance of male and female Wistar rats following oral doses of up to mg kg day when administered daily for more than 10 weeks in the males and 3 weeks in the females prior to mating and continued to day 7 of pregnancy. This dose in a rat is about 4 rimes the equivalent clinical dose of 60 mgq4h ma 50 kg patient. Pregnancy: Pregnancy Category C. Nimodipine has been shown to have a teratogenic effect in Himalayan rabbits. Incidences of malformations and stunted fetuses were increased at oral by gavage ; doses of I and lOmg kg day administered from day 6 through day 18ofpregnancy but not at 3.0 mg kg day in one of two identical rabbit studies. In the second study an increased incidence of stunted fetuses was seen at 1.0 mg kg day but not at higher doses. Nimodipine was embryotoxic, causing resorption and stunted growth of fetuses, in Long Evans rats at 100 mg kg day administered by gavage from day 6 through day 15 of pregnancy. In two other rat studies, doses of 30 mg kg day nimodipine administered by gavage from day 16 of gestation and continued until sacrifice day 20 of pregnancy or day 21 post partum ; were associated with higher incidences of skeletal variation, stunted fetuses and stillbirths but no malformations. There art- no adequate and well controlled studies in pregnant women to directly assess the effect on human fetuses. Nimodipine should be used during pregnancy only if the potential benefit justifies the potential risk to trie fetus. Nursing Mothers: Nimodipine and or its metabolites have been shown to appear in rat milk at concentrations much higher than in maternal plasma. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, nursing mothers are advised not to breast feed their babies when taking the drug. Fedutrie Use: Safety and effectiveness in children have not been established. ADVERSE REACTIONS Adverse experiences were reported by 92 of 823 patients with subarachnoid hemorrhage 11.2% ; who were given nimodipine. The mosr frequently reported adverse experience was decreased bkx d pressure in 4 % these patients. Twenty-nine of 479 6.1% ; placebo treated patients also reported adverse experiences. The events reported with a frequency greater than 1% are displayed below by dose. DOSEq4h Number of Patients % ; Nimodipine Placebo 0.35 mg ki: 30 mg 60 mg 90 mg 120 mg Sign Symptom n 82 ; In 494 ; n 172 ; n 4 ; n 479 ; Decreased Blood Pressure 19 3.8 ; 14 8.1 ; 2 50.0 ; 6 1.2 ; 1 1.2 ; Abnormal Liver 7 1.5 ; Function Test 0 I 0.6 ; 1 1.2 ; 2 0.4 ; 3 0.6 ; Edema 0 0 2 0.4 ; 2 1.2 ; 0 3 0.6 ; Diarrhea 0 3 4.2 ; 3 17 ; 3 0.6 ; i 0.6 ; Rash 0 2 12 ; 2.4 ; 6 1.2 ; 1 0.2 ; 0 0 Headache I 1.4 ; Gastrointestinal 0 2 1.2 ; 0 Symptoms 2 2.4!

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Historically Elan's stock performance is strongly influenced by newsflow and analysis of the key milestones anticipated can help identify catalysts for the stock. In the Table below we have outlined some of the key events we anticipate over the coming year, which can generally be classified under three headings; 1 ; newsflow regarding regulatory approval of near-term pipeline drugs; 2 ; results of clinical trials for Alzheimer's, multiple sclerosis and irritable bowel disease; 3 ; the potential for further significant alliances, in particular Antegren and additional Alzheimer's developments. Submitted for publication december 31, 200 accepted for publication march 31, 200 support was provided solely from institutional and or departmental sources and indocin. This led to the concern that leukotriene inhibition may promote the biologic conversion of severe asthma atopic disease toward css 48.

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Carbohydrate Polymers, 38 1999 ; , S. 239-246 KOTELNIKOVA ET AL. 1999B Kotelnikova N.E.; Panarin E.F.; Kudina N.P.; Yongfa H.; Su L.S.; van Fuopan: Comparative Study of Adsorption of the Polymeric Anticeptic Catapol on Samples of Microcrystalline Cellulose of Various Natural Origins. In: Russian J. of General Chemistry, 69 1999 ; , S. 1325-1332 Krmer J.; Blume H.: Biopharmaceutical multiparticulates. In: Ghebre-Sellassie 1994.

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The following list of medications are eligible for up to 102-days supply. * GENERIC Levobunolol Levodopa Levodopa Carbidopa Levothyroxine Lisinopril Lisinopril hydrochlorothiazide Losartan Potassium Losartan Potassium hydrochlorothiazide Lovastatin Meclizine Meclofenamate Medroxyprogesterone Meloxicam Mephenytoin Mephobarbital Metformin Metformin glyburide Methazolamide Methimazole Methionine Methsuximide Methyclothiazide Methyclothiazide Deserpidine Methyclothiazide Reserpine Methyldopa Methyldopa Chlorothiazide Methyldopa hydrochlorothiazide Methylphenidate Methyltestosterone Estrogen Metipranolol Metolazone Metoprolol Metoprolol hydrochlorothiazide Metyrosine Mexiletine Miglitol Minoxidil Misoprostol Diclofenac Sodium Moexipril Moexipril hydrochlorothiazide Montelukast Moricizine HCL Nabumetone Nadolol Nadolol Bendroflumethiazide Naproxen Nateglinide Nicardipine Nifedipine Nimodipine Nisoldipine Nitroglycerin Norelgestromin Ethinyl Estradiol Norethindrone Oral Contraceptives various ; Oxaprozin Oxcarbazepine Oxtriphylline Oxybutynin chloride Papaverine Paramethadione Trandolapril Trandolapril Verapamil Travoprost Triamterene Triamterene hydrochlorothiazide Trichlormethiazide Trichlormethiazide Reserpine Trimethadione Valproate Sodium Valproic Acid Valsartan Verapamil Verapamil Trandolapril Warfarin Sodium Zafirlukast Zileuton BRAND NAME Betagan Larodopa Sinemet Levoxyl Prinivil, Zestril Prinizide, Zestoretic Cozaar Hyzaar Mevacor Antivert Meclomen Provera Mobic Mesantoin Mebaral Glucophage, Glucophage XR Glucovance Neptazane Tapazole Uranap Celontin Aquatensen, Enduron Enduronyl Diutensin-R Aldomet Aldoclor Aldoril Ritalin Estratest, Estratest H.S. 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MEDICATIONS continued C. ANTIEMETICS Pepcid 20 mg IV PO every 12 hours K Zofran 4 mg IV every 6 hours PRN for nausea K Reglan 10 mg IV every 6 hours PRN for nausea if Zofran not effective D. CALCIUM CHANNEL BLOCKER Nimotop 60 mg PO every 4 hours for 21 days E. ELECTROLYTE MAINTENANCE Magnesium Sulfate 2 grams IV over 1 hour every 6 hours for 21 days F. ICU SEDATION K Propofol 25 mcg kg minute IV titrate for minimal sedation RASS 1 ; , turn off every hour for 15 minutes for neurological examination, only use on patients with ventricular drain G. THROMBOLYTIC K PHYSICIAN TO ADMINISTER Alteplase TPA ; 2 mg IV daily for 3 days; please order only if patient has a ventricular drain; TO BE INJECTED BY NEUROSURGERY ONLY INTO THE VENTRICULAR DRAIN H. LIPID-LOWERING Zocor 20 mg PO nightly I. BOWEL MANAGEMENT Colace 100 mg 1 capsule PO twice daily K Dulcolax suppository 10 mg PR every other day K Milk of Magnesia 30 ml PO every other night J. PAIN MEDICATIONS K Tylenol 325 mg PO PR every 6 hours PRN for pain or temperature greater than 101.5F K Vicodin 5 325 1-2 tablets every 6 hours PRN pain if Tylenol is not effective start with one tablet and if continued pain at one hour mark, give second tablet ; K Morphine Sulfate 2 mg IV every 2 hours for 3 days PRN pain. Hold for over sedation. NDA 18-869 S-014 FDA approved Labeling text Hepatic Disease: The metabolism of Nimotop is decreased in patients with impaired hepatic function. Such patients should have their blood pressure and pulse rate monitored closely and should be given a lower dose see DOSAGE AND ADMINISTRATION ; . Intestinal pseudo-obstruction and ileus have been reported rarely in patients treated with nimodipine. A causal relationship has not been established. The condition has responded to conservative management. Laboratory Test Interactions: None known. Drug Interaction: It is possible that the cardiovascular action of other calcium channel blockers could be enhanced by the addition of Nimotop. In Europe, Nimotop was observed to occasionally intensify the effect of antihypertensive compounds taken concomitantly by patients suffering from hypertension; this phenomenon was not observed in North American clinical trials. A study in eight healthy volunteers has shown a 50% increase in mean peak nimodipine plasma concentrations and a 90% increase in mean area under the curve, after a one-week course of cimetidine at 1, 000 mg day and nimodipine at 90 mg day. This effect may be mediated by the known inhibition of hepatic cytochrome P-450 by cimetidine, which could decrease first-pass metabolism of nimodipine. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a two-year study, higher incidences of adenocarcinoma of the uterus and Leydig-cell adenoma of the testes were observed in rats given a diet containing 1800 ppm nimodipine equivalent to 91 to 121 mg kg day nimodipine ; than in placebo controls. The differences were not statistically significant, however, and the higher rates were well within historical control range for these tumors in the Wistar strain. Nimodipine was found not to be carcinogenic in a 91-week mouse study but the high dose of 1800 ppm nimodipine-in-feed 546 to 774 mg kg day ; shortened the life expectancy of the animals. Mutagenicity studies, including the Ames, micronucleus and dominant lethal tests were negative. Nimodipine did not impair the fertility and general reproductive performance of male and female Wistar rats following oral doses of up to mg kg day when administered daily for more than 10 weeks in the males and 3 weeks in the females prior to mating and continued to day 7 of pregnancy. This dose in a rat is about 4 times the equivalent clinical dose of 60 mg q4h in a 50 patient. Pregnancy: Pregnancy Category C. Nimodipine has been shown to have a teratogenic effect in Himalayan rabbits. Incidences of malformations and stunted fetuses were increased at oral doses of 1 and 10 mg kg day administered by gavage ; from day 6 through day 18 of pregnancy but not at 3.0 mg kg day in one of two identical rabbit studies. In the second study an increased incidence of stunted fetuses was seen at 1.0 mg kg day but not at higher doses. Nimodipine was embryotoxic, causing resorption and stunted growth of fetuses, in Long Evans rats at 100 mg kg day administered by gavage from day 6 through day 15 of pregnancy. In two other rat studies, doses of 30 mg kg day nimodipine administered by gavage from day 16 of gestation and continued until sacrifice day 20 of pregnancy or day 21 post partum ; were associated with higher incidences of skeletal variation, stunted fetuses and stillbirths but no malformations. There are no adequate and well controlled studies in pregnant women to directly assess the effect on human fetuses. Nimodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Nimodipine and or its metabolites have been shown to appear in rat milk at concentrations much higher than in maternal plasma. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, nursing mothers are advised not to breast feed their babies when taking the drug. Pediatric Use: Safety and effectiveness in children have not been established. Geriatric Use: Clinical studies of nimodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dosing in elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy and depo-medrol and Nimotop online!

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