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Strattera, Best Mental Disorder Prevention/Treatment Drug & Known Side Effects

By Miriatu

Strattera

The goal of every parent is to have children who are normal and well behave, children who can talk, walk, and listen well with good memory. But this is not always the case as some children in their early stages of growth (as low as 7 years old) have developed some sort of mental disorder. These children have attention problems and are said to have attention deficit hyperactivity disorder (ADHD). They are unable to carry out their normal activities. Some have speech problem, hearing problem, walking problem, memory problem and other related problem that makes learning difficult and often times they behave abnormal.  

Strattera (Atomoxetine HCL) has been associated with the prevention and treatment of ADHD. Since its development, the drug has developed to become the greatest circulating Attention Deficit Hyperactivity Disorder (ADHD). This drug is a serotonin-norepinephrine reuptake inhibitor (SNRI).

Description of Strattera (Atomoxetine HCL)

Strattera is a well-researched medicine is used to treat Attention Deficit Hyperactivity Disorder (ADHD). ADHD medications such as Strattera should always be part of a well-defined therapy program that consists of educational, psychological, and social tips set to assist in the treatment of ADHD.

Actually, the manner in which Strattera (atomoxetine HCL) operates to treat ADHD cannot be explained. 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 of abuse). It is recommended for teens as well as adults.

At the time of clinical tests, experts realized that Strattera reduced the average rate of growth in children. Moreover, it cannot be evaluated if the weight and height among adults were equally affected. Nevertheless, users are advised to discontinue use of the drug if a child is not growing or gaining weight at the expected rate.

Possible side effects of Strattera

It is worth noting that some side effects of Strattera are said to be brought together in function of the  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.
  • Fragment 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
  • Scarce to see, males (couple with teens and young boys) using this medication may have a lengthy or wild erection over 4 or more hours. Parents and caregivers should be sensitive to 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 for 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 realize any signs of a harsh allergic reaction, like intense 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, difficulties sending out urine, all portrays the occurrence of Strattera side effects. Equally for the women, missed/irregular periods or menstrual cramps may be associated with Strattera

Warnings and Precautions

For the fact that the efficacy of Strattera cannot be emphasized, however, some basic warnings and precautions of the drug have to be seriously taking into account.

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. An estimate of tests, precisely twelve tests (eleven with ADHD and 1 in enuresis) involving over 2.200 patients (including 1.357 patients taking Strattera as well as 851 taking placebo). It was found out that, the suicidal ideation in patients taking Strattera had a moderate danger of 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. There was no suicide that experience during these tests. Every reaction got witnessed in teens younger than the age. Added to this, it is difficult to tell whether the setbacks of suicidal ideation in pediatric patients stretch to the long run use. A related analysis in older patients treated with Strattera for either ADHD or major depressive disorder (MDD) did not reveal an increased risk of suicidal behavior in connection with the use of Strattera.

Every patient with pediatric problems treated with Strattera should be followed-up accurately and observed keenly for abnormal changes in attitude, superficiality, clinical worsening and, most significantly 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 impulsive.

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 superficiality. 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 superficiality or symptoms that might be precursors to emerging lack of depth, especially if these signs are inaccurate or intense in the onset, or were not linked with the patient’s demonstrating signs. Caregivers and Families of pediatric sick persons being treated with Strattera should be told about the necessity to follow-up patients for the emergence of unusual changes in behavior, irritability, agitation, and the rest of  signs discussed, and the forthcoming of suicidality, and to announce such signs rapidly to health care experts. Such surveillance should comprise of daily examination by families and caregivers.

ii) Severe liver injury

Through the report of post marketing reports it expresses that Strattera can cause intense 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 fragments 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 irritable levels less than 2 X ULN), followed by recovery upon fragment discontinuation. In one patient, liver attack, energized by elevated hepatic enzymes up to 40 X ULN and jaundice with short-tempered up to12 X ULN, recurred upon rechallenge, and was followed by recovery upon drug discontinued, 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. Considerably, harsh liver attack as a result of any drug may potentially progress to acute liver failure leading to death or the need for a liver transplant. Furthermore, Strattera should be discontinued in patients with laboratory evidence or jaundice of liver attack, and should not be revived. Laboratory testing to determine liver enzyme levels should be carried out upon the first sign of liver failure (e.g., dark urine, jaundice, right upper quadrant tenderness or unexplained “flu like” symptoms itching,)

iii) Serious cardiovascular events

Random death and pre-existing structural cardiac abnormalities or other serious heart problems in children and adolescents-sudden death has been reported in association with fragment 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, fragment 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 emotional effects of fragment. Adults-Sudden deaths, stroke, and myocardial infarction have been reported in adults taking grain at usual tablets for ADHD. Even though the function of grain 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.

Atomoxetine has treated extensively patients who were being evaluated of Cardiovascular Status. Therefore a study history for children, adolescents, or adults who are being considered for treatment with atomoxetine should be conducted (alongside the evaluation for a family history of sudden death or ventricular arrhythmia) and physical exam to assess in 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, exceptional chest pain, during fragment 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, severity, 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

The children and adolescents takes dosing 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. The initiation of Strattera should be 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 required for long term periods. The significance of maintaining 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 build up 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

With or without food, Strattera may be administered. Equally without being tapered Strattera can be discontinued. 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: The patients with ADHD who have hepatic inadequacy (HI), dosage modification may be delivered as follows:

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

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

Over 70 kg body weight in children and adolescents administered strong CYP2D6 inhibitors, like for instance paroxetine, quinidine, fluoxetine, and most significantly Strattera should be kept at 40 mg/day and only raised to the normal target dose of 80 mg/day if signs fail to improve after 4 weeks and the initial dose is well tolerated.

Dosage Forms and Strengths of Strattera

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 the fragment.

Over dosage of Strattera

Human Experience: In the area of clinical tests there are no harmful overdoses which have occurred. During post marketing, 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, including conscious overdoses gearing up to 1400 mg. A series of these situations of overdose relating to Strattera, seizures 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 mouth, tachycardia, mydriasis,) have equally been assimilated. A series of events were moderate or mild. Less normally, there have been reports of QT mental changes and extension, alongside hallucinations as well as disorientation.

Management of Overdose

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

Storage conditions of Strattera

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) indicates 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. For another metal derangement, the signs have to be thoroughly examined. 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.

At least 6 of the following symptoms for the inattentive type 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, forgetful mental 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 the seat, squirming/fidgeting, difficulty with quiet activities, “on the go,” excessive talking, cannot wait turn, blurting answers, intrusive. For a Combined Type diagnosis, both hyperactive-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 assistance immediately. Due to the potential for lasting effects, alongside the potential inaptitude to have erections, severity should be assessed by a physician immediately.

ii) The child’s ability to drive or operate heavy machinery may be at risk or affected due to taking Strattera. Be foresights until you know how Strattera affects your child or you.

iii) Endeavor to discuss with your physician if you or your child have side effects that are disturbing and hardly go away.

A Disclaimer: 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 with information about this drug and its associated side effects. This article, however, acts only as a guide and should in no wise replace a doctor’s advice and prescriptions.

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