2011 ASH Program Book - American Society of Hypertension

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Animal Data No reproductive toxicity studies have been conducted with the combination of aliskiren and amlodipine besylate. However, these studies have been conducted for aliskiren and amlodipine besylate alone. Aliskiren In developmental toxicity studies, pregnant rats and rabbits received oral aliskiren hemifumarate during organogenesis at doses up to 20 and 7 times the maximum recommended human dose (MRHD) based on body surface area (mg/m 2 ), respectively, in rats and rabbits. (Actual animal doses were up to 600 mg/kg/day in rats and up to 100 mg/kg/day in rabbits.) No teratogenicity was observed; however, fetal birth weight was decreased in rabbits at doses 3.2 times the MRHD based on body surface area (mg/m 2 ). Aliskiren was present in placentas, amniotic fluid and fetuses of pregnant rabbits. Amlodipine In developmental toxicity studies, pregnant rats and rabbits received oral amlodipine maleate during organogenesis at doses approximately 10 and 20 times the maximum recommended human dose (MRHD) based on body surface area (mg/m 2 ), respectively, in rats and rabbits. (Actual animal doses were up to 10 mg/kg/day.) No evidence of teratogenicity or other embryo fetal toxicity was observed. However, litter size was decreased approximately 50% and the num ber of intrauterine deaths was increased approximately 5-fold for rats receiving amlodipine maleate at doses approximately 10 times the MRHD based on body surface area (mg/m 2 ) for 14 days before mating and throughout mating and gestation. Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose. 8.3 Nursing Mothers It is not known whether aliskiren or amlodipine is excreted in human milk. Both aliskiren and amlodipine are secreted in the milk of lactating rats. Because of the potential for serious adverse reactions in human milk-fed infants from Tekamlo, a decision should be made whether to discontinue nursing or discontinue Tekamlo, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Safety and effectiveness of Tekamlo in pediatric patients have not been established. 8.5 Geriatric Use Tekamlo In the short-term controlled clinical trials of Tekamlo, 17% of patients treated with Tekamlo were ≥65 years. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Aliskiren Impact of aging on aliskiren pharmacokinetics has been assessed, when compared to young adults (18-40 years), aliskiren mean AUC and C max in elderly subjects (>65 years) are increased by 57% and 28%, respectively. However, differences in efficacy and safety between the elderly and younger populations were minor, indicating that differences in exposure due to age do not significantly alter the clinical effect of the drug. Therefore, no starting dose adjustment in geriatric population is required. Amlodipine Other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approx - imately 40-60%. In general dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. 10 OVERDOSAGE Aliskiren Limited data are available related to overdosage in humans. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension should occur, provide supportive treatment.
Amlodipine besylate Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. Reports of intentional overdosage include a patient who ingested 250 mg and was asymptomatic and was not hospitalized; another (120 mg) was hospitalized, underwent gastric lavage and remained normotensive; the third (105 mg) was hospitalized and had hypotension (90/50 mmHg) which normalized following plasma expansion. A case of accidental drug overdose has been documented in a 19-month-old male who ingested 30 mg amlodipine (about 2 mg/kg). During the emergency room presentation, vital signs were stable with no evidence of hypotension, but a heart rate of 180 bpm. Ipecac was administered 3.5 hours after ingestion and on subsequent observation (overnight) no sequelae were noted. If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative mea sures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Intravenous calcium gluco - nate may help to reverse the effects of calcium entry blockade. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 T2011-52 March 2011 ©Novartis
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American Society of Hypertension, I
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Visit booth #1100 to find out more
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Past Presidents of the American Soc
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Program Color Key The pages of this
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General Information continued Discl
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2011 ASH Corporate Members Boehring
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ASH Leadership 2010-2011 Board of D
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Special Lecture Monday, May 23, 201
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Young Scholar Award* Monday, May 23
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Special Lecture Monday, May 23, 201
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2011 Abstract Reviewers Lawrence J.
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More than half of hypertensive pati
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Poster Category Presentation Poster
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2011 ASH Faculty Rajiv Agarwal, MD
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2011 ASH Faculty continued David L.
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American Society of Hypertension, I
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MAY 21 Saturday Morning Hypertensio
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MAY 22 Sessions Sunday Morning 9:00
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MAY 22 Debates Sunday Morning 11:00
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2011 American Society of Hypertensi
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Page 171 and 172: Author Index Berezina, Aelita V., 8
Page 173 and 174: Author Index Eguchi, Kazuo, 110, 13
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Page 187 and 188: Tekamlo (aliskiren and amlodipine)
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Page 193: amlodipine and sildenafil were used
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2011 ASH Program Book - American Society of Hypertension

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