Parkinson's Disease Tulip


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Old 11-08-2007, 12:31 AM #1
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Default What to expect from too much Sinemet?

What would be the effect of accidentally taking an extra dose of Sinemet? I think I may have taken two pills at noon today. By 3:00 PM, I was so tired I had to leave work to go home and sleep. Was this a possible result of having taken extra Sinemet or was it just the PD asserting itself? I can usually make it through the afternoon. I'm just trying to figure out what happened.

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Old 11-08-2007, 02:17 AM #2
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Default Sinemet........

Too much sinemet does make you want to head for a bed. If my morning dose of 400mg doesn't get me moving satisfactorily, i'll take 200mg more, and that usually puts me to sleep. When i've had a couple of hours sleep i get up and can usuallly walk satisfactorily. What a merry go round it is getting your dose right after so many years on sinemet. cs
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Old 11-08-2007, 10:38 AM #3
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Default Yes, possibly

K.....my pwp has just recently increased her dosage of Sinemet, and she has noticed that she seems to feel more tired since having done so. At first, she didn't make the "sleepiness" connection to the Sinemet...actually thought it was the addition of the Amantadine...but, now, she tends to think it's the result of the increased Sinemet dosage...so, yes...I think it is quite possible in this particular instance with you that it just might have been too much Sinemet...your body not accustomed to that extra amount.

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Old 11-09-2007, 12:16 PM #4
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Default

I've done that too, and boy was I tired. I walked around one day thinking "Did I take the pill, or didn't I?", and apparently I did.

So to avoid that problem, I dole out the pills I'll need during the day and place them in a bottle. This is part of my morning routine, and I do this before I take my first dose.

As I take each pill, I know that I haven't taken too many because there's only a certain number of pills in the bottle at any given time. When the bottle is empty, it's time for bed.

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Old 11-10-2007, 06:16 AM #5
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Lightbulb if you had the pharmacy sheet that comes w/ box

sinemet / generic -is more than likely what you take but I have the document regarding sinemet made by BMS - Bristol Meyers Squibb:



WARNINGS
When SINEMET (Carbidopa-Levodopa) is to be given to patients who are being treated with levodopa, levodopa must be discontinued at least twelve hours before therapy with SINEMET (Carbidopa-Levodopa) is started.
In order to reduce adverse reactions, it is necessary to individualize therapy. See DOSAGE AND ADMINISTRATION section before initiating therapy.

The addition of carbidopa with levodopa in the form of SINEMET reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa. Because carbidopa permits more levodopa to reach the brain and more dopamine to be formed,
certain adverse CNS effects, e.g., dyskinesias
(involuntary movements), may occur at lower dosages and sooner with SINEMET than with levodopa alone.
Levodopa alone, as well as SINEMET, is associated with dyskinesias.
The occurrence of dyskinesias may require dosage reduction.
As with levodopa, SINEMET may cause mental disturbances.
These reactions are thought to be due to increased brain dopamine following administration of levodopa.
All
patients should be observed carefully for the development of depression with
concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution.
SINEMET should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.
As with levodopa, care should be exercised in administering SINEMET to patients with a
history of myocardial infarction who have residual atrial, nodal, or ventricular
arrhythmias. In such patients, cardiac function should be monitored with particular care


during the period of initial dosage adjustment, in a facility with provisions for intensive cardiac care.
As with levodopa, treatment with SINEMET may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.

Neuroleptic Malignant Syndrome (NMS): Sporadic cases of a symptom complex
resembling NMS have been reported in association with dose reductions or withdrawal of therapy with SINEMET.

Therefore, patients should be observed carefully when the
dosage of SINEMET is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.
NMS is an uncommon but life-threatening syndrome characterized by fever or
hyperthermia. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper- or hypotension; laboratory
findings, such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin have been reported.

The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute
illnesses (e.g., pneumonia, systemic infection, etc.) is essential.

This may be especially
complex if the clinical presentation includes both serious medical illness and untreated or
inadequately treated extrapyramidal signs and symptoms (EPS).

Other important
considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.

The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring and 2) treatment of any concomitant serious medical problems for
which specific treatments are available.

Dopamine agonists, such as bromocriptine, and
muscle relaxants, such as dantrolene, are often used in the treatment of NMS, however,
their effectiveness has not been demonstrated in controlled studies.

PRECAUTIONS

General
As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular, and renal function are recommended during extended therapy.
7
Patients with chronic wide-angle glaucoma may be treated cautiously with SINEMET
provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy.

Dopaminergic agents, including levodopa, may be associated with somnolence and very rarely episodes of sudden onset of sleep. In some cases, these episodes may occur without awareness or warning during daily activities.
Patients must be informed of this
and advised to exercise caution while driving or operating machines while being treated with dopaminergic agents, including levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines (see Information for Patients).

Information for Patients
The patient should be informed that SINEMET is an immediate-release formulation of carbidopa-levodopa that is designed to begin release of ingredients within 30 minutes.
It is important that SINEMET be taken at regular intervals according to the schedule outlined by the physician. The patient should be cautioned not to change the prescribed dosage regimen and not to add any additional antiparkinson medications, including other
carbidopa-levodopa preparations, without first consulting the physician.
Patients should be advised that sometimes a ‘wearing-off’ effect may occur at the end of the dosing interval.

The physician should be notified if such response poses a problem to
lifestyle. Patients should be advised that occasionally, dark color (red, brown, or black) may appear in saliva, urine, or sweat after ingestion of SINEMET. Although the color appears to be clinically insignificant, garments may become discolored.
The patient should be advised that a change in diet to foods that are high in protein may delay the absorption of levodopa and may reduce the amount taken up in the circulation.
Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa. Iron salts (such as in multivitamin tablets) may also reduce the amount of levodopa available to the body.
The above factors may reduce the clinical effectiveness
of the levodopa or carbidopa-levodopa therapy.
Patients should be alerted to the possibility of sudden onset of sleep during daily activities, in some cases without awareness or warning signs, when they are taking
8
dopaminergic agents, including levodopa. Patients should be advised to exercise caution while driving or operating machinery and that if they have experienced somnolence
and/or sudden sleep onset, they must refrain from these activities.

(SeePRECAUTIONS: General.)
NOTE: The suggested advice to patients being treated with SINEMET is intended to aid
in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Laboratory Tests
Abnormalities in laboratory tests may include elevations of liver function tests such as
alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, and bilirubin.
Abnormalities in blood urea nitrogen and positive Coombs test have also been reported.
Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during
administration of SINEMET than with levodopa.
SINEMET may cause a false-positive reaction for urinary ketone bodies when a test tape
is used for determination of ketonuria. This reaction will not be altered by boiling the
urine specimen. False-negative tests may result with the use of glucose-oxidase methods
of testing for glucosuria.
Cases of falsely diagnosed pheochromocytoma in patients on carbidopa-levodopa therapy
have been reported very rarely. Caution should be exercised when interpreting the plasma
and urine levels of catecholamines and their metabolites in patients on levodopa or
carbidopa-levodopa therapy.
Drug Interactions
Caution should be exercised when the following drugs are administered concomitantly -(at the same time)
with SINEMET (Carbidopa-Levodopa).

Symptomatic postural hypotension occurred when SINEMET was added to the treatment of a patient receiving antihypertensive drugs.

Therefore, when therapy with SINEMET is
started, dosage adjustment of the antihypertensive drug may be required.
For patients receiving MAO inhibitors (Type A or B), see CONTRAINDICATIONS.
Concomitant therapy with selegiline and carbidopa-levodopa may be associated with
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severe orthostatic hypotension not attributable to carbidopa-levodopa alone (see
CONTRAINDICATIONS).
There have been rare reports of adverse reactions, including hypertension and dyskinesia,
resulting from the concomitant use of tricyclic antidepressants and SINEMET
.
Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone)
and isoniazid may reduce the therapeutic effects of levodopa.

In addition, the beneficial
effects of levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with SINEMET should be carefully observed for loss of therapeutic response.
Iron salts may reduce the bioavailability of levodopa and carbidopa. The clinical relevance is unclear.
Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.

Carcinogenesis, Mutagenesis, Impairment of Fertility
In a two-year bioassay of SINEMET, no evidence of carcinogenicity was found in rats
receiving doses of approximately two times the maximum daily human dose of carbidopa
and four times the maximum daily human dose of levodopa.
In reproduction studies with SINEMET, no effects on fertility were found in rats
receiving doses of approximately two times the maximum daily human dose of carbidopa
and four times the maximum daily human dose of levodopa.
Pregnancy
Pregnancy Category C. No teratogenic effects were observed in a study in mice receiving up to 20 times the maximum recommended human dose of SINEMET.
There was a decrease in the number of live pups delivered by rats receiving approximately two times
the maximum recommended human dose of carbidopa and approximately five times the maximum recommended human dose of levodopa during organogenesis.
SINEMET
caused both visceral and skeletal malformations in rabbits at all doses and ratios of carbidopa/levodopa tested, which ranged from 10 times/5 times the maximum
10
recommended human dose of carbidopa/levodopa to 20 times/10 times the maximum
recommended human dose of carbidopa/levodopa.
There are no adequate or well-controlled studies in pregnant women. It has been reported from individual cases that levodopa crosses the human placental barrier, enters the fetus,
and is metabolized.
Carbidopa concentrations in fetal tissue appeared to be minimal.

Use
of SINEMET in women of childbearing potential requires that the anticipated benefits of the drug be weighed against possible hazards to mother and child.
Nursing Mothers
In a study of one nursing mother with Parkinson’s disease, excretion of levodopa in human breast milk was reported. Therefore, caution should be exercised when SINEMET is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use of the drug in patients below the age of 18 is not recommended.
[RLS patients?]

ADVERSE REACTIONS
The most common adverse reactions reported with SINEMET have included dyskinesias,
such as choreiform, dystonic, and other involuntary movements and nausea.
The following other adverse reactions have been reported with SINEMET:
Body as a Whole: chest pain, asthenia.
Cardiovascular: cardiac irregularities, hypotension, orthostatic effects including
orthostatic hypotension, hypertension, syncope, phlebitis, palpitation.
Gastrointestinal: dark saliva, gastrointestinal bleeding, development of duodenal ulcer,
anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations.
Hematologic: agranulocytosis, hemolytic and non-hemolytic anemia, thrombocytopenia,
leukopenia.
Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schonlein purpura, bullous
lesions (including pemphigus-like reactions).
11
Musculoskeletal: back pain, shoulder pain, muscle cramps.
Nervous System/Psychiatric: psychotic episodes including delusions, hallucinations, and
paranoid ideation, neuroleptic malignant syndrome (see WARNINGS), bradykinetic
episodes ("on-off" phenomenon), confusion, agitation, dizziness, somnolence, dream
abnormalities including nightmares, insomnia, paresthesia, headache, depression with or
without development of suicidal tendencies, dementia, increased libido. Convulsions also
have occurred; however, a causal relationship with SINEMET has not been established.
Respiratory: dyspnea, upper respiratory infection.
Skin: rash, increased sweating, alopecia, dark sweat.
Urogenital: urinary tract infection, urinary frequency, dark urine.
Laboratory Tests: decreased hemoglobin and hematocrit; abnormalities in alkaline
phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, blood urea
nitrogen (BUN), Coombs test; elevated serum glucose; white blood cells, bacteria, and
blood in the urine.


Other adverse reactions that have been reported with levodopa alone and with various
carbidopa-levodopa formulations, and may occur with SINEMET are:
Body as a Whole: abdominal pain and distress, fatigue.
Cardiovascular: myocardial infarction.
Gastrointestinal: gastrointestinal pain, dysphagia, sialorrhea, flatulence, bruxism,
burning sensation of the tongue, heartburn, hiccups.
Metabolic: edema, weight gain, weight loss.
Musculoskeletal: leg pain.
Nervous System/Psychiatric: ataxia, extrapyramidal disorder, falling, anxiety, gait
abnormalities, nervousness, decreased mental acuity, memory impairment, disorientation,
euphoria, blepharospasm (which may be taken as an early sign of excess dosage;
consideration of dosage reduction may be made at this time), trismus, increased tremor,
numbness, muscle twitching, activation of latent Horner's syndrome, peripheral
neuropathy.
12
Respiratory: pharyngeal pain, cough.
Skin: malignant melanoma (see also CONTRAINDICATIONS), flushing.
Special Senses: oculogyric crises, diplopia, blurred vision, dilated pupils.
Urogenital: urinary retention, urinary incontinence, priapism.
Miscellaneous: bizarre breathing patterns, faintness, hoarseness, malaise, hot flashes,
sense of stimulation.
Laboratory Tests: decreased white blood cell count and serum potassium; increased
serum creatinine and uric acid; protein and glucose in urine.
OVERDOSAGE
Management of acute overdosage with SINEMET is the same as management of acute overdosage with levodopa.

Pyridoxine is not effective in reversing the actions of SINEMET.
General supportive measures should be employed, along with immediate gastric lavage.
Intravenous fluids should be administered judiciously and an adequate airway
maintained. Electrocardiographic monitoring should be instituted and the patient
carefully observed for the development of arrhythmias; if required, appropriate
antiarrhythmic therapy should be given. The possibility that the patient may have taken
other drugs as well as SINEMET should be taken into consideration. To date, no
experience has been reported with dialysis; hence, its value in overdosage is not known.
Based on studies in which high doses of levodopa and/or carbidopa were administered, a
significant proportion of rats and mice given single oral doses of levodopa of
approximately 1500-2000 mg/kg are expected to die. A significant proportion of infant
rats of both sexes are expected to die at a dose of 800 mg/kg. A significant proportion of
rats are expected to die after treatment with similar doses of carbidopa. The addition of
carbidopa in a 1:10 ratio with levodopa increases the dose at which a significant
proportion of mice are expected to die to 3360 mg/kg.

DOSAGE AND ADMINISTRATION
The optimum daily dosage of SINEMET must be determined by careful titration in each
patient. SINEMET tablets are available in a 1:4 ratio of carbidopa to levodopa
13
(SINEMET 25-100) as well as 1:10 ratio (SINEMET 25-250 and SINEMET 10-100).
Tablets of the two ratios may be given separately or combined as needed to provide the
optimum dosage.
Studies show that peripheral dopa decarboxylase is saturated by carbidopa at
approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa
are more likely to experience nausea and vomiting.
Usual Initial Dosage
Dosage is best initiated with one tablet of SINEMET 25-100 three times a day. This
dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one
tablet every day or every other day, as necessary, until a dosage of eight tablets of
SINEMET 25-100 a day is reached.
If SINEMET 10-100 is used, dosage may be initiated with one tablet three or four times a
day. However, this will not provide an adequate amount of carbidopa for many patients.
Dosage may be increased by one tablet every day or every other day until a total of eight
tablets (2 tablets q.i.d.) is reached.
How to Transfer Patients from Levodopa
Levodopa must be discontinued at least twelve hours before starting SINEMET
(Carbidopa-Levodopa). A daily dosage of SINEMET should be chosen that will
provide approximately 25% of the previous levodopa dosage. Patients who are taking
less than 1500 mg of levodopa a day should be started on one tablet of SINEMET 25-100
three or four times a day. The suggested starting dosage for most patients taking more
than 1500 mg of levodopa is one tablet of SINEMET 25-250 three or four times a day.
Maintenance
Therapy should be individualized and adjusted according to the desired therapeutic
response. At least 70 to 100 mg of carbidopa per day should be provided. When a greater
proportion of carbidopa is required, one tablet of SINEMET 25-100 may be substituted
for each tablet of SINEMET 10-100. When more levodopa is required, SINEMET 25-250
should be substituted for SINEMET 25-100 or SINEMET 10-100. If necessary, the
dosage of SINEMET 25-250 may be increased by one-half or one tablet every day or
every other day to a maximum of eight tablets a day. Experience with total daily dosages
of carbidopa greater than 200 mg is limited.
14
Because both therapeutic and adverse responses occur more rapidly with SINEMET than
with levodopa alone, patients should be monitored closely during the dose adjustment
period. Specifically, involuntary movements will occur more rapidly with SINEMET
than with levodopa. The occurrence of involuntary movements may require dosage
reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.
Addition of Other Antiparkinsonian Medications
Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase
inhibitor, may be used concomitantly while SINEMET is being administered, although
dosage adjustments may be required.
Interruption of Therapy
Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome
(NMS) have been associated with dose reductions and withdrawal of SINEMET. Patients
should be observed carefully if abrupt reduction or discontinuation of SINEMET is
required, especially if the patient is receiving neuroleptics. (See WARNINGS.)
If general anesthesia is required, SINEMET may be continued as long as the patient is
permitted to take fluids and medication by mouth. If therapy is interrupted temporarily,
the patient should be observed for symptoms resembling NMS, and the usual daily
dosage may be administered as soon as the patient is able to take oral medication.
HOW SUPPLIED
SINEMET 25-100 Tablets are yellow, oval, uncoated tablets, that are scored and coded
“650” on one side and “SINEMET” on the other side. They are supplied as follows:
NDC 0056-0650-68 bottles of 100
SINEMET 10-100 Tablets are dark dapple-blue, oval, uncoated tablets, that are scored
and coded “647” on one side and “SINEMET” on the other side. They are supplied as
follows:
NDC 0056-0647-68 bottles of 100
SINEMET 25-250 Tablets are light dapple-blue, oval, uncoated tablets, that are scored and coded “654” on one side and “SINEMET” on the other side.
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Resolve to be tender with the young, compassionate with the aged, sympathetic with the striving, and tolerant with the weak and the wrong. Sometime in your life you will have been all of these.
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Old 11-10-2007, 09:28 AM #6
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Heart

Karl, I wouldn't worry about one pill too many, we all do this, sometime intentionally to get an extra boost, but in the event you forget and take several here is some info

from Family Health Information.com

Overdose

Too much Sinemet CR may cause muscle twitches, inability to open the eyes [including sleepiness], or other symptoms of levodopa overdosage. After taking Sinemet CR, if you feel that overdose is suspected, then contact with your doctor immediately.

and from InhousePhamacy.com

If you take too much - Overdose

In the case of severe overdose, the treatment is basically the same as with severe overdose with treatment of Levodopa used alone. General first-aid measures should be carried out in addition to immediate gastric lavage. The application of liquid intravenously must be measured and air passages must be kept clear. Adequate electrocardiograph control should be carried out to permit the prompt detection of the development of the arrhythmia. The possibility that the patient may have taken another medication at the same time as Sinemet should be taken into account. As yet, there has been no research carried out regarding dialysis and thus it's possible application in the case of overdose is unknown. Vitamin B6 will not affect the action of Sinemet.
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Old 11-10-2007, 01:12 PM #7
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Default the usual symptom of a Sinemet overdose is.......

dyskinesia, is it not???

CHas
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Old 09-30-2014, 08:01 PM #8
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Crazy Current pd patient

Don't worry about it. I've been on the stuff for 4 years. I take 9 per day
per my prescription. But sometimes I might take 10-11 per day if I have a busy day at work.

I have seen people in this chat room that take 17/day. But this is what they need to stay afloat........

A doctor said he has patients with modrate cases using 15-18 a day
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Old 10-01-2014, 08:18 AM #9
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Default

when l-dopa was first tested they gave people dosages of up to 16GRAMS, that's grams, not milligrams!! that was pre-carbidopa of course and was only available to researchers who could carefully monitor the patients. made people very sick but they had no other drugs to relieve their terrible pd symptoms. that doesn't mean you won't have unpleasant side affects taking a 100mg too soon.

i think the few times i took too much C/L my main side affect was low blood pressure, stood up and fell right back down from vertigo, a little scarey. never have had diskinesias.

when you have some down time you could try 1.5 tabs and see what that does. bigger question is do you have a system to prevent this from happening again?

how are things in pullman? graduated from there a long long time ago. GO COUGS!!
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Old 10-01-2014, 01:08 PM #10
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Default Sinemet dosage

I was on 21 25/100 pills per day in addition to 3 50/200. My paranoia was so bad along with on and off time every hour. I was dx in 2005 although symptoms were visable in 1999. The worse my symptoms got the dosages were increased. I went from normal functioning to off time unable to walk in 5 minutes. Unpredictable to make my life totally unmanageable. Sometimes I was in a wheel chair sometimes not. DBS was my only option. The past 2 months I have only had on time and have not needed the wheel chair. I go to the gym every day for an hour. My stimulator has been adjusted twice and my medication reduced to 14 25/100 and 2 50/200. I have my third programming in 3 weeks. The plan is to reduce my medication again. I have been totally "on" and hope that it lasts. I would recommend DBS to anyone who has problems like mine . There is a book by authors Farris and Giroux a patient guide to DBS
available from Amazon. The surgery was no big deal and all my fears did not happen. It has given me my life back. I hope it lasts . It does not stop progression but the neuro can program as needed.
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