Question:
When's my generic? How are prices in Canada?
Answer:
The US FDA has recently granted Lamictal (lamotrigine) approval to be
used to treat Bipolar Disorder. Now retrograde pdocs have NO excuse not
to prescribe it! Lamictal joins the ranks of lithium carbonate and
Depakote as having gone through the rigorous testing required by the
FDA. All other psychotropic meds are being prescribed in an "off-label"
fashion - which is perfectly legal as long as they have been proven safe
for some other purpose (usually as an anticonvulsant). It is interesting to note that on page 41, it confirmed my
recommendation that 200 mg/day is the usual target dose. No additional
benefit was seen from 400 mg/day when Lamictal was used as monotherapy.
My suggested dosage escalation protocol is more conservative than that
of Table 13 on page 42. I believe that if my protocol were followed,
fewer adverse side effects would result and a higher percentage of
people would be able to take Lamictal with success.
Here is my protocol for Lamictal:
Conservative Initial Ramp Up Protocol for Lamictal (lamotrigine)
for Outpatient Treatment of Bipolar Disorder in Adults (Dosage in mg)
---------------------------------------------------------------------
Breakfast Lunch Supper Bedtime TOTAL
---------------------------------------------- -----
Week 1 25 25
Week 2 25 25
Week 3 25 25 50
Week 4 25 25 50
Week 5 50 25 75
Week 6 50 25 75
Week 7 50 50 100
Week 8 50 50 100
Week 9 75 50 125
Week 10 75 50 125
Week 11 75 75 150
Week 12 75 75 150
Week 13 100 75 175
Week 14 100 75 175
Week 15 100 100 200
Week 16 100 100 200
You will note that my protocol takes 15 weeks to get to 200 mg/day. But
Table 13 gets there in only 6 weeks!!! IMO this is entirely too RAPID!
IMO the PI's recommended discontinuation schedule is also entirely too
fast.
One other source of disagreement I have is that the PI allows once a day
dosing. The half-life varies considerably from 14 to 103 hours with a
mean of 32.8 hours. If you have a rapid metabolism for lamotrigine, once
a day dosing will be insufficient to maintain a near steady state level.
If you have an average or slow metabolism for lamotrigine, once a day
dosing will be adequate. Since I do not know what rate my metabolism is,
I take Lamictal twice daily in equal doses.
I no longer have mood swings and I used to have Ultra Rapid Cycles
(several a day). A point of clarification - I should have added the words "used as mood
stabilizers" after "meds" in the above sentence. Of course
antidepressants, antipsychotics, hypnotics, etc. also have to go through
the testing process prior to being approved by the FDA. Since Lamictal received FDA approval on December 27, 1994, its 7-year
patent protection should have been up on December 27, 2001. I do not
know why there has not been a generic brought out for lamotrigine. It is
a popular drug - though not as popular as Neurontin (gabapentin). Prices in Canada and Mexico (or anywhere else in the world) are bound to
be less expensive than in the US! Pharmaceutical companies know that
many people have insurance companies or Medicaid that will pay whatever
outrageous prices they demand.
If you meet certain financial requirements and do not have prescription
insurance, you can get free or low cost meds through these websites:
Prescription Drug Patient Assistance Programs:
http://www.needymeds.com
http://www.themedicineprogram.com
http://www.mhsanctuary.com/resources/freemed.htm
When meds are approved for new uses, the patent is extended AFAIK. That is
why there is so much pressure to increase uses as in the pressure to push
Neurontin. If the patent wasn't extended you wouldn't see the push to find
new uses.
