Atomoxetine hydrochloride

What is Atomoxetine hydrochloride?

• Atomoxetine hydrochloride (Strattera) is a selective norepinephrine reuptake inhibitor used for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

Atomoxetine

Atomoxetine ball-and-stick model

What are the uses of this medicine?

• Atomoxetine hydrochloride (Strattera) is a selective norepinephrine reuptake inhibitor medicine.
• It is used for the treatment of attention deficit and hyperactivity disorder (ADHD).
• Strattera may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
• Strattera should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

How does this medicine work?

• The hydrochloride salt of atomoxetine, a phenoxy-3-propylamine derivative and selective non-stimulant, norepinephrine reuptake inhibitor with cognitive-enhancing activity.
• Although its precise mechanism of action is unknown, atomoxetine appears to selectively inhibit the pre-synaptic norepinephrine transporter, resulting in inhibition of the presynaptic reabsorption of norepinephrine and prolongation of norepinephrine activity in the synaptic cleft; the effect on cognitive brain function may result in improved attention and decreased impulsivity and activity levels.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil® (phenelzine sulfate), Parnate® (tranylcypromine sulfate) and Emsam® (selegiline transdermal system).
• have an eye problem called narrow angle glaucoma
• are allergic to anything in Strattera.
• have or have had a rare tumor called pheochromocytoma.

What drug interactions can this medicine cause?

• Strattera and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether Strattera can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• asthma medicines
• anti-depression medicines including MAOIs
• blood pressure medicines
• cold or allergy medicines that contain decongestants

Is this medicine FDA approved?

• Atomoxetine was approved for use in adults, adolescents and children above the age of 6 years with attention deficit hyperactivity disorder in the United States in 2002.

How should this medicine be used?

Recommended dosage: Dosing of children and adolescents up to 70 kg body weight:

• Strattera should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening.
• No additional benefit has been demonstrated 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 afternoon/early evening.
• After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response.
• There are no data that support increased effectiveness at higher doses.
• The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.

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, initial and target doses should be reduced to 50% of the normal dose.
• For patients with severe HI , initial dose and target doses should be reduced to 25% of normal.

Dosing adjustment for use with a strong CYP2D6 inhibitor or in patients who are known to be CYP2D6 PMs:

• In children and adolescents up to 70 kg body weight administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, or in patients who are known to be CYP2D6 PMs, 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.

Administration:

• Strattera comes in different dose strength capsules. Your doctor may adjust the dose until it is right for you or your child.
• Do not chew, crush, or open the capsules. Swallow Strattera capsules whole with water or other liquids. Tell your doctor if you or your child cannot swallow Strattera whole. A different medicine may need to be prescribed.
• Avoid touching a broken Strattera capsule. Wash hands and surfaces that touched an open Strattera capsule. If any of the powder gets in your eyes or your child's eyes, rinse them with water right away and call your doctor.
• Strattera can be taken with or without food.
• Strattera is usually taken once or twice a day. Take Strattera at the same time each day to help you remember. If you miss a dose of Strattera, take it as soon as you remember that day. If you miss a day of Strattera, do not double your dose the next day. Just skip the day you missed.
• From time to time, your doctor may stop Strattera treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Strattera. Children should have their height and weight checked often while taking Strattera. Strattera treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much Strattera or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine.

This medicine is available in fallowing brand namesː

• Strattera

What side effects can this medication cause?

Common side effects in children and teenagers include:

• upset stomach
• decreased appetite
• nausea or vomiting
• dizziness
• tiredness
• mood swings

Common side effects in adults include:

• constipation
• dry mouth
• nausea
• decreased appetite
• dizziness
• sexual side effects
• problems passing urine

Other serious side effects include:

* Suicidal thoughts and actions in children and teenagers
* serious allergic reactions
* slowing of growth (height and weight) in children
* problems passing urine

What special precautions should I follow?

• Strattera increased the risk of suicidal ideation in short-term studies in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Monitor for suicidality, clinical worsening, and unusual changes in behavior.
• Postmarketing reports indicate that Strattera can cause severe liver injury. Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury.
• Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease. Strattera generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects. Consideration should be given to not using Strattera in adults with clinically significant cardiac abnormalities.
• Increase in blood pressure and heart rate; orthostasis and syncope may occur. Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.
• Psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania can be caused by Strattera at usual doses. Consider discontinuing Strattera if such new symptoms occur.
• Patients with bipolar disorder or risk factors for bipolar disorder may be at increased risk of developing mania or mixed episodes during treatment with Strattera. Screen patients for bipolar disorder.
• Patients beginning treatment with Strattera should be monitored for the appearance or worsening of aggressive behavior or hostility.
• Although uncommon, allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash, have been reported in patients taking Strattera.
• Urinary hesitation were increased among atomoxetine subjects.
• Priapism, defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported for pediatric and adult patients treated with Strattera. Prompt medical attention is required in the event of suspected priapism.
• Height and weight should be monitored in pediatric patients.
• Dosage adjustment of Strattera may be necessary when coadministered with potent CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine) or when administered to CYP2D6 PMs.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• gastrointestinal symptoms
• somnolence
• dizziness
• tremor
• abnormal behavior
• Hyperactivity
• agitation
• tachycardia
• blood pressure increased
• mydriasis
• dry mouth
• QT prolongation
• mental changes
• disorientation
• hallucinations

Management of overdosage:

• Consult with a Certified Poison Control Center for up to date guidance and advice.
• Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose.

Can this medicine be used in pregnancy?

• Available published studies with atomoxetine use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Strattera, during pregnancy.

Can this medicine be used in children?

• Strattera has not been studied in children less than 6 years old.

What are the active and inactive ingredients in this medicine?

• Active ingredient: atomoxetine hydrochloride.
• Inactive ingredients: pregelatinized starch, dimethicone, gelatin, sodium lauryl sulfate, FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide, and edible black ink.

Who manufactures and distributes this medicine?

• Marketed by: Lilly USA, LLC
• Indianapolis, IN , USA

What should I know about storage and disposal of this medication?

• Store Strattera in a safe place at room temperature, 59 to 86°F (15 to 30°C).
• Keep Strattera and all medicines out of the reach of children.

• Dailymed label info on Atomoxetine hydrochloride
• FDA Atomoxetine hydrochloride

Atomoxetine hydrochloride Resources
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The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone