Timothy Wood38 said:The link isn't working on my end... could you give me the gist of what it's talking about?
Abilify Tablets (Otsuka America)
Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related
Studies show that when elderly patients dealing with dementia-related psychosis are given atypical antipsychotics, they face a higher risk of death than those receiving a placebo. After looking closely at seventeen different placebo-controlled trials—which usually lasted around ten weeks—it turns out the mortality risk for those on the medication was about 1.6 to 1.7 times higher than the placebo group. To put some numbers on it, during a standard ten-week study, the death rate for patients on the drugs sat at roughly 4.5%, while the placebo group stayed lower at about 2.6%. While the specific causes of death varied, most cases seemed to stem from cardiovascular issues—think things like heart failure or sudden cardiac events—or infections, such as pneumonia. Just a heads-up: ABILIFY (aripiprazole) isn't actually approved to treat patients suffering from dementia-related psychosis.
DESCRIPTION
ABILIFY® (aripiprazole) is a psychotropic medication that comes in both tablet and oral solution forms. Chemically speaking, it's identified as 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril—which, if you're looking at the math, gives us an empirical formula of C 23 H 27 Cl 2 N 3 O 2 and a molecular weight of 448.38. Here’s a look at the chemical structure:
...
DOSAGE AND ADMINISTRATION
Living with schizophrenia—it’s an incredibly complex journey, isn't it? It really forces you to navigate a reality that feels entirely different from everyone else's.
Standard dosage.
When you're looking at starting Abilify, the typical move is to aim for a daily dose of either 10 or 15 mg—just take it once a day, and honestly, it doesn't even matter if you eat beforehand or not. Clinical studies have pretty much confirmed that staying within the 10 to 30 mg per day range works well for the tablet version, though there's a bit of a catch: increasing the dose beyond those initial 10 or 15 mg levels didn't actually show any extra benefit in the trials. Also, you really shouldn't try to bump up the dosage until at least two weeks have passed—you need to give the medication enough time to reach a steady state in your system first.
Dosage in special Populations Dosage
You don't typically need to tweak the dosage based on things like age, gender, race, or whether someone has kidney or liver issues—though you should definitely check out the section on Dosage in special Populations Dosage for more details.
If you're managing someone on aripiprazole while they're also taking a potential CYP3A4 inhibitor—for instance, if they're on ketoconazole—you'll need to cut that aripiprazole dose right in half. Once that inhibitor is cleared out of their system and they stop the combination therapy, you'll want to gradually bump the aripiprazole dosage back up.
If you're managing someone on aripiprazole who is also taking a potential CYP2D6 inhibitor—think drugs like fluoxetine, paroxetine, or even quinidine—you really need to adjust the dosage. In those cases, the aripiprazole dose should be cut down to at least half of what it would normally be. Once that inhibitor is cleared out of the treatment plan, you can go ahead and scale the aripiprazole dose back up.
Regarding dosage adjustments for those on potential CYP3A4 inducers: If you add a potential CYP3A4 inducer like carbamazepine to an aripiprazole regimen, you’ll want to double that aripiprazole dose—we're talking 20 or 30 mg. Any further increases really come down to individual clinical assessment. Just keep in mind that once the carbamazepine is taken off the table, the aripiprazole dose needs to be scaled back to somewhere between 10 and 15 mg.
Maintenance therapy—it’s such a delicate balancing act, isn't it? One day you feel like you've finally found that sweet spot, and the next, you're back to square one.
Since we don't have a definitive roadmap on exactly how long someone should stay on aripiprazole, researchers decided to run a study to see what happens when you switch things up. They took patients with schizophrenia who had been doing great—totally stable—on different antipsychotics for at least three months, stopped those meds, and started them on Abilify Tablets at 15 mg/day instead. After watching them for up to 26 weeks, the results showed that staying on this maintenance treatment really does help prevent a relapse (you can check out the details under CLINICAL PHARMACOLOGY: Clinical Studies). Basically, doctors should keep checking in regularly to figure out if continuing the maintenance dose is still necessary.
Transitioning From Other Antipsychotics
We don't actually have specific, systematic data regarding the process of switching patients with schizophrenia from different antipsychotics over to Abilify, nor do we have data on what happens when they are taken alongside other antipsychotics. Depending on the individual, some patients might handle stopping their previous medication immediately, while others will definitely need a more gradual taper. Regardless of the approach, you really want to keep that overlap period between different antipsychotics as short as possible.
Bipolar Disorder
Standard Dosage
During clinical trials, researchers started patients off at 30 mg once daily. Using the tablet version, a 30 mg/day dose proved effective. It's worth noting that about 15% of those patients ended up having their dose dropped down to 15 mg due to how well they could tolerate it. We haven't tested the safety of going above 30 mg/day in any clinical trials yet.
Dosage in special Populations Dosage
Please refer to the section for Dosage in special Populations Dosage located under DOSAGE AND ADMINISTRATION for Schizophrenia.
Long-term Maintenance
There isn't a definitive set of evidence to tell us exactly how long someone should stay on aripiprazole. However, for patients with Bipolar I Disorder who stayed symptomatically stable on Abilify Tablets (either 15 mg/day or 30 mg/day, starting at 30 mg/day) for at least six straight weeks—and were then randomized to either the tablets or a placebo to watch for relapses—there was a clear benefit to continuing the maintenance treatment (check out CLINICAL PHARMACOLOGY: Clinical Studies for details). Generally speaking, doctors agree that sticking with pharmacological treatment after an acute manic episode is a good idea to maintain stability and prevent new episodes, even though we lack systematic data supporting aripiprazole use for these longer durations (anything beyond that 6-week mark).
Liquid Oral Solution
The oral solution can be used interchangeably with the 5-, 10-, 15-, or 20-mg tablets on a milligram-for-milligram basis. You can swap the solution for tablet doses up to a 25 mg tablet strength. For those taking 30-mg tablets, they should take 25 mg of the solution instead (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
LAB STUDIES IN ANIMALS
In a 26-week chronic toxicity study, aripiprazole caused retinal degeneration in albino rats at a 60 mg/kg dose, and this also occurred during a 2-year carcinogenicity study at doses of 40 and 60 mg/kg. To put that in perspective, those 40 and 60 mg/kg doses are 13 to 19 times higher than the maximum recommended human dose (MRHD) when looking at mg/m2, and roughly 7 to 14 times the human exposure based on AUC. Interestingly, looking at the retinas of albino mice and monkeys didn't show any signs of retinal degeneration. We haven't done extra studies to dig deeper into why this happened, so we honestly don't know if this finding poses a real risk to humans.
AVAILABILITY
Abilify Tablets are provided in the following strengths and packaging options.
The 5-mg Abilify tablets are blue, modified rectangles, marked on one side with "A-007" and "5".
30-count bottles NDC 59148-007-13
100-count blisters NDC 59148-007-35
The 10-mg Abilify tablets are pink, modified rectangles, marked on one side with "A-008" and "10".
30-count bottles NDC 59148-008-13
100-count blisters NDC 59148-008-35
The 15-mg Abilify tablets are yellow, round tablets, marked on one side with "A-009" and "15".
30-count bottles NDC 59148-009-13
100-count blisters NDC 59148-009-35
The 20-mg Abilify tablets are white, round tablets, marked on one side with "A-010" and "20".
30-count bottles NDC 59148-010-13
100-count blisters NDC 59148-010-35
The 30-mg Abilify tablets are pink, round tablets, marked on one side with "A-011" and "30".
30-count bottles NDC 59148-011-13
100-count blister packs NDC 59148-011-35
ABILIFY® (aripiprazole) Oral Solution (1 mg/mL) comes in child-resistant bottles—it even includes a calibrated dosing cup for accuracy. Here is how you can get ABILIFY oral solution:
150-mL bottle NDC 59148-012-15
Storage Information
Tablets
Keep at room temperature—about 77° F (25° C)—though it’s fine if it fluctuates between 59° F and 86° F (15° C to 30° C) per standard US guidelines.
Oral Solution
This needs to stay chilled in the fridge between 36° F and 46° F (2° C to 8° C). Once you crack open a bottle of ABILIFY oral solution, make sure it stays refrigerated; it'll stay good for about 6 months.
Tablets are produced by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan or Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
Oral Solution is produced by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
Handled and sold by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA
Sold by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
U.S. Patent Nos. 4,734,416 and 5,006,528
Bristol-Myers Squibb Company
Princeton, NJ 08543 U.S.A.
Otsuka America Pharmaceutical, Inc.
Rockville, MD 20850 U.S.A.
AP4996/04-05 1156731B4
D6-B0001-04-05 Revised April 2005
©2005 Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535
Japan
try again...
http://www.theodora.com/drugs/abilif...a_america.html