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Atomoxetine Hcl

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(Treatment for attention deficit/hyperactivity disorder (ADHD))

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CAS: 82248-59-7

Appearance: white crystal powder

Chemical Name: (R)-N-methyl-gamma-(2-methylphenoxy)-benzenepropanamine

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. The chemical structure is:

Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water.

What is ADHD?

ADHD has 3 main types of symptoms: inattention, hyperactivity, and impulsiveness. Symptoms of inattention include not paying attention, making careless mistakes, not listening, not finishing tasks, not following directions, and being easily distracted. Symptoms of hyperactivity and impulsiveness include fidgeting, talking excessively, running around at inappropriate times, and interrupting others. Some patients have more symptoms of hyperactivity and impulsiveness while others have more symptoms of inattentiveness. Some patients have all 3 types of symptoms.

Symptoms of ADHD in adults may include a lack of organization, problems starting tasks, impulsive actions, daydreaming, daytime drowsiness, slow processing of information, difficulty learning new things, irritability, lack of motivation, sensitivity to criticism, forgetfulness, low self-esteem, and excessive effort to maintain some organization. The symptoms shown by adults who primarily have attention problems but not hyperactivity have been commonly described as Attention-Deficit Disorder (ADD).

Many people have symptoms like these from time to time, but patients with ADHD have these symptoms more than others their age. Symptoms must be present for at least 6 months to be certain of the diagnosis.

Atomoxetine Hcl capsules are intended for oral administration only.

Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, or 60 mg of atomoxetine. The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. The capsule shells also contain one or more of the following: FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide. The capsules are imprinted with edible black ink.

DOSAGE AND ADMINISTRATION

Initial Treatment

Dosing of children and adolescents up to 70 kg body weight -- Atomoxetine Hcl 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 -- Atomoxetine Hcl 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.

What is Atomoxetine HCL?

Atomoxetine Hcl is a non-stimulant medicine used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). Atomoxetine Hcl contains atomoxetine hydrochloride, a selective norepinephrine reuptake inhibitor. Your doctor has prescribed this medicine as part of an overall treatment plan to control your symptoms of ADHD.

Who should NOT take Atomoxetine Hcl?

Do not take Atomoxetine Hcl if:

What are the possible side effects of Atomoxetine Hcl?

The most common side effects of Atomoxetine Hcl used in teenagers and children over 6 years old are:

Weight loss may occur after starting Atomoxetine Hcl. It is not known if growth will be slowed in children who use Atomoxetine Hcl for a long period of time. Your doctor will watch your weight and height. If you are not growing or gaining weight as expected, your doctor may change your treatment of Atomoxetine Hcl.

The most common side effects of Atomoxetine Hcl used in adults are:

Stop taking Atomoxetine Hcl and call your doctor right away if you get swelling or hives. Atomoxetine Hcl can cause a serious allergic reaction in rare cases.

This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.

General advice about Atomoxetine Hcl

Atomoxetine Hcl has not been studied in children under 6 years old.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Atomoxetine Hcl for a condition for which it was not prescribed. Do not give Atomoxetine Hcl to other people, even if they have the same symptoms you have.