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Strattera is prescribed to help with ADHD symptoms. However, Strattera is
actually an antidepressant medication.
If you wish to remain on Strattera but eliminate current Strattera withdrawal
side effects, click here. If you want to taper off the Strattera and you are not
sure where to start, you can click here and read the bestselling book, How to
Get Off Psychoactive Drugs Safely or send Jim Harper an email at
Jim@theroadbnack.org and he will guide you through the process of Strattera
withdrawal.
Find how to get Strattera withdrawal relief as well as Strattera withdrawal side
effects. Strattera withdrawal. If you are taking Strattera as well as an
anti-anxiety medication (benzodiazepine), the anti-anxiety medication must be
discontinued first. If you are only discontinuing the Strattera, the Strattera
must be reduced very slowly to prevent withdrawal side effects from the
anti-anxiety drug. Strattera slows the metabolism rate of anti-anxiety drugs and
when the Strattera is removed from the system the anti-anxiety medication will
not take as long to metabolize and this creates a withdrawal effect from the
anti-anxiety medication. See chapter 9 on the right side of each page for
anti-anxiety medication procedures.
Strattera, also known as atomoxetine, is a medication used to treat attention
deficit hyperactivity disorder (ADHD). It works by increasing the levels of
norepinephrine in the brain, which helps to improve focus and concentration.
Like many medications, Strattera can cause withdrawal symptoms when it is
discontinued after long-term use. These symptoms can vary in severity depending
on the length of time the medication was taken, the dosage, and other individual
factors.
Some common symptoms of Strattera withdrawal include: Mood changes: People who
stop taking Strattera may experience mood changes such as depression, anxiety,
irritability, and aggression.
Fatigue: Strattera withdrawal can cause feelings of fatigue and lethargy, making
it difficult to stay motivated and productive.
Sleep disturbances: Insomnia, vivid dreams, and other sleep disturbances are
common during Strattera withdrawal.
Nausea and vomiting: Strattera withdrawal can cause digestive issues such as
nausea and vomiting.
Headaches: Headaches are a common symptom of Strattera withdrawal and can range
in intensity from mild to severe.
Flu-like symptoms: Some people may experience flu-like symptoms such as fever,
chills, and body aches during Strattera withdrawal.
Dizziness and lightheadedness: Strattera withdrawal can cause feelings of
dizziness and lightheadedness, which can be dangerous if not managed properly.
Increased heart rate: Strattera withdrawal can cause an increase in heart rate,
which can be uncomfortable and anxiety-provoking.
It is important to note that not everyone will experience all of these symptoms,
and some people may not experience any symptoms at all. Additionally, the
severity and duration of symptoms can vary widely from person to person.
If you are considering stopping Strattera, it is important to speak with your
healthcare provider first. They can help you develop a plan for safely tapering
off the medication to minimize the risk of withdrawal symptoms.
Tapering involves gradually reducing the dosage of Strattera over a period of
several weeks or months, depending on how long you have been taking the
medication and the dosage you are on. This gradual approach allows your body to
adjust to the lower dosage and helps to prevent withdrawal symptoms.
If you do experience withdrawal symptoms despite tapering off Strattera, there
are several things you can do to manage them. Some strategies include:
Stay hydrated: Drinking plenty of water can help to alleviate symptoms such as
headaches and nausea.
Get plenty of rest: Rest is important during Strattera withdrawal, as it can
help to combat feelings of fatigue and lethargy.
Practice stress-reduction techniques: Techniques such as deep breathing,
meditation, and yoga can help to reduce feelings of anxiety and irritability.
Exercise: Exercise can help to improve mood, reduce stress, and increase energy
levels. Seek support: Talking to friends, family, or a mental health
professional can help to provide emotional support during Strattera withdrawal.
In some cases, medication may be necessary to manage withdrawal symptoms. Your
healthcare provider can help determine whether medication is appropriate for you
based on your individual symptoms and medical history.
In conclusion, Strattera withdrawal can be challenging, but with the right
support and management strategies, it is possible to minimize the impact of
withdrawal symptoms. If you are considering stopping Strattera, be sure to speak
with your healthcare provider to develop a safe and effective plan for tapering
off the medication.
Strattera Withdrawal
Strattera is usually prescribed for ADD/ADHD
but is really an antidepressant and tapering off Strattera needs to follow that
protocol. Click Program and follow the antidepressant
taper suggestions.
The web site you are on now, The Road Back, offers information on how to get off
Strattera, prevent Strattera withdrawal side effects as well as eliminating
current Strattera side effects.
You will find on this site the complete book, How to Get Off Psychoactive Drugs
Safely. Since 1999, over 40,000 people have now used this information to get off
their antidepressant or other type of psychoactive medication.
Withdrawal off of Strattera does not have to be difficult and handling current
Strattera side effects can be resolved quickly.
Note: If you are taking Strattera as well as an anti-anxiety medication
(benzodiazepine), the anti-anxiety medication must be discontinued first. If you
are only discontinuing the Strattera the Strattera must be reduced very slowly
to prevent withdrawal side effects from the anti-anxiety drug. Strattera slows
the metabolism rate of anti-anxiety drugs and when the Strattera is removed from
the system the anti-anxiety medication will not take as long to metabolize and
this creates a withdrawal effect from the anti-anxiety medication. See chapter 9
on the right side of each page for anti-anxiety medication procedures.
FDA Talk Paper
T04-60
December 17, 2004 Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
New Warning for Strattera
The Food and Drug Administration (FDA) is advising health care professionals
about a new warning for Strattera, a drug approved for attention deficit
hyperactivity disorder (ADHD) in adults and children. The labeling is being
updated with a bolded warning about the potential for severe liver injury
following two reports (a teenager and an adult) in patients who had been treated
with Strattera for several months, both of whom recovered.
The labeling warns that severe liver injury may progress to liver failure
resulting in death or the need for a liver transplant in a small percentage of
patients. The labeling also notes that the number of actual cases of severe
liver injury is unknown because of under-reporting of post-marketing adverse
events.
The bolded warning indicates that the medication should be discontinued in
patients who developed jaundice (yellowing of the skin or whites of the eyes) or
laboratory evidence of liver injury.
Strattera has been on the market since 2002 and has been used in more than 2
million patients. In clinical trials of 6000 patients, no signal for liver
problems (hepatotoxicity) had emerged.
FDA has asked the manufacturer to add a bolded warning about severe liver injury
to the labeling. Eli Lilly has agreed to alert health care professionals about
the new information in a Dear Health Professional letter. The company will also
update the patient package insert with information about the signs and symptoms
of liver problems, which include:
Pruritus (Itchy skin)
Jaundice
Dark urine
Upper right-sided abdominal tenderness
Or unexplained “flu-like” symptoms
Health care professionals are encouraged to report any unexpected adverse events
associated with Strattera directly to Eli Lilly, Indianapolis, Ind., at
1800-LillyRx or to the FDA MedWatch program at 1800-FDA-1088. The MedWatch form
is available online at http://www.fda.gov/medwatch/safety/3500.pdf for download
by mail (or fax, 1800-FDA-0178) to MedWatch, HFD-410, FDA, 5600 Fishers Lane,
Rockville, Md. 20857.
Strattera is really an antidepressant that Eli Lilly could not find a market for
in the early 1990's. Eli Lilly sat on the drug until they came up with the idea
of using it for ADHD. If you are giving Strattera to your child or thinking
about doing so, know you are really giving them an antidepressant and all
caution should be taken.
Before allowing your child to take Strattera, please read down this page and pay
special note to the bold text. We know most parents would not give their child
medication if they knew it would cause more harm than good. We also understand
the need for a parent to receive verifiable information that is also reliable.
The Strattera information below is from the Physicians' Desk Reference, supplied
by Eli Lilly. Their report, not ours. We are only evaluating their data.
At issue with Strattera as well as with the class of antidepressants called
SSRIs, is the metabolism and side effects.
STRATTERA™ (Lilly) (atomoxetine HCl)
DESCRIPTION
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.
CLINICAL PHARMACOLOGY
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.
Human Pharmacokinetics
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
extensive biotransformation.
Drug-Drug Interactions
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 alone.
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.
Precautions
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.
Laboratory Tests
Routine laboratory tests are not required.
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
tolerated.