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Merck gives aspartame (methanol, formaldehyde) to babies in Singulair



 
 
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Old October 27th 03, 04:17 AM
Rich Murray
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair

http://groups.yahoo.com/group/aspartameNM/message/1031
Merck gives aspartame (methanol, formaldehyde) to babies in Singulair
asthma medicine: Murray 10.26.3 rmforall

"SINGULAIR chewable tablets contain aspartame, a source of
phenylalanine.
Phenylketonurics: SINGULAIR 4-mg and 5-mg chewable tablets contain 0.674
and 0.842 mg phenylalanine, respectively."

[Notes by Rich Murray: This means 1.35 and 1.68 mg aspartame
respectively, which, if chewed in the mouth, is largely absorbed
directly there (buccal absorption), increasing the potency of the dose.

For 4 mg doses, the methanol dose is 11% of the 1.35 mg aspartame,
giving 0.15 mg methanol, of which as much as 30% may remain in body
tissues as cumulative toxic products of formaldehyde and formic acid:
0.05 mg-- which is about 8% of the allowable formaldehyde dose that
would result from 30% retention of the 2 mg EPA limit for formaldehyde
in 2 liters daily drinking water for 60 kg adults, 0.6 mg retained
formaldehyde, 0.01 mg retained formaldehyde per kg adult body weight.

The 37 mg likely daily formaldehyde retention from 2 liters diet soda,
5.6 12 oz. cans, for 60 kg adults gives 0.62 mg retained formaldehyde
per kg adult body weight, SIXTY times the EPA allowable level. Most
reports by adult aspartame reactors describe daily use higher than this
level of about 6 cans for years.

HOWEVER: "One packet of 4-mg oral granules for children 12 to 23 months
of age." means, since most 1-year olds weigh about 22 lbs, 10 kg, they
will be getting 1.35 mg aspartame, 0.15 mg methanol, with .045 retained
formaldehyde and 0.0045 mg per kg body weight. This is about half of
the retained formaldehyde level allowed by the EPA from drinking water
of 0.01 mg per kg body weight.

It is reasonable to guess that a baby would be far more vulnerable to
this complex cumulative toxicity than adults, especially a small, thin
baby with asthmatic symptoms, for whom the 4-mg oral granules would be
an even larger dose per kg.

Recent reports give cases of reaction to very small single doses of
aspartame.

http://groups.yahoo.com/group/aspartameNM/message/846
aspartame in Merck Maxalt-MLT worsens migraine:
AstraZeneca Zomig, Eli Lilly Zyprexa,
J&J Merck Pepcid AC (Famotidine 10mg) Chewable Tab,
Pfizer Cool Mint Listerine Pocketpaks 7.16.2 Murray rmforall
Migraine MLT-Down: an unusual presentation of migraine
in patients with aspartame-triggered headaches.
Newman LC, Lipton RB Headache 2001 Oct; 41(9): 899-901.
[Merck 10-mg Maxalt-MLT, for migraine, has 3.75 mg aspartame,
while 12 oz diet soda has 200 mg.]
Headache Institute, St. Lukes-Roosevelt Hospital Center, New York, NY
Department of Neurology
Albert Einstein College of Medicine, Bronx, NY
Innovative Medical Research


http://groups.yahoo.com/group/aspartameNM/message/855
RTM: Blumenthall & Vance:
aspartame chewing gum headaches Nov 1997 7.28.2 rmforall
Harvey J. Blumenthal, MD, Dwight A Vance, RPh
Chewing Gum Headaches.
Headache 1997 Nov-Dec; 37(10): 665-6.
Department of Neurology, University of Oklahoma College of Medicine,
Tulsa, USA.
Aspartame, a popular dietetic sweetener, may provoke headache in some
susceptible individuals. Herein, we describe three cases of young women
with migraine who reported their headaches could be provoked by chewing
gum sweetened with aspartame. [6-8 mg aspartame per stick chewing gum]

H.J. Roberts cites many cases of reactions to very low doses of
aspartame, especially from absorption in the mouth.

http://www.dorway.com/tldaddic.html 5-page review
Roberts HJ Aspartame (NutraSweet) addiction.
Townsend Letter 2000 Jan;
http://www.sunsentpress.com/
Sunshine Sentinel Press P.O.Box 17799 West Palm Beach, FL 33416
800-814-9800 561-588-7628 561-547-8008 fax

http://groups.yahoo.com/group/aspartameNM/message/669
1038-page medical text "Aspartame Disease: An Ignored Epidemic"
published May 30 2001 $ 60.00 postpaid data from 1200 cases
available at http://www.amazon.com
over 600 references from standard medical research

I spent about nine hours scanning "Asparame Disease" for cases of small
doses of aspartame in breath mints [1.5 mg aspartame per mint], pills
[about 4 mg per pill], and chewing gum [6-8 mg aspartame per stick],
since if there are a variety of symptoms to such small doses, then it
is a foregone conclusion that much more serious reactions must exist to
diet drinks [180-330 mg aspartame per 12 oz]. Many cases describe
people who had become reactors to large doses of aspartame, who then
find severe and immediate reactions to a stick or less of chewing gum.

[Excerpts, pp 79-85]
D. REACTIONS TO SMALL QUANTITIES
Some reactors evidenced severe symptoms and signs after ingesting or
chewing small amounts of aspartame products.
* Mention was made of convulsions occurring in a nursing infant as its
mother drank an aspartame soft drink.
* Children developed severe headache, convulsions, or both, within
minutes after chewing either acetaminophen (given for fever) or gum
containing aspartame...
* Case III-1, a 31-year-old nurse with an aspartame-induced seizure,
subsequently drank "only three sips" of a drink believed to be
"regular" soda, but which contained aspartame. She promptly
became "very incoherent." [case described on pages 113-115]
* A chemist who developed migraine from certain foods and additives
performed six double-blind experiments on himself. He found that as
little as 4.0 mg aspartame in a capsule predictably induced headache
(Strong 2000)....
[ http://groups.yahoo.com/group/aspartameNM/message/285
Strong FC Why do some dietary migraine patients claim
they get headaches from placebos?
Clin Exp Allergy 2000 May; 30(5): 739-43.]

The precipitation of severe neurological and other reactions within
minutes or a few hours after ingesting aspartame (see below) casts
doubts on the assertion by the FDA: "The agency does not regard the
possible consumption of aspartame in a single large dose as posing any
safety problem whatever."
(Federal Register February 22, 1984, p. 6678)...

E. ASPARTAME GUM
I have been impressed by the role of aspartame gum in patients
suffering severe neurologic aspartame reactions, especially headache
and seizures (see below).
* A 24-year-old woman stated that she was "on the very verge of dying"
from aspartame disease. Dramatic improvement occurred when she learned
about this disorder, and then stopped such products. She emphasized
her marked sensitivity to even a single stick of aspartame gum.
Symptoms would recur within minutes after chewing it, and lasted one
week. [6-8 mg aspartame per stick of chewing gum]
* Aspartame gum was specifically incriminated by Case IX-C-16, a
35-year-old woman with shortness of breath, dizziness, irritability,
fatigue, heavy menstrual bleeding, hair loss and weight gain. (She did
not drink diet sodas.) These reactions-- "within the hour I could not
catch my breath"-- reoccurred on multiple retests.

Few realize the enormity of gum consumption. It is estimated that
Americans chew $2.5 billion worth of gum annually, the equivalent of
190 sticks per person. Some aspartame reactors chewed 15-20 sticks or
more daily, in addition to using other aspartame products (see Case
II-4). [20 sticks would be as much as 160 mg aspartame, almost as much
as
12 oz diet drink]

Owing to its prolonged sweetness, persons tend to chew aspartame
as much as five time longer than regular gum....

The habitual sucking of popular mints containing aspartame may induce
seizures and other neuropsychiatric disorders. An aspartame reactor
with prior complaints (vision impairment; slurred speech; loss of
muscle strength) remained symptom-free after avoiding aspartame.
She then experienced "painfully dry eyes" immediately after taking
a breath mint containing aspartame...[1.5 mg aspartame per mint]

Absorption
Chewing gum exposes the body to aspartame thorough its absorption
in the upper gastrointestinal tract, and from the lining of the mouth.
Additional ingredients could pose added problems. For example, I have
repeatedly encountered difficulty with peppermint gum and wafers
(Roberts 1983). [see case on page 456]

The rapidity with which reactions can occur after chewing aspartame gum
is not necessarily an "allergy". The prompt absorption of aspartame or
its breakdown products (Chapter XXV) from the mouth is akin to placing
nitroglycerine under the tongue for the rapid relief of angina pectoris.

Pharmacologists recognize that absorption through the oral mucosa
(without swallowing) can be an efficient route of delivery for amino
acids and small proteins because the basal lamina under the epithelial
layer contains blood vessels. Moreover, the enzymatic activity of the
oral cavity is relatively low (principally, an amylase that hydrolyzes
only sugars.).

* The blood flow in the buccal mucosa is comparable to that of the
sublingual mucosa. Absorbed molecules are collected by the internal
jugular veins, thereby directly reaching the circulating blood.

* The buccal route for drug administration is illustrated by its
effectiveness in treating childhood seizures with midazolam (Scott
1999). The rich blood supply to the mouth enables absorption directly
into the systemic circulation, thereby avoiding the considerable
"first-pass" metabolism by the liver. A rapid effect on the central
nervous system has been demonstrated electroencephalographically.

Another possible mechanism involves the transport of aspartame from the
back of the mouth (oropharynx) directly to the brain. This phenomenon
has been documented for small molecules such as glucose,
sodium chloride and ethyl alcohol (Editorial, British Medical Journal,
1: 184, 1966; Maller 1967). [End of quotes from "Aspartame Disease: An
Ignored Epidemic"]

Virtually all the side effects mentioned by Merck are well known
features in hundreds of reports by aspartame reactors. It is necessary
to carefully examine and test individuals to determine if aspartame is
one causal agent.

It is possible that no long-term studies have been done on 1 year olds--
yet this risky dose level is blindly recommended by Merck-- as usual,
hiding behind the skirts of the FDA's extremely corrupt, irregular
approval of aspartame in July, 1981, against the vote of its own
scientific Board of Inquiry.

http://groups.yahoo.com/group/aspartameNM/message/857
RTM: www.dorway.com: original documents and long reviews of flaws in
aspartame toxicity research 7.31.2 rmforall

http://www.dorway.com/upipart1.txt
http://groups.yahoo.com/group/aspartameNM/message/262
aspartame expose 96K Oct 1987 Part 1/3: Gregory Gordon, UPI reporter:
Murray 7.10.0 rmforall

http://www.dorway.com/enclosur.html
http://groups.yahoo.com/group/aspartameNM/message/53
aspartame history Part 1/4 1964-1976: Gold: Murray 11.6.9: rmforall

http://groups.yahoo.com/group/aspartameNM/message/927
Rumsfeld, 1977 head of Searle Corp., got aspartame FDA approval:
Turner: Murray 12.23.2 rmforall

http://groups.yahoo.com/group/aspartameNM/message/928
revolving door, Monsanto, FDA, EPA: NGIN: Murray 12.23.2 rmforall
************************************************** ***********************

http://www.merck.com/

Merck & Co., Inc. One Merck Drive P.O. Box 100

Whitehouse Station, NJ 08889-0100 USA Phone: 908-423-1000
Monday-Friday 8:30 AM - 5:30 PM ET

http://www.singulair.com/singulair/s...nglish/ppi.pdf

1 of 4

Patient Information
SINGULAIR® (SING-u-lair) Tablets, Chewable Tablets, and Oral Granules
Generic name: montelukast (mon-te-LOO-kast) sodium

Read this information before you start taking SINGULAIR®. Also, read the
leaflet you get each time you refill SINGULAIR, since there may be new
information in the leaflet since the last time you saw it. This leaflet
does not take the place of talking with your doctor about your medical
condition and/or your treatment.

What is SINGULAIR*?

.. SINGULAIR is a medicine called a leukotriene receptor antagonist. It
works by blocking substances in the body called leukotrienes. Blocking
leukotrienes improves asthma and seasonal allergic rhinitis (also known
as hay fever). SINGULAIR is not a steroid.

SINGULAIR is prescribed for the treatment of asthma and seasonal
allergic rhinitis:

1. Asthma.
SINGULAIR should be used for the long-term management of asthma in
adults and children ages 12 months and older.
Do not take SINGULAIR for the immediate relief of an asthma attack. If
you get an asthma attack, you should follow the instructions your doctor
gave you for treating asthma attacks. (See the end of this leaflet for
more information about asthma.)

2. Seasonal Allergic Rhinitis.
SINGULAIR is used to help control the symptoms of seasonal allergic
rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) in
adults and children ages 2 years and older. (See the end of this leaflet
for more information about seasonal allergic rhinitis.)

Who should not take SINGULAIR?
Do not take SINGULAIR if you are allergic to SINGULAIR or any of its
ingredients.
The active ingredient in SINGULAIR is montelukast sodium.
See the end of this leaflet for a list of all the ingredients in
SINGULAIR.

What should I tell my doctor before I start taking SINGULAIR?
Tell your doctor about:

.. Pregnancy: If you are pregnant or plan to become pregnant, SINGULAIR
may not be right for you.

.. Breast-feeding: If you are breast-feeding, SINGULAIR may be passed in
your milk to your baby. You should consult your doctor before taking
SINGULAIR if you are breast-feeding or intend to breast-feed.

.. Medical Problems or Allergies: Talk about any medical problems or
allergies you have now or had in the past.

.. Other Medicines: Tell your doctor about all the medicines you take,
including prescription and non-prescription medicines, and herbal
supplements. Some medicines may affect how SINGULAIR works, or SINGULAIR
may affect how your other medicines work.

* Registered trademark of MERCK & CO., Inc.
COPYRIGHT © MERCK & CO., Inc., 1998, 2001, 2002 All rights reserved

9094216 2 of 4

How should I take SINGULAIR?

For adults and children 12 months of age and older with asthma:
.. Take SINGULAIR once a day in the evening.
.. Take SINGULAIR every day for as long as your doctor prescribes it,
even if you have no asthma symptoms.
.. You may take SINGULAIR with food or without food.
.. If your asthma symptoms get worse, or if you need to increase the use
of your inhaled rescue medicine for asthma attacks, call your doctor
right away.
.. Do not take SINGULAIR for the immediate relief of an asthma attack. If
you get an asthma attack, you should follow the instructions your doctor
gave you for treating asthma attacks.
.. Always have your inhaled rescue medicine for asthma attacks with you.
.. Do not stop taking or lower the dose of your other asthma medicines
unless your doctor tells you to.
.. If your doctor has prescribed a medicine for you to use before
exercise, keep using that medicine unless your doctor tells you not to.

For adults and children 2 years of age and older with seasonal allergic
rhinitis:
.. Take SINGULAIR once a day, at about the same time each day.
.. Take SINGULAIR every day for as long as your doctor prescribes it.
.. You may take SINGULAIR with food or without food.

How should I give SINGULAIR oral granules to my child?
Do not open the packet until ready to use.
SINGULAIR 4-mg oral granules can be given either:
.. directly in the mouth;
OR . mixed with a spoonful of one of the following soft foods at cold or
room temperatu applesauce, mashed carrots, rice, or ice cream. Be
sure that the entire dose is mixed with the food and that the child is
given the entire spoonful of the mixture right away (within 15 minutes).
IMPORTANT: Never store any oral granule/food mixture for use at a later
time. Throw away any unused portion.
Do not put SINGULAIR oral granules in liquid drink. However, your child
may drink liquids after swallowing the SINGULAIR oral granules.

What is the daily dose of SINGULAIR for asthma or seasonal allergic
rhinitis?
For Asthma (Take in the evening):
.. One 10-mg tablet for adults and adolescents 15 years of age and older,
.. One 5-mg chewable tablet for children 6 to 14 years of age,
.. One 4-mg chewable tablet or one packet of 4-mg oral granules for
children 2 to 5 years of age, or
.. One packet of 4-mg oral granules for children 12 to 23 months of age.

For Seasonal Allergic Rhinitis (Take at about the same time each day):
.. One 10-mg tablet for adults and adolescents 15 years of age and older,

9094216 3 of 4

.. One 5-mg chewable tablet for children 6 to 14 years of age, or
.. One 4-mg chewable tablet or one packet of 4-mg oral granules for
children 2 to 5 years of age.

What should I avoid while taking SINGULAIR?
If you have asthma and if your asthma is made worse by aspirin, continue
to avoid aspirin or other medicines called non-steroidal
anti-inflammatory drugs while taking SINGULAIR.

What are the possible side effects of SINGULAIR?
The side effects of SINGULAIR are usually mild, and generally did not
cause patients to stop taking their medicine. The side effects in
patients treated with SINGULAIR were similar in type and frequency to
side effects in patients who were given a placebo (a pill containing no
medicine).

The most common side effects with SINGULAIR include:
.. stomach pain
.. stomach or intestinal upset
.. heartburn
.. tiredness
.. fever
.. stuffy nose
.. cough
.. flu
.. upper respiratory infection
.. dizziness
.. headache
.. rash

Less common side effects that have happened with SINGULAIR include
(listed alphabetically):
agitation including aggressive behavior, allergic reactions (including
swelling of the face, lips, tongue, and/or throat, which may cause
trouble breathing or swallowing), hives, and itching, bad/vivid dreams,
increased bleeding tendency, bruising, diarrhea, hallucinations (seeing
things that are not there), hepatitis, indigestion, inflammation of the
pancreas, irritability, joint pain, muscle aches and muscle cramps,
nausea, palpitations, pins and needles/numbness, restlessness, seizures
(convulsions or
fits), swelling, trouble sleeping, and vomiting.

Rarely, asthmatic patients taking SINGULAIR have experienced a condition
that includes certain symptoms that do not go away or that get worse.
These occur usually, but not always, in patients who were taking steroid
pills by mouth for asthma and those steroids were being slowly lowered
or stopped.
Although SINGULAIR has not been shown to cause this condition, you must
tell your doctor right away if you get one or more of these symptoms:
.. a feeling of pins and needles or numbness of arms or legs
.. a flu-like illness
.. rash
.. severe inflammation (pain and swelling) of the sinuses (sinusitis)

These are not all the possible side effects of SINGULAIR. For more
information ask your doctor or pharmacist.

Talk to your doctor if you think you have side effects from taking
SINGULAIR.

General Information about the safe and effective use of SINGULAIR
Medicines are sometimes prescribed for conditions that are not mentioned
in patient information leaflets.
Do not use SINGULAIR for a condition for which it was not prescribed. Do
not give SINGULAIR to other people even if they have the same symptoms
you have. It may harm them. Keep SINGULAIR and all medicines out of the
reach of children.

9094216 4 of 4

Store SINGULAIR at 25°C (77°F). Protect from moisture and light. Store
in original package.

This leaflet summarizes information about SINGULAIR. If you would like
more information, talk to your doctor. You can ask your pharmacist or
doctor for information about SINGULAIR that is written for health
professionals.

What are the ingredients in SINGULAIR?
Active ingredient: montelukast sodium
SINGULAIR chewable tablets contain aspartame, a source of phenylalanine.
Phenylketonurics: SINGULAIR 4-mg and 5-mg chewable tablets contain 0.674
and 0.842 mg phenylalanine, respectively.

Inactive ingredients:
.. 4-mg oral granules: mannitol, hydroxypropyl cellulose, and magnesium
stearate.
.. 4-mg and 5-mg chewable tablets: mannitol, microcrystalline cellulose,
hydroxypropyl cellulose, red ferric oxide, croscarmellose sodium, cherry
flavor, aspartame, and magnesium stearate.
.. 10-mg tablet: microcrystalline cellulose, lactose monohydrate,
croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate,
hydroxypropyl methylcellulose, titanium dioxide, red ferric oxide,
yellow ferric oxide, and carnauba wax.

What is asthma?
Asthma is a continuing (chronic) inflammation of the bronchial
passageways which are the tubes that carry air from outside the body to
the lungs.
Symptoms of asthma include:
.. coughing
.. wheezing
.. chest tightness
.. shortness of breath

What is seasonal allergic rhinitis?
.. Seasonal allergic rhinitis, also known as hay fever, is an allergic
response caused by pollens from trees, grasses and weeds.
.. Symptoms of seasonal allergic rhinitis may include:
.. stuffy, runny, and/or itchy nose
.. sneezing

Rx only Issued May 2003

MERCK & CO., INC. Whitehouse Station, NJ 08889, USA
************************************************** ***********************

aspartame (methanol, formaldehyde) toxicity: Murray 10.26.3 rmforall,
plain text

Rich Murray, MA Room For All
1943 Otowi Road, Santa Fe, New Mexico 87505 USA 505-986-9103

http://groups.yahoo.com/group/aspartameNM/message/1026
brief aspartame review: formaldehyde toxicity: Murray 9.11.3 rmforall

http://google.com gives 221,000 websites for "aspartame" , with the top
9 of 10 listings being anti-aspartame, while
http://groups.google.com finds on 700 MB of posts from 20 years of
Usenet groups, 83,800 posts, the top 10 being anti-aspartame.
http://news.google.com 28 recent aspartame items from 4500 sources.
http://www.AllTheWeb.com gives 291,700, the top 7 of 10 being
leading and very well informed volunteer anti-aspartame sites.
http://teoma.com/index.asp gives 85,700 websites, top 8 of 10 anti.
http://www.ncbi.nlm.nih.gov/PubMed lists 742 aspartame items.

http://groups.yahoo.com/group/aspartameNM/message/989
EU votes 440 to 20 to approve sucralose, limit cyclamates & reevaluate
aspartame & stevia: Murray 4.12.3 rmforall

http://groups.yahoo.com/group/aspartameNM/message/1025
aspartame & formaldehyde toxicity: Murray 9.9.3 rmforall

http://groups.yahoo.com/group/aspartameNM/messages
for 1031 posts in a public searchable archive

http://groups.yahoo.com/group/aspartame/messages 730 members

http://groups.yahoo.com/group/aspartameNM/message/1024
aspartame review: methanol, formaldehyde, formic acid toxicity:
Murray 9.5.3 rmforall

http://groups.yahoo.com/group/aspartameNM/message/910
formaldehyde & formic acid from methanol in aspartame:
Murray: 12.9.2 rmforall

It is certain that high levels of aspartame use, above 2 liters daily
for months and years, must lead to chronic formaldehyde-formic acid
toxicity, since 11% of aspartame (1,120 mg in 2L diet soda, 5.6 12-oz
cans) is 123 mg methanol (wood alcohol), immediately released into the
body after drinking (unlike the large levels of methanol locked up in
molecules inside many fruits), then quickly transformed into
formaldehyde, which in turn becomes formic acid, both of which in
time are partially eliminated as carbon dioxide and water.

However, about 30% of the methanol remains in the body as cumulative
durable toxic metabolites of formaldehyde and formic acid-- 37 mg daily,
a gram every month. [Metabolism of aspartame in monkeys.
Oppermann JA, Muldoon E, Ranney RE.
J. Nutrition 1973 Oct; 103(10): 1454-1459.]
If 10% of the methanol is retained as formaldehyde, that would give 12
mg daily formaldehyde accumulation, about 60 times more than the 0.2 mg
from 10% retention of the 2 mg EPA daily limit for formaldehyde in
water.

Bear in mind that the EPA limit for formaldehyde in drinking water is
1 ppm, or 2 mg daily for a typical daily consumption of 2 L of water.

http://groups.yahoo.com/group/aspartameNM/message/835
RTM: ATSDR: EPA limit 1 ppm formaldehyde in drinking water July 1999
5.30.2 rmforall

This long-term low-level chronic toxic exposure leads to typical
patterns of increasingly severe complex symptoms, starting with
headache, fatigue, joint pain, irritability, memory loss, and
leading to vision and eye problems, and even seizures. In many cases
there is addiction. Probably there are immune system disorders, with a
hypersensitivity to these toxins and other chemicals.

http://groups.yahoo.com/group/aspartameNM/message/872
immune system reactions due to formaldehyde from the 11% methanol in
aspartame: Thrasher: Tephly: Monte: Murray 9.27.2 rmforall

J. Nutrition 1973 Oct; 103(10): 1454-1459.
Metabolism of aspartame in monkeys.
Oppermann JA, Muldoon E, Ranney RE.
Dept. of Biochemistry, Searle Laboratories,
Division of G.D. Searle and Co. Box 5110, Chicago, IL 60680
They found that about 70% of the radioactive methanol in aspartame put
into the stomachs of 3 to 7 kg monkeys was eliminated within 8 hours,
with little additional elimination, as carbon dioxide in exhaled air
and as water in the urine. They did not mention
that this meant that about 30% of the methanol must transform
into formaldehyde and then into formic acid, both of which must remain
as toxic products in all parts of the body. They did not report any
studies on the distribution of radioactivity in body tissues, except
that blood plasma proteins after 4 days held 4% of the initial
methanol. This study did not monitor long-term use of aspartame.

The low oral dose of aspartame and for methanol was 0.068 mmol/kg,
about 1 part per million [ppm] of the acute toxicity level of 2,000
mg/kg, 67,000 mmol/kg, used by McMartin (1979). Two L daily use of
diet soda provides 123 mg methanol, 2 mg/kg for a 60 kg person, a dose
of 67 mmole/kg, a thousand times more than the dose in this study.
By eight hours excretion of the dose in air and urine had leveled off
at 67.1 +-2.1% as CO2 in the exhaled air and 1.57+-0.32% in the urine,
so 68.7 % was excreted, and 31.3% was retained. [This data is the
average of 4 monkeys.]

http://groups.yahoo.com/group/aspartameNM/message/915
formaldehyde toxicity: Thrasher & Kilburn: Shaham: EPA: Gold: Murray:
Wilson: CIIN: 12.12.2 rmforall

Thrasher (2001): "The major difference is that the Japanese demonstrated
the incorporation of FA and its metabolites into the placenta and fetus.
The quantity of radioactivity remaining in maternal and fetal tissues
at 48 hours was 26.9% of the administered dose." [Ref. 14-16]

Arch Environ Health 2001 Jul-Aug; 56(4): 300-11.
Embryo toxicity and teratogenicity of formaldehyde. [100 references]
Thrasher JD, Kilburn KH.
Sam-1 Trust, Alto, New Mexico, USA.
http://www.drthrasher.org/formaldehy..._toxicity.html full text

http://groups.yahoo.com/group/aspartameNM/message/934
24 recent formaldehyde toxicity [Comet assay] reports:
Murray 12.31.2 rmforall

http://groups.yahoo.com/group/aspartameNM/message/935
Comet assay finds DNA damage from sucralose, cyclamate, saccharin in
mice: Sasaki YF & Tsuda S Aug 2002: Murray 1.1.3 rmforall
[Also borderline evidence, in this pilot study of 39 food additives,
using test groups of 4 mice, for DNA damage from for stomach, colon,
liver, bladder, and lung 3 hr after oral dose of 2000 mg/kg aspartame--
a very high dose.]

http://groups.yahoo.com/group/aspartameNM/message/961
genotoxins, Comet assay in mice: Ace-K, stevia fine; aspartame poor;
sucralose, cyclamate, saccharin bad: Y.F. Sasaki Aug 2002:
Murray 1.27.3 rmforall [A detailed look at the data]

Many scientific studies and case histories report: * headaches
* many body and joint pains (or burning, tingling, tremors, twitching,
spasms, cramps, stiffness, numbness, difficulty swallowing)
* fever, fatigue, swollen glands * "mind fog", "feel unreal", poor
memory, confusion, anxiety, irritability, depression, mania, insomnia,
dizziness, slurred speech, sexual problems, poor vision, hearing
(deafness, tinnitus), or taste * red face, itching, rashes, hair loss,
burning eyes or throat, dry eyes or mouth, mouth sores, burning tongue
* obesity, bloating, edema, anorexia, poor appetite or excessive hunger
or thirst * breathing problems, shortness of breath * nausea,
diarrhea or constipation * coldness * sweating * racing heart, low or
high blood pressure, erratic blood sugar levels * hypothryroidism or
hyperthyroidism * seizures * birth defects * brain cancers
* addiction * aggrivates diabetes, autism, allergies, lupus, ADHD,
fibromyalgia, chronic fatigue syndrome, multiple chemical sensitivity,
multiple sclerosis, and interstitial cystitis (bladder pain).
************************************************** *********

http://www.ncbi.nlm.nih.gov/PubM Merck, Singulair, "montelukast
sodium"

7 studies listed-- leaving out "Merck" finds 14 more studies since
August 1998, including from Italy, Romania, Russia, Japan, Turkey,
England, Australia, and Saudi Arabia. None of the 14 studies tested
animals or people more than a week. It is not clear if any of the 7 or
14 studies included aspartame. Only the most recent study, by Merck,
which covered a year of use (with the number of people not given in the
abstract), had any chance of finding any symptoms from cumulative
aspartame (chronic long-term, low-dose methanol, formaldehyde, formic
acid exposure) toxicity.

Manag Care Interface. 2003 Aug; 16(8): 30-5.
Outcomes of patients treated with fluticasone propionate or montelukast
sodium.
Allen-Ramey FC, Duong PT, Goodman DC, Sajjan SG, Nelsen LM, Markson L.
Department of Epidemiology, Merck and Company, West Point, Pennsylvania,
USA.

The authors conducted a retrospective database study of patients with
asthma (age range, 6-55 yr) who initiated fluticasone propionate or
montelukast sodium treatment between an index period of July 1998 and
June 1999. All patients were observed for 12 months before and after the
index period. Changes in asthma-related hospitalizations, emergency
department visits, oral corticosteroid use, and short-acting
beta-agonist use were analyzed. The odds of postindex asthma-related
events were estimated. In multivariate analysis, use of a short-acting
beta agonist (SABA) was significantly associated with fluticasone
treatment (odds ratio [OR], 1.65; 95% confidence interval [CI],
1.21-2.26) and preindex use of SABAs (OR, 1.84; 95% CI, 1.34-2.53). In
this managed care population, fluticasone and montelukast provided
similar effectiveness. PMID: 12964550

Arch Intern Med. 2000 Sep 11; 160(16): 2481-8.
Comment in: a.. Arch Intern Med. 2001 Aug 13-27;161(15):1920.
Montelukast, a leukotriene receptor antagonist, in combination with
loratadine, a histamine receptor antagonist, in the treatment of chronic
asthma.
Reicin A, White R, Weinstein SF, Finn AF Jr, Nguyen H, Peszek I,
Geissler L, Seidenberg BC.
Pulmonary/Immunology, Merck Research Laboratories, PO Box 2000,
RY32-649, Rahway, NJ 07065.


CONCLUSION: Montelukast-loratadine significantly improved end points of
asthma control during a 2-week treatment period.

Arch Intern Med. 1998 Jun 8; 158(11): 1213-20.
Montelukast, a once-daily leukotriene receptor antagonist, in the
treatment of chronic asthma: a multicenter, randomized, double-blind
trial.
Montelukast Clinical Research Study Group.
Reiss TF, Chervinsky P, Dockhorn RJ, Shingo S, Seidenberg B, Edwards TB.
Department of Pulmonary/Immunology, Merck Research Laboratories, Rahway,
NJ 07065, USA.

CONCLUSIONS: Montelukast, compared with placebo, significantly improved
asthma control during a 12-week treatment period. Montelukast was
generally well tolerated, with an adverse event profile comparable with
that of placebo.

Biopharm Drug Dispos. 1997 Dec; 18(9): 769-77.
Pharmacokinetics and bioavailability of montelukast sodium (MK-0476) in
healthy young and elderly volunteers.
Zhao JJ, Rogers JD, Holland SD, Larson P, Amin RD, Haesen R, Freeman A,
Seiberling M, Merz M, Cheng H.
Department of Drug Metabolism, Merck Research Laboratories, West Point,
PA 19486, USA.

Twelve healthy young and twelve elderly people were compared for a week.

Drug Metab Dispos. 1997 Nov; 25(11): 1282-7.
Metabolic profiles of montelukast sodium (Singulair), a potent cysteinyl
leukotriene1 receptor antagonist, in human plasma and bile.
Balani SK, Xu X, Pratha V, Koss MA, Amin RD, Dufresne C, Miller RR,
Arison BH, Doss GA, Chiba M, Freeman A, Holland SD, Schwartz JI,
Lasseter KC, Gertz BJ, Isenberg JI, Rogers JD, Lin JH, Baillie TA.
Department of Drug Metabolism, Merck Research Laboratories

Six healthy young people got a single 102 mg dose.

Pharm Res. 1996 Mar; 13(3): 445-8.
Pharmacokinetics, bioavailability, and safety of montelukast sodium
(MK-0476) in healthy males and females.
Cheng H, Leff JA, Amin R, Gertz BJ, De Smet M, Noonan N, Rogers JD,
Malbecq W, Meisner D, Somers G.
Merck Research Laboratories, Department of Drug Metabolism, West Point,
Pennsylvania 19486, USA.

[Six males and six females] Safety results from this study indicate
that intravenous doses of montelukast sodium from 3 to 18 mg and a 10-mg
oral dose are well tolerated.

Can J Physiol Pharmacol. 1995 Feb; 73(2): 191-201.
Erratum in: a.. Can J Physiol Pharmacol 1995 Jun; 73(6): 747.
Pharmacology of montelukast sodium (Singulair), a potent and selective
leukotriene D4 receptor antagonist.
Jones TR, Labelle M, Belley M, Champion E, Charette L, Evans J,
Ford-Hutchinson AW, Gauthier JY, Lord A, Masson P, et al.
Department of Pharmacology, Merck Frosst Canada Inc., Pointe
Claire-Dorval, QC.

Montelukast sodium (Singulair), also known as MK-0476
(1-(((1(R)-(3-(2-(7-chloro-2-quinolinyl)-(E)-ethenyl)phenyl)(3-2-(1-
hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropane ) acetic
acid sodium salt,... [a variety of tests on animal tissues]
************************************************** *****

; ; ;
; ;
;
************************************************** *****
  #2  
Old October 27th 03, 02:26 PM
Markasurusi Probertasaurusi
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair asthma medicine: Murray 10.26.3 rmforall

Another scaremong4ering post from Generalissimo Murray of the
Anti-Aspartamistas.

Where are the legions of blind people that the anti-asparatmistas predicted?

"Rich Murray" wrote in message
...
http://groups.yahoo.com/group/aspartameNM/message/1031
Merck gives aspartame (methanol, formaldehyde) to babies in Singulair
asthma medicine: Murray 10.26.3 rmforall

"SINGULAIR chewable tablets contain aspartame, a source of
phenylalanine.
Phenylketonurics: SINGULAIR 4-mg and 5-mg chewable tablets contain 0.674
and 0.842 mg phenylalanine, respectively."

[Notes by Rich Murray: This means 1.35 and 1.68 mg aspartame
respectively, which, if chewed in the mouth, is largely absorbed
directly there (buccal absorption), increasing the potency of the dose.

For 4 mg doses, the methanol dose is 11% of the 1.35 mg aspartame,
giving 0.15 mg methanol, of which as much as 30% may remain in body
tissues as cumulative toxic products of formaldehyde and formic acid:
0.05 mg-- which is about 8% of the allowable formaldehyde dose that
would result from 30% retention of the 2 mg EPA limit for formaldehyde
in 2 liters daily drinking water for 60 kg adults, 0.6 mg retained
formaldehyde, 0.01 mg retained formaldehyde per kg adult body weight.

The 37 mg likely daily formaldehyde retention from 2 liters diet soda,
5.6 12 oz. cans, for 60 kg adults gives 0.62 mg retained formaldehyde
per kg adult body weight, SIXTY times the EPA allowable level. Most
reports by adult aspartame reactors describe daily use higher than this
level of about 6 cans for years.

HOWEVER: "One packet of 4-mg oral granules for children 12 to 23 months
of age." means, since most 1-year olds weigh about 22 lbs, 10 kg, they
will be getting 1.35 mg aspartame, 0.15 mg methanol, with .045 retained
formaldehyde and 0.0045 mg per kg body weight. This is about half of
the retained formaldehyde level allowed by the EPA from drinking water
of 0.01 mg per kg body weight.

It is reasonable to guess that a baby would be far more vulnerable to
this complex cumulative toxicity than adults, especially a small, thin
baby with asthmatic symptoms, for whom the 4-mg oral granules would be
an even larger dose per kg.

Recent reports give cases of reaction to very small single doses of
aspartame.

http://groups.yahoo.com/group/aspartameNM/message/846
aspartame in Merck Maxalt-MLT worsens migraine:
AstraZeneca Zomig, Eli Lilly Zyprexa,
J&J Merck Pepcid AC (Famotidine 10mg) Chewable Tab,
Pfizer Cool Mint Listerine Pocketpaks 7.16.2 Murray rmforall
Migraine MLT-Down: an unusual presentation of migraine
in patients with aspartame-triggered headaches.
Newman LC, Lipton RB Headache 2001 Oct; 41(9): 899-901.
[Merck 10-mg Maxalt-MLT, for migraine, has 3.75 mg aspartame,
while 12 oz diet soda has 200 mg.]
Headache Institute, St. Lukes-Roosevelt Hospital Center, New York, NY
Department of Neurology
Albert Einstein College of Medicine, Bronx, NY
Innovative Medical Research


http://groups.yahoo.com/group/aspartameNM/message/855
RTM: Blumenthall & Vance:
aspartame chewing gum headaches Nov 1997 7.28.2 rmforall
Harvey J. Blumenthal, MD, Dwight A Vance, RPh
Chewing Gum Headaches.
Headache 1997 Nov-Dec; 37(10): 665-6.
Department of Neurology, University of Oklahoma College of Medicine,
Tulsa, USA.
Aspartame, a popular dietetic sweetener, may provoke headache in some
susceptible individuals. Herein, we describe three cases of young women
with migraine who reported their headaches could be provoked by chewing
gum sweetened with aspartame. [6-8 mg aspartame per stick chewing gum]

H.J. Roberts cites many cases of reactions to very low doses of
aspartame, especially from absorption in the mouth.

http://www.dorway.com/tldaddic.html 5-page review
Roberts HJ Aspartame (NutraSweet) addiction.
Townsend Letter 2000 Jan;
http://www.sunsentpress.com/
Sunshine Sentinel Press P.O.Box 17799 West Palm Beach, FL 33416
800-814-9800 561-588-7628 561-547-8008 fax

http://groups.yahoo.com/group/aspartameNM/message/669
1038-page medical text "Aspartame Disease: An Ignored Epidemic"
published May 30 2001 $ 60.00 postpaid data from 1200 cases
available at http://www.amazon.com
over 600 references from standard medical research

I spent about nine hours scanning "Asparame Disease" for cases of small
doses of aspartame in breath mints [1.5 mg aspartame per mint], pills
[about 4 mg per pill], and chewing gum [6-8 mg aspartame per stick],
since if there are a variety of symptoms to such small doses, then it
is a foregone conclusion that much more serious reactions must exist to
diet drinks [180-330 mg aspartame per 12 oz]. Many cases describe
people who had become reactors to large doses of aspartame, who then
find severe and immediate reactions to a stick or less of chewing gum.

[Excerpts, pp 79-85]
D. REACTIONS TO SMALL QUANTITIES
Some reactors evidenced severe symptoms and signs after ingesting or
chewing small amounts of aspartame products.
* Mention was made of convulsions occurring in a nursing infant as its
mother drank an aspartame soft drink.
* Children developed severe headache, convulsions, or both, within
minutes after chewing either acetaminophen (given for fever) or gum
containing aspartame...
* Case III-1, a 31-year-old nurse with an aspartame-induced seizure,
subsequently drank "only three sips" of a drink believed to be
"regular" soda, but which contained aspartame. She promptly
became "very incoherent." [case described on pages 113-115]
* A chemist who developed migraine from certain foods and additives
performed six double-blind experiments on himself. He found that as
little as 4.0 mg aspartame in a capsule predictably induced headache
(Strong 2000)....
[ http://groups.yahoo.com/group/aspartameNM/message/285
Strong FC Why do some dietary migraine patients claim
they get headaches from placebos?
Clin Exp Allergy 2000 May; 30(5): 739-43.]

The precipitation of severe neurological and other reactions within
minutes or a few hours after ingesting aspartame (see below) casts
doubts on the assertion by the FDA: "The agency does not regard the
possible consumption of aspartame in a single large dose as posing any
safety problem whatever."
(Federal Register February 22, 1984, p. 6678)...

E. ASPARTAME GUM
I have been impressed by the role of aspartame gum in patients
suffering severe neurologic aspartame reactions, especially headache
and seizures (see below).
* A 24-year-old woman stated that she was "on the very verge of dying"
from aspartame disease. Dramatic improvement occurred when she learned
about this disorder, and then stopped such products. She emphasized
her marked sensitivity to even a single stick of aspartame gum.
Symptoms would recur within minutes after chewing it, and lasted one
week. [6-8 mg aspartame per stick of chewing gum]
* Aspartame gum was specifically incriminated by Case IX-C-16, a
35-year-old woman with shortness of breath, dizziness, irritability,
fatigue, heavy menstrual bleeding, hair loss and weight gain. (She did
not drink diet sodas.) These reactions-- "within the hour I could not
catch my breath"-- reoccurred on multiple retests.

Few realize the enormity of gum consumption. It is estimated that
Americans chew $2.5 billion worth of gum annually, the equivalent of
190 sticks per person. Some aspartame reactors chewed 15-20 sticks or
more daily, in addition to using other aspartame products (see Case
II-4). [20 sticks would be as much as 160 mg aspartame, almost as much
as
12 oz diet drink]

Owing to its prolonged sweetness, persons tend to chew aspartame
as much as five time longer than regular gum....

The habitual sucking of popular mints containing aspartame may induce
seizures and other neuropsychiatric disorders. An aspartame reactor
with prior complaints (vision impairment; slurred speech; loss of
muscle strength) remained symptom-free after avoiding aspartame.
She then experienced "painfully dry eyes" immediately after taking
a breath mint containing aspartame...[1.5 mg aspartame per mint]

Absorption
Chewing gum exposes the body to aspartame thorough its absorption
in the upper gastrointestinal tract, and from the lining of the mouth.
Additional ingredients could pose added problems. For example, I have
repeatedly encountered difficulty with peppermint gum and wafers
(Roberts 1983). [see case on page 456]

The rapidity with which reactions can occur after chewing aspartame gum
is not necessarily an "allergy". The prompt absorption of aspartame or
its breakdown products (Chapter XXV) from the mouth is akin to placing
nitroglycerine under the tongue for the rapid relief of angina pectoris.

Pharmacologists recognize that absorption through the oral mucosa
(without swallowing) can be an efficient route of delivery for amino
acids and small proteins because the basal lamina under the epithelial
layer contains blood vessels. Moreover, the enzymatic activity of the
oral cavity is relatively low (principally, an amylase that hydrolyzes
only sugars.).

* The blood flow in the buccal mucosa is comparable to that of the
sublingual mucosa. Absorbed molecules are collected by the internal
jugular veins, thereby directly reaching the circulating blood.

* The buccal route for drug administration is illustrated by its
effectiveness in treating childhood seizures with midazolam (Scott
1999). The rich blood supply to the mouth enables absorption directly
into the systemic circulation, thereby avoiding the considerable
"first-pass" metabolism by the liver. A rapid effect on the central
nervous system has been demonstrated electroencephalographically.

Another possible mechanism involves the transport of aspartame from the
back of the mouth (oropharynx) directly to the brain. This phenomenon
has been documented for small molecules such as glucose,
sodium chloride and ethyl alcohol (Editorial, British Medical Journal,
1: 184, 1966; Maller 1967). [End of quotes from "Aspartame Disease: An
Ignored Epidemic"]

Virtually all the side effects mentioned by Merck are well known
features in hundreds of reports by aspartame reactors. It is necessary
to carefully examine and test individuals to determine if aspartame is
one causal agent.

It is possible that no long-term studies have been done on 1 year olds--
yet this risky dose level is blindly recommended by Merck-- as usual,
hiding behind the skirts of the FDA's extremely corrupt, irregular
approval of aspartame in July, 1981, against the vote of its own
scientific Board of Inquiry.

http://groups.yahoo.com/group/aspartameNM/message/857
RTM: www.dorway.com: original documents and long reviews of flaws in
aspartame toxicity research 7.31.2 rmforall

http://www.dorway.com/upipart1.txt
http://groups.yahoo.com/group/aspartameNM/message/262
aspartame expose 96K Oct 1987 Part 1/3: Gregory Gordon, UPI reporter:
Murray 7.10.0 rmforall

http://www.dorway.com/enclosur.html
http://groups.yahoo.com/group/aspartameNM/message/53
aspartame history Part 1/4 1964-1976: Gold: Murray 11.6.9: rmforall

http://groups.yahoo.com/group/aspartameNM/message/927
Rumsfeld, 1977 head of Searle Corp., got aspartame FDA approval:
Turner: Murray 12.23.2 rmforall

http://groups.yahoo.com/group/aspartameNM/message/928
revolving door, Monsanto, FDA, EPA: NGIN: Murray 12.23.2 rmforall
************************************************** ***********************

http://www.merck.com/

Merck & Co., Inc. One Merck Drive P.O. Box 100

Whitehouse Station, NJ 08889-0100 USA Phone: 908-423-1000
Monday-Friday 8:30 AM - 5:30 PM ET

http://www.singulair.com/singulair/s...nglish/ppi.pdf

1 of 4

Patient Information
SINGULAIR® (SING-u-lair) Tablets, Chewable Tablets, and Oral Granules
Generic name: montelukast (mon-te-LOO-kast) sodium

Read this information before you start taking SINGULAIR®. Also, read the
leaflet you get each time you refill SINGULAIR, since there may be new
information in the leaflet since the last time you saw it. This leaflet
does not take the place of talking with your doctor about your medical
condition and/or your treatment.

What is SINGULAIR*?

. SINGULAIR is a medicine called a leukotriene receptor antagonist. It
works by blocking substances in the body called leukotrienes. Blocking
leukotrienes improves asthma and seasonal allergic rhinitis (also known
as hay fever). SINGULAIR is not a steroid.

SINGULAIR is prescribed for the treatment of asthma and seasonal
allergic rhinitis:

1. Asthma.
SINGULAIR should be used for the long-term management of asthma in
adults and children ages 12 months and older.
Do not take SINGULAIR for the immediate relief of an asthma attack. If
you get an asthma attack, you should follow the instructions your doctor
gave you for treating asthma attacks. (See the end of this leaflet for
more information about asthma.)

2. Seasonal Allergic Rhinitis.
SINGULAIR is used to help control the symptoms of seasonal allergic
rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) in
adults and children ages 2 years and older. (See the end of this leaflet
for more information about seasonal allergic rhinitis.)

Who should not take SINGULAIR?
Do not take SINGULAIR if you are allergic to SINGULAIR or any of its
ingredients.
The active ingredient in SINGULAIR is montelukast sodium.
See the end of this leaflet for a list of all the ingredients in
SINGULAIR.

What should I tell my doctor before I start taking SINGULAIR?
Tell your doctor about:

. Pregnancy: If you are pregnant or plan to become pregnant, SINGULAIR
may not be right for you.

. Breast-feeding: If you are breast-feeding, SINGULAIR may be passed in
your milk to your baby. You should consult your doctor before taking
SINGULAIR if you are breast-feeding or intend to breast-feed.

. Medical Problems or Allergies: Talk about any medical problems or
allergies you have now or had in the past.

. Other Medicines: Tell your doctor about all the medicines you take,
including prescription and non-prescription medicines, and herbal
supplements. Some medicines may affect how SINGULAIR works, or SINGULAIR
may affect how your other medicines work.

* Registered trademark of MERCK & CO., Inc.
COPYRIGHT © MERCK & CO., Inc., 1998, 2001, 2002 All rights reserved

9094216 2 of 4

How should I take SINGULAIR?

For adults and children 12 months of age and older with asthma:
. Take SINGULAIR once a day in the evening.
. Take SINGULAIR every day for as long as your doctor prescribes it,
even if you have no asthma symptoms.
. You may take SINGULAIR with food or without food.
. If your asthma symptoms get worse, or if you need to increase the use
of your inhaled rescue medicine for asthma attacks, call your doctor
right away.
. Do not take SINGULAIR for the immediate relief of an asthma attack. If
you get an asthma attack, you should follow the instructions your doctor
gave you for treating asthma attacks.
. Always have your inhaled rescue medicine for asthma attacks with you.
. Do not stop taking or lower the dose of your other asthma medicines
unless your doctor tells you to.
. If your doctor has prescribed a medicine for you to use before
exercise, keep using that medicine unless your doctor tells you not to.

For adults and children 2 years of age and older with seasonal allergic
rhinitis:
. Take SINGULAIR once a day, at about the same time each day.
. Take SINGULAIR every day for as long as your doctor prescribes it.
. You may take SINGULAIR with food or without food.

How should I give SINGULAIR oral granules to my child?
Do not open the packet until ready to use.
SINGULAIR 4-mg oral granules can be given either:
. directly in the mouth;
OR . mixed with a spoonful of one of the following soft foods at cold or
room temperatu applesauce, mashed carrots, rice, or ice cream. Be
sure that the entire dose is mixed with the food and that the child is
given the entire spoonful of the mixture right away (within 15 minutes).
IMPORTANT: Never store any oral granule/food mixture for use at a later
time. Throw away any unused portion.
Do not put SINGULAIR oral granules in liquid drink. However, your child
may drink liquids after swallowing the SINGULAIR oral granules.

What is the daily dose of SINGULAIR for asthma or seasonal allergic
rhinitis?
For Asthma (Take in the evening):
. One 10-mg tablet for adults and adolescents 15 years of age and older,
. One 5-mg chewable tablet for children 6 to 14 years of age,
. One 4-mg chewable tablet or one packet of 4-mg oral granules for
children 2 to 5 years of age, or
. One packet of 4-mg oral granules for children 12 to 23 months of age.

For Seasonal Allergic Rhinitis (Take at about the same time each day):
. One 10-mg tablet for adults and adolescents 15 years of age and older,

9094216 3 of 4

. One 5-mg chewable tablet for children 6 to 14 years of age, or
. One 4-mg chewable tablet or one packet of 4-mg oral granules for
children 2 to 5 years of age.

What should I avoid while taking SINGULAIR?
If you have asthma and if your asthma is made worse by aspirin, continue
to avoid aspirin or other medicines called non-steroidal
anti-inflammatory drugs while taking SINGULAIR.

What are the possible side effects of SINGULAIR?
The side effects of SINGULAIR are usually mild, and generally did not
cause patients to stop taking their medicine. The side effects in
patients treated with SINGULAIR were similar in type and frequency to
side effects in patients who were given a placebo (a pill containing no
medicine).

The most common side effects with SINGULAIR include:
. stomach pain
. stomach or intestinal upset
. heartburn
. tiredness
. fever
. stuffy nose
. cough
. flu
. upper respiratory infection
. dizziness
. headache
. rash

Less common side effects that have happened with SINGULAIR include
(listed alphabetically):
agitation including aggressive behavior, allergic reactions (including
swelling of the face, lips, tongue, and/or throat, which may cause
trouble breathing or swallowing), hives, and itching, bad/vivid dreams,
increased bleeding tendency, bruising, diarrhea, hallucinations (seeing
things that are not there), hepatitis, indigestion, inflammation of the
pancreas, irritability, joint pain, muscle aches and muscle cramps,
nausea, palpitations, pins and needles/numbness, restlessness, seizures
(convulsions or
fits), swelling, trouble sleeping, and vomiting.

Rarely, asthmatic patients taking SINGULAIR have experienced a condition
that includes certain symptoms that do not go away or that get worse.
These occur usually, but not always, in patients who were taking steroid
pills by mouth for asthma and those steroids were being slowly lowered
or stopped.
Although SINGULAIR has not been shown to cause this condition, you must
tell your doctor right away if you get one or more of these symptoms:
. a feeling of pins and needles or numbness of arms or legs
. a flu-like illness
. rash
. severe inflammation (pain and swelling) of the sinuses (sinusitis)

These are not all the possible side effects of SINGULAIR. For more
information ask your doctor or pharmacist.

Talk to your doctor if you think you have side effects from taking
SINGULAIR.

General Information about the safe and effective use of SINGULAIR
Medicines are sometimes prescribed for conditions that are not mentioned
in patient information leaflets.
Do not use SINGULAIR for a condition for which it was not prescribed. Do
not give SINGULAIR to other people even if they have the same symptoms
you have. It may harm them. Keep SINGULAIR and all medicines out of the
reach of children.

9094216 4 of 4

Store SINGULAIR at 25°C (77°F). Protect from moisture and light. Store
in original package.

This leaflet summarizes information about SINGULAIR. If you would like
more information, talk to your doctor. You can ask your pharmacist or
doctor for information about SINGULAIR that is written for health
professionals.

What are the ingredients in SINGULAIR?
Active ingredient: montelukast sodium
SINGULAIR chewable tablets contain aspartame, a source of phenylalanine.
Phenylketonurics: SINGULAIR 4-mg and 5-mg chewable tablets contain 0.674
and 0.842 mg phenylalanine, respectively.

Inactive ingredients:
. 4-mg oral granules: mannitol, hydroxypropyl cellulose, and magnesium
stearate.
. 4-mg and 5-mg chewable tablets: mannitol, microcrystalline cellulose,
hydroxypropyl cellulose, red ferric oxide, croscarmellose sodium, cherry
flavor, aspartame, and magnesium stearate.
. 10-mg tablet: microcrystalline cellulose, lactose monohydrate,
croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate,
hydroxypropyl methylcellulose, titanium dioxide, red ferric oxide,
yellow ferric oxide, and carnauba wax.

What is asthma?
Asthma is a continuing (chronic) inflammation of the bronchial
passageways which are the tubes that carry air from outside the body to
the lungs.
Symptoms of asthma include:
. coughing
. wheezing
. chest tightness
. shortness of breath

What is seasonal allergic rhinitis?
. Seasonal allergic rhinitis, also known as hay fever, is an allergic
response caused by pollens from trees, grasses and weeds.
. Symptoms of seasonal allergic rhinitis may include:
. stuffy, runny, and/or itchy nose
. sneezing

Rx only Issued May 2003

MERCK & CO., INC. Whitehouse Station, NJ 08889, USA
************************************************** ***********************

aspartame (methanol, formaldehyde) toxicity: Murray 10.26.3 rmforall,
plain text

Rich Murray, MA Room For All
1943 Otowi Road, Santa Fe, New Mexico 87505 USA 505-986-9103

http://groups.yahoo.com/group/aspartameNM/message/1026
brief aspartame review: formaldehyde toxicity: Murray 9.11.3 rmforall

http://google.com gives 221,000 websites for "aspartame" , with the top
9 of 10 listings being anti-aspartame, while
http://groups.google.com finds on 700 MB of posts from 20 years of
Usenet groups, 83,800 posts, the top 10 being anti-aspartame.
http://news.google.com 28 recent aspartame items from 4500 sources.
http://www.AllTheWeb.com gives 291,700, the top 7 of 10 being
leading and very well informed volunteer anti-aspartame sites.
http://teoma.com/index.asp gives 85,700 websites, top 8 of 10 anti.
http://www.ncbi.nlm.nih.gov/PubMed lists 742 aspartame items.

http://groups.yahoo.com/group/aspartameNM/message/989
EU votes 440 to 20 to approve sucralose, limit cyclamates & reevaluate
aspartame & stevia: Murray 4.12.3 rmforall

http://groups.yahoo.com/group/aspartameNM/message/1025
aspartame & formaldehyde toxicity: Murray 9.9.3 rmforall

http://groups.yahoo.com/group/aspartameNM/messages
for 1031 posts in a public searchable archive

http://groups.yahoo.com/group/aspartame/messages 730 members

http://groups.yahoo.com/group/aspartameNM/message/1024
aspartame review: methanol, formaldehyde, formic acid toxicity:
Murray 9.5.3 rmforall

http://groups.yahoo.com/group/aspartameNM/message/910
formaldehyde & formic acid from methanol in aspartame:
Murray: 12.9.2 rmforall

It is certain that high levels of aspartame use, above 2 liters daily
for months and years, must lead to chronic formaldehyde-formic acid
toxicity, since 11% of aspartame (1,120 mg in 2L diet soda, 5.6 12-oz
cans) is 123 mg methanol (wood alcohol), immediately released into the
body after drinking (unlike the large levels of methanol locked up in
molecules inside many fruits), then quickly transformed into
formaldehyde, which in turn becomes formic acid, both of which in
time are partially eliminated as carbon dioxide and water.

However, about 30% of the methanol remains in the body as cumulative
durable toxic metabolites of formaldehyde and formic acid-- 37 mg daily,
a gram every month. [Metabolism of aspartame in monkeys.
Oppermann JA, Muldoon E, Ranney RE.
J. Nutrition 1973 Oct; 103(10): 1454-1459.]
If 10% of the methanol is retained as formaldehyde, that would give 12
mg daily formaldehyde accumulation, about 60 times more than the 0.2 mg
from 10% retention of the 2 mg EPA daily limit for formaldehyde in
water.

Bear in mind that the EPA limit for formaldehyde in drinking water is
1 ppm, or 2 mg daily for a typical daily consumption of 2 L of water.

http://groups.yahoo.com/group/aspartameNM/message/835
RTM: ATSDR: EPA limit 1 ppm formaldehyde in drinking water July 1999
5.30.2 rmforall

This long-term low-level chronic toxic exposure leads to typical
patterns of increasingly severe complex symptoms, starting with
headache, fatigue, joint pain, irritability, memory loss, and
leading to vision and eye problems, and even seizures. In many cases
there is addiction. Probably there are immune system disorders, with a
hypersensitivity to these toxins and other chemicals.

http://groups.yahoo.com/group/aspartameNM/message/872
immune system reactions due to formaldehyde from the 11% methanol in
aspartame: Thrasher: Tephly: Monte: Murray 9.27.2 rmforall

J. Nutrition 1973 Oct; 103(10): 1454-1459.
Metabolism of aspartame in monkeys.
Oppermann JA, Muldoon E, Ranney RE.
Dept. of Biochemistry, Searle Laboratories,
Division of G.D. Searle and Co. Box 5110, Chicago, IL 60680
They found that about 70% of the radioactive methanol in aspartame put
into the stomachs of 3 to 7 kg monkeys was eliminated within 8 hours,
with little additional elimination, as carbon dioxide in exhaled air
and as water in the urine. They did not mention
that this meant that about 30% of the methanol must transform
into formaldehyde and then into formic acid, both of which must remain
as toxic products in all parts of the body. They did not report any
studies on the distribution of radioactivity in body tissues, except
that blood plasma proteins after 4 days held 4% of the initial
methanol. This study did not monitor long-term use of aspartame.

The low oral dose of aspartame and for methanol was 0.068 mmol/kg,
about 1 part per million [ppm] of the acute toxicity level of 2,000
mg/kg, 67,000 mmol/kg, used by McMartin (1979). Two L daily use of
diet soda provides 123 mg methanol, 2 mg/kg for a 60 kg person, a dose
of 67 mmole/kg, a thousand times more than the dose in this study.
By eight hours excretion of the dose in air and urine had leveled off
at 67.1 +-2.1% as CO2 in the exhaled air and 1.57+-0.32% in the urine,
so 68.7 % was excreted, and 31.3% was retained. [This data is the
average of 4 monkeys.]

http://groups.yahoo.com/group/aspartameNM/message/915
formaldehyde toxicity: Thrasher & Kilburn: Shaham: EPA: Gold: Murray:
Wilson: CIIN: 12.12.2 rmforall

Thrasher (2001): "The major difference is that the Japanese demonstrated
the incorporation of FA and its metabolites into the placenta and fetus.
The quantity of radioactivity remaining in maternal and fetal tissues
at 48 hours was 26.9% of the administered dose." [Ref. 14-16]

Arch Environ Health 2001 Jul-Aug; 56(4): 300-11.
Embryo toxicity and teratogenicity of formaldehyde. [100 references]
Thrasher JD, Kilburn KH.
Sam-1 Trust, Alto, New Mexico, USA.
http://www.drthrasher.org/formaldehy..._toxicity.html full text

http://groups.yahoo.com/group/aspartameNM/message/934
24 recent formaldehyde toxicity [Comet assay] reports:
Murray 12.31.2 rmforall

http://groups.yahoo.com/group/aspartameNM/message/935
Comet assay finds DNA damage from sucralose, cyclamate, saccharin in
mice: Sasaki YF & Tsuda S Aug 2002: Murray 1.1.3 rmforall
[Also borderline evidence, in this pilot study of 39 food additives,
using test groups of 4 mice, for DNA damage from for stomach, colon,
liver, bladder, and lung 3 hr after oral dose of 2000 mg/kg aspartame--
a very high dose.]

http://groups.yahoo.com/group/aspartameNM/message/961
genotoxins, Comet assay in mice: Ace-K, stevia fine; aspartame poor;
sucralose, cyclamate, saccharin bad: Y.F. Sasaki Aug 2002:
Murray 1.27.3 rmforall [A detailed look at the data]

Many scientific studies and case histories report: * headaches
* many body and joint pains (or burning, tingling, tremors, twitching,
spasms, cramps, stiffness, numbness, difficulty swallowing)
* fever, fatigue, swollen glands * "mind fog", "feel unreal", poor
memory, confusion, anxiety, irritability, depression, mania, insomnia,
dizziness, slurred speech, sexual problems, poor vision, hearing
(deafness, tinnitus), or taste * red face, itching, rashes, hair loss,
burning eyes or throat, dry eyes or mouth, mouth sores, burning tongue
* obesity, bloating, edema, anorexia, poor appetite or excessive hunger
or thirst * breathing problems, shortness of breath * nausea,
diarrhea or constipation * coldness * sweating * racing heart, low or
high blood pressure, erratic blood sugar levels * hypothryroidism or
hyperthyroidism * seizures * birth defects * brain cancers
* addiction * aggrivates diabetes, autism, allergies, lupus, ADHD,
fibromyalgia, chronic fatigue syndrome, multiple chemical sensitivity,
multiple sclerosis, and interstitial cystitis (bladder pain).
************************************************** *********

http://www.ncbi.nlm.nih.gov/PubM Merck, Singulair, "montelukast
sodium"

7 studies listed-- leaving out "Merck" finds 14 more studies since
August 1998, including from Italy, Romania, Russia, Japan, Turkey,
England, Australia, and Saudi Arabia. None of the 14 studies tested
animals or people more than a week. It is not clear if any of the 7 or
14 studies included aspartame. Only the most recent study, by Merck,
which covered a year of use (with the number of people not given in the
abstract), had any chance of finding any symptoms from cumulative
aspartame (chronic long-term, low-dose methanol, formaldehyde, formic
acid exposure) toxicity.

Manag Care Interface. 2003 Aug; 16(8): 30-5.
Outcomes of patients treated with fluticasone propionate or montelukast
sodium.
Allen-Ramey FC, Duong PT, Goodman DC, Sajjan SG, Nelsen LM, Markson L.
Department of Epidemiology, Merck and Company, West Point, Pennsylvania,
USA.

The authors conducted a retrospective database study of patients with
asthma (age range, 6-55 yr) who initiated fluticasone propionate or
montelukast sodium treatment between an index period of July 1998 and
June 1999. All patients were observed for 12 months before and after the
index period. Changes in asthma-related hospitalizations, emergency
department visits, oral corticosteroid use, and short-acting
beta-agonist use were analyzed. The odds of postindex asthma-related
events were estimated. In multivariate analysis, use of a short-acting
beta agonist (SABA) was significantly associated with fluticasone
treatment (odds ratio [OR], 1.65; 95% confidence interval [CI],
1.21-2.26) and preindex use of SABAs (OR, 1.84; 95% CI, 1.34-2.53). In
this managed care population, fluticasone and montelukast provided
similar effectiveness. PMID: 12964550

Arch Intern Med. 2000 Sep 11; 160(16): 2481-8.
Comment in: a.. Arch Intern Med. 2001 Aug 13-27;161(15):1920.
Montelukast, a leukotriene receptor antagonist, in combination with
loratadine, a histamine receptor antagonist, in the treatment of chronic
asthma.
Reicin A, White R, Weinstein SF, Finn AF Jr, Nguyen H, Peszek I,
Geissler L, Seidenberg BC.
Pulmonary/Immunology, Merck Research Laboratories, PO Box 2000,
RY32-649, Rahway, NJ 07065.


CONCLUSION: Montelukast-loratadine significantly improved end points of
asthma control during a 2-week treatment period.

Arch Intern Med. 1998 Jun 8; 158(11): 1213-20.
Montelukast, a once-daily leukotriene receptor antagonist, in the
treatment of chronic asthma: a multicenter, randomized, double-blind
trial.
Montelukast Clinical Research Study Group.
Reiss TF, Chervinsky P, Dockhorn RJ, Shingo S, Seidenberg B, Edwards TB.
Department of Pulmonary/Immunology, Merck Research Laboratories, Rahway,
NJ 07065, USA.

CONCLUSIONS: Montelukast, compared with placebo, significantly improved
asthma control during a 12-week treatment period. Montelukast was
generally well tolerated, with an adverse event profile comparable with
that of placebo.

Biopharm Drug Dispos. 1997 Dec; 18(9): 769-77.
Pharmacokinetics and bioavailability of montelukast sodium (MK-0476) in
healthy young and elderly volunteers.
Zhao JJ, Rogers JD, Holland SD, Larson P, Amin RD, Haesen R, Freeman A,
Seiberling M, Merz M, Cheng H.
Department of Drug Metabolism, Merck Research Laboratories, West Point,
PA 19486, USA.

Twelve healthy young and twelve elderly people were compared for a week.

Drug Metab Dispos. 1997 Nov; 25(11): 1282-7.
Metabolic profiles of montelukast sodium (Singulair), a potent cysteinyl
leukotriene1 receptor antagonist, in human plasma and bile.
Balani SK, Xu X, Pratha V, Koss MA, Amin RD, Dufresne C, Miller RR,
Arison BH, Doss GA, Chiba M, Freeman A, Holland SD, Schwartz JI,
Lasseter KC, Gertz BJ, Isenberg JI, Rogers JD, Lin JH, Baillie TA.
Department of Drug Metabolism, Merck Research Laboratories

Six healthy young people got a single 102 mg dose.

Pharm Res. 1996 Mar; 13(3): 445-8.
Pharmacokinetics, bioavailability, and safety of montelukast sodium
(MK-0476) in healthy males and females.
Cheng H, Leff JA, Amin R, Gertz BJ, De Smet M, Noonan N, Rogers JD,
Malbecq W, Meisner D, Somers G.
Merck Research Laboratories, Department of Drug Metabolism, West Point,
Pennsylvania 19486, USA.

[Six males and six females] Safety results from this study indicate
that intravenous doses of montelukast sodium from 3 to 18 mg and a 10-mg
oral dose are well tolerated.

Can J Physiol Pharmacol. 1995 Feb; 73(2): 191-201.
Erratum in: a.. Can J Physiol Pharmacol 1995 Jun; 73(6): 747.
Pharmacology of montelukast sodium (Singulair), a potent and selective
leukotriene D4 receptor antagonist.
Jones TR, Labelle M, Belley M, Champion E, Charette L, Evans J,
Ford-Hutchinson AW, Gauthier JY, Lord A, Masson P, et al.
Department of Pharmacology, Merck Frosst Canada Inc., Pointe
Claire-Dorval, QC.

Montelukast sodium (Singulair), also known as MK-0476
(1-(((1(R)-(3-(2-(7-chloro-2-quinolinyl)-(E)-ethenyl)phenyl)(3-2-(1-
hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropane ) acetic
acid sodium salt,... [a variety of tests on animal tissues]
************************************************** *****

; ; ;
; ;
;
************************************************** *****



  #3  
Old October 28th 03, 01:16 AM
Jeff
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair asthma medicine: Murray 10.26.3 rmforall


"Markasurusi Probertasaurusi" wrote in
message t...
Another scaremong4ering post from Generalissimo Murray of the
Anti-Aspartamistas.


Really? I would have been concerned that kids who have PKU would be taking
it.

Jeff


  #4  
Old October 28th 03, 04:47 AM
Joy
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair asthma medicine: Murray 10.26.3 rmforall



"Jeff" wrote in message
...

"Markasurusi Probertasaurusi" wrote in
message t...
Another scaremong4ering post from Generalissimo Murray of the
Anti-Aspartamistas.


Really? I would have been concerned that kids who have PKU would be taking
it.

Jeff

So if they are tested like most in the US are, explain your concern.


  #5  
Old October 29th 03, 02:27 AM
Jeff
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair asthma medicine: Murray 10.26.3 rmforall


"Joy" wrote in message
ink.net...


"Jeff" wrote in message
...

"Markasurusi Probertasaurusi" wrote in
message t...
Another scaremong4ering post from Generalissimo Murray of the
Anti-Aspartamistas.


Really? I would have been concerned that kids who have PKU would be

taking
it.

Jeff

So if they are tested like most in the US are, explain your concern.


People who have PKU, especially children, must eat a diet very low in the
amino acid phenylalanine. If the diet has too much phenylalanine, kids with
PKU will develop mental retardation. Aspartame contains phelylalanine. So
kids and parents who know they have PKU need to avoid aspartame, especially
taken on a chronic basis.

So both testing and avoidance are necessary to prevent retardation from PKU.

Jeff


  #6  
Old October 29th 03, 03:05 AM
Joy
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair asthma medicine: Murray 10.26.3 rmforall

The recommend a limit of consumption is 7.8 mg/day. Singulair contains .842
my phenylalanine, so I guess you'd be safe if you didn't cheat on other
things you consume.


  #7  
Old October 29th 03, 03:29 AM
Jeff
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair asthma medicine: Murray 10.26.3 rmforall


"Joy" wrote in message
link.net...
The recommend a limit of consumption is 7.8 mg/day. Singulair contains

..842
my phenylalanine, so I guess you'd be safe if you didn't cheat on other
things you consume.


Yeah, but if you took 7.5 mg / day + the Singulair, you would be over.
Information is power.

Jeff


  #8  
Old October 29th 03, 05:35 AM
Joy
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair asthma medicine: Murray 10.26.3 rmforall

Gee, I just don't know anyone who takes more than ONE. Information is POWER.


  #9  
Old October 29th 03, 12:59 PM
Jeff
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair asthma medicine: Murray 10.26.3 rmforall


"Joy" wrote in message
link.net...
Gee, I just don't know anyone who takes more than ONE. Information is

POWER.

Neither do I. But a dose is about 10% of the daily allowance of phenylanine,
so it is a significant dose.


  #10  
Old October 29th 03, 02:31 PM
Markasurusi Probertasaurusi
external usenet poster
 
Posts: n/a
Default Merck gives aspartame (methanol, formaldehyde) to babies in Singulair asthma medicine: Murray 10.26.3 rmforall


"Jeff" wrote in message
...

"Markasurusi Probertasaurusi" wrote in
message t...
Another scaremong4ering post from Generalissimo Murray of the
Anti-Aspartamistas.


Really? I would have been concerned that kids who have PKU would be taking
it.


The anti-aspartame scaremongers, and the OP is a generalissimo of them, wil
use anything to scare people.

The issue wrt PKU is valid, but not what they are talking about. they are
talking about imaginary problems.

Several years ago Betty Martini, one the leaders of them, claimed that
aspartame was making everyone go blind.

AFAIAC, they are a pack of scaremongering liars.



 




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