ATOMOXETINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

ATOMOXETINE HYDROCHLORIDE

Composition:

ATOMOXETINE 18 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies (14)] . A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequa

Product summary:

Atomoxetine Capsules, USP equivalent to 10 mg of atomoxetine are white to off-white powder filled in size "5" empty hard gelatin capsules with opaque white colored cap  printed with "ZA 67" in black ink and opaque white colored body printed with "10 mg" in black ink and are supplied as follows: NDC 68382-215-06 in bottles of 30 capsules NDC 68382-215-14 in bottles of 60 capsules NDC 68382-215-16 in bottles of 90 capsules NDC 68382-215-10 in bottles of 1000 capsules NDC 68382-215-02 in bottles of 2000 capsules NDC 68382-215-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Atomoxetine  Capsules, USP equivalent to 18 mg of atomoxetine are white to off-white powder filled in size "4" empty hard gelatin capsules with golden-colored cap printed with "ZA 68" in black ink and opaque white colored body printed with "18 mg" in black ink and are supplied as follows: NDC 68382-216-06 in bottles of 30 capsules NDC 68382-216-14 in bottles of 60 capsules NDC 68382-216-16 in bottles of 90 capsules NDC 68382-216-10 in bottles of 1,000 capsules NDC 68382-216-02 in bottles of 2,000 capsules Atomoxetine  Capsules, USP equivalent to 25 mg of atomoxetine are white to off-white powder filled in size "2" empty hard gelatin capsules with opaque blue colored cap imprinted with "ZA 69" in black ink and opaque white colored body imprinted with "25 mg" in black ink and are supplied as follows: NDC 68382-217-06 in bottles of 30 capsules NDC 68382-217-14 in bottles of 60 capsules NDC 68382-217-16 in bottles of 90 capsules NDC 68382-217-10 in bottles of 1,000 capsules NDC 68382-217-02 in bottles of 2,000 capsules NDC 68382-217-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Atomoxetine  Capsules, USP equivalent to 40 mg of atomoxetine are white to off-white powder filled in size "2" empty hard gelatin capsules  with opaque blue colored cap imprinted with "ZA 70" in black ink and opaque blue colored body imprinted with "40 mg" in black ink and are supplied as follows: NDC 68382-218-06 in bottles of 30 capsules NDC 68382-218-14 in bottles of 60 capsules NDC 68382-218-16 in bottles of 90 capsules NDC 68382-218-10 in bottles of 1,000 capsules NDC 68382-218-02 in bottles of 2,000 capsules NDC 68382-218-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Atomoxetine  Capsules, USP equivalent to 60 mg of atomoxetine are white to off-white powder filled in size "1" empty hard gelatin capsules  with opaque blue colored cap imprinted with "ZA 71" in black ink and golden-colored body imprinted with "60 mg" in black ink and are supplied as follows: NDC 68382-219-06 in bottles of 30 capsules NDC 68382-219-14 in bottles of 60 capsules NDC 68382-219-16 in bottles of 90 capsules NDC 68382-219-10 in bottles of 1,000 capsules NDC 68382-219-02 in bottles of 2,000 capsules NDC 68382-219-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Atomoxetine  Capsules, USP equivalent to 80 mg of atomoxetine are white to off-white powder filled in size "1" empty hard gelatin capsules  with opaque brown colored cap imprinted with "ZA 72" in black ink and white colored body imprinted with "80 mg" in black ink and are supplied as follows: NDC 68382-220-06 in bottles of 30 capsules NDC 68382-220-14 in bottles of 60 capsules NDC 68382-220-16 in bottles of 90 capsules NDC 68382-220-10 in bottles of 1,000 capsules NDC 68382-220-02 in bottles of 2,000 capsules NDC 68382-220-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Atomoxetine  Capsules, USP equivalent to 100 mg of atomoxetine are white to off-white powder filled in size "0" empty hard gelatin capsules with opaque brown colored cap imprinted with "ZA 73" in black ink and opaque brown colored body imprinted with "100 mg" in black ink and are supplied as follows: NDC 68382-223-06 in bottles of 30 capsules NDC 68382-223-14 in bottles of 60 capsules NDC 68382-223-16 in bottles of 90 capsules NDC 68382-223-10 in bottles of 1,000 capsules NDC 68382-223-02 in bottles of 2,000 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ATOMOXETINE- ATOMOXETINE CAPSULE
Zydus Pharmaceuticals USA Inc.
----------
MEDICATION GUIDE
Atomoxetine
(a" toe mox' e teen)
Capsules, USP
Read the Medication Guide that comes with atomoxetine capsules before
you or your child starts taking it
and each time you get a refill. There may be new information. This
Medication Guide does not take the
place of talking to your doctor about your treatment or your child's
treatment with atomoxetine capsules.
What is the most important information I should know about atomoxetine
capsules?
The following have been reported with use of atomoxetine capsules:
1.
Suicidal thoughts and actions in children and teenagers:
Children and teenagers sometimes think about suicide, and many report
trying to kill themselves. Results
from atomoxetine capsules clinical studies with over 2200 child or
teenage ADHD patients suggest that
some children and teenagers may have a higher chance of having
suicidal thoughts or actions. Although
no suicides occurred in these studies, 4 out of every 1,000 patients
developed suicidal thoughts. Tell your
child or teenager's doctor if your child or teenager (or there is a
family history of):
•
has bipolar illness (manic-depressive illness)
•
had suicide thoughts or actions before starting atomoxetine capsules
The chance for suicidal thoughts and actions may be higher:
•
early during atomoxetine capsules treatment
•
during dose adjustments
Prevent suicidal thoughts and action in your child or teenager by:
•
paying close attention to your child or teenager's moods, behaviors,
thoughts, and feelings during
atomoxetine capsules treatment
•
keeping all follow-up visits with your child or teenager's doctor as
scheduled
Watch for the following signs in your child or teenager during
atomoxetine capsules treatment:
•
anxiety
•
agitation
•
panic attacks
•
trouble sleeping
•
irritability
•
hostility
•
aggressiveness
•
impulsivity
•
restlessness
•
mania
•
depression
•
suicide thoughts
Call your child or teenager's doctor right away if

Summary of Product characteristics

ATOMOXETINE- ATOMOXETINE CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATOMOXETINE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ATOMOXETINE CAPSULES.
ATOMOXETINE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL IDEATION IN CHILDREN OR ADOLESCENTS (5.1)
NO SUICIDES OCCURRED IN CLINICAL TRIALS (5.1)
PATIENTS STARTED ON THERAPY SHOULD BE MONITORED CLOSELY (5.1)
INDICATIONS AND USAGE
Atomoxetine is a selective norepinephrine reuptake inhibitor indicated
for the treatment of Attention-
Deficit/Hyperactivity Disorder (ADHD). (1.1)
DOSAGE AND ADMINISTRATION
Initial, Target and Maximum Daily Dose (2.1)
(Acute and Maintenance/Extended Treatment)
BODY WEIGHT
INITIAL DAILY
DOSE
TARGET TOTAL DAILY
DOSE
MAXIMUM TOTAL DAILY
DOSE
Children and adolescents up to 70 kg
0.5 mg/kg
1.2 mg/kg
1.4 mg/kg
Children and adolescents over 70 kg
and adults
40 mg
80 mg
100 mg
Dosing adjustment - Hepatic Impairment, Strong CYP2D6 Inhibitor, and
in patients known to be CYP2D6
poor metabolizers (PMs). (2.5, 12.3)
DOSAGE FORMS AND STRENGTHS
Each capsule contains atomoxetine hydrochloride equivalent to 10 mg or
18 mg or 25 mg or 40 mg or 60
mg or 80 mg or 100 mg of atomoxetine. (3, 11, 16)
CONTRAINDICATIONS
Hypersensitivity to atomoxetine or other constituents of product.
(4.1)
Atomoxetine use within 2 weeks after discontinuing MAOI or other drugs
that affect brain monoamine
concentrations. (4.2, 7.1)
Narrow Angle Glaucoma. (4.3)
Pheochromocytoma or history of pheochromocytoma. (4.4)
Severe Cardiovascular Disorders that might deteriorate with clinically
important increases in HR and
BP. (4.5)
WARNINGS AND PRECAUTIONS
Suicidal Ideation - Monitor for suicidality, clinical worsening, and
unusual changes in behavior. (5.1)
Severe Liver Injury - Should be discontinued and not re