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Strattera (Atomoxetine HCL): All the Possible Side Effects of Stratteras

By Miriatu

Strattera

Strattera (Atomoxetine HCL) is a serotonin-norepinephrine reuptake inhibitor (SNRI). Following its released in December 2002, it has grown to become the highest circulating Attention Deficit Hyperactivity Disorder (ADHD) medicine, capturing 16.3% of the market share in just nine months.

 

 

 

Description of Strattera (Atomoxetine HCL)

 

Strattera is used to treat Attention Deficit Hyperactivity Disorder (ADHD). ADHD medications such as Strattera should always be part of a comprehensive treatment program that includes educational, psychological, and social tips set to assist in the treatment of ADHD.

 

Exactly how Strattera (atomoxetine HCL) works to treat ADHD is anonymous. It is thought to work by beefing up the degree of norepinephrine, one of the brain chemicals liable for controlling activity. This may disrupt attention behavior. Strattera is the first ADHD medication to avoid classification as a controlled substance (a drug with elements for abuse). It is recommended for teens as well as adults.

 

During clinical tests, researchers noticed that Strattera slowed children's average rate of growth. It is not known whether final adult height and weight are also affected. However, users are advised to discontinue use of the drug if a child is not growing or gaining weight at the expected rate.

 

This article is therefore only to empower you with detail knowledge you seek to know about Strattera as a drug, such as the side effects of Strattera and the uses of Strattera and should for no reason be taken as a replacement of a doctor’s advice or prescription.  

 

 

 

Possible side effects of Strattera

 

There are some side effects of Strattera recorded based on clinical studies. Some of which are said to be serious and thus require that you call the emergency help once you notice it. Such adverse reactions include:

 

Difficulty urinating.

 

  • Urinating problems such as trouble starting or keeping a urine stream and not being able to fully empty the bladder
  • Slowing of growth (height and weight) in children
  • Unusually irregular or fast heartbeat, numbness or tingling, and fainting.
  • Atomoxetine may rarely cause serious (possibly fatal) liver disease.
  • Any symptoms that suspect liver damage, such as dark urine, persistent nausea, vomiting, loss of appetite, stomach or abdominal pain, yellowing eyes or skin.
  • Strattera may rarely cause serious problems like a heart attack or stroke.
  • Chest, jaw or left arm pain, shortness of breath,
  • Unusual sweating, 
  • Weakness on one side of the body,
  • Confusion, slurred speech, and
  • Sudden vision changes.
  • Rarely, males (including teens and young boys) using this medication may have a prolonged or painful erection lasting 4 or more hours. Parents and caregivers should be watchful for this serious side effect on boys. If it occurs, stop using this drug immediately and get medical help right away in order to prevent permanent problems from occurring. Seek more details from your doctor or pharmacist.
  • It is rare for a serious allergic reaction to this drug to occur. However, you should get medical help promptly if you notice any symptoms of a serious allergic reaction, such as severe dizziness, hives or rash, trouble breathing, and itching or swelling (especially of the face, tongue, and/or throat).

 

 

 

Common side effects of Strattera as seen in children and adults

 

Below are some of the common Strattera side effects in children and teenagers

 

Upset stomach, dizziness, drowsiness, trouble sleeping, decreased appetite, loss of appetite/weight loss, dry mouth, nausea or vomiting, dizziness, tiredness, mood swings, constipation, tiredness, or decrease in sexual ability or desire, sexual side effects, sleeping difficulties, decreased appetite, problems passing urine all depicts Strattera side effects may occur.

 

In women, missed/irregular periods or menstrual cramps may be associated with Strattera

 


 

Warnings and Precautions

 

In as much as the performance of Strattera cannot be emphasized, nevertheless certain basic warnings and precautions of the drug have to be considered.

 

i). Suicidal Ideation

 

Strattera increased the risk of suicidal ideation in short-term studies in children and adolescents with attention deficit/hyperactivity disorder (ADHD). Pooled developments of short-term (six to eighteen weeks) placebo-controlled trials of Strattera in children and adolescents have revealed a greater risk of suicidal ideation early during treatment in those taking Strattera. There were a number of twelve tests (eleven with ADHD and 1 in enuresis) involving over 2.200 patients (including 1.357 patients receiving Strattera and 851 taking placebo). The moderate danger of suicidal ideation in patients receiving Strattera was 0.4% (5/1357 patients), compared to none in placebo-treated sick persons. There was one attempted suicide between these, approximately 2.200 sick persons, happening in a sick person cured with Strattera. No suicides happened during these tests. All reactions happened in teens younger than twelve years of age. It is not known whether the danger of suicidal ideation in pediatric patients extends to future use. A related analysis in adult sick persons cured with Strattera for either ADHD or major depressive disorder (MDD) did not reveal an increased risk of suicidal ideation or behavior in association with the use of Strattera.

 

All pediatric patients being treated with Strattera should be monitored appropriately and observed closely for unusual changes in behavior, suicidality, clinical worsening and, particularly during the initial past months of a course of drug treatment, or sometimes of tablets changes, either decreases or increases. The following symptoms have been reported with Strattera:

 

Agitation, insomnia, anxiety, hostility, aggressiveness, panic attacks, akathisia (psychomotor restlessness), irritability, hypomania, mania, and impulsivity.

 

Even though a causal combination between the emergence of such symptoms and the emergence of suicidal impulses has not been set up, there is an attention that such signs may represent precursors to upcoming suicidality. Hence, the sick persons being cured with Strattera should be observed for the emergence of such symptoms. Consideration should be given to changing the therapeutic regimen, consisting of possible non-continuing the treatment, in patients who are witnessing upcoming suicidality or symptoms that might be precursors to emerging suicidality, especially if these signs are abrupt or severe in the beginning, or were not associated of the patient’s showing signs. Caregivers and Families of pediatric sick persons being treated with Strattera should be alerted about the need to monitor patients for the emergence of unusual changes in behavior, irritability, agitation, and the other signs explained above, and the upcoming of suicidality, and to report such signs rapidly to healthcare practitioners. Such surveillance should comprise of daily examination by families and caregivers.

 

ii). Severe Liver Injury

 

Post marketing reports indicate that Strattera can cause severe liver attack. Even though no proof of liver attack was detected in clinical trials of about six thousand patients, there have been scarce situation of clinically significant liver injury that were considered probably or possibly related to Strattera use in post marketing experience. Because of probable insufficient reporting, it is not possible to offer an exact approximation of the true incidence of these manifestations. Reported situations of liver attack happened within 120 days of initiation of atomoxetine in the majority of cases and some patients presented with markedly elevated liver enzymes greater than the 20 X upper limit of proper (ULN), and jaundice with importantly raised bilirubin levels less than 2 X ULN), followed by recovery upon atomoxetine non-continuation. In one patient, liver attack, energized by elevated hepatic enzymes up to 40 X ULN and jaundice with bilirubin up to12 X ULN, recurred upon rechallenge, and was followed by recovery upon drug non-continuation, offering proof that Strattera most probably caused the liver attack. Such manifestations may happen many months after treatment is done, however, laboratory abnormalities may progress to worsen for several weeks after the drug is taken. The patient portrayed above renewed from his liver attack, and did not need a liver transplant. By and large, harsh liver attack as a result of any drug may potentially progress to acute liver failure resulting in death or the need for a liver transplant. Strattera should be discontinued in patients with jaundice or laboratory evidence of liver attack, and should not be revived. Laboratory testing to determine liver enzyme levels should be done upon the first symptom or sign of liver failure (e.g., dark urine, jaundice, right upper quadrant tenderness or unexplained “flu like” symptoms pruritus,)

 

iii). Serious Cardiovascular Events

 

Sudden death and pre-existing structural cardiac abnormalities or other serious heart problems in children and adolescents-sudden death has been reported in association with atomoxetine treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart difficulties. Even though some serious heart situations alone carry an increased risk of a quick death, atomoxetine generally should not be applied in children or adolescents with known structural cardiac cardiomyopathy, abnormalities, other serious cardiac problems or serious heart rhythm abnormalities that may place them at increased vulnerability to the noradrenergic effects of atomoxetine. Adults-Sudden deaths, stroke, and myocardial infarction have been reported in adults taking atomoxetine at usual tablets for ADHD. Even though the function of atomoxetine in these adult cases is also not known, adults have a greater possibility than teens of having serious structural cardiomyopathy, serious heart rhythm abnormalities, cardiac abnormalities, other serious cardiac problems or coronary artery disease. Consideration should be allocated not to treat adults with clinically significant cardiac abnormalities.

 

Assessing Cardiovascular Status in Patients being Treated with Atomoxetine Children, adolescents, or adults who are being considered for treatment with atomoxetine should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should obtain further cardiac assessment if findings suggest such ailment (e.g, echocardiogram and electrocardiogram). Patients who develop symptoms such as other symptoms suggestive of cardiac disease or unexplained syncope, exertional chest pain, during atomoxetine treatment should undergo a prompt cardiac evaluation.

 

Apart from these three areas of warnings and precautions, there are other areas where same warnings and precautions should be considered. These include; effects on blood pressure and heart rate, emergence of new psychotic or manic symptoms, screening patients for bipolar disorder, aggressive behavior or hostility, allergic events, effects on urine outflow from the bladder, priapism, effects on growth, laboratory tests and concomitant use of potent CYP2D6 inhibitors or use in patients who are known to be CYP2D6 PMs respectively.

 

 

 

Dosage of Strattera

 

The prescribe dosage of Strattera is analyzed subsequently to the fullest:

 

i).    Acute treatment

 

Dosing of children and adolescents up to 70 kg body weight, Strattera should be initiated at a total daily dose of exactly 0.5 mg/kg and elevated after a minimum of three days to a target total daily dose of exactly 1.2 mg/kg taken either as a single daily dose in the morning or as evenly divided doses in the morning and late early evening/afternoon. No further return has been shown for doses higher than 1.2 mg/kg/day. The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less. Dosing of children and adolescents over 70 kg body weight and adults- Strattera should be initiated at a total daily dose of 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late early evening/afternoon/. After two to four additional weeks, the tablet may be added to a maximum of 100 mg in patients who have not achieved an optimal compliance. There is no information that supports accelerated effectiveness at higher doses. The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.

 

ii).    Maintenance/extended treatment

 

It is generally agreed that pharmacological treatment of ADHD may be needed for future periods. The importance of keeping pediatric patients (ages six to fifteen years) with ADHD on Strattera after achieving a response in a dose estimate of 1.2 to 1.8 mg/kg/day was shown in a controlled test. Patients programmed to take Strattera in the buildup phase were generally continued on the same dose used to achieve a response in the open label stage. The doctor who approves to use Strattera for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

 

iii).   General Dosing Information

 

Strattera may be taken with or without food. Strattera can be discontinued without being tapered. Strattera capsules are not intended to be opened, they should be taken whole. The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated.

 

iv).    Dosing in Specific Populations

 

Dosing adjustment for hepatically impaired patients: For those ADHD sick persons who have hepatic inadequacy (HI), dosage modification may be prescribed as follows

 

For patients with moderate HI (Child-Pugh Class B), initial and require doses should be minimized to 50% of the normal dose.

 

For patients with harsh HI (Child-Pugh Class C), initial tablet and require tablets should be reduced to 25% of normal dosing adjustment. In children and adolescents up to 70 kg body weight administered with strong CYP2D6 inhibitors, e.g., fluoxetine, paroxetine, in patients or quinidine, who are known to be CYP2D6 PMs, Strattera should be prescribed at 0.5 mg/kg/day and only elevated to the normal target dose of 1.2 mg/kg/day if symptoms fail to improve after 4 weeks and the initial dose is well considered.

 

In children and adolescents over 70 kg body weight and adults administered strong CYP2D6 inhibitors, like for instance paroxetine, quinidine, fluoxetine, and most significantly Strattera should be positioned 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.

 

 

 

Strattera: Dosage Forms and Strengths

 

Every capsule constitutes atomoxetine HCl properties to 10 mg (Opaque White, Opaque White), 18 mg (Gold, Opaque White), 25 mg (Opaque Blue, Opaque White), 40 mg (Opaque Blue, Opaque Blue), 60 mg (Opaque Blue, Gold), 80 mg (Opaque Brown, Opaque White), or 100 mg (Opaque Brown, Opaque Brown) of atomoxetine.

 

 

 

Over dosage of Strattera

 

Human Experience: No fatal overdoses occurred in clinical tests. There is limited clinical test knowledge with Strattera overdose. During postmarketing, there have been some setbacks reported involving a mixed ingestion of overdose of Strattera and at least one other dose. There have been no reports of death relating to the overdose of Strattera, involving conscious overdoses amounting up to 1400 mg. Some of the cases of overdose relating to Strattera, confiscation have been reported. The most known reported symptoms accompanying acute and chronic overdoses of Strattera were tremor, somnolence, gastrointestinal symptoms, abnormal behavior and dizziness. Agitation and hyperactivity have also been released. Symptoms and signs consistent with mild to moderate sympathetic nervous system reaction (e.g., blood pressure increased, dry mouthtachycardia, mydriasis,) have equally been assimilated. A series of events were moderate or mild. Less normally, there have been reports of QT mental changes and prolongation, including hallucinations and disorientation.

 

 

 

Management of Overdose

 

Consult with a Certified Poison Control Center for up to date advice and guidance. Because atomoxetine is so much protein constituted, dialysis is not probably to be useful in the treatment of overdose.

 

 

 

Storage conditions

 

Store at 77°F (25°C), excursions permitted to 15° to 30°C (59° to 86°F).

 

 

 

Indications and Uses of Strattera

 

It is of almost importance to understand the various Strattera uses. Not being able to apply it accurately could rather make an already bad situation worse. Therefore the uses of Strattera could be shortlisted and explained briefly below:

 

Attention-deficit/hyperactivity disorder (ADHD)

 

Strattera is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD). The strength of Strattera capsules was set up in seven clinical trials in outpatients with ADHD: for 6 to 9-week trials in pediatric patients (ages six to eight), two ten-weeks test in adults, and a maintenance trial in pediatrics (ages 6 to 15) and thus Strattera uses.

 

Diagnostic considerations

 

A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age of seven years. The signs have to be persistent, must be more harsh than is typically noticed in individuals at a comparable level of growth, must cause clinically important impairment, e.g., occupational functioning or academic, in social, and must be present in 2 or more environments, e.g., work or school and at home. The signs must also be better analyzed for by another mental disorder. The specific etiology of ADHD is not known, and there is no one diagnostic test. Ample diagnosis needs the use not only of medical but also of special social resources, educational and psychological. Learning may be or may not be impaired. The diagnosis has to be based upon a whole history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.

 

For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to poor listener, careless mistakes/details, lack of sustained attention, failure to go through on poor organization,tasks, avoids tasks requiring sustained loses things, forgetfulmental effort,  easily distracted. For the Hyperactive-Impulsive Type, at least six of the preceding signs must have persisted for at least 6 months: inappropriate running/climbing, leaving seat,squirming/fidgeting, difficulty with quiet activities, “on the go,” excessive talking,cannot wait turn, blurting answers, intrusive. For a Combined Type diagnosis, bothhyperactive-impulsive and inattentive and criteria must be met.

 

 

 

Need for Comprehensive Treatment Program

 

Strattera is indicated as an integral part of a total treatment program for ADHD that may include other measures (social, psychological, and educational) for patients with this sign. Drug treatment may not be the case for all patients with this sign. Drug treatment is not meant for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric mix up, alongside psychosis. Right educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is always encouraging. When remedial tips alone are inadequate, the decision to order drug therapy and medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.

 

 

 

Other information for children, teenagers, and adults:

 

i). Erections that won’t go away (priapism) have occurred rarely during treatment that goes the direction of Strattera. If you have an erection that lasts more than four hours, consult medical assistant immediately. Due to the potential for lasting effects, alongside the potential inaptitude to have erections, priapism should be assessed by a physician immediately.

 

ii). Strattera may affect your ability or your child’s ability to drive or operate heavy machinery. Be foresights until you know how Strattera affects your child or you.

 

iii). Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

 

In concluding this article, it is hoped that the detail review done on the drug Strattera (Atomoxetine HCL) covering Strattera uses, side effects Strattera, dosage of Strattera, and the rest of the vital areas explained will help you to be inform about this drug and its associated side effects.

 

This article however, acts only as a help and should in no wise replace a doctor’s advice and prescriptions.

 

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