Teva Clonazepam (Page 2) (Top voted first)

What does clonazepam have in it to make it fall under the controlled substance act? I have been taking this medication for some time. I was told it has a controlled substance in it. What is it?

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Re: Kitty Moosy (# 30)

Both the FDA and generic drugmakers say that generic drugs are clinically identical to the branded originals, but you'd never know it from reading Internet chat forums and blog posts.

Take the mixture of amphetamine and dextroamphetamine, branded as Adderall.

"I was prescribed Adderall 5mg [twice] a day to start," wrote a patient with ADHD on a drug forum.

"When I got my script [sic] filled it was the generic brand," he continued. "I didn't think anything of it, just assumed it would work the same, but it's totally different. It's only been two days and I feel jittery, like I drank two pots of coffee."

Another contributor to the same forum wrote, "When I was taking brand Adderall XR, I wouldn't get increased heart rate, racing thoughts, feeling like I'm on crack etc. UNLESS I ingested caffeine within the first few hours of taking it. On the generic, I experience these symptoms even without caffeine. And they remain for about 10-12 hours."

How can patients report such dramatic differences in drug effects when the products are supposed to be equivalent? This second installment in our three-part series on generic drugs examines that issue.

What the regulations call for:

The FDA requires that generic manufacturers conduct bioequivalence studies that compare blood levels of the generic and branded drug following the normal route of administration and dose.

To pass muster with the FDA, the 90% confidence intervals for maximal concentration and the area under the concentration-time curve must be no less than 80% and no more than 125% of the means for the branded drug.

This range was established in the 1980s soon after Congress authorized the regulatory pathway for generic drugs with the Hatch-Waxman Act, aka Public Law 98-417, Sept 24, 1984.

Bioequivalence studies are nearly always done in healthy volunteers, per FDA's guidances to industry.

Patients tend to have greater variability in drug absorption because of their illness or comorbidities.

"The goal is to limit the variability as much as you can," explained Gary Buehler, RPh, director of the FDA's Office of Generic Drugs, so that whatever variability is encountered can be considered the normal baseline.

The agency said it recently evaluated 2,070 bioequivalence studies conducted from 1996 to 2007 for approved generic drugs and found that the mean difference in bioavailability between the generics and their branded counterparts was just 2.3%.

Studies comparing different lots of the same branded drugs had found similar variation.

"There will always be a slight, but not medically important, level of natural variability" in drug absorption, according to a review of concerns about generic drugs posted on the FDA's Web site. (See Facts and Myths about Generic Drugs)

"Much of the criticism we get really centers around anecdotes from patients," said Buehler in an interview.

"The criticism is not based on any real scientific studies that have been done showing that the process presently used is flawed in some way. If we had some real hard scientific evidence -- a good study, that was brought to us by anybody, an innovator company, a public interest group -- that showed somehow or another generics weren't performing the way they're supposed to, then we would take a very hard look at the way we do things."

One size does not fit all

Actually, a number of studies do suggest that variation in bioavailability of generic drugs does have clinical consequences.

Randomized clinical comparisons of at least five important drugs have been published in recent years showing large pharmacokinetic differences or significantly different clinical effects.

Franck Chenu, PharmD, PhD, of the University of Ottawa, and colleagues recently reported on one of these, a randomized crossover study comparing a generic version of the antidepressant drug venlafaxine with its branded version, Effexor.

The researchers found that side effects were three times as common with the generic drug.

Maximal concentrations were about 50% greater with the generic venlafaxine (52 ng/ml, SD 8 ng/ml, versus 36 ng/ml, SD 6 ng/ml), the researchers said in the July issue of the Journal of Clinical Psychiatry.

...But data submitted to the FDA by generic manufacturers indicate that drugs meeting the agency's bioequivalence standard can differ markedly from each other -- that is, when one version falls at the low end of the 80% to 125% range and the other is at the high end.

Gregory Krauss, MD, of Johns Hopkins University, and colleagues obtained summary bioequivalence data -- via Freedom of Information Act requests, because the FDA does not publish them -- on five generic versions of the epilepsy drug carbamazepine.

They found that maximal concentrations could differ between ostensibly equivalent products by up to 40% -- definitely of clinical significance for a drug intended to prevent seizures, he said when presenting the findings at the American Academy of Neurology's annual meeting last April. (See AAN: Wide Variability in Generic Versions of Epilepsy Drug - medpagetoday)

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Re: Joseph (# 28)

What do you think this discussion has been about?

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Re: Jeanne (# 7)

This is due to BO and the liberal push to socialized medicine and health 'care'.

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Re: Patrice (# 6)

The entire controlled substance scheme is all about euphoria. It's only because there is a high to be gotten that these and other pills are so strictly controlled.

A bottle of 100 aspirin will kill you. So will Tylenol, which will damage your liver. Advil? Increased risk of heart attack.

Not controlled because they don't get you high.

Now go try and buy some cough syrup without showing ID...why? In larger doses it gets you high, some like LSD and some carry the basics to make methamphetamine.

When you use a drug which causes euphoria and you are truly in need, the "euphoria" is not such a problem.... but when others not in need take benzos, they get high. Three and they cannot walk.

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Klonopin is an Extremely Dangerous Drug, as are all drugs. In the Benzodiazepine Class Of Medication. I became permanently Disabled due to Klonopin Withdrawal and severe depression. I was prescribed Xanax in 1989 and I am Still trying to come off of this medication.

Tapering off of Benzodiazepine is a long and painful process for many people. Do not Stop taking this Medication. You could have Seizures. Be Well

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I take the Teva Clonazepam yellow pill .5mg 2x a day and I feel nothing when I take this pill. Did Roche stop making this pill? I need help finding a medication that works.

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Re: Joseph (# 8)

Stuffs crap. Should be given away like aspirin, it’s nothing. Don’t even put me to sleep lol. Gotta put myself in a coma to get some sleep. It’s a joke.

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Re: Joseph (# 13)

You’re incorrect

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Re: Joseph (# 20)

20%. + or - that’s it that’s all. Just to clear it up

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I've read Teva is no longer making Clonazepam. However I have been on 1 mg x 4 per day. I always get teva. The accord make me sleepy then wears off. Any current news of teva not manufacturing? If so what alternative do we have? Much thanks

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Re: James (# 3)

CVS has Teva contract.

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Re: Verwon (# 1)

It's actually prone to being abused. That is the only reason for "controlled substances."

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Re: Eric (# 9)

I also take Clonazepam twice daily for anxiety, I have had the name brand Klonopin (with the hole in the tablet shaped like a K) as well as most of the generics, I have been on Clonazepam for quite a number of years now, they're all the same to me Same active ingredient. I don't prefer one pharmaceutical company over another.

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Re: Joseph (# 10)

I really don't get it when people say that one brand is better than the other. You and I both can remember when these drugs had no generics and they are the same. The only time I remember a better medication is when a friend of mine sent me some xanax from South Africa. They were very light purple and taking one was like taking three.. Other than that a drugs are the same, at least for me.

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Re: Eric (# 23)

Binders and fillers yes, but the active ingredient no. Think about all the generic antibiotics, if there was a 24% plus or minus like you claim, people's lives would be in jeopardy, diseases not cured, and so on. For example if someone had Syphilis and was prescribed Penicillin, if the dose was -24% it would never be cured! Really just give it some thought.

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It is a benzo, in the same family as Valium, Ativan, Xanax, etc.. It is a controlled substance because it is addicting.

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Re: Amsterdameric (# 15)

Rumors, myths, and urban legends. They're all the same. It's psychosomatic preferring one pharmaceutical company's Clonazepam over the other.

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Re: Amsterdameric (# 18)

Binders and fillers do nothing to alter the active ingredient, in this case Clonazepam. I have been on Clonazepam for many years and I have had the brand name Klonopin by Roche and many of the generics, they are all equivalent. Don't believe everything you hear.

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Re: Amsterdameric (# 18)

Also, the FDA doesn't allow plus or minus 24%, if that was true think of all the medications that are literally lifesavers, chemotherapy drugs, antibiotics, etc.. plus or minus 24% with those meds and many more can be fatal to a patient. Again, don't believe everything that you hear.

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Hello, Mimi! How are you?

Clonazepam itself is the controlled substance, it is a benzodiazepine that carries the risk of being habit forming, so the FDA and DEA make sure it is regulated.

It may also cause side effects, such as nausea, dizziness, headache and irritability.

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