Atomoxetine Hydrochloride Capsules (Attentrol)

Atomoxetine Hydrochloride Capsules
© Clearsky Pharmacy
Attentrol (Atomoxetine Hydrochloride Capsules)
is a medicine that is prescribed for treating
children, adolescents and adults with attention
deficit hyperactivity disorder (ADHD).

Attentrol Capsules
Attentrol Capsules are manufactured
by Sun Pharmaceutical Industries Ltd.
in the strengths of 10 mg, 18 mg and
25 mg.
(Website: www.sunpharma.com)

Atomoxetine Hydrochloride Capsules – Brand Names
are available as Strattera, Attentrol,
Tomoxetin , Attentin and Axepta.

Active Ingredient
The active ingredient contained in Attentrol
Capsules is Atomoxetine Hydrochloride.
Each capsule of Atomoxetine (Attentrol)
contains Atomoxetine HCl equivalent to 10
mg, 18 mg, or 25 mg of Atomoxetine.

Chemical Structure
The structure of Atomoxetine Hydrochloride
is given below:

Uses of Atomoxetine Capsules
Atomoxetine Hydrochloride Capsules (Attentrol) is
used as part of a total treatment program for
treating children, adolescents and adults with
attention deficit hyperactivity disorder (ADHD).
The treatment aims to increase the ability to pay
attention and decrease impulsiveness and
hyperactivity in children, adolescents and adults
with ADHD.
Atomoxetine (Attentrol capsules) is in a class of
medicines called selective norepinephrine reuptake
inhibitors. This medicine works by increasing the
levels of norepinephrine, a natural substance in the
brain that is needed to control behavior.

Storage Instructions
(Attentrol) have to be stored at controlled
room temperature i.e. from 20°C to 25°C
(68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

Atomoxetine Capsules Dosage
➢ Dosing of children and adolescents over 70 kg body
weight and adults — Therapy with Atomoxetine
capsules should be started 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.
Treatment must be started by a specialist in the
treatment of ADHD, such as a paediatrician,
child/adolescent psychiatrist, or psychiatrist. The
dosage of Atomoxetine Capsules (Attentrol) is
given below:

Atomoxetine Capsules Dosage
➢ Dosing of children and adolescents up to 70
kg body weight — Therapy with Atomoxetine
Capsules should be started 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.
The dosage of Atomoxetine Hydrochloride
Capsules (Attentrol) is given below:

Warnings
Suicidal Ideation - Monitor patients for suicidality, clinical
worsening, and unusual changes in behavior.
Severe Liver Injury - Attentrol Capsules should be
discontinued and not restarted in patients with jaundice
or laboratory evidence of liver injury.
Serious Cardiovascular Events - Sudden death, stroke
and myocardial infarction have been reported in
association with Atomoxetine therapy. Generic Strattera
generally should not be used in children or adolescents
with known serious structural cardiac abnormalities,
cardiomyopathy, serious heart rhythm bnormalities, or
other serious cardiac problems. Consideration has be
given to not using Attentrol capsules in adults with
clinically significant cardiac abnormalities.
Emergent Cardiovascular Symptoms - Patients should
undergo prompt cardiac evaluation.

Warnings
Effects on Blood Pressure and Heart Rate - Attentrol can
increase blood pressure as well as heart rate. There is
a possibility that orthostasis, syncope and Raynaud's
phenomenon may occur. Use with caution in patients
with hypertension, tachycardia, or cardiovascular or
cerebrovascular disease.
Emergent Psychotic or Manic Symptoms - Discontinuing
treatment with Attentrol Capsules should be considered
if such new Psychotic or Manic Symptoms symptoms
occur.
Bipolar Disorder - Patients must be screened to avoid
possible induction of a mixed/manic episode.
Aggressive behavior - Aggressive behavior or hostility in
patients undergoing treatment with this medicine should
be monitored.

Warnings
Possible allergic reactions - Possible allergic reactions
including anaphylactic reactions, angioneurotic edema,
urticaria, and rash can occur in patients undergoing
Attentrol therapy.
Effects on Urine Outflow - Urinary hesitancy and
retention may occur.
Priapism - Prompt medical attention is necessary in the
event of suspected priapism.
Growth - Height and weight should be carefully
monitored in pediatric patients. Use of Potent CYP2D6
Inhibitors along with Attentrol or use in patients known to
be CYP2D6 poor metabolizers may require dose
adjustment of Attentrol.

Attentrol Capsules
Contraindications
Attentrol is contraindicated in patients with a
hypersensitivity to Atomoxetine Hydrochloride or
any other component of this medication.
Use of Atomoxetine Capsules (Attentrol) within 2
weeks after discontinuing MAOI or other drugs that
affect brain monoamine concentrations and is
therefore contraindicated.
Attentrol is contraindicated in patients with Narrow
Angle Glaucoma, Pheochromocytoma or history of
pheochromocytoma.
This medicine is also contraindicated in cases of
Severe Cardiovascular Disorders that might
deteriorate with clinically important increases in HR
and BP.

Atomoxetine Capsules Side Effects
➢ Child and Adolescent Clinical Trials – Nausea, vomiting,
fatigue, decreased appetite, abdominal pain, and
somnolence.
➢Adult Clinical Trials – Constipation, dry mouth, nausea,
decreased appetite, dizziness, erectile dysfunction, and
urinary hesitation
Most common Atomoxetine Capsules (Attentrol) side
effects with an incidence rate of at least 5% and at least
twice the incidence of placebo patients

Atomoxetine Capsules Overdose
The most commonly reported symptoms
accompanying acute and chronic overdoses of
Atomoxetine Capsules were gastrointestinal
symptoms, somnolence, dizziness, tremor, and
abnormal behavior. Hyperactivity and agitation
have also been reported. In some cases of
overdose involving Atomoxetine Capsules,
seizures have been reported.
Signs and symptoms consistent with mild to
moderate sympathetic nervous system activation
(e.g., tachycardia, blood pressure increased,
mydriasis, dry mouth) have also been observed.
Most symptoms reported were mild to moderate.

Atomoxetine Overdose
In case of Atomoxetine overdose an airway
should be established. Monitoring of
cardiac and vital signs is recommended,
along with the necessary symptomatic and
supportive measures.
Gastric lavage may be indicated if
performed soon after ingestion. Activated
charcoal may be useful in limiting
absorption.
Since Atomoxetine is highly protein-bound,
dialysis is not likely to be useful in the
treatment of overdose.

Atomoxetine Capsules During
Pregnancy
Atomoxetine Hydrochloride (Attentrol
Capsules) has been classified by the US
FDA as Pregnancy Category C.
Animal reproduction studies have shown
an adverse effect on the fetus and there
have been no adequate and well-
controlled studies conducted in humans.
Use of this medicine is not recommended
during pregnancy unless the benefit
justifies the risk to the fetus.

Attentrol Capsules (Atomoxetine Hydrochloride)
For more details on
Attentrol Capsules click here
Attentrol (Atomoxetine Hydrochloride
capsules) by Sun Pharmaceutical
Industries Ltd., India

Atomoxetine Hydrochloride Capsules (Attentrol)

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