Shown: posts 1 to 25 of 25. This is the beginning of the thread.
Posted by Crazy Horse on June 29, 2006, at 10:24:22
Sorry Guys, I've been a little too lazy to do much research of my own lately. What are most of the studies/experts saying about EMSAM diet restrictions at the 9 mg. level? Thank you for your responses.
Monte
Posted by Phillipa on June 29, 2006, at 16:26:08
In reply to Diet restrictions on EMSAM 9 MGS?, posted by Crazy Horse on June 29, 2006, at 10:24:22
I think a lot of them are experimenting with small amounts of different foods. Where is everyone? Away for the forth of July? I wish Robert David was here he knows. Love Phillipa
Posted by kimcrazylady on June 30, 2006, at 15:31:12
In reply to Diet restrictions on EMSAM 9 MGS?, posted by Crazy Horse on June 29, 2006, at 10:24:22
From what I've read, they are similar to the restrictions you would have on Parnate or any other MAOi. I did read a study that said they found no difference and no need for restrictions on the 9 mg patch but the study stated the litigation gods wouldn't let them market it that way for fear of lawsuits and accidents.
Sorry I can't be more help.
Kim
Posted by Donna Louise on July 2, 2006, at 22:27:24
In reply to Re: Diet restrictions on EMSAM 9 MGS?, posted by kimcrazylady on June 30, 2006, at 15:31:12
> From what I've read, they are similar to the restrictions you would have on Parnate or any other MAOi. I did read a study that said they found no difference and no need for restrictions on the 9 mg patch but the study stated the litigation gods wouldn't let them market it that way for fear of lawsuits and accidents.
>
> Sorry I can't be more help.
>
> KimI think that is what held up getting the patch to market for so long. FDA insisting on food restrictions because there was only one test which found no dietary reactions to 9 or 12 mg. I am guinea pigging it for you with the tofu. It is all I eat that is on the diet anyway and so far I have not had a problem. I am really not worried about the food. As I said elsewhere, I think the higher doses have a greater chance of causing reactions with containdicated drugs.
Now, I have not eaten a whole lb. of tofu at a time, probably just about 1/5 of a lb. It seems to me that if it bypasses first pass metabolism, then that is what it does, regardless of the dose. Like Kim said, I think it is a fear thing due to minimal testing. I wouldn't recommend going out and eating everything on the list to see what happens. I myself, am just going to test the tofu until I am sure it is ok. Although I feel sure it is. For what that is worth and it is not gospel..donna
Posted by trx resistant on October 29, 2007, at 15:41:02
In reply to Re: Diet restrictions on EMSAM 9 MGS? » kimcrazylady, posted by Donna Louise on July 2, 2006, at 22:27:24
> > From what I've read, they are similar to the restrictions you would have on Parnate or any other MAOi. I did read a study that said they found no difference and no need for restrictions on the 9 mg patch but the study stated the litigation gods wouldn't let them market it that way for fear of lawsuits and accidents.
> >
> > Sorry I can't be more help.
> >
> > Kim
>
> I think that is what held up getting the patch to market for so long. FDA insisting on food restrictions because there was only one test which found no dietary reactions to 9 or 12 mg. I am guinea pigging it for you with the tofu. It is all I eat that is on the diet anyway and so far I have not had a problem. I am really not worried about the food. As I said elsewhere, I think the higher doses have a greater chance of causing reactions with containdicated drugs.
> Now, I have not eaten a whole lb. of tofu at a time, probably just about 1/5 of a lb. It seems to me that if it bypasses first pass metabolism, then that is what it does, regardless of the dose. Like Kim said, I think it is a fear thing due to minimal testing. I wouldn't recommend going out and eating everything on the list to see what happens. I myself, am just going to test the tofu until I am sure it is ok. Although I feel sure it is. For what that is worth and it is not gospel..
>
> donna
>
After 4 weeks on 6mg patch just started 9mg. The food warnings are scaring me to death . I called Bristol Meyers and found no real answers to food questions. Am I going to drop dead if I injest something that contains soybean oil as I find in my favorite canned protein shakes or soy lecithin found in most protein bars, or whole grain bead containing sprouted soybean? It seems every label I read says it may or may not contain some sort of soy.
Pharmacist gave me a list for food that said no bananas, figs, raisins, avacado etc. Bristol Meyers say those were OK. What is your experience? Thanks,
trx resistant
Posted by Larry Hoover on October 29, 2007, at 17:22:31
In reply to Re: Diet restrictions on EMSAM 9 MGS?, posted by trx resistant on October 29, 2007, at 15:41:02
> After 4 weeks on 6mg patch just started 9mg. The food warnings are scaring me to death . I called Bristol Meyers and found no real answers to food questions. Am I going to drop dead if I injest something that contains soybean oil as I find in my favorite canned protein shakes or soy lecithin found in most protein bars, or whole grain bead containing sprouted soybean?
No, those foods are perfectly safe.
The problem substance is called tyramine. Tyramine raised blood pressure. Tyramine is produced from bacterial action on protein. There is no protein in soy oil (or any vegetable oil), so they are all perfectly safe. Lecithin may or may not contain soy protein, but it is not fermented, so again, it should present zero risk. Sprouted soybeans are also safe. Bean curd is safe, if totally fresh.
> It seems every label I read says it may or may not contain some sort of soy.
The problematic soya products are all fermented. Soy sauce, miso, black bean paste, and such like.
> Pharmacist gave me a list for food that said no bananas, figs, raisins, avacado etc. Bristol Meyers say those were OK. What is your experience? Thanks,
> trx resistantI know of no reason to avoid those fruits. Somebody once posted here an updated list of risky foods. I hope they'll repost it.
Lar
Posted by trx resistant on October 29, 2007, at 20:36:46
In reply to Re: Diet restrictions on EMSAM 9 MGS? » trx resistant, posted by Larry Hoover on October 29, 2007, at 17:22:31
Thanks so much for the info Larry. After reading the various posts I think I can breathe a little easier. But Bristol Meyers said no soy products which is what I found so confusing. So some tofu is OK?
Posted by Larry Hoover on October 30, 2007, at 8:51:08
In reply to Re: Diet restrictions on EMSAM 9 MGS? » Larry Hoover, posted by trx resistant on October 29, 2007, at 20:36:46
> Thanks so much for the info Larry. After reading the various posts I think I can breathe a little easier. But Bristol Meyers said no soy products which is what I found so confusing. So some tofu is OK?
Fresh tofu is okay. I would never eat old tofu, in any case.
The longer food sits around, the more likely it is to have been acted on by bacteria. It's a theoretical risk, which cannot be accurately assessed. It just comes with the territory.
When Emsam 9 mg was being put through the clinical trials, one trial was to assess reactivity to known amounts of dietary tyramine. As far as I recall, there were no incidents of hypertensive crisis, and only a few fairly modest rises in blood pressure. Nothing serious, in other words. It's the old "abundance of caution" thingie, to make the food warnings mandatory for the 9 mg patch. Most people had no noticeable reaction to tyramine, but a few showed some reactivity.
Lar
Posted by trx resistant on October 30, 2007, at 16:57:04
In reply to Re: Diet restrictions on EMSAM 9 MGS? » trx resistant, posted by Larry Hoover on October 30, 2007, at 8:51:08
Thanks again Larry. Wondering if you know of any clinical trials about incidence of 9mg EMSAM raising seizure risk. Had 7 seizures in 5 hours induced by 450mg Wellbutrin in combo with 30mg Dexidrine. Bristol Meyers told me risk is less than 1 in a thousand for 6mg. Do you think the unique delivery system of the drug via patch might reduce seizure risk.
trx resitant
Posted by Astounder on October 31, 2007, at 7:10:33
In reply to Re: Diet restrictions on EMSAM 9 MGS?, posted by trx resistant on October 29, 2007, at 15:41:02
> After 4 weeks on 6mg patch just started 9mg. The food warnings are scaring me to death . I called Bristol Meyers and found no real answers to food questions. Am I going to drop dead if I injest something that contains soybean oil as I find in my favorite canned protein shakes or soy lecithin found in most protein bars, or whole grain bead containing sprouted soybean? It seems every label I read says it may or may not contain some sort of soy.
> Pharmacist gave me a list for food that said no bananas, figs, raisins, avacado etc. Bristol Meyers say those were OK. What is your experience? Thanks,
> trx resistant
>Honestly, I was using 2x 12 mg EMSAM patches daily (24 mg/d) for two months, while taking 90 mg/d of Remeron, which by blocking the feedback alpha-2 adrenoceptor, would make the tyramine-induced hypertension malignant. I was using propranolol for somatic anxiety & angina, which by unopposed beta blockade would further exacerbate the syndrome. I was also taking various stimulants/sympathomimetics: yohimbine, nicotine, dl-phenylalanine, arecoline (betel nut), ephedrine, caffeine, provigil, and a 600 mg dose of Wellbutrin.
I ate everything I wanted--chocolate, cheeses, pork, nuts and fruit, and though I checked my blood pressure constantly, I never had any trouble with hypertension.
The only issue was a mild serotonin syndrome when I tried taking a few microcapsules of Effexor after a prolonged 5-HTP supplementation to see how much MAO-A had been inhibited, but I was able to bring the temperature down with cyproheptadine.
So my conclusion is that EMSAM is a remarkably safe drug even at supratherapeutic doses and should not require strict dietary guidelines.
If you're really worried, ask for a script for a low dose of desipramine or another norepinephrine reuptake inhibitor. NRIs abolish the pressor response to tyramine by preventing it from entering the noradrenergic terminal and displacing the stored norepinephrine.
A caveat: If you're using Dexedrine or Adderall, it won't work right if you're also using a NRI; you'd want to switch to Desoxyn or Ritalin.
Posted by trx resistant on October 31, 2007, at 12:51:31
In reply to Re: Diet restrictions on EMSAM 9 MGS? » trx resistant, posted by Astounder on October 31, 2007, at 7:10:33
Thanks Astounder. Your knowledge is truly astounding! My present regime is 25mg Xanax 3X day and 5mg. at bedtime, along with 12.5 Ambien CR which doesn't seem to be helping with sleep. I noticed EMSAM negates the Ambien and I toss and turn all night. How long did you take EMSAM before you felt full benefits? Bristol said about 5 weeks.
With regard to the food issues I am relieved by what I have read here. I will be a little cautious, no Chinese or Japanese food I guess. If I were to have a reaction would it be immediate like instant hypotensive crisis or would I get a headache? My doctor hasn't used MAIO or EMSAM before so he gives me no information. Thanks
trx resistant
Posted by Astounder on November 1, 2007, at 18:01:59
In reply to Re: Diet restrictions on EMSAM 9 MGS?, posted by trx resistant on October 31, 2007, at 12:51:31
> Thanks Astounder. Your knowledge is truly astounding! My present regime is 25mg Xanax 3X day and 5mg. at bedtime, along with 12.5 Ambien CR which doesn't seem to be helping with sleep. I noticed EMSAM negates the Ambien and I toss and turn all night. How long did you take EMSAM before you felt full benefits? Bristol said about 5 weeks.
> With regard to the food issues I am relieved by what I have read here. I will be a little cautious, no Chinese or Japanese food I guess. If I were to have a reaction would it be immediate like instant hypotensive crisis or would I get a headache? My doctor hasn't used MAIO or EMSAM before so he gives me no information. Thanks
> trx resistantI'd say the mood elevating effects maxed out with the 12 mg/d dose at I suppose around 4 weeks; past that it probably started inhibiting MAO-A, which increases serotonin levels, and I've never had a positive response to serotonergics. You might get an immediate stimulant effect because some of these cytochrome P450 enzymes that metabolize EMSAM exist past the blood-brain barrier, and will convert it into L-methamphetamine & L-amphetamine.
I went off it two weeks or so after increasing the dose from 18 mg/d to 24 mg/d, because I suddenly became delirious and had to be hospitalized. An agrypnia, a profound insomnia that left me awake for days, unresponsive to Lunesta (very similar to Ambien CR) and Remeron, was the major factor, likely because of large concentrations of amphetamine metabolites and the fact I was wearing the patches through the night. I suggest taking them off before you sleep.
There were other contributing factors, specifically too high doses of desipramine that were enough to cause frank visual and auditory hallucinations. Many of the drugs I was taking inhibited or competed for the CYP2D6 enzyme that metabolizes amphetamines. It's not that EMSAM is a bad or dangerous drug, but next time I'd rather try Azilect, which lacks amphetamine metabolites and is more potently neuroprotective.
Symptoms of the tyramine-induced hypertensive crisis are severe headache, neck stiffness, palpitations, nausea, and a cold sweat. You might want to carry a card that notes you're on a MAOI. I really wouldn't worry about it though.
Posted by Phillipa on November 1, 2007, at 22:09:00
In reply to Re: Diet restrictions on EMSAM 9 MGS?, posted by Astounder on November 1, 2007, at 18:01:59
Is this a new MAOI or another name for one? Phillipa no patch? And any idea why all these parkinson's meds are being used for depression?
What is the most important information I should know about Azilect?
Do not take Azilect if you have liver disease or an adrenal gland tumor (also called pheochromocytoma). Do not take Azilect within 14 days before having surgery.
There are many other medicines that should not be taken together with Azilect or serious medical problems could result. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.While you are taking Azilect and for 2 weeks after you stop taking it, you must not eat or drink certain foods and beverages that are high in tyramine, listed in the "What should I avoid while taking Azilect?" section of this leaflet. Eating these foods while you are taking Azilect can raise your blood pressure to dangerous levels. This may cause life-threatening symptoms such as sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body). Call your doctor at once if you have any of these symptoms.
You should become very familiar with the list of foods you must avoid while taking Azilect. Continue avoiding these foods for a full 14 days after you stop taking the medication.Azilect can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
What is Azilect?
Azilect is a monoamine oxidase-B (MAO-B) inhibitor. It works by increasing the levels of certain chemicals in the brain.Azilect is used to treat the symptoms of Parkinson's disease. Azilect is sometimes used with another drug called levodopa.
Azilect may also be used for purposes other than those listed in this medication guide.
What should I discuss with my health care provider before taking Azilect?
Do not take Azilect if you have liver disease or an adrenal gland tumor (also called pheochromocytoma). Do not take Azilect within 14 days before having surgery. Do not take Azilect if you have taken any of the following drugs within the past 14 days:
meperidine (Demerol);tramadol (Ultram);
propoxyphene (Darvon, Darvocet);
methadone (Methadose, Dolophine);
over-the-counter cough, cold, or allergy medicines containing dextromethorphan, pseudoephedrine, or phenylephrine;
St. John's wort;
mirtazapine (Remeron);
cyclobenzaprine (Flexeril);
amphetamines (such as ADHD medication), stimulants, diet pills; or
other MAO inhibitors such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam).
Some people taking Azilect have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk than most people for developing melanoma. Talk to your doctor about your specific risk and what skin symptoms to watch for.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Azilect passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Azilect?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Azilect is usually taken once daily. Your doctor may occasionally change your dose to make sure you get the best results from this medication.Take this medication with a full glass of water. Azilect is only part of a complete program of treatment that also includes a diet plan created for you by your doctor or nutrition counselor. While you are taking Azilect and for 2 weeks after you stop taking it, you must not eat foods that are high in tyramine, listed in the "What should I avoid while taking Azilect?" section of this leaflet. Eating these foods while you are taking Azilect can raise your blood pressure to dangerous levels. This may cause life-threatening side effects such as sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body). Call your doctor at once if you have any of these symptoms.
Foods that you may eat include:fresh meat, poultry, or fish (including lunch meat, hot dogs, breakfast sausage, and cooked sliced ham);
any vegetables except broad bean pods (fava beans);
canned or bottled beer, white wine;
processed cheese, mozzarella, ricotta, cottage cheese;
pizza made with cheeses low in tyramine;
soy milk, yogurt; or
Brewer's or baker's yeast.
It is important to use Azilect regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Azilect. You will need to stop using the medicine for at least 14 days before your surgery.
Store Azilect at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a Azilect overdose may include drowsiness, severe headache, feeling agitated or irritable, vision problems, fast and uneven heartbeats, sweating, cold or clammy skin, shallow breathing, fainting, or seizure (convulsions).
What should I avoid while taking Azilect?
While you are taking Azilect and for 2 weeks after you stop taking it, you must not eat foods that are high in tyramine, including:
air dried meats, aged or fermented meats, sausage or salami (including cacciatore and mortadella), pickled herring, and any spoiled or improperly stored beef, poultry, fish, or liver;beer from a tap, beer that has not been pasteurized, or red wine;
aged cheeses, including blue, boursault, brick, brie, camembert, cheddar, emmenthaler, gruyere, parmesan, romano, roquefort, stilton, and swiss;
sauerkraut;
over-the-counter supplements or cough and cold medicines that contain tyramine;
soy beans, soy sauce, tofu, miso soup, bean curd, fava beans; or
yeast extracts (such as Marmite).
Eating tyramine while you are taking Azilect can raise your blood pressure to dangerous levels which could cause life-threatening side effects.
You should become very familiar with the list of foods you must avoid while you are taking Azilect. Continue avoiding these foods for a full 14 days after you stop taking the medication.
Azilect can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
What are the possible side effects of Azilect?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Azilect and call your doctor at once if you have any of these serious side effects:
increased blood pressure (sudden and severe headache, confusion, blurred vision, chest pain, nausea, vomiting, seizure);sudden numbness or weakness (especially on one side of the body), problems with speech or balance;
unusual thoughts or behavior, confusion, extreme agitation;
fever, sweating, muscle stiffness;
feeling light-headed, fainting;
blistering skin rash;
twitching muscle movements; or
hallucinations (seeing things that are not there).
Continue using Azilect and talk with your doctor if you have any of these less serious side effects:
joint pain;
mild headache, dizziness, or depressed mood;
hair loss;
numbness or tingly feeling;
dry mouth, loss of appetite;
constipation, diarrhea, upset stomach, vomiting, weight loss;
decreased sex drive, impotence, or difficulty having an orgasm; or
flu symptoms.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Azilect?
Before taking Azilect, tell your doctor if you are using any of the following drugs:ciprofloxacin (Cipro);
theophylline (Theo-Dur, Respbid, Uniphyl); or
antidepressants such as amitriptyline (Elavil), amoxapine (Ascendin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft).
If you are using any of these drugs, you may not be able to use Azilect, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect Azilect. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
Your pharmacist has more information about Azilect written for health professionals that you may read.
What does my medication look like?
Rasagiline is available with a prescription under the brand name Azilect. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.Azilect 0.5 mg--white round tablet
Azilect 1 mg--white round tablet
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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Posted by Astounder on November 1, 2007, at 22:45:44
In reply to Re: Diet restrictions on EMSAM 9 MGS? » Astounder, posted by Phillipa on November 1, 2007, at 22:09:00
> Is this a new MAOI or another name for one? Phillipa no patch? And any idea why all these parkinson's meds are being used for depression?
It's a new one--approved last year. Parkinson's meds, like the DA agonists and MAO-B inhibitors, are useful for depression because in addition to activating the nigrostriatal pathway (which is dysfunctional in Parkinson's), they also innervate the mesolimbic pathway, which is involved in reward. Reward deficiency is an explanatory model of depression.
Posted by Phillipa on November 1, 2007, at 23:00:45
In reply to Re: Diet restrictions on EMSAM 9 MGS? » Phillipa, posted by Astounder on November 1, 2007, at 22:45:44
Astounder apologize for spelling your name wrong before. Are you new? You seem to know a lot about meds do you mind saying how you learned so much. Phillipa
Posted by Astounder on November 1, 2007, at 23:22:01
In reply to Re: Diet restrictions on EMSAM 9 MGS? » Astounder, posted by Phillipa on November 1, 2007, at 23:00:45
> Astounder apologize for spelling your name wrong before. Are you new? You seem to know a lot about meds do you mind saying how you learned so much. Phillipa
I've lurked on this board for about a year. I don't have academic credentials, just a lot of online research and personal experimentation like many others here. My main interest is psychopharmacology, and I plan on working towards an MD when I finally stop convalescing and go back to college.
Posted by Phillipa on November 1, 2007, at 23:00:10
In reply to Re: Diet restrictions on EMSAM 9 MGS? » Phillipa, posted by Astounder on November 1, 2007, at 22:22:01
Are you in the States? Are you planning to study psych and be a pdoc as you understand the meds so well. Need more like you been there done that. Phillipa and you've studied a lot.
Posted by Astounder on November 2, 2007, at 0:28:28
In reply to Re: Diet restrictions on EMSAM 9 MGS? » Astounder, posted by Phillipa on November 2, 2007, at 0:00:10
> Are you in the States? Are you planning to study psych and be a pdoc as you understand the meds so well. Need more like you been there done that. Phillipa and you've studied a lot.
I'm in the US. I'm probably going for a hard science undergraduate like biochemistry over psychology though. Don't whether I'd go into research, practice, or academia after becoming a doctor.
Posted by War-Face on November 2, 2007, at 15:38:03
In reply to Re: Diet restrictions on EMSAM 9 MGS? » Phillipa, posted by Astounder on November 1, 2007, at 22:45:44
Astounder: based on my personal battle with MDD & inattentive ADD, I am very interested in the thesis on reward-deficiency: do you think you might be able to remember where you saw this theory or study developed?
Posted by Astounder on November 2, 2007, at 16:42:48
In reply to Re: Diet restrictions on EMSAM 9 MGS? » Astounder, posted by War-Face on November 2, 2007, at 15:38:03
> Astounder: based on my personal battle with MDD & inattentive ADD, I am very interested in the thesis on reward-deficiency: do you think you might be able to remember where you saw this theory or study developed?
>
>An exhaustive review on dopamine, reward, and depression:
Posted by danr49 on November 4, 2007, at 14:43:13
In reply to Re: Diet restrictions on EMSAM 9 MGS?, posted by trx resistant on October 29, 2007, at 15:41:02
J Affect Disord. 2007 Jun 11.
The selegiline transdermal system in major depressive disorder: A systematic review of safety and tolerability.
Robinson DS, Amsterdam JD.
Worldwide Drug Development, 102 East Avenue, Burlington, VT 05401, United States.BACKGROUND: Monoamine oxidase inhibitors (MAOIs) are highly efficacious antidepressants, but safety concerns have limited their broad use. METHODS: We reviewed key safety and tolerability data from all clinical trials of patients with major depressive disorder (MDD) accrued during the clinical development of the selegiline transdermal system (STS), as reported to the Food and Drug Administration. This review includes data from both controlled and uncontrolled clinical trials involving STS-treated (n=2036) and placebo-treated (n=668) patients. RESULTS: Except for the initial trial, subsequent trials, which involved STS doses ranging from 3 mg/24 h to 12 mg/24 h, lacked tyramine restrictions, and no acute hypertensive reactions occurred during study treatment. Safety experience with STS 6 mg/24 h supports this therapeutic dose without tyramine dietary modifications, but until more data are available for STS doses 9 mg/24 h and 12 mg/24 h, foods that are rich sources of tyramine should be avoided. The principal side effects of STS therapy were local dermal reactions and insomnia, both of which were dose-related. Side effects associated with MAOI treatment, such as sexual dysfunction and excessive weight gain, were uncommon. CONCLUSIONS: A comprehensive review of safety from the clinical development program suggests that the STS is safe and well tolerated, with an improved safety margin compared with orally administered MAOIs.
Posted by Phillipa on November 4, 2007, at 18:11:45
In reply to Re: Diet restrictions on EMSAM 9 MGS?, posted by danr49 on November 4, 2007, at 14:43:13
The weight makes a lot of sense since it bypasses the gut does go through liver but that is not where the weight gain occurrs. Phillipa
Posted by trx resistant on November 12, 2007, at 2:26:32
In reply to Re: Diet restrictions on EMSAM 9 MGS? » danr49, posted by Phillipa on November 4, 2007, at 18:11:45
Thanks everyone for your caring responses. The information is very helpful. Unfortunately after 5-7 days on the 9mg dose experienced extremely uncomfortable tightening in chest, like a broncho-spasm,had to double Xanax (anxiety level so high it was like brain freeze)and doubled Ambien Cr. Way too revved up, couldn't sleep. Tried to just live with it, but day 10 or 11 my throat felt like it was closing up. Just took the patch off before my dr. greturned my call. I kept it off completely for 3 days. Dr. decided I should go back down to 6mg and take off before bed. Couldn't face the 6mg. so I cut 9mg in half and have been removing before bed. I seem to be coming down a bit, hopefully. I'm worried this chest tightening could be an allergic reation that might prevent me from using even 6mg. Has anyone ever heard of a drug allergy to this?
Posted by Astounder on November 15, 2007, at 18:22:18
In reply to Re: Diet restrictions on EMSAM 9 MGS?, posted by trx resistant on November 12, 2007, at 2:26:32
> Thanks everyone for your caring responses. The information is very helpful. Unfortunately after 5-7 days on the 9mg dose experienced extremely uncomfortable tightening in chest, like a broncho-spasm,had to double Xanax (anxiety level so high it was like brain freeze)and doubled Ambien Cr. Way too revved up, couldn't sleep. Tried to just live with it, but day 10 or 11 my throat felt like it was closing up. Just took the patch off before my dr. greturned my call. I kept it off completely for 3 days. Dr. decided I should go back down to 6mg and take off before bed. Couldn't face the 6mg. so I cut 9mg in half and have been removing before bed. I seem to be coming down a bit, hopefully. I'm worried this chest tightening could be an allergic reation that might prevent me from using even 6mg. Has anyone ever heard of a drug allergy to this?
Major metabolites of Selegiline (L-deprenyl) are L-methamphetamine (Vicks Inhaler), and L-amphetamine (1/4 of Adderall). These metabolites do not penetrate well through the blood brain barrier, and so mostly cause peripheral sympathetic stimulation. What may have happened is you've saturated MAO-B and now have a large amount of fee L-deprenyl, so more of the metabolites are being formed (L-deprenyl's affinity for MAO-A is over tenfold less than for MAO-B).
Your doctor should be able to do a prick test for an allergic reaction. If it's not an allergic reaction, excessive sympathetic discharge (causing spastic bronchodilation, tightening of smooth muscle around the esophagous, or vasospastic angina) might be responsible. You could test this yourself buy buying a Vick's Inhaler over the counter and seeing if symptoms worsen. If this is the reason, your anxiety over this is certainly worsening the symptoms: You may be able to allay your fears by getting a stress test or try a beta blocker.
I actually had left chest pain on EmSam, Remeron, and Desipramine. After the stress test turned up negative, I realized the psych was right in that I was exacerbating it by running from a transient somatic symptom, and it went away a week after I tried focusing on the sensation.
Posted by trx resistant on November 15, 2007, at 21:20:58
In reply to Re: Diet restrictions on EMSAM 9 MGS? » trx resistant, posted by Astounder on November 15, 2007, at 18:22:18
Astounder, you are correct again! I actually discussed your responses with my Dr. He thanks you too! As I mentioned, I went from 1/2 of 9mg patch for two days (removed at bedtime), last weekend. Felt fantastic. Afraid I might lose my previoius response so on Monday went on 6mg. after 3 days, started getting really bad headaches and that racing feeling. Today I did not put anything on. Headached gone. No chest tightening. Saw Dr.. He agrees with me that I must have too much in my system. He does not know how long the drug actually stays in blood. So he suggested I try tinkering with cutting the 6mg in half for a few days, then go up to half of the 9mg since I still have a supply. But your info last week about the seizures made me feel so much less scared. I think I'm beginning to get a sense of what this drug feels like and think the states of extreme anxiety and the broncho-spasms are directly related to the drug dosage. I don't think I'm allergic, thank God! I have been more active in the last week than in the last entire 6 months put together. I'm starting to believe (don't want to jinx it) I might get myself back, despite my Dr.'s dire prediction that I won't ever be able to function as I once did or find a job and return to work at the same level. I'm so grateful to all of you out there who take the time to share your knowledge and experiences.
trx resitant
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