Psych Drug Truth

Common Strattera Side Effects

Strattera should not be reduced quickly.

Strattera

Anxiety - Insomnia - Agitation - Weight Gain - Fatigue

Strattera withdrawal

 
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 Strattera withdrawal. Strattera withdrawal side effects, withdrawal warnings, withdrawal precautions, withdrawal adverse effects, overdose, withdrawal symptoms and natural alternatives. Before you begin the spiral down with Strattera, try giving your body what it really wants.

Strattera
(atomoxetine)  

Strattera Side Effects
(atomoxetine)  

Are you experiencing Strattera withdrawal?

The Road Back Program has been assisting people with Strattera withdrawal since 1999, and have helped over 50,000 people become drug free.

If you are suffering from Strattera withdrawal or Strattera side effects, The Road Back Program will likely be of help.

Head symptoms, anxiety, insomnia and other Strattera side effects can be a thing of the past. Click here and you will be directed to The Road Back Program web site. Their assistance is free.

Strattera is an antidepressant developed by Eli Lilly in 1992 but prescribed for ADHD today.

Strattera - Side Effects Defined - Strattera withdrawal side effects

  1. Anorexia Strattera – No longer having a desire to eat.
     
  1. Apothous Stomatitis Strattera – Painful red and swollen open sores on a mucus membrane of the mouth commonly called a canker sore.
     
  1. Ataxia Strattera – Loss of the ability to move the body with coordination.
     
  1. Arterial Fibrillation 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.
     
  1. 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.
     
  1. 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.
     
  1. 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.

  1. Cardiac Failure Strattera – A heart disorder where the heart does not function as usual and may completely stop working.
     
  1. 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.
     
  1. 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 nervousness.
     
  1. Colitis Strattera – A condition where the large intestine becomes irritated from the use of the drug.
     
  1. 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.
     
  1. Dehydration Strattera – An extreme loss of water from the body or the organs of the body as in sickness or not drinking enough fluids.
     
  1. 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.
     
  1. 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.
     
  1. Dysarthria Strattera – The inability to control the mouth muscles when forming words so the words are not clearly spoken and heard.
     
  1. Dyslipidemia Strattera – The normal fat metabolism in the blood is interfered with.
     
  1. Dysphagia Strattera – Trouble swallowing or the inability to swallow.
     
  1. Ecchymosis Strattera – When a blood vessel breaks and creates a purple discoloration of the skin.
     
  1. Edema Strattera – An abnormal build up of excess fluids in the cells, tissues, and the spaces between the tissues creating swelling.
     
  1. 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.
     
  1. Ejaculation Delayed 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.
     
  1. Ejaculation Dysfunction 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.
     
  1. Erectile Dysfunction 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.
     
  1. Erythema Strattera – a skin redness caused by the swelling with blood of the tiny blood vessels of the skin as in burns.
     
  1. Erythematous Rash Strattera – Redness of the skin from the swelling of the tiny blood vessels with skin irritation (itching, burning, tingling, pain) and breakouts (eruptions).

 

  1. Esophageal Stenosis Acquired Strattera – The tube that moves food from the mouth to the stomach narrows.
     
  1. Exfoliative Dermatitis Strattera – The unusual and not normal condition of scaling and shedding of the skin cells.  The skin is usually red colored.
     
  1. Face Edema Strattera – The tissues of the face become swollen.
     
  1. Feeling Jittery Strattera – A physical sensation of nervous unease.
     
  1. Gastric Irritation Strattera – An inflamed and sore stomach.
     
  1. Gastric Ulcer Strattera – An open, irritated, and infected sore in the wall of the stomach.
     
  1. Gingivitis Strattera – Sore, swollen and red gums in the mouth that bleed easily.
     
  1. 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.
     
  1. Hepatic Steatosis Strattera – Excessive amounts of fat in the liver.
     
  1. 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.
     
  1. Hyperkeratosis Strattera – An abnormal enlargement of the skin tissues causing the skin cells to increase in size.
     
  1. Hyperlipidemia Strattera – An abnormally high number of fat cells in the blood.
     
  1. Hypertriglyceridemia Strattera – Too many triglycerides in the blood. 

Triglycerides are three fatty acids bound together in one molecule stored by the body and available to create high levels of energy when used. 

  1. Hypoesthesia – A partial loss of sensation or general loss of awareness.
     
  1. 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.
     
  1. 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.
     
  1. 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.
     
  1. 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.
     
  1. 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.
     
  1. Leukopenia – An unnaturally low number of white blood cells circulating in the blood.
     
  1. Loose Stools – The bowel movement is runny instead of formed.
     
  1. 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.
     
  1. Lymphadenopathy – The lymph nodes, where the immune cells are located, become larger than is normal because of a high concentration of white blood cells.
     
  1. Macular Degeneration – The gradual loss of central vision, which is the sharpest vision while peripheral eyesight, is unaffected.
     
  1. 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 sharp vision.
     
  1. Mania – Unusually irrational, excessive and/or exaggerated behavior or moods ranging from enthusiasm, sexuality, gaiety, impulsiveness and irritability to violence.
     
  1. 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.
     
  1. Micturition Urgency – A sudden desire to urinate usually followed by leakage.
     
  1. Mood Swings – An emotional shifting as from a state of happiness to a state of depression for a period of time.
     
  1. Myocardial Infarction – The blood going to the heart is delayed or stopped causing middle muscle tissue in the heart wall to die.
     
  1. 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.
     
  1. Nephropathy – An abnormally functioning or diseased kidney.
     
  1. Nervousness – Jumpy, jittery, anxious, and troubled with an irritable temperament.
     
  1. 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 sleep.
     
  1. Nightmare – Dreams that make you afraid or leave feelings of fear, terror, and upset long after waking up.
     
  1. Orgasm Abnormal – Unable to have an orgasm with normal sexual stimulation.
     
  1. Oropharyngeal Swelling – A swelling in the area from the soft part of the roof of the mouth to the back of the mouth.
     
  1. Pain in Extremity – A painful feeling in the legs, arms, hands, and feet.
     
  1. Pharyngolaryngeal Pain – Pain in the area of the respiratory tract (organs of breathing) from the throat to the voice box and above the windpipe.
     
  1. Photopsia – A condition where a person see lights, sparks or colors in front of your eyes.
     
  1. Photosensitivity Reaction – An exaggerated sunburn reaction that is not normal in proportion to the amount of exposure to the light.
     
  1. Pollakiuria – Urinating much more frequently than normal – as often as once every five to fifteen minutes.
     
  1. 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.
     
  1. Pruritic Rash – Extremely itchy, red, swollen bumps on the skin.
     
  1. Pyrexia – Fever or the increase in body temperature that is usually a sign of infection.
     
  1. 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.
     
  1. Rigors – Shivering or shaking of the body as if chilled, preventing normal responses.
     
  1. Skin Ulcer – An open sore or infected skin eruption with swelling, redness, pus, and irritation.
     
  1. 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.
     
  2. Suicide, Completed – An attempted attack on oneself that is life threatening results in death.
     
  1. 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.
     
  1. Urinary Hesitation – Hard to start or hard to continue emptying one’s bladder.
     
  1. 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.
     
  1. 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.
     
  1. Urine Flow Decreased – Dehydration of the body causing a lesser flow of urine than normal with the body reabsorbing the waste.
     
  1. Urine Output Decreased – A condition where the output of urine produced in a 24-hour period is less than 500 ml.
     
  1. Weight Decreased – Unintentional weight loss.

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.

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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.

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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.

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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).

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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.

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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.

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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.

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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.

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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.

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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.

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