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atomoxetine hcl 18 mg capsule generic strattera

Out of Stock Manufacturer TEVA USA 00093354356
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Uses

Atomoxetine hydrochloride is used as an adjunct to psychological, educational, social, and other remedial measures in the treatment of attention-deficit hyperactivity disorder (ADHD).

Attention Deficit Hyperactivity Disorder

Atomoxetine hydrochloride is used as an adjunct to psychological, educational, social, and other remedial measures in the treatment of ADHD (hyperkinetic disorder, hyperkinetic syndrome of childhood, minimal brain dysfunction) in adults and children 6 years of age and older. Efficacy of the drug for this indication was established in short-term (6-9 weeks) controlled clinical studies in children and adolescents 6-18 years of age and also in 10-week controlled clinical studies in adults who met DSM-IV criteria for ADHD. Efficacy of atomoxetine in the treatment of ADHD also was established in one longer-term (12 months) controlled clinical study in children and adolescents 6-15 years of age.

In controlled clinical studies in children 7-13 years of age with ADHD, therapy with atomoxetine (mean final dosage of 1.6 mg/kg daily, administered in 2 divided doses in the morning and late afternoon for 9 weeks) was more effective than placebo in decreasing inattention and hyperactive/impulsive symptoms, as measured by the ADHD Rating Scale-IV-Parent Version (ADHDRS), Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S), and Conners Parent Rating Scale-Revised: Short Form (CPRS-R:S). In another controlled clinical study in children and adolescents 6-16 years of age with ADHD, therapy with atomoxetine (mean final dosage of 1.3 mg/kg once daily in the morning for 6 weeks) was more effective than placebo in decreasing inattention and hyperactive/impulsive symptoms, as measured by the ADHDRS, Conners Parent Rating Scale, and Conners Teacher Rating Scale.

In a randomized, placebo-controlled, dose-response study with atomoxetine (0.5, 1.2, or 1.8 mg/kg daily, administered in 2 divided doses in the morning and late afternoon for 8 weeks) in children and adolescents 8-18 years of age with ADHD, therapy with atomoxetine 1.2 or 1.8 mg/kg daily was more effective than placebo in decreasing inattention and hyperactive/impulsive symptoms, as measured by the ADHDRS, and improving social and family functioning, as measured by the Child Health Questionnaire (CHQ). Patients receiving atomoxetine 0.5 mg/kg daily exhibited responses intermediate to those observed in patients receiving placebo or atomoxetine at higher dosages (1.2 or 1.8 mg/kg daily), but no differences in response were observed between patients receiving dosages of 1.2 versus 1.8 mg/kg daily.

In an open-label, multicenter study in boys 7-15 years of age and girls 7-9 years of age with ADHD, therapy with atomoxetine (up to 2 mg/kg daily, administered in 2 divided doses in the morning and late afternoon) or methylphenidate (up to 60 mg daily, administered once daily or in 2 or 3 divided doses) for 10 weeks produced similar results in the reduction of ADHD symptoms; however, double-blind clinical studies are needed to establish the comparative efficacy and tolerance of these therapies.

In a randomized, double-blind, placebo-controlled maintenance study, 604 children and adolescents 6-15 years of age with ADHD initially received open-label atomoxetine (1.2-1.8 mg/kg daily in 2 divided doses) for 10 weeks. Patients who responded to therapy during the open-label phase were randomized at week 12 to receive either atomoxetine (at the same dosage) or placebo for an additional 9 months. At study end point, relapse (defined as an increase in ADHDRS total score to 90% of baseline score and an increase of 2 or more points on the CGI-S scale) occurred in fewer patients receiving atomoxetine compared with those receiving placebo (22 versus 38%). When the more sensitive secondary definition of relapse (an increase in ADHDRS total score to 50% of baseline score and an increase of 2 or more points on the CGI-S scale) was used, the relapse rate also was substantially lower in atomoxetine-treated patients (28%) than in placebo-treated patients (48%). In addition, patients who continued receiving atomoxetine experienced a longer time to relapse and achieved superior psychosocial functioning compared to those receiving placebo.

In controlled clinical studies in adults with ADHD, therapy with atomoxetine (mean final dosage of 95 mg daily, administered in 2 equally divided doses in the morning and late afternoon/early evening for 10 weeks) was more effective than placebo in decreasing inattention and hyperactive/impulsive symptoms, as measured by the Conners Adult ADHD Rating Scale (CAARS).

Dosage and Administration

Administration

Atomoxetine hydrochloride may be administered orally once daily in the morning or in 2 equally divided doses in the morning and late afternoon/early evening. The drug may be administered without regard to meals.

The manufacturer states that atomoxetine is an ocular irritant; therefore, the capsules should be swallowed whole and should not be broken or opened, nor should the capsule contents be sprinkled on food.

Dosage

Dosage of atomoxetine hydrochloride is expressed in terms of atomoxetine.

The usual initial dosage of atomoxetine in adults or in children and adolescents weighing more than 70 kg is 40 mg daily; dosage may be increased after a minimum of 3 days to a target dosage of approximately 80 mg daily. If an optimum response has not been achieved after 2-4 additional weeks of therapy, dosage may be increased to a maximum of 100 mg daily; dosages exceeding 100 mg daily have not been shown in clinical trials to result in additional therapeutic benefit. In adults or in children and adolescents weighing more than 70 kg, if atomoxetine is used concomitantly with potent inhibitors of the cytochrome P-450 2D6 (CYP2D6) isoenzyme (e.g., paroxetine, fluoxetine, quinidine) or in patients with poor metabolizer phenotypes of the CYP2D6 isoenzyme, the initial atomoxetine dosage should be 40 mg daily and dosage should be increased to the usual target dosage of 80 mg daily only if ADHD symptoms fail to improve after 4 weeks of therapy and the initial dosage is well tolerated. The maximum recommended dosage of atomoxetine in adults or in children and adolescents weighing more than 70 kg is 100 mg daily. The safety of single doses exceeding 120 mg and total daily dosages exceeding 150 mg has not been established.

The usual initial dosage of atomoxetine in children and adolescents weighing 70 kg or less is approximately 0.5 mg/kg daily; dosage may be increased after a minimum of 3 days to a target dosage of approximately 1.2 mg/kg daily. In children and adolescents weighing 70 kg or less, if atomoxetine is used concomitantly with potent CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) or in patients with poor metabolizer phenotypes of the CYP2D6 isoenzyme, the initial atomoxetine dosage should be 0.5 mg/kg daily and dosage should be increased to the usual target dosage of 1.2 mg/kg daily only if ADHD symptoms fail to improve after 4 weeks of therapy and the initial dosage is well tolerated. Daily dosage of atomoxetine in children and adolescents weighing 70 kg or less should not exceed 100 mg or 1.4 mg/kg, whichever is less; dosages exceeding 1.2 mg/kg daily have not been shown in clinical trials to result in additional therapeutic benefit.

Because the effectiveness of atomoxetine for long-term use (i.e., more than 12 months in children and adolescents 6-15 years of age, more than 9 weeks in those 16-18 years of age, and more than 10 weeks in adults) has not been established, patients receiving atomoxetine for extended periods should be periodically reevaluated to assess the long-term usefulness of the drug.

Atomoxetine may be discontinued without tapering the dosage.

Special Populations

The manufacturer recommends that usual initial and target dosages of atomoxetine be reduced by 50% in patients with moderate hepatic impairment (Child-Pugh class B) and by 75% in those with severe hepatic impairment (Child-Pugh class C).

Cautions

Contraindications

Known hypersensitivity to atomoxetine or any ingredient in the formulation.

The manufacturer states that atomoxetine is contraindicated in patients currently receiving or having recently received (i.e., within 2 weeks) monoamine oxidase (MAO) inhibitor therapy. In addition, at least 2 weeks should elapse after discontinuing atomoxetine before initiating MAO inhibitor therapy. Severe, potentially fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) have been reported in patients receiving other drugs that affect brain monoamine concentrations concomitantly with MAO inhibitor therapy.

The manufacturer also states that atomoxetine should not be used in patients with angle-closure glaucoma, since the drug was associated with an increased risk of mydriasis in some patients during controlled clinical trials.

Warnings/Precautions

Warnings

Suicidality Risk

Atomoxetine may increase the risk of suicidal ideation in children and adolescents with attention deficit hyperactivity disorder (ADHD).(See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.) Pediatric patients should be closely monitored for clinical worsening, suicidality (suicidal ideation or behaviors), or unusual changes in behavior, particularly during the first few months after initiation of therapy and during periods of dosage adjustments. Monitoring should include daily observation by family members and caregivers and frequent contact with the prescribing clinician, particularly if the patient's behavior changes or is a concern. The manufacturer recommends face-to-face contact between clinicians and patients or their family members or caregivers at least weekly during the first 4 weeks of therapy and then every other week for the next 4 weeks, with subsequent face-to-face contact at 12 weeks and as clinically indicated thereafter; additional contact via telephone may be appropriate between visits.

Discontinuance of therapy should be considered in patients with emergent suicidality or manifestations that may be precursors to emerging suicidality (e.g., anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania), particularly if such manifestations are severe or abrupt in onset or were not part of the patient's presenting symptoms.

Sensitivity Reactions

Allergic reactions, including angioedema, urticaria, and rash, have been reported rarely in patients receiving atomoxetine.

Other Warnings and Precautions

Severe Hepatic Injury

Severe hepatic injury was reported during postmarketing surveillance in 2 patients (an adolescent and an adult) who had received atomoxetine for several months. In one patient, hepatic injury was manifested by increased hepatic enzymes (up to 40 times the upper limit of normal [ULN]) and jaundice (bilirubin up to 12 times the ULN); manifestations recurred upon rechallenge with atomoxetine and resolved upon discontinuance of the drug, providing evidence that the hepatic injury was caused by atomoxetine. Both patients recovered and did not require liver transplantation. However, the manufacturer notes that severe drug-related hepatic injury may progress to acute hepatic failure resulting in death or requiring liver transplantation in a small percentage of patients. The actual incidence of hepatic injury in patients receiving atomoxetine is unknown because of possible underreporting of postmarketing adverse effects.

Adverse hepatic effects may occur several months after initiation of atomoxetine, and laboratory abnormalities may continue to worsen for several weeks after discontinuance of the drug. Hepatic enzyme concentrations should be determined after the first manifestation of hepatic dysfunction (e.g., pruritus, dark urine, jaundice, right upper quadrant tenderness, unexplained flu-like symptoms) in patients receiving atomoxetine. Atomoxetine should be discontinued in patients with jaundice or laboratory evidence of hepatic injury, and therapy with the drug should not be reinitiated in such patients.

Sudden Death and Serious Cardiovascular Events

Although a causal relationship to atomoxetine has not been established, sudden unexplained death, stroke, and myocardial infarction have been reported in adults receiving usual dosages of atomoxetine for the treatment of ADHD. Sudden unexplained death also has been reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of atomoxetine. Children, adolescents, and adults who are being considered for atomoxetine therapy should undergo a thorough medical history review (including evaluation for a family history of sudden death or ventricular arrhythmia) and physical examination to detect the presence of cardiac disease, and should receive further cardiac evaluation (e.g., ECG, echocardiogram) if initial findings suggest such disease. Although some serious cardiac conditions are independently associated with an increased risk of sudden death, atomoxetine generally should not be used in children, adolescents, or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac conditions. Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during atomoxetine therapy should undergo prompt cardiac evaluation.

For further information on screening for cardiac conditions, selecting appropriate candidates for stimulant therapy, and monitoring for treatment-emergent cardiac conditions, see Cardiovascular Precautions under Cautions: Precautions and Contraindications, in the Amphetamines General Statement 28:20.04.

Psychiatric Effects

Atomoxetine should be used with caution in the management of ADHD in patients with comorbid bipolar disorder because of the potential for precipitation of mixed or manic episodes in such patients. Prior to initiating atomoxetine therapy, patients with ADHD and comorbid depressive symptoms should be carefully screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, or depression).

Psychotic or manic symptoms (e.g., hallucinations, delusional thinking, mania) have been reported in children and adolescents without prior history of psychotic illness or mania who received usual dosages of atomoxetine. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.2% of patients receiving usual dosages of atomoxetine compared with 0% of those receiving placebo. If psychotic or manic symptoms occur, a causal relationship to atomoxetine should be considered, and discontinuance of therapy may be appropriate.

Cardiovascular Effects

Increased blood pressure and heart rate were reported in children, adolescents, and adults receiving atomoxetine in controlled clinical studies. The drug should be used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease that might be affected by increases in blood pressure or heart rate. Blood pressure and pulse rate should be measured before initiation of atomoxetine, following any increase in dosage, and periodically during therapy.

Orthostatic hypotension and syncope also were reported in patients receiving atomoxetine in controlled clinical studies. The drug should be used with caution in patients with conditions that would predispose them to hypotension.

Peripheral Vascular Effects

Exacerbation or precipitation of Raynaud's phenomenon was reported during postmarketing surveillance in patients receiving atomoxetine.

Genitourinary Effects

Urinary retention and urinary hesitation were reported in adults receiving atomoxetine in controlled clinical studies.

Growth Effects

Temporary suppression of normal weight and height patterns has been observed in pediatric patients receiving atomoxetine therapy. Gains in weight and height generally lag behind predicted population values for about the first 9-12 months of therapy; however, weight and height gains rebound with continued treatment. Similar growth patterns have been observed regardless of metabolizer phenotype (poor or extensive metabolizer of the drug) or pubertal status upon initiation of treatment. The manufacturer states that growth should be monitored in patients receiving therapy with atomoxetine.

Children and adolescents 6-18 years of age receiving atomoxetine for up to 9 weeks in controlled clinical studies had an average weight loss of 0.4 kg compared with an average weight gain of 1.5 kg in those receiving placebo for the same time period; similar rates of weight loss have been reported in other controlled clinical studies with the drug. In one clinical trial, decreases in body weight of at least 3.5% occurred in 7-29% of patients receiving atomoxetine at various dosages, compared with 1.3% of patients receiving placebo. However, in patients receiving atomoxetine for 3 years, weight increased by an average of 17.9 kg (0.5 kg more than predicted by baseline data) and height increased by an average of 19.4 cm (0.4 cm less than predicted by baseline data) at 3 years. Gain in height stabilized at about 12 months.

Behavioral Effects

Aggressive behavior and hostility frequently are observed in pediatric patients with ADHD and have been reported in patients receiving drug therapy (including atomoxetine) for the disorder. In controlled clinical studies in pediatric patients, aggressive behavior or hostility was reported slightly (overall risk ratio of 1.33), but not significantly, more frequently in those receiving atomoxetine compared with those receiving placebo. Patients beginning treatment for ADHD should be monitored for the onset or worsening of aggressive behavior or hostility.

Priapism

Priapism was reported rarely during postmarketing surveillance in pediatric and adult patients receiving atomoxetine; if priapism is suspected, prompt medical attention is required.(See Advice to Patients.)

Tics

In a controlled study, atomoxetine did not worsen tics in patients with ADHD and comorbid Tourette's disorder.

Specific Populations

Pregnancy

Category C.

Lactation

Atomoxetine and/or its metabolites are distributed into milk in rats; it is not known whether the drug is distributed into milk in humans. Therefore, atomoxetine should be used with caution in nursing women.

Pediatric Use

Safety and efficacy of atomoxetine have not been established in children younger than 6 years of age.

Atomoxetine may increase the risk of suicidal ideation in children and adolescents with ADHD. In a pooled analysis of 12 short-term controlled clinical studies in pediatric patients with ADHD (11 studies) or enuresis (1 study), the risk of suicidal ideation was about 0.4% in those receiving atomoxetine versus 0% in those receiving placebo. One child receiving the drug attempted suicide; no completed suicides were reported. All events representing suicidal behavior or thinking occurred in children 12 years of age or younger and occurred during the first month of therapy. It is not known whether the risk of suicidal ideation in pediatric patients extends to long-term use of the drug. A similar analysis of data from adults with ADHD or major depressive disorder found no increased risk of suicidal ideation or behavior in those receiving atomoxetine. The potential risks of suicidality should be weighed against the clinical need for the drug prior to initiating atomoxetine therapy in children or adolescents.(See Suicidality Risk under Warnings/Precautions: Warnings, in Cautions.)

Sudden death has been reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants.(See Sudden Death and Serious Cardiovascular Events under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)

Temporary suppression of normal weight and/or height patterns has been reported during the first 9-12 months of atomoxetine therapy; however, weight and height gains have rebounded with continued treatment.(See Growth Effects under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) The growth of pediatric patients receiving atomoxetine should be monitored.

Geriatric Use

Safety and efficacy of atomexetine have not been established in geriatric patients.

Hepatic Impairment

Systemic exposure to atomoxetine concentrations is increased twofold in patients with moderate hepatic impairment (Child-Pugh class B) and fourfold in those with severe hepatic impairment (Child-Pugh class C).(See Dosage and Administration: Special Populations.)

Common Adverse Effects

Abdominal pain, decreased appetite, vomiting, somnolence, nausea, fatigue, irritability, and dizziness each occurred in 5% or more of children and adolescents receiving atomoxetine in controlled clinical studies and were at least twice as frequent in patients receiving the drug as in those receiving placebo. Dry mouth, nausea, insomnia, decreased appetite, constipation, fatigue, erectile dysfunction, hot flush, urinary disorders (urinary hesitation, urinary retention), and dysmenorrhea each occurred in 5% or more of adults receiving atomoxetine in controlled clinical studies and were at least twice as frequent in patients receiving the drug as in those receiving placebo.

Drug Interactions

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction (decreased metabolism of atomoxetine) when atomoxetine is used concomitantly with drugs that inhibit the activity of the cytochrome P-450 2D6 (CYP2D6) isoenzyme. Inhibitors of CYP2D6 may increase plasma concentrations of atomoxetine in patients with the extensive-metabolizer phenotype to such an extent that plasma concentrations of the drug are similar to those achieved in poor metabolizers. When atomoxetine is used concomitantly with potent CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine), or in patients with poor-metabolizer phenotypes of the CYP2D6 isoenzyme, the manufacturer states that dosage adjustment of atomoxetine should be considered.(See Dosage and Administration: Dosage.) However, in vitro studies suggest that concomitant use of atomoxetine with CYP2D6 inhibitors will not increase plasma concentrations of atomoxetine in patients with the poor-metabolizer phenotype.

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interaction unlikely; evidence to date suggests that atomoxetine does not cause clinically important inhibition or induction of cytochrome P-450 enzymes, including CYP1A2, CYP3A, CYP2D6, and CYP2C9.

GI Drugs

No important pharmacokinetic interactions reported with drugs that increase gastric pH (e.g., antacids containing magnesium hydroxide and aluminum hydroxide, omeprazole).

Protein-bound Drugs

Pharmacokinetic interaction unlikely. In vitro studies indicate that atomoxetine is not displaced from binding sites by, and does not displace from binding sites, other highly protein-bound drugs (e.g., warfarin, aspirin, phenytoin, diazepam) in therapeutic concentrations.

Alcohol

No change in the intoxicating effects of alcohol when alcohol was ingested by individuals receiving atomoxetine.

β-Adrenergic Agonists

Potential pharmacologic interaction (increased cardiovascular effects [e.g., increased heart rate and blood pressure]) when atomoxetine is used concomitantly with oral or parenteral β2-adrenergic agonists (e.g., albuterol). Use with caution.

Cardiovascular Agents

Potential pharmacologic interaction (increased hypertensive effects) with concomitant use of pressor agents (e.g., dopamine, dobutamine) and atomoxetine. Use with caution.

Methylphenidate

No increase in cardiovascular effects with concomitant use of methylphenidate and atomoxetine relative to use of methylphenidate alone.

Monoamine Oxidase Inhibitors

Potential pharmacologic interaction (inhibition of catecholamine metabolism).(See Cautions: Contraindications.)

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