Does topamax work well for bipolar?!


Question:

Does topamax work well for bipolar?


Answers:

FAQ: Topiramate (Topamax), Mood Disorders and PTSD.
NOTE: Topiramate is only approved for the
treatment of people with seizures. There are
few systematic studies that establish the safety
or efficacy of topiramate as a treatment
for people with mood disorders, PTSD, or eating
disorders While such studies are underway, what
is currently known about the use of topiramate
for the control of mood disorders, PTSD and eating
disorders comes mostly from uncontrolled case reports.



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1. What is topiramate (Topamax)?

Topiramate is an anticonvulsant that is chemically unrelated to any other anticonvulsant or mood regulating medication. The mechanism of action is unknown.



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2. When was topiramate approved for marketing in the USA and for what indications may it be promoted?

topiramate received final approval for marketing in the USDA on 24 December 1996 and is labeled for use as an anticonvulsant.



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3. Is a generic version of topiramate available?

There is no generic topiramate as the manufacturer has patent protection.



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4. How does topiramate differ from other mood stabilizing drugs?

Topiramate differs from other mood stabilizing drugs in two major ways:

1. topiramate's frequent effectiveness for patients who have failed to respond to antidepressants or mood stabilizers;

2. topiramate's unique side-effect profile.



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5. What, if anything, uniquely distinguishes topiramate from carbamazepine and valproate?

Topiramate has been successful in controlling rapid cycling and mixed bipolar states in people who have not received adequate relief from carbamazepine and/or valproate.



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6. People with what sorts of disorders are candidates for treatment with topiramate?

It is too early to be very specific about which mood disorders are most likely to respond to treatment with topiramate. There are just about no published reports on topiramate's use in psychiatry. Patients with hard-to-treat bipolar syndromes have been treated more often than patients with "treatment-resistant" unipolar disorders.


Topiramate seems especially useful when it comes to treating people who have become manic as the result treatment with lamotrigine.


There has recently been a report regarding the control of the symptoms of PTSD by topiramate.


Topiramate has also been successfully used to decrease binge eating and overeating that is caused by other psychiatric medications.



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7. Is topiramate useful for the treatment of acute depressed, manic and mixed states, and can it also be used to prevent future episodes of mania and/or depression?

The initial use of topiramate was to treat people with depressed, manic rapid-cycling, and mixed states that did not respond to existing medications. Some patients are now being maintained on topiramate on a long term basis in an attempt to prevent future episodes. The effectiveness of topiramate as a long-term prophylactic agent is currently being established.



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8. Are there any laboratory tests that should precede the start of topiramate therapy?

Before topiramate is prescribed the patient should have a thorough medical evaluation, including blood and urine tests, to rule out any medical condition, such as thyroid disorders, that may cause or exacerbate a mood disorder.



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9. How is treatment with topiramate initiated?

Topiramate is usually initially prescribed at an initial dose of 12.5 -25 mg once or twice a day and the total daily dose is increased by 12.5 - 25 mg every week. When prescribed in addition to other anticonvulsants being used as mood stabilizers, the final dose is often between 100 and 200 mg per day. Some patient with Bipolar Disorder do well on as little as a total daily dose of 50 mg/day. When used for the control of the symptoms of PTSD the average final dose is about 175 mg/day (with a range of 25 - 500 mg/day).



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10. Are there any special problems prescribing topiramate for people taking lithium, carbamazepine (Tegretol), or valproate (Depakene, Depakote)?

An interaction between lithium and topiramate has not been reported.

Carbamazepine and valproate both have the ability to lower plasma levels of topiramate . . . carbamazepine by about 50% and valproate by about 15%. Topiramate has no effect on the plasma level of carbamazepine but can reduce the plasma level of valproate by about 10%. Pharmacokinetic interactions between topiramate and either lamotrigine (Lamictal) or gabapentin (Neurontin) have not been reported.



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11. What is the usual final dose of topiramate?

When used as a mood-stabilizing agent the final dose of topiramate is most often between 50 and 200 mg/day. Some people require doses as high as 400 mg/day to achieve a good mood stabilizing effect . . . especially when topiramate is being used as a monotherapy . . . while others do fine on 25 mg/day.



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12. How long does it take for topiramate to 'kick-in?'

While some people notice the antimanic and antidepressant effects early in treatment, others have to take a therapeutic amount of topiramate for up to a month before being aware of a significant amount of improvement.



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13. What are the side-effects of topiramate?

Here is a listing of topiramate's side effects that affected 10% or more of the 711 people taking the drug during clinical trials and the frequency of those side effects in the 419 people treated with placebo in those trials:


Common Adverse Reactions (%)
(Topiramate = 200 mg/day)

Adverse Reaction Topiramate Placebo


Somnolence 30 10
Dizziness 28 14
Vision problems 28 9
Unsteadiness 21 7
Speech problems 17 3
Psychomotor slowing 17 2
"Pins and needles" 15 3
Nervousness 16 8
Nausea 12 6
Memory problems 12 3
Tremor 11 6
Confusion 10 6

Side-effects are most noticeable the few days after an increase in dose and then often fade.



14. Which side-effects are severe enough to force people to discontinue topiramate?

The side-effects that most frequently caused people to discontinue therapy with topiramate were: psychomotor slowing (4.1%), memory problems ( (3.3%), fatigue (3.3%), confusion (3.2%), and somnolence (3.2%).

Much less frequently happening but more serious side-effects that force people to stop topiramate therapy include kidney stones, which affect about 1% of people taking the drug, and acute glaucoma, which to date had been reported in about one person in 35,000 taking topiramate. The sudden onset of back pain may indicate the presence of a kidney stone, while eye pain, changes in vision or the develpment of redness in the eye may indicate glaucoma. Most cases of glaucoma have developed within the first two months of therapy with topiramate.

Information from the FDA on topiramate and glaucoma.



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15. Does topiramate have any psychiatric side effects?

Among the reported side effects of topiramate are sedation, psychomotor slowing, agitation, anxiety, concentration problems, forgetfulness, confusion, depression, and depersonalization. As with other anticonvulsants, psychosis has rarely been reported as a side-effect.



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16. How does topiramate interact with prescription and over-the-counter medications?

Only a few interactions between topiramate and other drugs have been identified. Topiramate may increase the plasma level of phenytoin (Dilantin). Phenytoin lowers the concentration of topiramate in the blood by about 50%. While topiramate has little effect on the plasma level of carbamazepine, the latter may decrease the plasma level of topiramate by about 50%. Valproate lowers the plasma level of topiramate by about 15%. Topiramate may lead to decreased effectiveness of some oral anticontraceptives.

Interactions with other prescription and over-the-counter drugs are not known at this time.



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17. Is there an interaction between topiramate and alcohol?

Alcohol may increase the severity of the side-effects of topiramate.



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18. Is topiramate safe for a woman who is about to become pregnant, pregnant or nursing an infant?

Topiramate is has been placed in the FDA pregnancy Category C:

"Animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans; The benefits from the use of the drug in pregnant women may be acceptable despite its potential risks . . . ."



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19. Is topiramate safe for children and adolescents?

The FDA has recently approved the use of topiramate in children.



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20. Can topiramate be used in elderly people?

Older people seem to handle topiramate similarly to younger ones. There is little experience using topiramate for the treatment of psychiatric disorders in the elderly.



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21. Do symptoms develop if topiramate is suddenly discontinued?

There are no specific symptoms that have been described following the abrupt discontinuation of topiramate, other than the seizures that sometimes follow the rapid discontinuation of any anticonvulsant. Only when necessary because of a serious side effect, should topiramate be suddenly discontinued.



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22. Is topiramate toxic if taken in overdose?

There is only limited data on the effects of overdoses of topiramate. There have been no reports of deaths following an overdose.



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23. Can topiramate be taken along with MAO inhibitors?

Yes, the combination has been used without any special problems.



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24. What does topiramate cost?

As of 3 April 2005, an on-line pharmacy (Drugstore.com) was selling topiramate for the following amounts per tablet (when bought in lots of 100 tablets):



25 mg - $1.45
100 mg - $3.73
200 mg - $5.75




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25. Might topiramate be effective in people who have failed to receive benefit from other psychopharmacologic agents?

The major use of topiramate in psychiatry is with people who have mood disorders that have not been adequately controlled by other medications at times including lamotrigine and gabapentin. A developing use is for people with PTSD.


Topiramate has also been shown to decrease craving for alcohol in people with alcoholism, and to prevent migraine headaches.



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26. What are the advantages of topiramate?

Topiramate seems to be effective in some people with bipolar mood disorders that have not responded to lithium and/or other mood-stabilizers. Some people who have not been able to tolerate any antidepressant because of switches to mania or increased speed or intensity of cycling, or because of the development of mixed states, have been able to tolerate therapeutic doses of anti- depressants when taking topiramate.

For most people, topiramate has tolerable side effects and it can be taken twice a day.

The weight loss that accompanies topiramate therapy in some instances is useful for those individuals who have gained weight while taking other mood stabilizing drugs. In some studies 20-50% of people taking topiramate lost weight.



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27. What are the disadvantages of topiramate?

As topiramate has only been available for a relatively short time, it was first marketed in 1996, there is no information about long term side-effects. As its use with people with mood disorders started even more recently, it is not known if people who initially do well on topiramate continue to do so after many years of treatment.

Topiramate increases the probability of kidney stones. the development of kidney stones may be prevented by increasing one's intake of water.



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28. Why should physicians prescribe, and patients take, topiramate, when there are mood regulating medications that have been available for many years and which have been shown to be effective in double-blind placebo- controlled studies?

There are two major reasons why physicians prescribe and patients take topiramate rather than conventional, better established drugs. They are that not everyone benefits from treatment with the older, better known drugs, and that some patients find the side effects of the established drugs to be unacceptable.


As there has not been a good psychopharmacologic treatment for people with PTSD, topiramate offers such people the possibility of medically -induced relief.



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29. Is topiramate available in countries other than the USA?

Topiramate is available in many countries throughout the world.




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