N I M O D I P I N E use in M.E. / CFS
SP - June 2008
"...I believe effective medication can dramatically improve the
health of a person with CFS for the better and change general practioners'
perceptions of the patient as improvements occur. Every one feels more
positive. Something can be done now." Dr. Marilyn McNeill (Ref. 33.)
Please do not take any prescription drug without the express
permission and guidance of a qualified medical doctor.
C O N T E N T S
I.
II.
III.
IV.
V.
VI.
VII.
VIII.
IX.
X.
XI.
XII.
Preface.
Page 1.
Description of the drug nimodipine.
Page 1.
Non-M.E. research and use of nimodipine.
Page 2.
M.E. research applicable to nimodipine.
Page 3.
Clinical advice for use of calcium channel blockers in M.E.
Page 4.
Accounts of persons with M.E. who have used nimodipine.
Page 7.
My use of nimodipine.
Page 8.
My suggestions for use of nimodipine by others.
Page 10.
The prescribing and purchasing of nimodipine.
Page 11.
Table: Personal accounts of nimodipine use in ME.
Page 13.
References.
Page 15.
U. K. Nimotop patient information leaflet, 10 February 2005. Page 19.
I.
PREFACE: I was housebound in the U.K. for many years due to M.E.
but quickly improved such that I could go shopping, be involved in my local
community, and enjoy foreign holidays. This significant improvement in my
functioning is due to my use of nimodipine / Nimotop. I hope that others will
have the opportunity of trying this treatment but, before they do, they and their
doctors may seek more information about the drug. To aid them, this document
is a compilation of my research on nimodipine.
Any feedback to this document by doctors, patients, researchers or other
interested parties from any part of the world is welcome and desired. Please
contact me, the author SP, throught the 25% ME Group, 21 church Street,
Troon, Ayrshire KA10 6HT, U.K. or email enquiry@25megroup.og.
As further case studies are added to this account, perhaps enough interest
will be sparked so that meaningful research into the effects of nimodipine on
M.E. patients will be undertaken, encouraging its wider use.
II.
THE DRUG: Nimodipine is a calcium channel blocker in the
dihydropyridine class. Nimodipine is unique in that it is the only calcium
channel blocker to work primarily on the blood vessels and cerebral artieries in
NIMODIPINE USE IN M.E. / CFS
Page 2
the brain. (Ref. 41.)
Calcium channel blockers affect the way that calcium ions move across
the muscle cell membrane and influence mitochondrial provision of energy to
cells. They relax the blood vessels making it easier for the heart to pump. This
will reduce the workload on the heart, lower blood pressure, treat angina,
increase the blood flow to the brain, repair central neurochemical transmission,
and inhibit the contractions of vascular smooth muscle. (Ref. 1, 14, 42, 47.)
These drugs do not interfere with the way calcium is used to maintain bones.
Bayer's brand name Nimotop tablet which is sold in the U.K. contains 30
mg of the active ingredient nimodipine along with microcrystalline cellulose,
macrogol, hypromellose, maize starch, povidone, crospovidone, magnesium
sterates, titanium dioxide (E171), yellow iron oxide (E172). (Ref. 43.) As far
as I know, a generic nimodipine tablet is not being manufactured anywhere.
Nimodipine has a half-life of 1.1 to 2.0 hours with peak concentrations
attained within 60 to 90 minutes. (Ref. 41, 42.) The benefit is maximized if
taken on an empty stomach. (Ref. 38.) Animal tests show that it is safe at 3
mg/kg of body weight/day. (Ref. 41.) This is equivalent to 150 mg/day for
eight stone/50 kg of body weight.
III. NON-M.E. RESEARCH and USE: Nimodipine is listed in the British
National Formulary only for treatment following bleeding in the brain.
Nimodipine is used to prevent neurological problems by reducing the effects of
spasms which narrow the arteries at the base of the brain. (Ref. 6.) The
suggested use is 60 mg every 4 hours up to 360 mg per day for 21 days. (Ref.
15.) This treatment is normally given to patients in hospital.
Nimodipine is frequently prescribed in 23 countries worldwide, several of
them European, for cognitive impairment and dementia in old age. The
effectiveness of this has been proven in eleven rigorous studies and, in general,
nimodipine was well tolerated, giving few side effects. (Ref. 19, 27.)
Nimodipine "is sometimes prescribed to manage the side effects of
bipolar disorder medications" but this benefit has not been scientifically proven.
Many antipsychotic drugs induce involuntary movements and nimodipine may
relieve these effects. (Ref. 4.)
Researchers in several fields have been interested in nimodipine. Trials
have found that 60 mg of nimodipine improves the monochrome and colour
contrast sensitivity of vision and the ocular blood flow of patients with
glaucoma, (Ref. 5, 28); 50 to 60 mg daily gave improvement to some patients
with tinnitus, (Ref. 12); and was even used to treat intractable hiccups. (Ref.
20.)
A nimodipine dose of 30 to 40 mg every 4 hours has been shown in other
studies to benefit patients with migranes and thunderclap headaches, and is
thought to work by preventing the release of calcium from smooth muscles that
cause vasoconstriction. (Ref. 2, 29.)
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
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In a small study on patients with panic attacks, the decrease in blood flow
of arteries at the base of the skull was successfully treated with nimodipine,
measured by transcranial Doppler ultrasonography. (Ref. 17.)
From the information that I presently have, the longest nimodipine human
trial was for a length of seven years, although this was not continuous usage.
That trial on patients with cluster headaches, using a 120 mg daily dose at the
start of the cluster, reduced headaches in over 50% of the cases and some saw
lasting benefit. The researchers also noted that the "treatment effectiveness
tends to diminish in subsequent bouts". (Ref. 13.) The longest use of a higher
dose that I have seen was of 180 mg daily on a 24 week trial that gave benefit to
patients with dementia. (Ref. 27.)
IV. M.E. RESEARCH: I don't know of any peer-reviewed, published
research studies exploring the use of nimodipine in M.E. There have been
studies of verapamil-SR, a calcium channel blocker that works by a different
method than nimodipine. In one study, Verapamil-SR was given for six months
to twenty-five CFS patients. Immune system improvements were noted, as
were enhanced memory, and reduced fatigue and muscle pain. (Ref. 55, 58).
There is, however, evidence of physical abnomalities to do with blood
flow in persons with M.E. and some studies have improved blood flow. Some
of these are related below, as well as some ongoing research.
"Single Photon Emission Computed Tomography (SPECT) brain scans
have demonstrated significant abnormalities to blood flow in certain parts of the
brain in people with ME/CFS." (Ref. 45, 48, 53.) When using Xenoncomputed tomography (CT) patients had "reduced cortical blood flow in the
distribution of both right and left middle cerebral arteries.... Those devoid of
psychopathology had the most reductions in cortical flow." (Ref. 60.) SPECT
studies give insight into how "the diffuse vascular site of injury rather than a
neurological cellular site of injury explains the natural history of ME-type
illness." (Ref. 22.)
"...An important feature of the disease process in ME/CFS is damage to
blood vessels caused by ... free radicals. These injure the vessels' inner lining
(or endothelium) which is important for controlling blood flow." (Ref. 40.) "It
is proposed that in M.E./CFS the key abnomality is dysfunctional ion channels
in the cell membranes." (Ref. 9.) Problems include spasms of arterial blood
vessels, thus reducing blood flow. (Ref. 21.)
.
In M.E., "the energy supply to every cell in the body [is] impaired. This
includes the heart. Many of the symptoms of M.E. could be explained by heart
failure because the heart muscle cannot work properly. In CFS the heart failure
is caused by poor muscle function [which is called] cardiomyopathy. This
means the function of the heart will be very abnormal, but traditional tests of
heart failure, such as ECG, ECHOs, angiograms, etc. will be normal....
"A test to judge this disability in M.E. patients....called Impedance
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
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Cardiography" has been developed. It "measures cardiac output using
electrical impedence across the chest wall and has found that in M.E. sufferers
the output when standing drops significantly from the output when lying down.
The level when standing is so low that it ... causes borderline organ failure....
This explains why CFS patients feel much better [when] lying down." (Ref. 36,
44.)
In adult M.E. patients it has been shown that the internal cells of the small
blood vessels will quickly relax when they are exposed to the nerve messenger
acetylcholine and this is unusual, as in other diseases the blood vessels would
react in the opposite way. Also found are increased cardiovascular stress
chemical indicators. "We provisionally inferred that CFS/ME might be a
chronic inflammatory disorder" resulting from these irregularities. A similar
study is now being done in children with M.E. (Ref. 23.)
"Many patients...with symptoms of fatigue, dizziness or lightheadedness
on standing, or palpitations have low blood levels of aldosterone,...a hormone
produced by the adrenal gland.... The low aldosterone causes the kidney to lose
salt which leads to low blood volume. Other faults in the autonomic nervous
system and leg veins that don't constrict properly may be involved. (Ref. 16.)
"Endocardiography tests [show] that pulmonary artery pressure (PAP)
does not drop in CFS patients during exercise..." as is necessary to increase
blood flow to the heart. Researchers gave "20 mg. tadalafil (Cialis)* every 3
days to 30 CFS patients for a total of 5 doses.... Symptom reduction occurred in
90% and PAP improved in 84%. Both shortness of breath and fatigue after
exercise improved." (Ref. 50.)
A current study is being undertaken "to determine whether CFS is due to
inadequate blood flow to the brain" and to test 100 mg 3 times a day of
sildenafil (Viagra)* "which may increase blood flow to the brain and improve
the symptoms of CFS." (Ref. 16, 56.)
* Tadalafil and sildenafil are in a class of drugs called phosphodiesterase
inhibitors that also includes vardenafil (Levitra). They increase the amount of
blood inside blood vessels and are prescribed to treat impotence.
V.
CLINICAL ADVICE FOR USE in ME: Calcium channel blockers
work in various ways and, although there have been a few successes with
verapamil-SR and nifedipine, it is generally thought that nimodipine's action on
the brain will give the best result in M.E. Various professional bodies and
doctors are advocates of the use of these drugs, yet others advise caution. I
have tried to state their advice as they would give it.
The Canadian ME/CFS Guidelines suggests the use of nimodipine as it
acts "primarily on the cerebral circulation. Improves mental clarity in some but
not all patients with ME, but may also have a global effect to increase
relaxation, reduce fatigue, decrease tender points, and improve exercise
tolerance. Common side-effects include hypotension, nausea, headache,
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
Page 5
bradycardia, skin rash, and peripheral edema. Start with 30 mg. Check effect
on blood pressure. Gradually increase to 60 mg twice a day as tolerated." (Ref.
8.)
A provider of pharmacy education in the U.S.A. suggests using the
calcium channel blockers nimodipine and verapamil-SR to treat patients with
M.E. and fibromyalgia (FM),an immune system disorder often overlapping with
M.E.. "It is thought that calcium channel blockers may increase the threshold of
chronic pain receptors, thus reducing the number that fire throughout the night
and interfere with sleep and immune function." Patients using nimodipine
report "decreased pain sensitivity, increased energy level, excercise tolerance
and mental clarity. It acts primarily on cerebral arteries, has few side effects....
A verapamil study has shown immune system improvements, enhanced
memory, and reduced fatigue and muscle pain." (Ref. 55.)
The pharmacy educator suggests a dose of nimodipine of 30 mg daily; the
patient should show improvements within four days. Also suggested is
verapamil-SR, 60mg to 120mg at bedtime "to protect against hazards
associated with blood pressure drops and dizziness."
Dr. D. Mason Brown, a retired U.K. doctor, treated M.E. patients with
nimodipine for more than seven years. He has written about his treatment plan
and he spoke to my general practioner in February 2007. "Nimodipine
normalises the blood circulation in the brain and relieves areas of localised
vessel spasm in the brain decreasing the vascular headaches sometimes
associated with CFS/ME.... Restoring the circulation to the brain and to the
pituitary gland relieves the 'brain fog' and allows hormones to reach various
glands in the body.... Patients must drink eight glasses of water each day to
flush out neurotoxins released during the re-stabilisation of the brain" during the
first week or two. He also suggests the use of 400 mg of Ginkgo Biloba per
day to thin the blood, making it easier to flow through the brain.
Dr. Mason Brown feels it is vital to begin at 1/4 tablet per day, or even
just a sliver for those that are severely ill, and gradually increase the dosage
each week up to four tablets per day. When a headache, flushing or rapid
heartbeat is brought on by a new dose, then return to the previous dose for a
week. Try the higher dose again, reducing it if these symptoms are seen.
The symptoms are due to toxins being expelled and are necessary to the
healing. Maintain the maximum tolerated dose until that dose generates sideeffects, then reduce the dosage by 1/4 tablet. Most patients find that after a time
they will stablilize on a low daily amount, such as 1/2 tablet or 15 mg, with
exceptional days of up to 120 mg if extreme activity is anticipated. (Ref. 30.)
Dr. M. McNeill, a doctor in Scotland, was bedbound with M.E. for three
years, having severe postural hypotension and low intracranial blood pressure.
She was treated with nimodipine by Dr. Mason Brown and was so impressed by
her recovery that she has written letters to medical and patient support journals.
I have gained further knowledge through our personal communications.
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NIMODIPINE USE IN M.E. / CFS
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She has described her use of the drug. "On the fourth day...I was feeling
very ill.... On the fifth day...I felt an upswell of energy and had started to feel
much better." Her mental activity improved to such a point that she was able to
return to professional activity. She cautions that it is very easy to do too much
and get a relapse; activity should be increased gradually without a high
expectation. She says that her general practioner "was so impressed that he now
prescribes it for me on the NHS."
Regarding dosage, she relates that "I never took more than one and a
quarter tablets daily (37.5 mg) and the total course was less than two months."
She suggests limiting long-term use to one tablet in the morning, or the lowest
dose that gives the patient's brain a boost, although at some point it should be
tapered down to see if it is still needed. She further suggests "taking
[additional] low doses on an 'as-needed' basis if you anticipate extra effort."
(Ref. 32.)
Dr. R. Wilson is a Consultant Psychiatrist in Haverfordwest, Pembs, U.K.
At the request of a patient with M.E., he has investigated the use of nimodine
and is willing to work with the patient's GP in prescribing the drug, starting at a
low dose and possibly building up to 120 mg per day. (Ref. 59.)
Dr. J. Goldstein, now retired, specialized in the treatment of CFS/ME
patients in California. He used nimodipine as a primary treatment for M.E.
"About 40% of CFS/FM patients taking nimodipine experience relaxation,
increased energy, decrease in tender point sensitivity, improved exercise
tolerance, and enhanced mental clarity.... Nimodipine has been shown to
release dopamine, serotonin, and acetylcholine.... Tolerance does not develop to
the vasodiliatory effects of nimodipine, but sometimes does to its amelioration
of CFS/FM symptoms." He recommends taking 30mg to 60mg 3 times a day.
(Ref. 18.) Dr. C. Shepherd of the M.E. Association has told me that he has met
Dr. Goldstein and was told that some of his patients had stayed on nimodipine
for years.
Dr. J. Sherkey is a family physician in Toronto who follows Dr.
Goldstein's advice in his treatment of CFS and FM patients. He has prescribed
nimodipine in combination with other drugs and has patients that have remained
symptom free for years. (Ref. 49.)
Dr. J. Teitlebaum is widely respected for his treatment of CFS/M.E.
patients in Maryland. He suggests taking 30 mg of nimodipine 1 to 4 times a
day. (Ref. 54.) Dr. S. Silverman is a Clinical Professor of Rheumatology at
UCLS/Cedars Sinai, California. He has found that some patients with FM have
received benefit from nimodipine. (Ref. 51.)
Dr. B. Natelson is a professor in the Department of Neurosciences at the
New Jersey School of Medicine. He prescribes calcium channel blockers,
including verapamil, to treat headache and vascular instability sysmptoms in
patients with CFS. (Ref. 24.) Dr. N. Klimas and Dr. R. Keller specialize in the
treatment and research of CFS/M.E. at the University of Miami School of
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NIMODIPINE USE IN M.E. / CFS
Page 7
Medicine, Florida. They use verapamil (a different calcium channel blocker) to
treat patients. (Ref. 25.) Dr. C. Lapp is a CFS researcher and clinician at the
Hunter-Hopkins Center in Charlotte, North Carolina, U.S.A. He prescribes
calcium channel blockers to relieve symptoms in those with headaches. (Ref.
26.)
Dr. A. B. Adolphe in Albuquerque, New Mexico, U.S.A. had an M.E.
patient to whom he prescribed 10 mg nifedipine three times a day to treat the
patient's "migraine-like presentation with headaches, numbness in [his] hands,
and a complaint of his right arm turning purple. After five days his headache
abated and his family noticed a marked increase in his level of attention, mental
organisation, and memory retention -- and most prominently, no excessive
fatigueability.... On several occasions, the patient has not taken the nifedipine,
and within 72 hours the symptoms have returned. Continuing the medication
seems to prevent the symptoms...." (Ref. 1.)
Dr. Charles Shepherd of the U.K.'s M.E. Association at one time
suggested a patient try the calcium channel blockers verapamil or nimodipine if
muscle pain and mental functioning does not respond to other treatment, but in
our 2008 conversation he emphasized caution due to the drug's lack of safety
trials on M.E. patients. (Ref. 46.)
Dr. A. Chaudhuri, when he was practicing at Southern General Hospital
in Glasgow along with Professor P. Behan, did research on the use of
nimodipine by ME patients. They began with 1/2 tablet (15 mg) per day and
found many cases of hypotension resulting. Despite finding that the drug was
"partially effective in improving myalgia" he said, in conversation with my
general practioner in 2007, that he would not use the drug again on M.E.
patients because of the hypotension concerns. (Ref. 10.)
In addition to the above, I have been told that there is an NHS
haematologist, a professor at a school of medicine, a private rheumatologist, a
private general practitioner, and a few NHS general practioners, all in the U.K.,
who have recently prescribed nimodipine to M.E. patients. Their names are not
in the public domain in this regard and I have not been given the right to publish
any of them.
VI. PERSONAL ACCOUNTS of nimodipine use in ME: Including my
own history, I have heard eleven first-hand and two second-hand accounts of
people who have M.E. and have taken nimodipine. Their nimodipine use is
charted in the table below. Four of them did not receive any benefit. The other
nine all had improved mental clarity or general functioning; half of them
achieved functioning of 50% to 100% of well. (Ref. 34, 39.)
Seven of the thirteen persons had side effects. Only one person had side
effects (or, perhaps, an exacerbation of M.E. symptoms) that continued after
stopping the medication, but only a few weeks had passed at the time of this
research and the symptoms may settle later. Four other people who had side
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NIMODIPINE USE IN M.E. / CFS
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effects lost them when the dose was reduced. Those following Dr. Mason
Brown's protocol use the side effects of flushing, palpitations, or headache as an
indication that they have risen to that dose too soon or, if they have been on that
dose for a while, that a breakthrough has been achieved at that dose and it is
time to reduce it.
Not considered here as side effects were fleeting symptoms during the
transition to a higher dose, usually on the fourth day. At least two of the cases
had nausea and strong smelling urine or sweat during this time. (Complete data
on fourth-day symptoms isn't available from this study.)
Five persons were able to retain the nimodipine benefits after a reduction
in dose, with two of the five able to stop the medication. They had used their
highest dose for nine weeks in one case and three years in the longest case.
Four of them had side effects whereupon they reduced their dose and continued;
one of them didn't have any side effects, just choosing to try a reduction.
Case TFG8 twice reduced her dosage to see if she would retain the
benefits but she did not, so she resumed the previous use.
In one case a person took 30 mg for three years without side effects. In
another case a person took 15 to 30 mg for six years without side effects, having
earlier reduced from 37.5 mg when she had side effects at that level.
This collection of information shows that nimodipine can give benefit to
some people with M.E. but it does not cure the M.E. It is still necessary to use
pacing to fit within the activity level envelope available to that person. The
patient must also bear in mind that his body may be deconditioned despite a
feeling of wellness. The drug itself may give a feeling of elation which could
drive away caution and lead to a relapse, as one person in this study found. It is
best to increase activities very slowly and gently, and to avoid commitments or
new responsibilities for the first year.
As evidence that nimodipine works differently to nifedipine, the person
given identification TFG2 had successfully been taking 60mg of nifedipine once
a day to control Raynaud's Syndrome symptoms. The nifedipine did not relieve
her M.E. When she started taking nimodipine she had to stop taking the
nefedipine. The Raynaud's Syndrome symptoms returned but she gained an
improvement in her M.E. symptoms, and she prefers that outcome.
VII. MY M.E. history and USE: I developed M.E. in 1991. From that time I
was housebound, so fatigued that I was sleeping most of the day and night, and
suffering from a broad range of M.E. symptoms. Medical tests and advice have
pointed me to some treatments that have reduced my symptoms. (Ref. 3, 7, 11,
35, 37, 52).
Magnesium sulphate injections halted my decline; high doses of evening
primrose oil for three months eliminated the twitching and "burning" in my
limbs; undertaking a elimination diet to discover foods to which I was intolerant
and then avoiding them cut out the chills, dizziness, swollen glands, a lot of the
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NIMODIPINE USE IN M.E. / CFS
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brain fog, and the constant heavy fatigue (I subsequently felt bright in the
mornings but needed a nap in the day, and more rest following activity).
DHEA supplements resolved my orthostatic intolerance (brief drop in
blood pressure upon standing) and slightly increased my energy and stamina; a
course of tropisetron / Navoban gave me a boost in functioning (but was
expensive so I didn't repeat it); seven years of dietary advice and supplements,
homeopathic treatments, and enzyme potentiated desentisation (EPD, an allergy
treatment) from the London Homoeopathic Hospital have improved my fitness
and resiliance, and I am continuing those treatments.
Despite the improvements, I was largely housebound, going out
occassionally on foot for short distances or on longer outings in a wheelchair. I
needed a long nap every afternoon and a day or more of rest after an outing. I
had a lot of muscle pain after a morning of light household tasks. I was about
20 to 25% of well.
I have listed these previous therapies to show the degree of improvement
that I had before I used nimodipine. If I had tried it earlier I would not have
evidenced much success as the benefit would have been masked by my food
intolerance symptoms. And, perhaps only at this time were enough of my
body's systems in a state to benefit from the increased blood flow to the brain
and its knock-on effects.
At this point in 2006 I started a trial of nimodipine. I started on 15 mg
(1/2 tablet) and increased the dose by 15 mg every two weeks. Then, at 45 mg
there was a response. On the fourth day I got a sudden rush of foul-smelling
perspiration and felt slightly nauseous.
On the fifth day my M.E. was notably better and the previous day's
symptoms had subsided. I found that I no longer felt sleepy the whole of the
night so stopped sleeping in the afternoon. I did, however, need an hour of rest
in a chair every afternoon. At this dose I couldn't do more outside of the house,
but I was more active inside the house. I was about 30% of well.
After two weeks I increased the dose by 60 mg and again got the coarse
symptoms on the fourth day, and then improved on the fifth day. At this point I
didn't even need the afternoon rest, and I could walk further and go out for a
whole day. My muscle soreness, joint stiffness, chilblains, and brain limitations
were reduced.
As some patients don't need to stay on the drug to maintain the benefits, I
tapered off the drug, but did see a regression. I lost all benefit when I reduced
to a dosage below that which first gave me benefit. I then tapered up to 75 mg.
I never had any side effects from nimodipine, other than the fleeting ones on the
fourth day following a dose increase.
I am continuing to take 75 mg per day split between morning, noon, and
late afternoon. My doctor thinks that due to my otherwise poor quality of life, I
should be allowed to take the unknown risk of using an untested drug, and I
readily accept the risk.
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NIMODIPINE USE IN M.E. / CFS
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Since starting the nimodipine, I am continuously improving in strength
and ability as new activities recondition my mind and body. I am very busy in
the home and can go out most days to do a little shopping, easing the burden of
care felt by my husband. I participate in volunteer and social activities, and I
have enjoyed some long day trips to other parts of the England, and have had a
holiday in Spain and one in the U.S.A.
I still have limits but they were much higher than before. Using a
pedometer to measure my steps, I feel well throughout that day if I have limited
the walking to a total of three miles/4.8 kilometers; anything more is a strain. I
still find repetition a problem, so could not maintain a job; I function better with
changes of activity and short breaks through the day, flexibility to follow an
active day with a more relaxed one, and without expectations and deadlines. I
am 55% of well.
VIII. MY SUGGESTIONS, as a distillation of the above, for the use of
nimodipine by others: If you are taking any heart medication, have epilepsy,
kidney or liver problems, low blood pressure, high blood pressure for which you
take medicine, have ever had bleeding in the brain, or have had a recent heart
attack, then this drug is not advised. For drug interactions, see Bayer's product
monograph. (Ref. 14, 41.) I have spoken to two persons who may have had a
change in the effect of their thyroid medication when they were using
Nimodipine.
Before you try nimodipine, be sure you are avoiding all foods to which
you may have a food intolerance, and have treated any DHEA/adrenal or
thyroid insufficiencies. These are common problems in M.E. and their
symptoms will probably mask any improvement you may receive from
nimodipine.
As this drug might make you feel dizzy, some doctors feel that the first
time you take it should be about an hour before bed. If that didn't cause any
dizziness, then begin taking it regularly in the morning.
Start regular use with 1/4 (or less if you are severely affected) of a 30 mg
tablet in the morning for two weeks, then slowly increase the dosage until no
more improvement is seen. A maximum dosage should be four tablets (120 mg)
a day. When you taper the dose upward, split it so that you can take it two or
three times a day, about every four hours.
Be consistent in the timing of the taking of nimodipine, and whether you
take it with food or on an empty stomach (which means at least one hour before
a meal or at least two hours following a meal.) (Ref. 38, 41.)
Do not take the drug near the time of eating grapefruit or drinking the
juice as it will increase the blood levels of the active ingredient. Talk to your
doctor before using salt substitutes containing potassium. (Ref. 38.)
Possible side-effects of the drug are dizziness after standing up
(orthostatic intolerance), throbbing headache, facial flushing, nausea, sweating,
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NIMODIPINE USE IN M.E. / CFS
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feeling of warmth, pounding in the chest due to a fast or slow heartbeat, red
spots on the skin (you should then test for low platelets), severe constipation or
vomiting. If you get any of these symptoms, tell your doctor and considering
lowering your dose. Later you may want to try the troublesome dose again as
the symptoms may not repeat, and this may be the dose that you will get benefit
from.
You should taper off the drug to see if you need to continue taking it to
maintain the benefit. You may ebb and flow in your response to the drug, and
the dosage may need to be reviewed from time to time. Be aware that the safety
of the long term continuous use of this drug has not been established.
IX. THE PRESCRIBING and purchasing: In the U.K., nimodipine is not
licensed for the treatment of M.E. or CFS. If a doctor prescribes it, it will be an
"off-label" use, and he will probably wish to do so with a "private" prescription.
The doctor may charge a fee for writing a private prescription. After the doctor
has seen that it gives benefit to the patient, the doctor may prescribed it on the
NHS, but this decision is many faceted and should not be expected.
Any chemist can fill a private prescription but may choose not to. Since
nimodipine is not commonly prescribed, a chemist may wish to fill a
prescription only if it will not leave them with a remainder. Nimodipine tablets
come in a box of 100, so it would be helpful if the doctor would write the
prescription for a multiple of 100.
Exemptions from prescription charges and pre-payment certificates do
not apply to private prescriptions, so the patient will have to pay for the drug.
The pharmacy will also charge a dispensing fee; this will be a flat fee so a
prescription for a greater quantity will give a lower cost per tablet.. Prices will
vary, so call a few different pharmacies asking for a quote for the quantity on
your prescription.
The best prices that I have found are from Boots Pharmacy Direct. Call
or email them for a price quote (via www.boots.com/pharmacydirect or 0845121-9040), then post them your prescription written by a U.K. doctor, credit
card details, and the address at which you wish to receive the drug. The
package will have to be taken-in by someone who can sign to certify the receipt.
Allow a week for delivery, but it will probably be quicker.
A private prescription of 30 mg tablets of Nimotop / nimodipine will be
filled for approximately:
Quantity 20
£12
Quantity 100
£46
Quantity 42
£22
Quantity 400
£195
Quantity 56
£26
Quantity 700
£300.
Importing the drug:
You may wonder if it is possible to save money
by getting the drug elsewhere. The short answer is, "No" if you live in the U.K.
If you want the long answer, please read the details below. This may help
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
Page 12
persons who don't live in the U.K. and it may lead to further discoveries. Please
pass on any similar information to me.
Legality of importing drugs: It is legal to import non-controlled
prescription drugs into the U.K. if they are for your own personal use. The
determination of "personal use" largely hinges on two things: 1) the drugs
must be accompanied by a U.K. doctor's prescription which includes the illness
to be treated, and 2) a quantity limited to three months' supply. If mailed, the
contents of the package should be listed on the outside. There is no tax or duty
owed, but they must be sent by Recorded Delivery or a similar service such that
they are signed for when received.
The regulations in the U.S.A. state that it is illegal to import prescription
drugs into the country by any method, even if it is for your own personal use.
However, it is routine for some Americans to cross into Mexico or Canada by
land, buy the medicines that they want and be open about it to the U.S.A.
official when they re-enter the U.S.A. without any problems.
(Visitors to any country should carry in their hand luggage any
prescription drugs that they will need for their stay with the drugs in the
packaging that has the prescription label.)
Is it the same? Switzerland and Mexico also sell a 30 mg nimodpine
tablet made by Bayer. My communications with a Swiss and Mexican
pharmacy lead me to believe that their tablets are probably the same as the one
available in the U.K. The Nimotop sold in the U.S.A. and Canada is a Bayer
variation -- a 30 mg nimodipine capsule with a liquid inside, and includes
peppermint and polyethylene glycol 400 as ingredients.
Prescription requirement. Switzerland and France need a prescription in
order to fill the order, but one from a U.K. doctor is accepted. (Ref. 57).
Mexico does not need a prescription to fill the order, but it is still required by
the U.K. authorities in order to legally import it into the U.K. The U.S.A. and
Canada require a prescription from a U.S. or Canadian doctor. I think the U.K.
requires a prescription written by a U.K. doctor; certainly Boots Pharmacy
Direct has this requirement.
Cost: In early 2008, the price of the drug alone in both Switzerland and
Mexico was roughly the same as it was in the U.K., and postage costs added on
would make it uneconomical. The price of Nimotop in the U.S.A. and Canada
is much higher than the U.K. price.
Purchasing by mail: Switzerland will post filled prescriptions to the U.K.
(Ref. 57). France cannot and I think that the U.K. cannot post to addresses
outside of the country; Boots Pharmacy Direct will not.. Mexican pharmacies
have made a business decision not to send prescriptions by mail because they
are always stolen en route.
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
X.
Page 13
ACCOUNTS OF PERSONS WITH M.E. WHO HAVE USED
NIMODIPINE
June 2007
(Data gathered by direct communication and Ref. 34, 39)
Those who did not gain benefit from using Nimodipine, in order of dosage used:
ID.
M/
F
Maximum Dose
Continuing
Dose
Benefits
Side Effects
TFG6
F
No.
None.
Worsening of existing
vision problems, head
pain and “icy”
sensation in head.
TFG4
F
7.5 mg, for 1 week.
Later, a second trial
of 1.875 mg for 1
week with same
results.
7.5 mg, for 2 months.
No.
None.
Splitting headache.
TFG3
F
90 mg, for 6 months,
not tapered up or
down as have the
others in this study.
No.
None.
None.
TFG1
M
120 mg, for 1 week,
recently finished
tapering down.
No.
None.
Maybe interfered with
thyroid meds.
Flatulence, swollen
glands continuing.
(Continued next page.)
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
Page 14
ACCOUNTS OF PERSONS WITH M.E. WHO HAVE USED
NIMODIPINE (Continued.)
Those who did gain benefit from using Nimodipine, in order of dosage used:
ID.
M/
F
Maximum Dose
Continuing
Dose
Benefits
Side Effects
BMJ1
M
Unknown.
Yes.
Benefit.
Unknown.
MEA2
F
Unknown.
Yes, for at least 1
year.
Improved energy,
mental clarity, to
70%.
None.
TFG7
F
22.5 mg, for 2
months.
7.5 mg, presently,
for 8 months.
Increased
energy, improved
general
functioning.
Palpitations, flushing
when needed to
decrease dose.
TFG5
F
30 mg, for 3 years,
ending 1 ½ years
ago.
No because has
retained the
benefit.
Improved mental
clarity.
None.
AME1
F
37.5 mg, for 3 weeks.
15 to 30 mg,
presently, for 6
years.
Improved general
functioning,
mental clarity,
walk ¼ mile.
Headache when
needed to decreease
dose.
MEA1
F
37.5 mg, for 2
months.
30 mg, or more if
needed for that
day’s activities,
for 3 years.
Improved mental
functioning to
90%.
Facial flushing,
headache when dose
increased but not on
second try.
AME2
M
45 mg, for 9 weeks,
ending 3 years ago.
No, because has
retained the
benefit.
Mental clarity
eliminating brain
fog and sluggishness, to 100%.
Cheeks warm and
tingly with dose
increase but not on
second try.
TFG8
F
75mg with
improvement to 50%
for 3 months.
Improved energy
levels, mental
functioning,
warmth, sleep.
None.
TFG2
F
90 mg, briefly, no
benefit above 45 mg.
45 mg but this has
reduced the
benefit to 30%,
presently, for 5
months.
45 mg, presently,
4for 4 months.
Improved mental
clarity, reduced
headaches,
improved sleep.
None.
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
XI.
Page 15
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17. Gibbs, D.M., "Hyperventilation-induced cerebral ischemia in panic disorder
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1567, seen on National Institutes of Health Pub Med, ncbi.nlm.nih.gov.
18. Goldstein, J.A., Betrayal by the Brain, The Haworth Medical Press, New
York/London, 1996, summarized CFS/ME Society of Victoria, vicnet.net.au/
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
Page 16
~mecfs/general/goldstein_summary.html and vicnet.net.au/~mecfs/general/
goldstein_treatment.html.
19. Grobe-Einsler, R. "Clinical aspects of nimodipine", Clin Neuropharmacol,
1993; 16 Suppl 1:539-45.
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www.nightingale.ca.
22. Hyde, B., speach, AACFS Conference, Madison, Wisconsin, 8 Oct. 2004,
reported by Cort Ronald Johnson, Phoenix Rising,
phoenixcfs.org/The%20SITE/
ConfAACFS04Hyde.htm.
23. Kennedy, G., "An investigation into biochemical and blood flow aspects of
ME/CFS in children", 2008, ME Research UK, meresearch.org.uk.
24. Kenney, K.K., "Treating CFIDS: Still More Art Than Science", table
"Treating the Symptoms of CFIDS: Three Perspectives", The CFIDS
Chronicle, Winter 1994, 24.
25. Klimas, N., Keller, R., CFIDS Foundation, Treatment News,
Winter 1994-5.
26. Lapp, C., Hunter-Hopkins Center, Charlotte, N. Caroline, drlapp.net.
27. Lopez-Arrieta, Birks. J., "Nimodipine for primary degenerative, mixed and
vascular dementia", The Cochrane Database of Systematic Reviews, 1997,
Iss. 3, Art. No.: CD000147, DOI:10.1002/1465 1858. Seen on The Cochrane
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28. Luksch, A. et. al., "Effect of nimodipine on ocular blood flow and colour
contrast sensitivity in patients with normal tension glaucoma", British Journal of
Ophthalmology, Jan. 2005, 89(1): 21-25.
29. Lu, S-R et.al., "Nimodipine for treatment of primary thunderclap
headache", Neurology 2004; 62: 1414-1416.
30. Mason Brown, D., CFS-ME, the website for sufferers of CFS and ME, cfsme.co.uk.
31. Mason Brown, D., Understanding ME and Laying the Foundations for
Getting Better, ME Action Pack 1, 2001.
32. McNeill, M., "Nimodipine: safe and effective for all with ME/CFS?", M.E.
Association's ME Essential, October 2004, page 29.
33. McNeill, M., "Possibility of more rapid recovery from CFS may change
G.P.'s attitudes", published 15 September 2004, Rapid Responses to Raine, R. et.
al.; "General practioners' perceptions of chronic fatigue syndrome and beliefs
about its management", British Medical J., 2004, 328, 1354-1357. Seen on
bmj.com.
34. Moncrieff, E., "Nimodipine overshadowed the effects of Vitamin B12",
letter, ME Association Perspectives, Autumn 2002, page 16.
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
Page 17
35. Mumby, K., Allergies...What Everyone Should Know, Unwin paperbacks,
London,1986.
36. Myhill, S., "CFS is Heart Failure Secondary to Mitochondrial
Malfunction", drmyhill.co.uk.
37. Myhill, S., "Thyroid disease -- how to persuade your GP to diagnose and
treat" and "DHEA -- an important adrenal hormone", drmyhill.co.uk.
38. National Institutes of Health, www.nim.nih.gov:80/medlineplus/druginfo/
medmaster/a689010.html.
39. Neillands, M., "Charmed by the woods?", published 8 Jan. 2002, Rapid
Responses to Eaton, L.; "Chronic fatigue report delayed as row breaks out over
content", BMJ 2002; 324: 7. Seen on bmj.com.
40. Newton, D., "The assessment of peripheral microvascular endothelial
function in ME/CFS", 2008, ME Research UK, meresearch.org.uk.
41. "Nimotop", product monograph, February 27, 1995, revised October 21,
2005, document SNDS-TSAH - Mar97, Bayer Health Care,
www.bayerhealth.com/display.cfm?Object_ID=272&Article_ID=196.
42. "Nimotop (nimodipine) capsules", insert leaflet, Bayer AG, Leverkusen,
Germany, univgraph.com/bayer/inserts/nimotop.pdf.
43. "Patient Information Leaflet for Nimotop 30mg tablets (nimodipine)", as
enclosed in U.K. packaging of Nimotop, Bayer AG, Leverkusen, Germany. A
copy follows as part of this publication.
44. Peckerman, A. et al., "Abnormal Impedance Cardiography (ICG) Predicts
Symptom Severity in CFS", American Journal of the Medical Sciences, August
2003, 326(2), 55-60. Also seen at The M.E. Society of America, cfidscab.org/cfs-inform/Coicfs/peckerman.etal.03.pdf.
45. Schwartz, R.B., et al, "Detection of Intracranial Abnormalities in Patients
with Chronic Fatigue Syndrome -- comparison of M.R. imaging with SPECT.",
American Journal of Roentgenology (1994), 162: 935-941.
46. Shepherd, C., Living with M.E., Vermillion, London, 1999., pg. 50.
47. Shepherd, C., "Medical Matters: Report of the Melvin Ramsay Society",
M.E. Association Perspectives, March 1998, Gawcott, Bucks., U.K., page ix.
48. Shepherd, C., "Nimodipine: safe and effective for all with ME/CFS?", M.E.
Association ME Essential, Gawcott, Bucks., U.K., October 2004, 29.
49. Sherkey, J.A., "Betrayal by the Brain", CFS/ME Society of Victoria,
vicnet.net.au/~mecfs/general/goldstein1.html.
50. Shoemaker, R., Maizel, M., "Treatment of CFS patients with low levels of
vasoactive intestinal polypeptide (VIP) and shortness of breath with tadalafil
improves exercise tolerance and pulmonary artery responses to exercise", poster
at the 8th IACFS Conference, Jan. 2007, as seen on Phoenix Rising, phoenixcfs.org.
51. Silverman, S.L., "Fibromyalgia: A multi disciplinary approach and drugs
for treatment", Sep. 2001, ProHealth, immunesupport.com.
52. Spath, M. et. al., "Treatment of chronic fatigue syndrome with 5-HT3
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
Page 18
receptor antagonists", Scandanavian Journal of Rheumatology, 2000, 29
Suppl 113, 72-7.
53. Spence, V., "Energising Biomedical Research in ME/CFS", lecture, DVD,
MERGE (now ME Research UK), Perth, U.K., 2006.
54. Teitlebaum, J., treatment protocol, endfatigue.com.
55. "Treatment of CFS and FMS", April 2006, W-F Professional Associates,
Inc., Deerfield, Illinois, pharmacy educator in the U.S.A., approved by the
American Council on Pharmaceutical Education, wfprofessional.com.
56. "Use of sildenafil (Viagra) to alter fatigue, functional status and impaired
cerebral blood flow in patients with CFS", on-going studies, U.S. National
Institutes of Health, 2008, clinicaltrails.gov.
57. Victoria Apotheke, Zurich, Mar. 2008, pharmaworld.com.
58. Walton, J., "Diffuse exercise-induced muscle pain of undetermined cause
relieved by verapamil", Lancet, 1981, i, 993.
59. Wilson, R., professional letter to M.B., 4 Jan. 2008, used with permissions.
60. Yoshiuchi, K. et. al., "Patients with chronic fatigue syndrome have reduced
absolute cortical blood flow", Clinical Physiology Functional Imaging, Mar.
2006, 26(2): 83-86.
This paper was written by SP and published June 2008
(first edition 2nd January 2007 with various editions following).
The author asserts her moral rights, including rights of attribution and
rights against distortion and alteration, as given by the Berne Convention.
Please send any feedback or further information to
the author SP through the 25% ME Group
21 Church Street, Troon, Ayrshire, KA10 6HT, U.K.
or email enquiry@25megroup.org
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
Page 19
CD/NIMOSPNJA
PATIENT INFORMATIO~J LEAFLET
NIMOTOP@ 30mg TABLETS
(nimcdipine)
PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING NIMOTOP 30mg TABLETS
.'
Nimotop 30mg Tablets are yellow.round, film-ccated tablets with marked SK cn one side and with the Bayer logo
on the reverse. Each film-coated tablet contains 30mg nimodipine as the active ingredient.
Nimotop 30mg Tablets also contain microcrystalline cellulose, macrogol, hypromellose, maize starch, povidone, crospovidone, magnesium
stearate, titanium dioxide (E171) and yellow iron oxide (E172).
The tablets come in boxes of 20, 30 and 10O, but your doctor will prescribe as many as you need.
Nimotop 30mg Tablets are one of a group of medicines called calcium antagonists. They are used for the treatment of neurological deficits
(change in brain function) following a subarachnoid haemorrhage, a form of bleeding inside the head.
The manufacturer is Bayer AG, Leverkusen, Germany. Procured from within the EU and repackaged in the UK on behalf of the Parallel Import
Product Licence holder: CD Pharma Ltd, Unit 3, Manor Point, Manor Way, Borehamwood, Herts WD6 1 EE.
Nimotop 30mg Tablets PL No. 20492/0067
Why have I been prescribed Nimotop 30mg Tablets?
Nimotop 30mg Tablets have been prescribed by your doctor as you have suffered from a subarachnoid haemorrhage. This is
the medical term for bleeding inside the head. Nimotop 30mg Tablets help to prevent brain damage that may result from the
bleeding.
When should I not take Nimotop 30mg Tablets?
You should not be treated with Nimotop 30mg Tablets if you have suffered from a head injury resulting in a traumatic subarachnoid
haemorrhage.
Do not take Nimotop 30mg Tablets if you are still receiving Nimodipine solution through a drip. The
tablets have been prescribed as a convenient way to continue your treatment.
Do not take Nimotop 30mg Tablets during or within one month of a heart attack.
If you suffer from angina and notice an increase in the frequency and severity of attacks, do not take Nimotop 30mg Tablets and consult your
doctor.
.
.
What special precautions should I take?
Nimotop 30mg Tablets should be used with care if you are suffering from an accumulation of fluid in the brain or severely raised pressure in
your skull. Your doctor will be able to advise you about this.
Tell yourdoctor:
. If you are taking tablets for high blood pressure such as nifedipine, diltiazem, verapamil, alphamethyldopa or beta-blockers, as Nimotop 30mg
Tablets may increase the effect of these medicines.
If you have liver disease, you will probably need to have your blood pressure measured regularly. Consult your doctor about this.
The effects of your tablets may be reduced if you are taking the antibiotic, rifampicin or drugs for epilepsy (fits) such as phencbarbitone, phenytoin
or carbamazepine.
The effect of Nimotop 30mg tablets may be increased if you are taking an anti-ulcer drug called cimetidine or an anti-epileptic (anti-fit) drug
called scdium valprcate.
If ycu are currently taking any antidepressants or haloperidcl inform yeur dector before starting your
tablets. If yeu are 'currently taking the anti-H IV drug zidovudine (.AZT), inform your doctor before starting your tablets.
The effect of the following drugs on Nimotop30mg Tablets is unknown. inform your doctor if you are ta!{ing:
The antibiotics eriihromycin, ketoconazcle, itraconazole or fiuconazole; The HIV protease inhibitors indinavir, ritonavir, ne!finavir or saquinavir.
If you are taking any of the above drugs, remind your doctor before taking Nimotop 30mg Tablets.
Nimotop 30mg Tablets should not be taken at the same time as grapefruit juice, or near the time of eating
. grapefruit. This is because grapefruit juice is known to increase the blood !evels of the active ingredient,
nimodipine.
If you are pregnant or are planning a family, tell your doctor before taking Nimotop 30mg Tablets. If you have already informed your doctor, follow
his/her instructions carefully.
Nimotop 30mg Tablets may make you feel dizzy; if you are affected you should not drive or operate machinery.
.<
When and how do I take Nimotop 30mg Tablets?
Take the tablets as prescribed by your doctor. Usually this will be two tablets every four hours to be swallowed whole with water. This gives a total
daily dose of 12 tablets (360mg). Treatment should be continued for as long as it is prescribed by your doctor. This may be for up to a maximum
of 21 days.
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)
NIMODIPINE USE IN M.E. / CFS
Page 20
DO NOT EXCEED THE PRESCRIBED DOSE
If you take more than the prescribed dose, or in the event of an overdose, seek medical advice immediately
and, if possible, take your tablets with you.
What should I do if I forgetto take my Nimotop 30mgTablets?
Take your normal dose immediately and the remaining days' tablets at four-hourly intervals.
What undesirable effects may I experience?
A number of side- effects are known for this drug. You may experience dizziness due to low blood pressure, pounding in the chest due to fast or
slow heartbeat, flushing, headache, gut disorders, feeling sick (nausea), sweating and a feeling of warmth. If you experience any of these sideeffects, contact your doctor.
While taking Nimotop 30mg Tablets you may experience abdominal pain with constipation. Very rarely, you may find that you bruise
more easily as seen by the appearance of small purple/red spots on the skin or nail bed. If you
have any of these symptoms, contact your doctor immediately.
IF YOU EXPERIENCE ANY OTHER UNDESIRABLE EFFECTS, TELL YOUR DOCTOR IMMEDIATELY.
How should I store my Nimotop 30mg tablets? Do not store above 30°C.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Do not use the tablet after the expiry date which is marked on both the outer carton and on each blister strip of tablets.
If you find that you have tablets after their expirj date, return them to your local pharmacist (chemist) who will dispose of them properly.
REMEMBER:
This medicine has been prescribed for you. Do not give it to anyone else under any circumstances. If you have any doubts about taking Nimotop 30mg Tablets
correctly, seek the advice of your doctor or pharmacist.
Date of preparation: 10 February 2005
CD/NIi'vl0SPNiA
(Author SP. Moral rights asserted. Contact the author through the 25% ME Group. June 2008.)