JAY W. SEASTRUNK II, M.D.

Neurontin (Gabapentin) was developed by the Japanese, who initially, were looking for an antispasmodic or muscle relaxant. Neurontin (Gabapentin) was later sold to Parke-Davis (Warner-Lambert), who discovered its effectiveness for use in treating epileptics. During their initial clinical studies, Neurontin (Gabapentin) was given in low doses and therefore efficacy was established as an add-on. In other words, the patient was first given another anti-convulsant, and then Neurontin (Gabapentin) was added. Another study, being done at this time, but as yet incomplete, will establish Neurontin (gabapentin) as a mono therapy. Neurontin is used by some doctors in doses up to 6,000 mg per day. There is, as yet, no generic form of Neurontin.

Neurontin (gabapentin) helps stabilize injured brain cells, tending to stop their misfiring. We are not sure what makes the medication work, but we do know that, it is a synthetic amino acid that is similar in molecular structure to L-Leucine. Studies have show that it does not work the same as either L-Leucine or GABA. It is so similar in molecular structure to L-Leucine, that the Leucine transport system makes Neurontin absorb rapidly into the blood and from the blood to the brain.

Neurontin (Gabapentin) is not metabolized in the liver. It is secreted by the kidney and passes out of the body unchanged. If you have kidney or liver problems, please inform us because if you have a kidney problem decreasing renal clearance, both Dr. Seastrunk and the PDR say that the dose of Neurontin (Gabapentin) needs to be adjusted.

Any weight gain (5 lbs. Max) due to taking Neurontin (Gabapentin), is usually due to fluid retention or increased absorption of food, and may be treated accordingly. While some people do experience weight gain, others will loose weight or maintain their current weight, due to the calming effect of the medication.

Because the body does not store Neurontin (Gabapentin), it must be taken in as evenly spaced intervals as possible. It is not wise for a person with focal brain injury to take Neurontin sporadically, or to take it only in the a.m. and then repeat it in the p.m. as it can actually cause increased firing due to the drop in the blood level between the doses.

There are other doctors across the United States that are using Neurontin (Gabapentin) to treat MCS or CHRONIC FATIGUE SYNDROME. Expertise is required in titrating these patients to a therapeutic level. The use of Neurontin (Gabapentin) as a mono therapy, at low doses, to treat focal brain injury, will not be effective, and a therapeutic dose that is able to stabilize focal brain injury, (i.e. resulting in MCS or Chronic Fatigue, etc.) will not be reached. Some doctors are only treating peripheral symptoms with low doses, therefore the over all outcome will not be favorable.

During the first part of the treatment, necessary medication, i.e. thyroid, heart medication, are perfectly fine to take, as is homeopathy. Neurontin (Gabapentin) has no cross-reaction with other medications. Non-essential medications and treatments are not recommended during the initial stage, because it confuses the monitoring of the response. Magnesium should not be taken in conjunction with Neurontin (Gabapentin), due to the fact that it blocks Neurontin (Gabapentin) from its receptor.

The antidepressant, Effexor is often added to encourage the body to increase its own serotonin. For those who tolerate it, Effexor can be a tremendous boost towards healing. Other neurotransmitter affecting medications as well as other anticonvulsants are frequently beneficial.

In the treatment of patients on Neurontin (Gabapentin), Dr. Seastrunk has found that they can be classified into three groups:

I. People that respond very quickly and have little psychological trouble, 10%-15%

II. People that respond, but take longer, 60%-70%

III. People that do no respond at all, or 5% of patients selected via the Organic Evaluator. About 5 to 10% won't comply with the treatment regimen for getting the medication up to a therapeutic level.

Of these three groups, the first group of people can go out dancing and kick up their heels, while the second group usually notices improvement, but it takes longer to really feel well. They are by far the largest group. The third group is greatly in the minority. People in the third group may respond to another type of treatment.

During the initial 3 months of therapy, there needs to be close contact between the doctor and the patient. This is necessary to fine-tune the dosage. At the end of the 3 months of medication, Dr. Seastrunk needs to evaluate the patient to see what symptoms are left. In the small percentage of cases, if there have been no benefits, it would be likely that another treatment might be more effective. Possibly 30% to 40% of people may be able to titrate off the medication in 2 years. If the patient had extensive brain injury many years ago, they might possibly have to be on the medication for the rest of their life. Response time tends to mirror the duration of illness prior to treatment.

In Focal Brain Injuries, the neurons misfire, thus activating symptoms that are stereotypical. The triggering mechanism for this reaction can be foods, chemicals, electrical exposure, stress and sleep deprivation. As stated previously, the reason Neurontin (Gabapentin) is well tolerated, (unlike other medications), is that it is similar to L-Leucine which is an essential amino acid. Initially, you may experience a slight discomfort during the first stage of the treatment, i.e., dizziness, drowsiness, fatigue, lack of muscle control, headaches or blurred vision. These symptoms will most likely disappear in the first couple of weeks. If you notice what appears to be a slight burning of the throat, it is most likely that you are not tolerating the capsule itself. If this is the case, remove the medication from the capsule, place it in another capsule that is tolerable, or take with food. The symptoms that you will experience, as you climb to higher doses, will never be worse than you have experienced from your illness prior to going on Neurontin (Gabapentin). It has been well tolerated even by some of the most chemically sensitive people that have not tolerated any other medication in years.

If you are not sure whether or not you have had a significant head injury to cause Focal Brain Injury, please request a copy of the Organic Evaluator.

For Outpatient Use of Neurontin

The initial cost of seeing the doctor will be $225.00 for an hour visit, if not in Texas. Neurontin (Gabapentin) is an anti-convulsant medication which in most cases insurance companies, as well as Medi-Cal, will pay for. For those who are uninsured, you may qualify for the Parke-Davis Patient Assistance Program (there are several).

After you have started taking your Neurontin (Gabapentin), you will need to have your blood drawn for a blood level test (Gabapentin level), to see how well you are absorbing the medication. The cost of having a blood level test will be approximately $90.00.

You will need to find a lab that is convenient to you and/or one that is a provider for your insurance. Note: If you choose Quest Labs (formerly Damon/Corning/MetWest) our account # is 85565 and we can receive the results over our office printer. You will need to call the doctor's office and tell them the FAX number of the lab you have chosen. We sometimes will need to send a written order for the blood work. You will need to have your blood drawn first thing in the morning before your first medication dose. You may not take your Neurontin (Gabapentin) until after your blood is drawn, however, you may eat prior to having your test as it is not a fasting test. The lab needs to draw only one vile of blood. Take your medication with you so that you can take it as soon as your blood has been drawn. There are no set standards for blood levels, but the average level, when taking a healing dose, is between 8-18. It will take between 5 to 8 days for the doctor to be notified of the results and you may call the office for the staff to give you the results. It is imperative to keep in close contact with the doctor so that you are regulated correctly and effectively.

If you stay up more hours than most people, you may spread your doses to 5-hour intervals. If you wake in the night, you may take more medication. If you do not feel well and feel like you are not on a high enough dose, you may always increase your dose by one 100 mg capsule at a time while you wait for the doctor to return your call. Please keep a record of the extra amount you have taken. It is all right to take your first dose of the day prior to starting your daily activities. Neurontin (Gabapentin) does not have to be taken with food.

When calling the doctor on what dose you should be taking, please give the following information:

1. I take a total of _______ mgs per day in divided doses _________ capsules at a time.

2. I feel more drowsy during the a.m./afternoon/evening or about the same all day.

3. I feel best in a.m./afternoon/evening.

4. State how long you have been on the medication.

If you have had symptoms of being spacey in the past, it is very possible that you will have that same symptom from time to time while on Neurontin (Gabapentin). If so, it is often difficult to remember if you have taken your medication. You may find that it is helpful to set an alarm to remind you to take your medication. Also, it may help to have little cups filled with the correct dosage and marked with the time to take your dose. This will both remind you that it is time to take your medication and will work as well to double check whether or not you have actually taken your medication.

GABAPENTIN (Neurontin) CONSENT FORM

The following information about gabapentin therapy is provided to inform patients, relatives, and their caretakers about a new medication with potential effectiveness, for the treatment of various painful conditions. This is not intended as a broad recommendation for the use of this or any other drug for purposes other than those of original research and production. Gabapentin was initially developed and marketed as an anticonvulsant medication, however, most medications that are approved by the FDA frequently find new uses that were not intended when originally released. All medications, including gabapentin, have adverse effects of allergic responses in some patients and treatment with a medication may not be beneficial to all patients. When new indications are discovered, physicians frequently prescribe the medication for other medical problems. As new uses become apparent, previously unrecognized adverse reactions (early or late) may be identified. The FDA and the pharmaceutical company typically do not recommend alternate uses for any drug other than the use for which it was originally marketed.

Jay W. Seastrunk II, M.D., a Dallas Psychiatrist and Geriatric specialist, first discovered the value of gabapentin therapy when he prescribed the medication for a patient with multiple chemical sensitivities who clinically demonstrated localized brain dysfunction. Subsequently, other patient responses to gabapentin therapy have often been equally encouraging. Gabapentin appears to provide various degrees of symptom relief for these patients as well as relief for agitated behavior in individuals with brain dysfunction and in certain patients with chronic fatigue syndrome. Dr. Seastrunk has also found gabapentin to benefit certain cases of Bipolar Disease, Affective Disorder secondary to brain injury, Personality Disorder secondary to brain injury, A.L.S., Torticollis, fibromyalgia, and various chronic pain syndromes.

Others have found that Neurontin benefits pain problems, which include sympathetic reflex dystrophy, nerve injury pain, phantom limb pain, reflex sympathetic dystrophy, post shingles pain, trigeminal neuralgia, peripheral neuropathy, restless leg syndrome, neck, back and arm pain. Gabapentin shows promise of significantly changing the method of treatment of various pain problems, and it may reduce patient disability and medical costs of treating some pain conditions.

GABAPENTIN IS NOT AN EXPERIMENTAL DRUG!!

It was approved and released by the FDA in February 1994, after $250 million dollars was spent in many years of research. Most of the investigation of gabapentin was for its safety and its efficacy to stop seizures. Recently, Dr. Gary Mellick has utilized this medication clinically and has also discovered its usefulness in pain management. Thus far, gabapentin (Neurontin) appears to be safe and is proving to effectively treat numerous painful conditions.