OK I'll start.

My LDs are random events and usually short-duration.

I have never been able to WILD, MILD, DILD or anything like that.  Not a single induced lucid.  Ever. The more I try, the worse my recall gets so I'm reluctant to try hard at all (and won't for a short while).

Could it be that I will never have an induced LD?  Any top tips?

OK, you've really got two related, but separate issues here, so let&#39s talk about the separately.

Quote from: Burned upOK I'll start.

My LDs are random events and usually short-duration. Could it be that I will never have an induced LD?  Any top tips?

First off, everyone is an individual and different.  Some are natural LD&#39ers, some are not.  Myself, I am a poster child for lucid dreaming.  Unless I really work at it, I just don&#39t have many, perhaps you are like me. 

I&#39m sorry I don&#39t know this, but how long have you been working at it?  Also, I&#39d like to ask a couple of questions.

1)   What time of the night do you have LD&#39s? 2)   What is your sleeping environment like? 3)   What time do you go to bed and how much sleep do you get?

I don&#39t know, how long have you been working on LD?

Quote from: Burned upI have never been able to WILD, MILD, DILD or anything like that.  Not a single induced lucid.  Ever. The more I try, the worse my recall gets so I'm reluctant to try hard at all (and won't for a short while).

This is a new one on me, I&#39ve never heard of induction methods causing problems with recall.  Usually, the opposite is true.  I have a hunch though that what you are doing or your mental state or anziety level is causing the problem.  Let&#39s try an exercise.

For the next days, while doing your induction techniques, try to keep detailed notes.  Keep up with the technique you are trying, your mental state, anxiety level and so on.   Also at night, log what time you try the technique, the time you go to bed, and any times you get up during the night.  You can keep all of this in your bedside or bathroom dream journal if you wish.

I hope with a little more information, we can find some clues.

Quote from: Seeker on May 25, 2008, 10:50:28 AMOK, you've really got two related, but separate issues here, so let&#39s talk about the separately.

Quote from: Burned upOK I'll start.

My LDs are random events and usually short-duration. Could it be that I will never have an induced LD?  Any top tips?

First off, everyone is an individual and different.  Some are natural LD&#39ers, some are not.  Myself, I am a poster child for lucid dreaming.  Unless I really work at it, I just don&#39t have many, perhaps you are like me. 

I&#39m sorry I don&#39t know this, but how long have you been working at it?  Also, I&#39d like to ask a couple of questions.

1)   What time of the night do you have LD&#39s? Usually at the end of sleep or when dozing before finally getting up.

Quote from: Seeker on May 25, 2008, 10:50:28 AM2)   What is your sleeping environment like?

Me and Mrs Bu in a double bed.  Generally quiet.

Quote from: Seeker on May 25, 2008, 10:50:28 AM3)   What time do you go to bed and how much sleep do you get? 1100-1130pm usually.  7 or even 8 hours typically.  Rarely in one stretch.  Usually wake at least once (which is good for recall).

Quote from: Seeker on May 25, 2008, 10:50:28 AMI don&#39t know, how long have you been working on LD?

"Working" is perhaps an over-statement.  I've been trying on and off for 6 months or so but more determined during May.

Quote from: Seeker on May 25, 2008, 10:50:28 AMQuote from: Burned upI have never been able to WILD, MILD, DILD or anything like that.  Not a single induced lucid.  Ever. The more I try, the worse my recall gets so I'm reluctant to try hard at all (and won't for a short while).

This is a new one on me, I&#39ve never heard of induction methods causing problems with recall.  Usually, the opposite is true.  I have a hunch though that what you are doing or your mental state or anziety level is causing the problem.  Let&#39s try an exercise.

For the next days, while doing your induction techniques, try to keep detailed notes.  Keep up with the technique you are trying, your mental state, anxiety level and so on.   Also at night, log what time you try the technique, the time you go to bed, and any times you get up during the night.  You can keep all of this in your bedside or bathroom dream journal if you wish.

I hope with a little more information, we can find some clues.

Thanks Seeker.  I'll do that.  I'll stick with DILD where I think I may stand a chance catching what I call a "WTF moment".  I'm trying to RC every time something weird or coincidental happens IRL.  My attempts to RC are pretty bad during the day and non-existent in dreams (apart from when I already know I'm lucid).

Quote from: Burned up on May 24, 2008, 01:23:49 PMMy LDs are random events and usually short-duration. Have you considered trying any supplements like galantamine? Before I started using galantamine my lucids which usually lasted about a minute or two, and I usually had no control. With galantamine though I've been able to have lucids lasting up to 2 hours with perfect control and mind set of what I want to do. The supplements just make me aware that I am dreaming. You just have to find the right combination, because too much of it can keep you awake all night.

Galantamine is very powerful

Thanks guys, but I'm a bit nervous about that.

Quote Posted by: Burned up

Thanks guys, but I'm a bit nervous about that. And it shouldn't be taken lightly, IMO.

However, why that said, I have taken multiple doses 5-6 years ago and then again with in the last several months and I think that I have benefited greatly from the experiences.  It has helped my life in general and my ability to go OBE and Lucid.  I often fell tired and groggy in the morning when I add the extra Choline.  Other than that I have not noticed any side effects.

At least I don't remember any.

Yuschak's book "Advanced Lucid Dreaming, the Power of Supplements" is an excellent read.  $5 download from lulu.com

There is a bit of research on Galantamine since it is being used for Alzheimer's patients to help them retain memory function.

Quote from: Burned up on May 28, 2008, 06:08:49 PMThanks guys, but I'm a bit nervous about that. It's definitely something you would want to research thoroughly before trying Burned up, and even after researching it, it would be best to start out with a very small dose if you decided to try it at all, because the first time I tried it, after having thoroughly researched it, I started with a small dose, and stil felt like I was going to blown right off of my bed because it was so strong.

And then there were the many times after taking it I became aware to find myself floating out of my body face down about a foot above my bedroom floor.

And then came the times when I start hearing voices, very nerve racking at first, until I finally learned that they were just an indication that I was close to the other dimension, and that if I just concentrated on floating when I started hearing them, that I would float out of my body and get away from the voices, and be able to enjoy an out of body experience.

And lastly, less than a week ago when I used it, I got sleep paralysis for the first time in about 30 years, again quite scary since I felt it was caused by the galantamine, so was unsure how long it might last.  I was able to to concentrate on floating and float out of my body once I achieved that state though.

Supplements are certainly nothing to be taken lightly, and are probably best if used after a person has already experienced a lucid dream or obe a few times since they could just scare the crap out of someone who is not ready for an experience like they can provide.

Back to why induction methods don't work.

It's possible that they do work and we might just not remember the experience.  I know that is true for me sometimes since I think that it has failed only to have the memory come up later in the day.  All those reasons to work on recall, if remembering the experiences is important to you.  I maintain that memory is overrated.

Also, remember that every induction method that you have ever read about or heard about is someone else's induction method.  Your induction method may be entirely different.  Maybe you need the light on or to have had sex ten times that week, or to have eaten fatty foods that are processed, or be in a bad relationship.  Some don't have the experience of getting out of their bodies until they have a heart attack.

I am getting a little extreme here but my point is that you will have a unique method of getting lucid or OOBE that is yours. It may resemble a method that I have and it may not.  Experiment.  Enjoy the process.

You have to be extremely careful with medication that can alter the brain function as one can never be sure what effect it will exert on ones brain and therefore psyche.

Galatamine is used to treat the cognitive defect in Parkinson disease and recently is being trialed to treat the same in schizophrenia. However, in some patients, it has been found to induce psychosis and hallucinations, not unlike those of a schizophrenic nature.

If you have any risk factor of possible mental illness such as past experience or family history then you need to be doubly careful. Wrong use of Galantamine and other similar medication can trigger whatever latent mental illness to develop and once its developed, you will be stuck with it.

Personally, I dont like using any drug/med to achieve these experiences. If I can not achieve them using natural methods like deep meditation and visualisation,etc. then I will simply accept that I am not meant to experience them yet.

QuoteGalatamine is used to treat the cognitive defect in Parkinson disease and recently is being trialled to treat the same in schizophrenia. However, in some patients, it has been found to induce psychosis and hallucinations, not unlike those of a schizophrenic nature. Annsie,

Do you know the kind of dosages being used in these studies?  I thought that they were quite high relative to what some of us have been taking. (4-8mg every week or two).

Could the psychosis and hallucinations you are referring to also be called Lucid Dreaming and Out-of-body travel?

If you have the references I would like to read them.  Do you have any personal experiences with these studies?  I do not meant to attack your information, just get to the bottom of it.  I also have a concern about fooling with the brain chemistry as anyone should.

Quote from: dallyup52 on May 29, 2008, 09:23:14 AMQuoteGalatamine is used to treat the cognitive defect in Parkinson disease and recently is being trialled to treat the same in schizophrenia. However, in some patients, it has been found to induce psychosis and hallucinations, not unlike those of a schizophrenic nature.

Annsie,

Do you know the kind of dosages being used in these studies?  I thought that they were quite high relative to what some of us have been taking. (4-8mg every week or two).

Could the psychosis and hallucinations you are referring to also be called Lucid Dreaming and Out-of-body travel?

If you have the references I would like to read them.  Do you have any personal experiences with these studies?  I do not meant to attack your information, just get to the bottom of it.  I also have a concern about fooling with the brain chemistry as anyone should.

I can get the references for you on those studies, which ones are you interested in ?

The usual dosage for Alzheimer and Parkinson is 4 mg twice a day to a maximum of 12 mg twice a day. Elderlies and those with kidney/liver impairment will need a reduced dose. The dose for Schizophrenia is between 8 mg to 12 mg twice a day.

Symptoms of overdose may include:

• muscle weakness or twitching
• upset stomach
• vomiting
• stomach cramps
• drooling
• teary eyes
• increased urination
• need to have a bowel movement
• sweating
• slowed, fast, or irregular heartbeat
• lightheadedness
• dizziness
• fainting
• slowed breathing
• collapse
• loss of conciousness
• seizures
• dry mouth
• chest pain
• hallucinations (seeing things or hearing voices that do not exist)

I dont think the psychosis and hallucinations experienced as side effects by these patients are LD or OBE as they occur during waking hours and they wont stop in some cases until treated with antipsychotics.

As you said, the dose taken for these conditions is higher but 8mg is considered a therapeutic dose on its own. For the dose to produce results its obviously high enough to exert changes in the brain. The question is : how well does your brain "recover" in between dosing? Its like cigarette smoking, some people can smoke all their lives and nothing happens to them, yet others only inhale 2nd hand smoke occasionally from someone else and develop cancer.

If you ask me what is the "safe" dose to take, I wont be able to tell you. What is safe for someone else may not be safe for you at all.

QuoteI dont think the psychosis and hallucinations experienced as side effects by these patients are LD or OBE as they occur during waking hours and they wont stop in some cases until treated with antipsychotics. I would be interested in the studies that produced the individuals with the psychosis and hallucinations. I would be interested in the dosages and conditions and what the patients were being treated for in the study.

I do have the drooling and the knuckle dragging.

This debate has really confirmed my reluctance to take what is, in effect, a recreational drug.  As for voices in the head - I have plenty of those already.

Quote from: Burned up on May 29, 2008, 05:48:39 PMAs for voices in the head - I have plenty of those already. No, the voices are not in the head at all, they are from the other dimension when you get close to an obe, just like some people hear music and others hear loud booms, etc.

You will hear those same voices or noises without taking galantamine if you are able to meditate deep enough.

And if you do, the best way I've found to deal with them is to just ignore them and concentrate on floating, because once you are out of your body, they will disappear, at least they do for me.

There is nothing wrong with sticking to natural means for learning lucid dreaming, and I would encourage everyone to first learn how to lucid dream naturally first before taking something else to help extend those lucid dreams.

These supplements are not for everyone as certain sites that sell them using long page ads that promise unlimited wealth and nightly sexual adventures would have people believe.

They need to be used responsibly with the full understanding of what their side effects can be, which is why I try to warn people of what they might experience when using them.

That said, they are for me, because they've allowed me to do things that it would have taken me years to accomplish without them.

QuoteThis debate has really confirmed my reluctance to take what is, in effect, a recreational drug.  As for voices in the head - I have plenty of those already.  Shocked Burnedup,

I would encourage you to listen to your intuition.  If it tells you not to do a certain something (like these supplements), then by all means, do not do that thing. It probably doesn't matter what the reasons are.  Go with your gut.

I know that for me it is the way to go.  My guidance has told me to ingest these particular substances. There are plenty of reasons to do or not to do them.  So the rationalization either way is compelling no matter what you or I  decide to do.

"Recreational Drug" sounds a little strong to me, but maybe it fits? I would normally reserve that term for drugs like alcohol, tobacco and marijuana.

I am sorry I didnt mean to "scare" people into not using these chemicals, I was simply stressing the importance of knowing what you are doing and being prepared for the outcome.

Personally I dont like taking any meds/chemicals because from my own experience they have unusual effects on me. I tried drinking coffee in the past to stay awake for final exam study, instead they sent me to sleep and I woke up with headaches and confusion the next day, from just 1 cup of white coffee. I didnt like that so I never drank coffee again. Black tea did the same thing. The only beverage I can safely drink is herbal tea like ginger and chamomile. I was also introduced to tobacco by my cousin at a young age, all it did was make me cough my lungs out for 3 days afterwards. In high school I took a drag of marijuana once and instead of feeling relaxed or high I got severely dizzy and nauseated. I tried phentermine once and it didnt keep me awake or alert, it just gave me heart palpitation.

For some reason, whenever I take some forms of man made chemicals, I dont seem to get the therapeutic effects, only the side effects !

INDICATIONS AND USAGE RAZADYNE&#174 ER/RAZADYNE&#174 (galantamine hydrobromide) is indicated for the treatment of mild to moderate dementia of the Alzheimer&#39s type. CONTRAINDICATIONS RAZADYNE&#174 ER/RAZADYNE&#174 (galantamine hydrobromide) is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. WARNINGS Anesthesia Galantamine, as a cholinesterase inhibitor, is likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia. Cardiovascular Conditions Because of their pharmacological action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with supraventricular cardiac conduction disorders or to patients taking other drugs concomitantly that significantly slow heart rate. Postmarketing surveillance of marketed anticholinesterase inhibitors has shown, however, that bradycardia and all types of heart block have been reported in patients both with and without known underlying cardiac conduction abnormalities. Therefore all patients should be considered at risk for adverse effects on cardiac conduction. In randomized controlled trials, bradycardia was reported more frequently in galantamine-treated patients than in placebo-treated patients, but was rarely severe and rarely led to treatment discontinuation. The overall frequency of this event was 2-3% for galantamine doses up to 24 mg/day compared with <1% for placebo. No increased incidence of heart block was observed at the recommended doses. Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope (placebo 0.7% [2/286]; 4 mg BID 0.4% [3/692]; 8 mg BID 1.3% [7/552]; 12 mg BID 2.2% [6/273]). Gastrointestinal Conditions Through their primary action, cholinomimetics may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk for developing ulcers, e.g., those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs (NSAIDS). Clinical studies of RAZADYNE&#174 (galantamine hydrobromide) have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. RAZADYNE&#174 ER/RAZADYNE&#174, as a predictable consequence of its pharmacological properties, has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss (see ADVERSE REACTIONS). Genitourinary Although this was not observed in clinical trials with RAZADYNE&#174 ER/RAZADYNE&#174, cholinomimetics may cause bladder outflow obstruction. Neurological Conditions Seizures: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. However, seizure activity may also be a manifestation of Alzheimer&#39s disease. In clinical trials, there was no increase in the incidence of convulsions with RAZADYNE&#174 ER/RAZADYNE&#174, compared to placebo. Pulmonary Conditions Because of its cholinomimetic action, galantamine should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. PRECAUTIONS Information for Patients and Caregivers: Caregivers should be instructed about the recommended dosage and administration of RAZADYNE&#174 ER/RAZADYNE&#174 (galantamine hydrobromide). RAZADYNE&#174 ER Extended-Release Capsules should be administered once daily in the morning, preferably with food (although not required). RAZADYNE&#174 Tablets and Oral Solution should be administered twice per day, preferably with the morning and evening meals. Dose escalation (dose increases) should follow a minimum of four weeks at prior dose. Patients and caregivers should be advised that the most frequent adverse events associated with use of the drug can be minimized by following the recommended dosage and administration. Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for several days or longer, the patient should be restarted at the lowest dose and the dose escalated to the current dose. Caregivers should be instructed in the correct procedure for administering RAZADYNE&#174 Oral Solution. In addition, they should be informed of the existence of an Instruction Sheet (included with the product) describing how the solution is to be administered. They should be urged to read this sheet prior to administering RAZADYNE&#174 Oral Solution. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist. Deaths in Subjects with Mild Cognitive Impairment (MCI) In two randomized placebo controlled trials of 2 years duration in subjects with mild cognitive impairment (MCI), a total of 13 subjects on RAZADYNE&#174 (n=1026) and 1 subject on placebo (n=1022) died. The deaths were due to various causes which could be expected in an elderly population; about half of the RAZADYNE&#174 deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death). Although the difference in mortality between RAZADYNE&#174 and placebotreated groups in these two studies was significant, the results are highly discrepant with other studies of RAZADYNE&#174. Specifically, in these two MCI studies, the mortality rate in the placebo-treated subjects was markedly lower than the rate in placebo-treated patients in trials of RAZADYNE&#174 in Alzheimer&#39s disease or other dementias (0.7 per 1000 person years compared to 22-61 per 1000 person years, respectively). Although the mortality rate in the RAZADYNE&#174-treated MCI subjects was also lower than that observed in RAZADYNE&#174-treated patients in Alzheimer&#39s disease and other dementia trials (10.2 per 1000 person years compared to 23-31 per 1000 person years, respectively), the relative difference was much less. When the Alzheimer&#39s disease and other dementia studies were pooled (n=6000), the mortality rate in the placebo group numerically exceeded that in the RAZADYNE&#174 group. Furthermore, in the MCI studies, no subjects in the placebo group died after 6 months, a highly unexpected finding in this population. Individuals with mild cognitive impairment demonstrate isolated memory impairment greater than expected for their age and education, but do not meet current diagnostic criteria for Alzheimer&#39s disease. Special Populations Hepatic Impairment In patients with moderately impaired hepatic function, dose titration should proceed cautiously (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). The use of RAZADYNE&#174 in patients with severe hepatic impairment is not recommended. Renal Impairment In patients with moderately impaired renal function, dose titration should proceed cautiously (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). In patients with severely impaired renal function (CLcr < 9 mL/min) the use of RAZADYNE&#174 is not recommended. Drug-Drug Interactions (see also CLINICAL PHARMACOLOGY, Drug-Drug Interactions) Use With Anticholinergics RAZADYNE&#174 has the potential to interfere with the activity of anticholinergic medications. Use With Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. 6 A) Effect of Other Drugs on Galantamine In vitro CYP3A4 and CYP2D6 are the major enzymes involved in the metabolism of galantamine. CYP3A4 mediates the formation of galantamine-N-oxide; CYP2D6 leads to the formation of O-desmethylgalantamine. Because galantamine is also glucuronidated and excreted unchanged, no single pathway appears predominant. In vivo Cimetidine and Ranitidine: Galantamine was administered as a single dose of 4 mg on day 2 of a 3-day treatment with either cimetidine (800 mg daily) or ranitidine (300 mg daily). Cimetidine increased the bioavailability of galantamine by approximately 16%. Ranitidine had no effect on the PK of galantamine. Ketoconazole: Ketoconazole, a strong inhibitor of CYP3A4 and an inhibitor of CYP2D6, at a dose of 200 mg BID for 4 days, increased the AUC of galantamine by 30%. Erythromycin: Erythromycin, a moderate inhibitor of CYP3A4 at a dose of 500 mg QID for 4 days, affected the AUC of galantamine minimally (10% increase). Paroxetine: Paroxetine, a strong inhibitor of CYP2D6, at 20 mg/day for 16 days, increased the oral bioavailability of galantamine by about 40%. Memantine: Memantine, an N-methyl-D-aspartate receptor antagonist, at a dose of 10 mg BID, had no effect on the pharmacokinetics of galantamine (16 mg/day) at steady state. B) Effect of Galantamine on Other Drugs In vitro Galantamine did not inhibit the metabolic pathways catalyzed by CYP1A2, CYP2A6, CYP3A4, CYP4A, CYP2C, CYP2D6 or CYP2E1. This indicates that the inhibitory potential of galantamine towards the major forms of cytochrome P450 is very low. In vivo Warfarin: Galantamine at 24 mg/day had no effect on the pharmacokinetics of R- and S-warfarin (25 mg single dose) or on the prothrombin time. The protein binding of warfarin was unaffected by galantamine. Digoxin: Galantamine at 24 mg/day had no effect on the steady-state pharmacokinetics of digoxin (0.375 mg once daily) when they were coadministered. In this study, however, one healthy subject was hospitalized for 2nd and 3rd degree heart block and bradycardia. Carcinogenesis, Mutagenesis and Impairment of Fertility In a 24-month oral carcinogenicity study in rats, a slight increase in endometrial adenocarcinomas was observed at 10 mg/kg/day (4 times the Maximum Recommended Human Dose [MRHD] on a mg/m2 basis or 6 times on an exposure [AUC] basis) and 30 mg/kg/day (12 times MRHD on a mg/m2 basis or 19 times on an AUC basis). No increase in neoplastic changes was observed in females at 2.5 mg/kg/day (equivalent to the MRHD on a mg/m2 basis or 2 times on an AUC basis) or in males up to the highest dose tested of 30 mg/kg/day (12 times the MRHD on a mg/m2 and AUC basis). Galantamine was not carcinogenic in a 6-month oral carcinogenicity study in transgenic (P 53-deficient) mice up to 20 mg/kg/day, or in a 24-month oral carcinogenicity study in male and female mice up to 10 mg/kg/day (2 times the MRHD on a mg/m2 basis and equivalent on an AUC basis). Galantamine produced no evidence of genotoxic potential when evaluated in the in vitro Ames S. typhimurium or E. coli reverse mutation assay, in vitro mouse lymphoma assay, in vivo micronucleus test in mice, or in vitro chromosome aberration assay in Chinese hamster ovary cells. No impairment of fertility was seen in rats given up to 16 mg/kg/day (7 times the MRHD on a mg/m2 basis) for 14 days prior to mating in females and for 60 days prior to mating in males. Pregnancy Pregnancy Category B: In a study in which rats were dosed from day 14 (females) or day 60 (males) prior to mating through the period of organogenesis, a slightly increased incidence of skeletal variations was observed at doses of 8 mg/kg/day (3 times the Maximum Recommended Human Dose [MRHD] on a mg/m2 basis) and 16 mg/kg/day. In a study in which pregnant rats were dosed from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at 8 and 16 mg/kg/day, but no adverse effects on other postnatal developmental parameters were seen. The doses causing the above effects in rats produced slight maternal toxicity. No major malformations were caused in rats given up to 16 mg/kg/day. No drug related teratogenic effects were observed in rabbits given up to 40 mg/kg/day (32 times the MRHD on a mg/m2 basis) during the period of organogenesis. There are no adequate and well-controlled studies of RAZADYNE&#174 in pregnant women. RAZADYNE&#174 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether galantamine is excreted in human breast milk. RAZADYNE&#174 has no indication for use in nursing mothers. Pediatric Use There are no adequate and well-controlled trials documenting the safety and efficacy of galantamine in any illness occurring in children. Therefore, use of RAZADYNE&#174 in children is not recommended. ADVERSE REACTIONS Pre-Marketing Clinical Trial Experience: The specific adverse event data described in this section are based on studies of the immediate-release tablet formulation. In clinical trials, once-daily treatment with RAZADYNE&#174 ER (galantamine hydrobromide) Extended-Release Capsules was well tolerated and adverse events were similar to those seen with RAZADYNE&#174 Tablets. Adverse Events Leading to Discontinuation: In two large scale, placebo-controlled trials of 6 months duration in which patients were titrated weekly from 8 to 16 to 24, and to 32 mg/day, the risk of discontinuation because of an adverse event in the galantamine group exceeded that in the placebo group by about threefold. In contrast, in a 5-month trial with escalation of the dose by 8 mg/day every 4 weeks, the overall risk of discontinuation because of an adverse event was 7%, 7%, and 10% for the placebo, galantamine 16 mg/day, and galantamine 24 mg/day groups, respectively, with gastrointestinal adverse effects the principle reason for discontinuing galantamine. Table 1 shows the most frequent adverse events leading to discontinuation in this study. Table 1: Most Frequent Adverse Events Leading to Discontinuation in a Placebo-Controlled, Double-Blind Trial With a 4-Week Dose Escalation Schedule 4-Week Escalation Placebo 16 mg/day 24 mg/day Adverse Event N=286 N=279 N=273 Nausea <1% 2% 4% Vomiting 0% 1% 3% Anorexia <1% 1% <1% Dizziness <1% 2% 1% Syncope 0% 0% 1% Adverse Events Reported in Controlled Trials: The reported adverse events in trials using RAZADYNE&#174 (galantamine hydrobromide) Tablets reflect experience gained under closely monitored conditions in a highly selected patient population. In actual practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior and the types of patients treated may differ. The majority of these adverse events occurred during the doseescalation period. In those patients who experienced the most frequent adverse event, nausea, the median duration of the nausea was 5-7 days. Administration of RAZADYNE&#174 with food, the use of anti-emetic medication, and ensuring adequate fluid intake may reduce the impact of these events. The most frequent adverse events, defined as those occurring at a frequency of at least 5% and at least twice the rate on placebo with the recommended maintenance dose of either 16 or 24 mg/day of RAZADYNE&#174 under conditions of every 4-week dose-escalation for each 7 dose increment of 8 mg/day, are shown in Table 2. These events were primarily gastrointestinal and tended to be less frequent with the 16 mg/day recommended initial maintenance dose. Table 2: The Most Frequent Adverse Events in the Placebo-Controlled Trial With Dose Escalation Every 4 Weeks Occurring in at Least 5% of Patients Receiving RAZADYNE&#174 and at Least Twice the Rate on Placebo. RAZADYNE&#174 RAZADYNE&#174 Placebo 16 mg/day 24 mg/day Adverse Event N=286 N=279 N=273 Nausea 5% 13% 17% Vomiting 1% 6% 10% Diarrhea 6% 12% 6% Anorexia 3% 7% 9% Weight decrease 1% 5% 5% Table 3: The most common adverse events (adverse events occurring with an incidence of at least 2% with RAZADYNE&#174 treatment and in which the incidence was greater than with placebo treatment) are listed in Table 3 for four placebo-controlled trials for patients treated with 16 or 24 mg/day of RAZADYNE&#174. Table 3: Adverse Events Reported in at Least 2% of Patients With Alzheimer&#39s Disease Administered RAZADYNE&#174 and at a Frequency Greater Than With Placebo Body System Placebo RAZADYNE&#174 1 Adverse Event (N=801) (N=1040) Body as a whole - general disorders Fatigue 3% 5% Syncope 1% 2% Central & peripheral nervous system disorders Dizziness 6% 9% Headache 5% 8% Tremor 2% 3% Gastrointestinal system disorders Nausea 9% 24% Vomiting 4% 13% Diarrhea 7% 9% Abdominal pain 4% 5% Dyspepsia 2% 5% Heart rate and rhythm disorders Bradycardia 1% 2% Metabolic and nutritional disorders Weight decrease 2% 7% Psychiatric disorders Anorexia 3% 9% Depression 5% 7% Insomnia 4% 5% Somnolence 3% 4% Red blood cell disorders Anemia 2% 3% Respiratory system disorders Rhinitis 3% 4% Urinary system disorders Urinary tract infection 7% 8% Hematuria 2% 3% 1 Adverse events in patients treated with 16 or 24 mg/day of RAZADYNE&#174 in four placebo-controlled trials are included. Adverse events occurring with an incidence of at least 2% in placebotreated patients that was either equal to or greater than with RAZADYNE&#174 treatment were constipation, agitation, confusion, anxiety, hallucination, injury, back pain, peripheral edema, asthenia, chest pain, urinary incontinence, upper respiratory tract infection, bronchitis, coughing, hypertension, fall, and purpura. There were no important differences in adverse event rates related to dose or sex. There were too few non-Caucasian patients to assess the effects of race on adverse event rates. No clinically relevant abnormalities in laboratory values were observed. Other Adverse Events Observed During Clinical Trials: RAZADYNE&#174 Tablets were administered to 3055 patients with Alzheimer's disease. A total of 2357 patients received galantamine in placebo-controlled trials and 761 patients with Alzheimer's disease received galantamine 24 mg/day, the maximum recommended maintenance dose. About 1000 patients received galantamine for at least one year and approximately 200 patients received galantamine for two years. To establish the rate of adverse events, data from all patients receiving any dose of galantamine in 8 placebo-controlled trials and 6 open-label extension trials were pooled. The methodology to gather and codify these adverse events was standardized across trials, using WHO terminology. All adverse events occurring in approximately 0.1% are included, except for those already listed elsewhere in labeling, WHO terms too general to be informative, or events unlikely to be drug caused. Events are classified by body system and listed using the following definitions: frequent adverse events - those occurring in at least 1/100 patients; infrequent adverse events - those occurring in 1/100 to 1/1000 patients; rare adverse events - those occurring in fewer than 1/1000 patients. These adverse events are not necessarily related to RAZADYNE&#174 treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies. Additional adverse events observed in other clinical trials are also included below. Body As a Whole &#8211 General Disorders: Frequent: chest pain, asthenia, fever, malaise Cardiovascular System Disorders: Infrequent: postural hypotension, hypotension, dependent edema, cardiac failure, myocardial ischemia or infarction Central & Peripheral Nervous System Disorders: Infrequent: vertigo, hypertonia, convulsions, involuntary muscle contractions, paresthesia, ataxia, hypokinesia, hyperkinesia, apraxia, aphasia, leg cramps, tinnitus, transient ischemic attack or cerebrovascular accident Gastrointestinal System Disorders: Frequent: flatulence; Infrequent: gastritis, melena, dysphagia, rectal hemorrhage, dry mouth, saliva increased, diverticulitis, gastroenteritis, hiccup; Rare: esophageal perforation Heart Rate & Rhythm Disorders: Infrequent: AV block, palpitation, atrial arrhythmias including atrial fibrillation and supraventricular tachycardia, QT prolonged, bundle branch block, T-wave inversion, ventricular tachycardia; Rare: severe bradycardia Metabolic & Nutritional Disorders: Infrequent: hyperglycemia, alkaline phosphatase increased Platelet, Bleeding & Clotting Disorders: Infrequent: purpura, epistaxis, thrombocytopenia Psychiatric Disorders: Infrequent: apathy, paroniria, paranoid reaction, libido increased, delirium; Rare: suicidal ideation, suicide Urinary System Disorders: Frequent: incontinence; Infrequent: hematuria, micturition frequency, cystitis, urinary retention, nocturia, renal calculi Post-Marketing Experience: Other adverse events from post-approval controlled and uncontrolled clinical trials and post-marketing experience observed in patients treated with RAZADYNE&#174 include: Body as a Whole &#8211 General Disorders: dehydration (including rare, severe cases leading to renal insufficiency and renal failure) 8 Psychiatric Disorders: aggression Gastrointestinal System Disorders: upper and lower GI bleeding Hepatobiliary Disorders: elevated liver enzymes, hepatitis Metabolic & Nutritional Disorders: hypokalemia These adverse events may or may not be causally related to the drug. OVERDOSAGE Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of an overdose of any drug. As in any case of overdose, general supportive measures should be utilized. Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. In addition to muscle weakness or fasciculations, some or all of the following signs of cholinergic crisis may develop: severe nausea, vomiting, gastrointestinal cramping, salivation, lacrimation, urination, defecation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Tertiary anticholinergics such as atropine may be used as an antidote for RAZADYNE&#174 (galantamine hydrobromide) overdosage. Intravenous atropine sulfate titrated to effect is recommended at an initial dose of 0.5 to 1.0 mg i.v. with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when coadministered with quaternary anticholinergics. It is not known whether RAZADYNE&#174 and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration). Dose-related signs of toxicity in animals included hypoactivity, tremors, clonic convulsions, salivation, lacrimation, chromodacryorrhea, mucoid feces, and dyspnea. In one postmarketing report, one patient who had been taking 4 mg of galantamine daily for a week inadvertently ingested eight 4 mg tablets (32 mg total) on a single day. Subsequently, she developed bradycardia, QT prolongation, ventricular tachycardia and torsades de pointes accompanied by a brief loss of consciousness for which she required hospital treatment. Two additional cases of accidental ingestion of 32 mg (nausea, vomiting, and dry mouth; nausea, vomiting, and substernal chest pain) and one of 40 mg (vomiting), resulted in brief hospitalizations for observation with full recovery. One patient, who was prescribed 24 mg/day and had a history of hallucinations over the previous two years, mistakenly received 24 mg twice daily for 34 days and developed hallucinations requiring hospitalization. Another patient, who was prescribed 16 mg/day of oral solution, inadvertently ingested 160 mg (40 mL) and experienced sweating, vomiting, bradycardia, and nearsyncope one hour later, which necessitated hospital treatment. His symptoms resolved within 24 hours. DOSAGE AND ADMINISTRATION RAZADYNE&#174 ER Extended-Release Capsules The dosage of RAZADYNE&#174 ER (galantamine hydrobromide) Extended- Release Capsules shown to be effective in a controlled clinical trial is 16- 24 mg/day. The recommended starting dose of RAZADYNE&#174 ER is 8 mg/day. The dose should be increased to the initial maintenance dose of 16 mg/day after a minimum of 4 weeks. A further increase to 24 mg/day should be attempted after a minimum of 4 weeks at 16 mg/day. Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose. RAZADYNE&#174 ER should be administered once daily in the morning, preferably with food. Patients currently being treated with RAZADYNE&#174 tablets can convert to RAZADYNE&#174 ER by taking their last dose of RAZADYNE&#174 tablets in the evening and starting RAZADYNE&#174 ER once daily treatment the next morning. Converting from RAZADYNE&#174 to RAZADYNE&#174 ER should occur at the same total daily dose. RAZADYNE&#174 Immediate-Release Tablets and Oral Solution The dosage of RAZADYNE&#174 Tablets shown to be effective in controlled clinical trials is 16-32 mg/day given as twice daily dosing. As the dose of 32 mg/day is less well tolerated than lower doses and does not provide increased effectiveness, the recommended dose range is 16-24 mg/day given in a BID regimen. The dose of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dose of 24 mg of RAZADYNE&#174 might provide additional benefit for some patients. The recommended starting dose of RAZADYNE&#174 Tablets and Oral Solution is 4 mg twice a day (8 mg/day). The dose should be increased to the initial maintenance dose of 8 mg twice a day (16 mg/day) after a minimum of 4 weeks. A further increase to 12 mg twice a day (24 mg/day) should be attempted after a minimum of 4 weeks at 8 mg twice a day (16 mg/day). Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose. RAZADYNE&#174 Tablets and Oral Solution should be administered twice a day, preferably with morning and evening meals. Patients and caregivers should be advised to ensure adequate fluid intake during treatment. If therapy has been interrupted for several days or longer, the patient should be restarted at the lowest dose and the dose escalated to the current dose. Caregivers should be instructed in the correct procedure for administering RAZADYNE&#174 Oral Solution. In addition, they should be informed of the existence of an Instruction Sheet (included with the product) describing how the solution is to be administered. They should be urged to read this sheet prior to administering RAZADYNE&#174 Oral Solution. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist. The abrupt withdrawal of RAZADYNE&#174 ER/RAZADYNE&#174 in those patients who had been receiving doses in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same doses of that drug. The beneficial effects of RAZADYNE&#174 ER/RAZADYNE&#174 are lost, however, when the drug is discontinued. Doses in Special Populations Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment. In patients with moderately impaired hepatic function (Child-Pugh score of 7-9), the total daily dose should generally not exceed 16 mg/day. The use of RAZADYNE&#174 ER/RAZADYNE&#174 in patients with severe hepatic impairment (Child-Pugh score of 10-15) is not recommended.For patients with moderate renal impairment the dose should generally not exceed 16 mg/day. In patients with severe renal impairment (creatinine clearance < 9 mL/min), the use of RAZADYNE&#174 ER/RAZADYNE&#174 is not recommended.

This is from https://www.ortho-mcneilneurologics.com/ortho-mcneilneurologics/.

The complete article is copyrighted so I cant copy the whole thing here.

http://www.druglib.com/druginfo/razadyne/side-effects/

This is a summary of the results of several studies, 2 of which I have a copy of the whole trial details but unfortunately they are copy righted.

Excerpt from the above article

Other Adverse Events Observed During Clinical Trials

RAZADYNEtm Tablets were administered to 3055 patients with Alzheimer's disease. A total of 2357 patients received galantamine in placebo-controlled trials and 761 patients with Alzheimer's disease received galantamine 24 mg/day, the maximum recommended maintenance dose. About 1000 patients received galantamine for at least one year and approximately 200 patients received galantamine for two years.

To establish the rate of adverse events, data from all patients receiving any dose of galantamine in 8 placebo-controlled trials and 6 open-label extension trials were pooled. The methodology to gather and codify these adverse events was standardized across trials, using WHO terminology. All adverse events occurring in approximately 0.1% are included, except for those already listed elsewhere in labeling, WHO terms too general to be informative, or events unlikely to be drug caused. Events are classified by body system and listed using the following definitions: frequent adverse events - those occurring in at least 1/100 patients; infrequent adverse events - those occurring in 1/100 to 1/1000 patients; rare adverse events - those occurring in 1/1000 to 1/10000 patients; very rare adverse events &#8211 those occurring in fewer than 1/10000 patients. These adverse events are not necessarily related to RAZADYNEtm treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies.

Body As a Whole &#8211 General Disorders: Frequent: chest pain, asthenia, fever, malaise

Cardiovascular System Disorders: Infrequent: postural hypotension, hypotension, dependent edema, cardiac failure, myocardial ischemia or infarction

Central & Peripheral Nervous System Disorders: Infrequent: vertigo, hypertonia, convulsions, involuntary muscle contractions, paresthesia, ataxia, hypokinesia, hyperkinesia, apraxia, aphasia, leg cramps, tinnitus, transient ischemic attack or cerebrovascular accident

Gastrointestinal System Disorders: Frequent: flatulence; Infrequent: gastritis, melena, dysphagia, rectal hemorrhage, dry mouth, saliva increased, diverticulitis, gastroenteritis, hiccup; Rare: esophageal perforation

Heart Rate & Rhythm Disorders: Infrequent: AV block, palpitation, atrial arrhythmias including atrial fibrillation and supraventricular tachycardia, QT prolonged, bundle branch block, T-wave inversion, ventricular tachycardia; Rare: severe bradycardia

Metabolic & Nutritional Disorders: Infrequent: hyperglycemia, alkaline phosphatase increased

Platelet, Bleeding & Clotting Disorders: Infrequent: purpura, epistaxis, thrombocytopenia

Psychiatric Disorders: Infrequent: apathy, paroniria, paranoid reaction, libido increased, delirium; Rare: suicidal ideation; Very rare: suicide

Urinary System Disorders: Frequent: incontinence; Infrequent: hematuria, micturition frequency, cystitis, urinary retention, nocturia, renal calculi

The paranoia, delirium and suicidal ideation as well as suicide attempts reported were very similar in those with schizophrenia. It is very rare but it does happen.

Annsie,

Thanks for finding and posting this very informative report. This is so much better than all of the hearsay that gets circulated around the Internet and labeled as "true".

Quote from: dallyup52 on May 29, 2008, 06:52:58 PMQuoteThis debate has really confirmed my reluctance to take what is, in effect, a recreational drug.  As for voices in the head - I have plenty of those already.  Shocked Burnedup,

I would encourage you to listen to your intuition.  If it tells you not to do a certain something (like these supplements), then by all means, do not do that thing. It probably doesn't matter what the reasons are.  Go with your gut.

I know that for me it is the way to go.  My guidance has told me to ingest these particular substances. There are plenty of reasons to do or not to do them.  So the rationalization either way is compelling no matter what you or I  decide to do.

"Recreational Drug" sounds a little strong to me, but maybe it fits? I would normally reserve that term for drugs like alcohol, tobacco and marijuana.

You're right.  I'm happy to drink alcohol but not to take drugs such as galantamine.  It's not really logic, just my wariness of the unknown which as you say is a gut feeling.  Thanks for challenging me on this!!!

Galantamine is very powerful