December 7, 2018
Tadalafil goes generic and generic sildenafil becomes cheaper still
Sildenafil (brand name Viagra) has been available as a generic for some time but the price has gone down substantially in the last few months due to more manufacturers getting approval to make generics.
In October 2018, another medication for erectile dysfunction, tadalafil (brand name Cialis), also became available as a generic.
How much do the generic versions cost? Let’s first look at the usual doses of these two medications.
– Sildenafil is usually given at 50 mg per day (when needed). Sometimes, the dose may need to be either increased to 100 mg or decreased to 25 mg.
– Tadalafil is usually given at 10 mg per day (when needed). Sometimes, the dose may need to be either increased to 20 mg per day or decreased to 5 mg.
Based on these doses, let’s look at the cost of the generic versions of these medications. According to Goodrx.com (accessed on December 7, 2018):
– Sildenafil 25, 50 mg, and 100 mg cost exactly the same! Approximately $27 to $45 for 30 pills of any strength. If the person takes 50 mg as half of a 100 mg pill, the cost per day of use is only 50 cents! Note: brand name Viagra when taken in the same way is $15 per dose.
– Tadalafil is much more expensive at this time, even as a generic. And the cost structure is strange. Even for the generic, both the 10 mg pills (the most commonly used dose) and the 20 mg pills are approximately $650 for 30 pills of either strength. But, the 5 mg pill is approximately $120 for 30 pills. So, 10 mg of tadalafil taken as two 5 mg pills is much cheaper than taking one 10 mg pill. Taken like this, one day’s dose of 10 mg will cost about $8. For comparison, brand name tadalafil, Cialis, taken in the same cheapest way costs $23 per dose.
It is probably safe to assume that, as happened for sildenafil, when more manufacturers get approved for making generic sildenafil, the price of tadalafil will fall dramatically too.
August 9, 2018
First ADHD medication to be taken at BEDTIME
The US Food and Drug Administration (FDA) has approved a new formulation of methylphenidate with brand name Jornay PM for the treatment of ADHD in patients 6 years and older.
Note: The product will not be commercially available to patients until early 2019.
I can hear the reader groaning–Did we really need one more formulation of methylphenidate? What is so unique about this Jornay PM? What is unique is that it is supposed to be taken at bedtime. Why? As we know, mornings are particularly difficult for persons with ADHD, especially the morning medication kicks in.
The manufacturer, Ironshore Pharmaceuticals & Development, Inc., has developed a proprietary drug delivery system, which they call Delexis™. There are two useful features of this system:
1. There is an outer delayed-release layer that consists of pH and time-dependent polymers. This leads predictably to the release in the medication starting about 10 hours later.
2. It also has of an inner layer consisting of polymers that regulate permeability and tightly control dissolution of the medication. This leads to the medication being released slowly throughout the next day.
So, Jornay PM is BOTH delayed-release AND extended-release.
The capsules will be available in 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg strengths.
It is recommended that Jornay PM be taken around 8 pm every night. The timing can then be adjusted between 6:30 pm to 9:30 pm depending on the effect in that patient.
Two randomized, double-blind, placebo-controlled studies were done in 278 children 6 to 12 years of age who had ADHD. These studies showed that Jornay PM did do the two things it was supposed to do–improve symptoms throughout the day and improve symptoms in the early mornings.
In addition to standard rating scales for ADHD symptoms during the day, to specifically assess morning symptoms, the studies used:
1. The morning subscale of the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale, and
2. The Before School Functioning Questionnaire (BSFQ).
As of August 2018, these studies have not been published anywhere and Simple and Practical Mental Health is unable to independently evaluate the data. We are only summarizing what has been made publicly available.
Here is the announcement from the company about the FDA approval:
Here is a link to the Prescribing Information for Jornay PM:
June 29, 2018
The FDA approved Aristada Initio®, a new formulation of aripiprazole lauroxil (675 mg). What is this new product? Let me explain:
Aristada® is the brand name of a long-acting preparation of aripiprazole (aripiprazole lauroxil) that has been available in the US since 2015. It is available in three strengths–441 mg, 662 mg, 882 mg, and 1064 mg. For more information on Aristada, see https://simpleandpractical.com/aripiprazole-lauroxil-aristada/
When Aristada is first given, we must also give oral aripiprazole along with it for the first 21 days. This is because it will take some time for Aristada to kick in. Aristada Initio allows the long-acting injection to be started immediately with only a single dose of aripiprazole needed.
For more information about this product, see:
Feb 16, 2018
On February 9, 2018, the FDA added the warning and instructions below to the approved drug label for brexpiprazole (brand name Rexulti). The Prescribing Information for aripiprazole (brand name Abilify) has carried the exact same warning since 2016. The third dopamine partial agonist, cariprazine (brand name Vraylar) does not carry this warning as of February 2018, but I would assume that it may have similar risks.
Note: Emphasis in red on this page is not from the FDA. It has been added by us.
Note that the FDA is not simply letting us know that this side effect can occur. It is instructing us that every patient prescribed brexpiprazole AND caregivers must be told about this possibility and then, in follow up, patients or their caregivers must specifically be asked about this.
I have one question on this: How long does the follow up visit need to have time to educate every patient on this and all other possible side effects AND to specifically ask patients if they have had this and other side effects?
Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking REXULTI. Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors.
Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with REXULTI.
In some cases, although not all, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviors may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.”
The following text was added to the Patient Counseling Information in the drug label:
“Pathological Gambling and Other Compulsive Behaviors
Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking REXULTI. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped.”
A 2016 Drug Safety Communication from the FDA about this risk with aripiprazole gave some additional guidance about who is at particularly higher risk, but that includes a lot of patients.
“Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse-control problems. These include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors.”
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