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Strattera Side Effects
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Strattera is an
antidepressant developed by Eli Lilly in 1992 but prescribed for ADHD today.
- Side Effects Defined - Strattera withdrawal side effects
Anorexia Strattera – No longer having a desire to eat.
Strattera – Painful red and swollen open
sores on a mucus membrane of the mouth commonly called a canker sore.
Ataxia Strattera – Loss of the ability to move the body with
Strattera – A condition of abnormal
twitching of the muscles in the blood vessels that moves the oxygenated
blood from the heart to the rest of the body. The unusual twitching is
rapid and irregular and replaces the normal rhythm of contraction of the
muscle, which sometimes causes a lack of circulation and pulse.
Blood Cholesterol Increased
Strattera – An abnormal condition
where there is a greater amount in the blood of the oily/fatty substances
known as cholesterol. Cholesterol is a necessary part of living cells
(along with proteins and carbohydrates). Because cholesterol only slightly
dissolves in water, it can build up on the walls of the blood vessels,
therefore blocking/decreasing the amount of blood flow, which causes blood
pressure to go up. If not corrected, this condition is associated with
coronary artery disease.
Blood Creatinine Increased
Strattera – A greater than normal
number of creatinine or muscular chemical waste molecules in the blood.
Creatinine plays a major role in energy production in muscles. Since
creatinine levels are normally maintained by the kidneys, Blood Creatinine
Increased is an indicator of kidney malfunction or failure.
Blood in Stool Strattera – The blood that is in your bowel
movement usually comes from any place along your digestive tract (from your
mouth to your anus). The stool can appear black and foul-smelling (usually
from the upper part of your digestive tract) or red or maroon-colored
(usually from the large intestine area). Hemorrhoids are the usual cause
for blood in the bowels.
8.Bundle Branch Block Right
Strattera – These are specialized cells in the
upper right heart chamber and are the heart’s pacemaker. They send electrical
signals to the heart that keeps it beating or contracting regularly. Normally
the signal goes to the lower heart chambers at the same time through the bundle
of His (hiss) on both the left and right sides of the heart, so the lower
chambers contract at the same time. When the bundle is damaged on the right
side, the signal does not fire at the same time as the left, which changes the
pace of blood flow. This can lead to a person fainting.
Cardiac Failure Strattera – A heart disorder where the heart
does not function as usual and may completely stop working.
Cardiac Failure Congestive
Strattera – The body is asking for
the heart to supply more blood than it is capable of producing and
maintaining. Normally, a body can tolerate an increased amount of work for
quite some time. The condition is characterized by weakness, shortness of
breath, and a fluid build-up in the body tissues causing swelling.
Cold Sweat Strattera – The skin is clammy and moist and you feel
chilled. This is a reaction to a shock or pain as well as to fear and
Colitis Strattera – A condition where the large intestine
becomes irritated from the use of the drug.
Coronary Artery Disease
Strattera – A condition where the blood
vessels that mainly carry the blood away from the heart become clogged up or
narrowed usually by fatty deposits. The first symptom is pain spreading
from the upper left body caused by not enough oxygen reaching the heart.
Dehydration Strattera – An extreme loss of water from the body
or the organs of the body as in sickness or not drinking enough fluids.
Diplopia Strattera – The condition where a person is looking a
one object and instead of normally seeing just the one object he sees two.
This is also call double vision.
Diverticulitis Strattera – There are pouches or sacs on the
inside of the intestines that look like fingers. This increases the area
for the body to absorb nutrients as they pass through the intestines. These
sacs become irritated and swollen and end up trapping waste that would
normally be eliminated, causing pain and constipation.
Dysarthria Strattera – The inability to control the mouth
muscles when forming words so the words are not clearly spoken and heard.
Dyslipidemia Strattera – The normal fat metabolism in the blood
is interfered with.
Dysphagia Strattera – Trouble swallowing or the inability to
Ecchymosis Strattera – When a blood vessel breaks and creates a
purple discoloration of the skin.
Edema Strattera – An abnormal build up of excess fluids in the
cells, tissues, and the spaces between the tissues creating swelling.
Edema Peripheral Strattera – The abnormal build up of fluids in
the tissues of the ankles and legs causing painless swelling in the legs,
ankles, and feet. If you squeeze the swollen area it leaves an indentation
on the skin for a few minutes.
Strattera – The man is not able to release
sperm either during sexual intercourse or with manual stimulation in the
presence of his sexual partner in spite of his wish to do so.
Strattera – A condition where the man
has one or more of the following symptoms: He is not able to have an
erection, not able to have an orgasm, has a decreased interest in sex, is
sexually inhibited, or it is painful to ejaculate sperm.
Strattera – Incapable of having sexual
intercourse. Even though a man desires sex he is inhibited in his sexual
activity and is unable to have or maintain an erection of the penis.
Erythema Strattera – a skin redness caused by the swelling with
blood of the tiny blood vessels of the skin as in burns.
Strattera – Redness of the skin from the
swelling of the tiny blood vessels with skin irritation (itching, burning,
tingling, pain) and breakouts (eruptions).
Esophageal Stenosis Acquired
Strattera – The tube that moves
food from the mouth to the stomach narrows.
Strattera – The unusual and not normal
condition of scaling and shedding of the skin cells. The skin is usually
Face Edema Strattera – The tissues of the face become swollen.
Feeling Jittery Strattera – A physical sensation of nervous
Strattera – An inflamed and sore stomach.
Gastric Ulcer Strattera – An open, irritated, and infected sore
in the wall of the stomach.
Gingivitis Strattera – Sore, swollen and red gums in the mouth
that bleed easily.
Glaucoma Strattera – The delicate nerve to the eye, the optic
nerve, becomes easily damaged with the build-up of excess fluid pressure
within the eyeball. The first sign of glaucoma is loss of peripheral (side)
vision. It can progress to total blindness.
Strattera – Excessive amounts of fat in the
Hyperhidrosis Strattera – The triggering of an excess of sweat
being produced on the soles of the feet, the palms, or the underarms which
can cause embarrassment or losing grip on a pen or other items.
Hyperkeratosis Strattera – An abnormal enlargement of the skin
tissues causing the skin cells to increase in size.
Hyperlipidemia Strattera – An abnormally high number of fat
cells in the blood.
Strattera – Too many triglycerides in the
Triglycerides are three fatty
acids bound together in one molecule stored by the body and available to create
high levels of energy when used.
Hypoesthesia – A partial loss of sensation or general
loss of awareness.
Impaired Gastric Emptying – The contents of the
stomach are not passed into the intestines as normal due to the stomach
losing the muscular strength to do so.
Increased White Blood cell Count – This is an increase
in the number of cells in the blood that are responsible for the removal of
bacteria and other unwanted particles. They fight disease and infection by
enclosing foreign particles and removing them. An example of a disease that
would increase white blood cell count would be Leukemia.
Insomnia – Not able to fall asleep or sleeping for a
shorter time than desired, thus not being able to properly rest and feeling
un-refreshed. As a result, a person can become irritable, have difficulty
concentrating and feel a lack of energy. This can be caused by stimulants
such as by caffeine or drugs or by mental anxiety and stress. Mental stress
can be communicated and relieved.
Irritable Bowel Syndrome – A painful condition where
the either the muscles or the nerves of the lower intestines, are not
responding normally. This results in an alternating condition of diarrhea
followed by constipation, back and forth.
Keratoconjunctivitis Sicca – A condition where the
outer coating of the eyeball is dry because of a decrease in the normal
amount of tears in the eye. As a result, the eyeball and inside of the
eyelid thickens and hardens sometimes causing the vision to be less sharp.
Leukopenia – An unnaturally low number of white blood
cells circulating in the blood.
Loose Stools – The bowel movement is runny instead of
Lower Abdominal Pain – A hurtful irritation of the
nerve endings in the area of the hipbones housing the lower digestive
tract. Pain usually means tissue damage.
Lymphadenopathy – The lymph nodes, where the immune
cells are located, become larger than is normal because of a high
concentration of white blood cells.
Macular Degeneration – The gradual loss of central
vision, which is the sharpest vision while peripheral eyesight, is
Maculopathy – An abnormal condition of the yellow spot
of the eye, which is located in the center of the inner lining of the
eyeball and connected to the main nerve to the eye and is responsible for
Mania – Unusually irrational, excessive and/or
exaggerated behavior or moods ranging from enthusiasm, sexuality, gaiety,
impulsiveness and irritability to violence.
Melena – Abnormally darkly colored stools as a result
of hemorrhaging in the digestive tract where the blood has interacted with
the digestive juices creating the dark color in the bowel movement.
Micturition Urgency – A sudden desire to urinate
usually followed by leakage.
Mood Swings – An emotional shifting as from a state of
happiness to a state of depression for a period of time.
Myocardial Infarction – The blood going to the heart
is delayed or stopped causing middle muscle tissue in the heart wall to die.
Nasopharyngitis – Irritation, redness and swelling
tissues in the nose and the tube leading from the mouth to the voice box as
well as the tubes leading to the ears.
Nephropathy – An abnormally functioning or diseased
Nervousness – Jumpy, jittery, anxious, and troubled
with an irritable temperament.
Night Sweats – The water-salt, waste product the skin
releases is called sweat or perspiration. With night sweats you become
wide awake in the middle of the night shivering and cold and wet with your
sheets/pajamas soaked in perspiration making it difficult to go back to
Nightmare – Dreams that make you afraid or leave
feelings of fear, terror, and upset long after waking up.
Orgasm Abnormal – Unable to have an orgasm with normal
Oropharyngeal Swelling – A swelling in the area from
the soft part of the roof of the mouth to the back of the mouth.
Pain in Extremity – A painful feeling in the legs,
arms, hands, and feet.
Pharyngolaryngeal Pain – Pain in the area of the
respiratory tract (organs of breathing) from the throat to the voice box and
above the windpipe.
Photopsia – A condition where a person see lights,
sparks or colors in front of your eyes.
Photosensitivity Reaction – An exaggerated sunburn
reaction that is not normal in proportion to the amount of exposure to the
Pollakiuria – Urinating much more frequently than
normal – as often as once every five to fifteen minutes.
Pressure of Speech – A condition where the individual
cannot voice his ideas fast enough with the pressure of there being not
enough time to say it.
Pruritic Rash – Extremely itchy, red, swollen bumps on
Pyrexia – Fever or the increase in body temperature
that is usually a sign of infection.
Retinal Detachment – The thin layer lining the back of
the eyeball (the retina) detaches from the back of the eyeball. This thin
layer is like the film of a camera because it sends the images a person
views to the brain. When it detaches it causes a reduced ability to see.
Rigors – Shivering or shaking of the body as if
chilled, preventing normal responses.
Skin Ulcer – An open sore or infected skin eruption
with swelling, redness, pus, and irritation.
Sleep Disorder – These are a list of sleep disorders
such as teeth grinding, insomnia, jet lag, sleep walking, abnormally falling
asleep during the middle of a conversation after a full night’s rest,
uncontrolled body motions keeping one awake, etc.
Suicide, Completed – An attempted attack on oneself
that is life threatening results in death.
Upper Respiratory Tract Infection – Where the organs
of breathing near the mouth such as the nose and sinuses, become infected
and are usually treated by antibiotics.
Urinary Hesitation – Hard to start or hard to continue
emptying one’s bladder.
Urinary Incontinence – Urinating without intending to
do so because of a weakening of the muscles in the hip area from the drug
affecting the nerves or the drug blocking a persons thinking process.
Urinary Retention – The inability to completely empty
the bladder despite having the urge to do so. This can lead to infections
or damage to the urinary organs.
Urine Flow Decreased – Dehydration of the body causing
a lesser flow of urine than normal with the body reabsorbing the waste.
Urine Output Decreased – A condition where the output
of urine produced in a 24-hour period is less than 500 ml.
Weight Decreased – Unintentional weight loss.
STRATTERA™ (Lilly) (atomoxetine HCl)
STRATTERA™ (atomoxetine HCl) is a selective norepinephrine reuptake
inhibitor. Atomoxetine HCl is the R (-) isomer as determined by x-ray
diffraction. The chemical designation is (-)- N -methyl-3-phenyl-3-( o
-tolyloxy)-propylamine hydrochloride. The molecular formula is C 17 H
21 NO•HCl, which corresponds to a molecular weight of 291.82.
Pharmacodynamics and Mechanism of Action
The precise mechanism by which atomoxetine produces its therapeutic
effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is unknown, but
is thought to be related to selective inhibition of the pre-synaptic
norepinephrine transporter, as determined in ex vivo uptake and
neurotransmitter depletion studies.
Atomoxetine is well-absorbed after oral administration and is minimally
affected by food. It is eliminated primarily by oxidative metabolism through
the cytochrome P450 2D6 (CYP2D6) enzymatic pathway and subsequent
glucuronidation. Atomoxetine has a half-life of about 5 hours. A fraction of
the population (about 7% of Caucasians and 2% of African Americans) are poor
metabolizers (PMs) of CYP2D6 metabolized drugs. These individuals have reduced
activity in this pathway resulting in 10-fold higher AUCs, 5-fold higher peak
plasma concentrations, and slower elimination (plasma half-life of about 24
hours) of atomoxetine compared with people with normal activity [extensive
metabolizers (EMs)]. Drugs that inhibit CYP2D6, such as fluoxetine, paroxetine,
and quinidine, cause similar increases in exposure.
The pharmacokinetics of atomoxetine have been evaluated in more than 400
children and adolescents in selected clinical trials, primarily using population
pharmacokinetic studies. Single-dose and steady-state individual pharmacokinetic
data were also obtained in children, adolescents, and adults. When doses were
normalized to a mg/kg basis, similar half-life, C max , and AUC
values were observed in children, adolescents, and adults. Clearance and volume
of distribution after adjustment for body weight were also similar.
Absorption and Distribution --Atomoxetine is rapidly absorbed after
oral administration, with absolute bioavailability of about 63% in EMs and 94%
in PMs. Maximal plasma concentrations (C max ) are reached
approximately 1 to 2 hours after dosing.
Metabolism and Elimination --Atomoxetine is metabolized primarily
through the CYP2D6 enzymatic pathway. People with reduced activity in this
pathway (PMs) have higher plasma concentrations of atomoxetine compared with
people with normal activity (EMs). For PMs, AUC of atomoxetine is approximately
10-fold and C ss,max is about 5-fold greater than EMs.Coadministration of
STRATTERA with potent inhibitors of CYP2D6, such as fluoxetine, paroxetine, or
quinidine, results in a substantial increase in atomoxetine plasma exposure, and
dosing adjustment may be necessary. Atomoxetine did not inhibit or induce
the CYP2D6 pathway.
The major oxidative metabolite formed, regardless of CYP2D6 status, is
4-hydroxyatomoxetine, which is glucuronidated. 4-Hydroxyatomoxetine is
equipotent to atomoxetine as an inhibitor of the norepinephrine transporter but
circulates in plasma at much lower concentrations (1% of atomoxetine
concentration in EMs and 0.1% of atomoxetine concentration in PMs).
4-Hydroxyatomoxetine is primarily formed by CYP2D6, but in PMs,
4-hydroxyatomoxetine is formed at a slower rate by several other cytochrome P450
enzymes. N-Desmethylatomoxetine is formed by CYP2C19 and other cytochrome P450
enzymes, but has substantially less pharmacological activity compared with
atomoxetine and circulates in plasma at lower concentrations (5% of atomoxetine
concentration in EMs and 45% of atomoxetine concentration in PMs).
Mean apparent plasma clearance of atomoxetine after oral administration in
adult EMs is 0.35 L/hr/kg and the mean half-life is 5.2 hours. Following oral
administration of atomoxetine to PMs, mean apparent plasma clearance is 0.03
L/hr/kg and mean half-life is 21.6 hours. For PMs, AUC of atomoxetine is
approximately 10-fold and C ss,max is about 5-fold greater than EMs.
The elimination half-life of 4-hydroxyatomoxetine is similar to that of N-desmethylatomoxetine
(6 to 8 hours) in EM subjects, while the half-life of N-desmethylatomoxetine is
much longer in PM subjects (34 to 40 hours).
Atomoxetine is excreted primarily as 4-hydroxyatomoxetine- O -glucuronide,
mainly in the urine (greater than 80% of the dose) and to a lesser extent in the
feces (less than 17% of the dose). Only a small fraction of the STRATTERA dose
is excreted as unchanged atomoxetine (less than 3% of the dose), indicating
CYP2D6 activity and atomoxetine plasma concentration --Atomoxetine is
primarily metabolized by the CYP2D6 pathway to 4-hydroxyatomoxetine. In EMs,
inhibitors of CYP2D6 increase atomoxetine steady-state plasma concentrations to
exposures similar to those observed in PMs. Dosage adjustment of STRATTERA in
EMs may be necessary when coadministered with CYP2D6 inhibitors, e.g.,
paroxetine, fluoxetine, and quinidine. In vitro studies suggest that
coadministration of cytochrome P450 inhibitors to PMs will not increase the
plasma concentrations of atomoxetine.
Effect of atomoxetine on P450 enzymes --Atomoxetine did not cause
clinically important inhibition or induction of cytochrome P450 enzymes,
including CYP1A2, CYP3A, CYP2D6, and CYP2C9.
Albuterol --Albuterol (600 mcg iv over 2 hours) induced increases in
heart rate and blood pressure. These effects were potentiated by atomoxetine (60
mg BID for 5 days) and were most marked after the initial coadministration of
albuterol and atomoxetine.
Alcohol --Consumption of ethanol with STRATTERA did not change the
intoxicating effects of ethanol.
Desipramine --Coadministration of STRATTERA (40 or 60 mg BID for 13
days) with desipramine, a model compound for CYP2D6 metabolized drugs (single
dose of 50 mg), did not alter the pharmacokinetics of desipramine. No dose
adjustment is recommended for drugs metabolized by CYP2D6.
Methylphenidate --Coadministration of methylphenidate with STRATTERA
did not increase cardiovascular effects beyond those seen with methylphenidate
Midazolam --Coadministration of STRATTERA (60 mg BID for 12 days) with
midazolam, a model compound for CYP3A4 metabolized drugs, (single dose of 5 mg),
resulted in 15% increase in AUC of midazolam. No dose adjustment is recommended
for drugs metabolized by CYP3A.
In pediatric placebo-controlled trials, STRATTERA-treated
subjects experienced a mean increase in heart rate of about 6 beats/minute
compared with placebo subjects. At the final study visit before drug
discontinuation, 3.6% (12/335) of STRATTERA-treated subjects had heart rate
increases of at least 25 beats/minute and a heart rate of at least 110
beats/minute, compared with 0.5% (1/204) of placebo subjects. No pediatric
subject had a heart rate increase of at least 25 beats/minute and a heart rate
of at least 110 beats/minute on more than one occasion. Tachycardia was
identified as an adverse event for 1.5% (5/340) of these pediatric subjects
compared with 0.5% (1/207) of placebo subjects. The mean heart rate increase
in extensive metabolizer (EM) patients was 6.7 beats/minute, and in poor
metabolizer (PM) patients 10.4 beats/minute.
CYP2D6 metabolism --Poor metabolizers (PMs) of CYP2D6 have a
10-fold higher AUC and a 5-fold higher peak concentration to a given dose of
STRATTERA compared with extensive metabolizers (EMs). Approximately 7% of a
Caucasian population are PMs. Laboratory tests are available to identify CYP2D6
PMs. The blood levels in PMs are similar to those attained by taking strong
inhibitors of CYP2D6. The higher blood levels in PMs lead to a higher rate of
some adverse effects of STRATTERA.
CYP2D6 inhibitors --Atomoxetine is primarily metabolized by the CYP2D6
pathway to 4-hydroxyatomoxetine. In EMs, selective inhibitors of CYP2D6 increase
atomoxetine steady-state plasma concentrations to exposures similar to those
observed in PMs. Dosage adjustment of STRATTERA may be necessary when
coadministered with CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and
quinidine. In EM individuals treated with paroxetine or fluoxetine, the AUC of
atomoxetine is approximately 6- to 8-fold and C ss,max is about 3- to
4-fold greater than atomoxetine alone.
Child and Adolescent Clinical Trials
Reasons for discontinuation of treatment due to adverse events in child
and adolescent clinical trials --In acute child and adolescent
placebo-controlled trials, 3.5% (15/427) of atomoxetine subjects and 1.4%
(4/294) placebo subjects discontinued for adverse events. For all studies,
(including open-label and long-term studies), 5% of extensive metabolizer (EM)
patients and 7% of poor metabolizer (PM) patients discontinued because of an
adverse event. Among STRATTERA-treated patients, aggression (0.5%, N=2);
irritability (0.5%, N=2); somnolence (0.5%, N=2); and vomiting (0.5%, N=2) were
the reasons for discontinuation reported by more than 1 patient.
The following adverse events occurred in at least 2% of
PM patients and were either twice as frequent or statistically significantly
more frequent in PM patients compared with EM patients: decreased appetite (23%
of PMs, 16% of EMs); insomnia (13% of PMs, 7% of EMs); sedation (4% of PMs, 2%
of EMs); depression (6% of PMs, 2% of EMs); tremor (4% of PMs, 1% of EMs); early
morning awakening (3% of PMs, 1% of EMs); pruritus (2% of PMs, 1% of EMs);
mydriasis (2% of PMs, 1% of EMs).
General Dosing Information
STRATTERA may be taken with or without food.
The safety of single doses over 120 mg and total daily doses above 150 mg
have not been systematically evaluated.
Dosing adjustment for hepatically impaired patients --For those ADHD
patients who have hepatic insufficiency (HI), dosage adjustment is recommended
as follows: For patients with moderate HI (Child-Pugh Class B), initial and
target doses should be reduced to 50% of the normal dose (for patients without
HI). For patients with severe HI (Child-Pugh Class C), initial dose and target
doses should be reduced to 25% of normal.
Dosing adjustment for use with a strong CYP2D6 inhibitor --In children
and adolescents up to 70 kg body weight administered strong CYP2D6 inhibitors,
e.g., paroxetine, fluoxetine, and quinidine, STRATTERA should be initiated at
0.5 mg/kg/day and only increased to the usual target dose of 1.2 mg/kg/day if
symptoms fail to improve after 4 weeks and the initial dose is well tolerated.
In children and adolescents over 70 kg body weight and adults administered
strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, STRATTERA
should be initiated at 40 mg/day and only increased to the usual target dose of
80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well