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MComes RPH

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  1. About Xadago (safinamide) Safinamide is a new chemical entity with a unique mode of action, including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels, which leads to modulation of abnormal glutamate release. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect over 2 years. Results from 24 month double-blind controlled studies suggest that safinamide shows statistically significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is a once-daily dose and has no diet restrictions due to its high MAO-B/MAO-A selectivity. Zambon has the rights to develop and commercialize Xadago® globally, excluding Japan and other key territories where Meiji Seika has the rights to develop and commercialize the compound. The rights to develop and commercialize Xadago® in the USA have been granted to US WorldMeds, by Zambon *Information provided by the FDA Website
  2. FDA Approves Xadago FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease March 21, 2017 -- The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. “Parkinson’s is a relentless disease without a cure,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.” An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement – such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson’s disease progresses more quickly than in others. The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Xadago experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment. In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment. Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome. The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia). Serious, but less common, risks include the following: exacerbated high blood pressure (hypertension); serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia (fever) and confusion; and retinal pathology. The FDA granted approval of Xadago to Newron Pharmaceuticals. Source: FDA Posted: March 2017
  3. As to when we should expect more generic companies on the market is up in the air. The exclusivity clause should be 6 months but could also be longer if the brand name company signed a clause with the generic company that they may be the sole proprietor of the production of the generic for an extended length of time. When it comes to Brand name and Generic medication production there are many laws that come into play and deals that are made between companies that it is really difficult to predict when other companies may have the opportunity to produce the generic. I always try to look on the bright side and with this situation I see that we are moving in the right direction with at least one company producing the generic now, which means there are more to come. I hope this helps and please keep me posted.
  4. Hello everyone, I have had many questions about when generic Azilect is coming out. I guess the best way to put it, now as we speak, is that just because a patent expires does not mean it will automatically go to generic. There are patent laws involved, as much as we may not like them, they are there for the brand name company to squeeze every dollar they can get. I found 2 terms that may make this a little easier to understand. I have posted them below, but as of today, I still have the release date of ABOUT FEBRUARY 2017. Here are the 2 terms used when it comes to patent law: TERM DEFINITION Drug Patent: A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. Drug Exclusivity: Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. Hope this helps clear up some confusion out there.
  5. I am glad I could help you. If there is anything else you need, please do not hesitate to get in contact with me. I hope I helped and please keep me posted.
  6. It appears that Dr. Okun are on the same sheet of music when it comes to this issue. In my first post to you I believe I covered many of the non medical interventions that one can do (meditation, yoga, exercise, etc...) to help delay the use of medication. I hope I helped and please keep me posted.
  7. It sounds like your symptoms and side effects are unique in themselves. Due to the long term use might go along the same path as other medications, where the majority of the bad effects my reduce very quickly and then the rest of the effects may take a bit longer. as long as you are aware of this, it should cetainly ease your mind as to what to expect when decreasing or eliminating medications in the future. I hope this helps and please keep me updated
  8. If anyone could help KLMDOC it would be much appreciated. Thank you.
  9. The generic company that I have heard the least amount of complaints and has also worked the best for me. It may differ from patient to patient and if someone does need to switch generic companies, they may only have to make minor changes to the regime (such as timing as far ass when to take it ti limit the "off" experience. As far as the cost of the medication once you go on Medicare will also very from patient to patient. Each Medicare patient will have a particular Medicare Part D (D for Drugs) from which to choose from. Once you find out who the Medicare Part D company is, You should call them and find out (1) which generic brands they will cover, (2) do they cover a 90 day supply (if so, is there a price break for receiving a 90 day supply as opposed to a 30 day supply, (3) how much will it cost for a 30 day and a 90 day supply (if it offered), and lastly find out if you are able to get your prescriptions filled at your local pharmacy or must you go through their Mail Order pharmacy. I hope this helps and please keep me osted.
  10. I did switch from a CR and IR Sinemet regime to a Rytary regime when Rytary first came out. The initial dose of Rytary (which came off of a conversion chart provided by Impax Pharmaceuticals which produced Rytary) seemed to too high of a dose and caused severe dystonia. When switching to a lower dose it did not seem I could get the timing of the Rytary and my symptoms in sync. I wanted to give Rytary a fair shot so I tried it for 3 months. I always give new medications 3 months to work unless I have a severe reaction. During that 3 months I kept a journal and for the life of me I could not maintain a level of relief as I did with the Sinemet ER and IR regime. So I opted to go back on the Sinemet regime where I did receive great coverage. There are many patients that have switched to the Rytary and have had excellent results. In the Parkinson's world, and the world in general, there is not a "one drug fit's all" situation. That is why there are so many medications for Parkinson's patients. I hope this helps and please keep me posted.
  11. According to the medication website, the maximum daily dose of Requip (or the generic) is 24mg. per day. The maximum daily dose of Requip XL, found in the same website, is also 24mg. per day. We must remember that these are the top doses that the manufacturer has studied, Doses any higher than this are possible but are completely up to the discretion of your physician. In my professional career I have seen doses of Requip or Requip XL above the 24mg. per day, but never both of them at the same time. Another thing to remember is that each form of Requip, and most Parkinson's medication, should be under a "Start low and go slow" guideline. With Requip the dose can be increased if need every 7 days to the next higher dose. I nhope this helps and please keep me posted.
  12. From what you have told me is that everything has remained the same as to when you were on Requip and when you were off Requip. The only thing you did not mention is whether your symptoms were better when you were on the Requip as they were when you were off the Requip. With all other factors staying the same (including that your symptoms were no better when you were on Requip as they were when you were off), I would suggest staying off the medication. If it is not helping your symptoms or quality of life, why be on it. Now if your symptoms were less while on Requip, then I would recommend trying the Requip again. The one major issue you had while being off the Requip was that you sleep issues. Sleep is very important to all people, but especially important to Parkinson's patients because that is when our muscles do not need as much dopamine because we are not moving and this allows our body to store up any dopamine that our body can still produce. To help with sleep there are a few things I recommend to patients before discussing medication. Try yoga, even if it is a mild for of yoga. It seems to help put the body in a state of rest. Mild stretching a few hours before bed can also help feel more relaxed and keeps our muscles loose. Meditation at night in a quiet area with very low light can put our brains in a mode that creates a good sleeping environment. Another very good breathing technique can help some people get to sleep in as little as 5 minutes. The technique is called the "4-7-8" breathing technique. You breath in through your nose for a count of 4 (Mississippi's), hold that breath for a count of 7 (Mississippi's), then expel the are the through pursed lips (like you are whistling) for a count of 8 (Mississippi's). This can be repeated about evrey 15 to 30 seconds for a maximum of 10 times. After the 10 times if you are not yet sleeping, you should wait about 15 minutes to attempt this again. Medication that can be tried as a first line is Benadryl. Benadryl (which is used for the side effect of drowsiness) is an antihistamine used for allergies but is also the number sleep aid used in hospitals. The starting dose of Benadryl (or it's house brand or generic) should be 25mg. Benadryl, at one point, was used to control symptoms of PD. Another medication, only available with a prescription, is Desyrel (generic name Trazadone). This is a medication that can be dosed up slowly if needed and causes very little side effects like the next morning "drug hangover." It can be taken with other PD medications. I hope this helps and please keep me posted.
  13. When a generic medication comes out (usually by one manufacturer) you will not see much of a price difference between what Azilect used to cost and what the generic price is now. What byou may also see is that when a generic becomes available, the price on the brand name will usually go up to try and make up for the loss of money due to the generic now being available. It is best to call around to Walmart, Sam's Club, Costco, Walgreens, CVS, Rite Aid, Kmart, etc.. to find the best price. I hope this helps.
  14. Your best bet is to call the Big Box stores like Walmart, Sam's Club, and Costco first. You do not need to be a member of Sam's Club or Costco to have a prescription filled their. Then call Walgreens, CVS, and Rite Aid. The big box stores buy in such large quantities that they can usually charge a lesser price. I hope this helps and please keep me posted.
  15. Let's take care of the dosing of the ropinirole, selegiline, and ldopa. Your thinking was straight on. I would recommend taking the ldopa and ropinirole at the same time first thing in the morning then take the selegiline about 1 hour later. As far as the interaction between the citalopram and selegine. According to the Idaho Drug Utilization Review, this interaction could happen with selegiline or rasagaline and ALL antidepressants: SSRI,s (which citalopram is), SNRI,s, Noradrenaline Reuptake Inhibitors, TCA's, RIMA,s, Tetracyclic Antidepressants, NaSSA's, MAOI's, and Melatonergic Antidepressants. It can also occur with Tramadol (synthetic opioid), Linezolid (antibiotic), Dextromethorphan (cough suppressant), Ginseng & St. John's Wort (herbal supplements), and Almotriptan, Eletriptan, Frovatriptan, Rizatriptan, Sumatriptan, Zolmitriptan (which are all known as "triptans). There are others but our major concern is Antidepressants. The interaction can cause "Serotonin Syndrome." This is a very rare interaction, but can be very serious (up to death) if it occurs. In my 26 years of practice and speaking with hundreds of specialists, neurologists, and movement disorder specialists not one of them has ever had this interaction happen to any of their patients. The incidence of Serotonin Syndrome occurring is really not known. The latest figure I could find was from a May 2010 Article in American Family Physicians which stated that approximately 0.2% deaths were caused by Serotonin Syndrome in 2005 which was caused by the patients taking more than the prescribed dose (ie. overdosing) of an SSRI, not by an interaction. Signs of Serotonin Syndrome can be anxiety, delirium, restlessness, disorientation, sweating, rapid or irregular heart beat, high blood pressure vomiting, diarrhea, tremor, muscle rigidity, and hyperreflexia. The symptoms usually come on anywhere from 6 to 24 hours after taking more than the prescribed dose or an increase in dose. So my professional opinion seems to coincide with your PCP and MDS. It should be ok for you to take the Citalopram with the selegine as long as you know the warning signs of the onset of Serotonin Syndrome. I do not blame the Pharmacist because many of the computer systems they use now will automatically let them know of any potential side effects and their severity. If the are not aware of the incidence of the situation, many would rather side on the cautionary side. I hope this helps and please keep me posted.
  16. Usually when a medication is prescribed 3 times a day I usually recommend 9:00am, 3:00pm, and 9:00pm. When a doctor prescribes a medication 3 or even 4 times a day it is expected that it will be taken during waking hours (12-15 hours) and a complete day of 24 hours. I hope this helps and please keep me posted.
  17. Let's tackle one issue at a time. As far as Levodopa (Sinemet) is concerned, there are many physicians that will use it as a last resort due to the posibility of losing it's effectiveness. It seems that a new wave of physicians and medical professionals that believe "why should we wait to improve someone's quality of life," let's use Sinemet (carbidopa/levodopa) now. When assessing whether someone should start medication at the onset of diagnoses or the onset of symptom severity, it is completely up to the patient. As you have stated you are very active with exercise, walking, and biking. This is a great way to stave off some of the symptoms of Parkinson's Disease. My recommendation is this, when the symptoms start to effect your quality of life, it is time to consider medication. Quality of life is one thing many of us lose with disease unless we stay active, which it sounds like you do. Even when medication is started it is crucial to stay as active as your body will let you. Walking, meditation, stretching, yoga, and staying nutritionally sound are
  18. TwoSmiley (I love that name), The usual half life of Artane is about 4 hours. This means that after taking the medication orally about half of the medication is still in your system after 4 hours. Which would lead one to conclude that the medication should theoretically be out of you system after 8 hours. But the side effects of the the Artane (also known as an anticholinergic) can last much longer. The length of time it may take for the effects to rid your body can also depend on how long you have taken it. Each dose you take can build on the previous dose you have taken. This over time can lead to a greater delay in the relief in side effects. The allergic reaction to the medication should start to decrease as soon as you stop taking the medication, The issues of the bladder may take a little longer to subside due to the fact that the muscles involved have a tendency to be the last ones to be resolved of the issue. The usual time of resolve from the side effects can take up to 72 hours with the side effects decreasing in intensity from there. If it has been longer than that you may want to see your family physician, internest, or general practitioner about the issue. I hope this helps and please keep me posted.
  19. I have heard of this happening in other patients before and it is one of the more common side effects of C/L. The origin, cause, and incidence is unknown but presents itself as twitching or uncontrolled movements of the arms, hands, and legs. It can also affect the face, lips, and tongue. It is not inclusive of just these parts of the body and can include other parts of the body. This issue may also have have an episode of stiff muscles associated with it. This is something I just wanted to make you aware of. I hope this helps and keep me posted.
  20. The duration of a medication is determined by what is called it's Half-life. Half is the amount of time it takes for one-half of the medication to be eliminated from the body. Requip XL has a half-life of about 6 hours. This means that when the medication is taken orally it will be slowly released into the body and the maximum concentration will be about the 6 hour mark. This maximum concentration can last anywhere from 30 to 60 minutes, which at that time the concentration will slowly decrease and will reach around zero at approximately 12 hours or so. Many of the manufacturers state that their sustained release, extended release, SR, ER, CR, or XL tablets are a once a day dosing. This means "hours of being awake." Which to most people can range from 12 hours up to 16 hours. Sometimes this is a miconseption amongst the population which believe a once-a-day medication probably lasts 24 hours. I hope this helps an please keep me posted
  21. I believe the IR and ER use at the same time should be used on a case by case situation. I will usually use my own experiences as an example when it is applicable. The IR is usually added to the ER regime when (1) someone is in need of a faster acting medication to get quick relief of their symptoms and (2) when people are finding that the ER dose is not lasting until the next dose so an IR may be used to hold off symptoms until the next ER dose is taken. In my own experience and medication regime I take 2 Sinemet IR 25/100 soon as I wake up in the morning to "jump start" my day. About 30 to 45 minutes later I take a Sinemet ER 50/200. Around 3:00pm, I take a Sinemet IR 25/100 followed with a Sinemet Er 50/200 around 4:00pm. In the evening, about 8:00pm, I take a Sinemet IR 25/100 followed by Sinemet ER 50/200. The reason my times are not exact is because it all depends on how I am feeling and if i am feeling like I am going to be "off." I also carry a few Sinemet IR 25/100 with me in case there is a situation where I may need a dose in case I am going "off." As for the issue of people who take Sinemet every 2 hours or so and how do the eat. If someone is in this position, they may eat about 30 minutes after taking the medication. Sinemet is best absorbed and most effective when taken on an empty stomach, food may decrease some of the absorption, but not all of it. Now if the person eats protein between doses, they my have to increase the dose after eating due to the interaction of protein and Sinemet. I hope this helps and please keep me posted.
  22. I could see why you would want to decrease some of your medications. Many of us with PD take so many medications that every once in a while we may want to see if our symptoms have decreased over time so we may try to cut back on a certain medication. Eventually, more sooner than later, we realize the important role that medication plays in our life. As far as you reducing the Requip, I think now you can see that the Requip has improved your quality of life. If you continue decreasing the amount of Requip you take, I am sure that your quality of life will diminish more. My suggestion is to stay on the Requip so you can sustain a better quality of life. The symptoms that the Requip is taking care of are not symptoms that will decrease on their own over time. They will, more than likely, only proceed to get worse. I would also like to address the supplements you are taking. No matter what the supplement is, I usually recommend that you sepperate the supplement from your PD medications by taking them at least an hour before taking your PD medications or two hours after taking your PD medication. This way we know that there is no interaction with your PD medication and any supplements. I hope this helps and please keep me posted.
  23. The only difference between carbidopa/levodopa and Stalevo is that Stalevo has an extra ingredient called Entacapone, which ha a primary purpose of extending the effects of the carbidopa/levodopa. So many of the side effects of these 2 medications will be similar. Here are some of the more common side effects that Entacapone: Urine Discoloration Diarrhea A possible decrease or full absence of body movement Uncontrolled twitching of the extremities ( arms and legs) and face, tongue, and lips Muscle stiffness or pain Muscle spasms I hope this helps and please keep me posted
  24. I agree with you that this whole issue can be very confusing. When one company buy another, it is very simple. It is not always that easy when it comes to pharmaceutical companies. In this situation companies can buy what inventory another company has, they can buy the manufacturing rights (process) to the medications and basically make the same medication (but may use different inactive ingredients) in the same way, and lastly they can buy the whole process and inventory from another company and re-pack the tablets and sell them under their name. I hope this helps straighten out some of the confusion.
  25. It appears there is only a generic available for the 1mg Azilect and the cash price, without insurance, will be about $749.00 (give or take a few dollars) for a quantity of #30 tablets. I hope this helps.