Atomoxetine (Page 7 of 9)

14.2 ADHD studies in Adults

The effectiveness of atomoxetine in the treatment of ADHD was established in 2 randomized, double-blind, placebo-controlled clinical studies of adult patients, age 18 and older, who met DSM-IV criteria for ADHD.

Signs and symptoms of ADHD were evaluated using the investigator-administered Conners Adult ADHD Rating Scale Screening Version (CAARS), a 30-item scale. The primary effectiveness measure was the 18-item Total ADHD Symptom score (the sum of the inattentive and hyperactivity/impulsivity subscales from the CAARS) evaluated by a comparison of mean change from baseline to endpoint using an intent-to-treat analysis.

In 2 identical, 10-week, randomized, double-blind, placebo-controlled acute treatment studies (Study 5, N=280; Study 6, N=256), patients received either atomoxetine or placebo. Atomoxetine was administered as a divided dose in the early morning and late afternoon/early evening and titrated according to clinical response in a range of 60 to 120 mg/day. The mean final dose of atomoxetine for both studies was approximately 95 mg/day. In both studies, ADHD symptoms were statistically significantly improved on atomoxetine, as measured on the ADHD Symptom score from the CAARS scale.

Examination of population subsets based on gender and age (<42 and ≥42) did not reveal any differential responsiveness on the basis of these subgroupings. There was not sufficient exposure of ethnic groups other than Caucasian to allow exploration of differences in these subgroups.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Atomoxetine Capsules 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 65841-606-06 in bottles of 30 capsules

NDC 65841-606-14 in bottles of 60 capsules

NDC 65841-606-16 in bottles of 90 capsules

NDC 65841-606-10 in bottles of 1000 capsules

NDC 65841-606-02 in bottles of 2000 capsules

Atomoxetine Capsules 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 65841-607-06 in bottles of 30 capsules

NDC 65841-607-14 in bottles of 60 capsules

NDC 65841-607-16 in bottles of 90 capsules

NDC 65841-607-10 in bottles of 1000 capsules

NDC 65841-607-02 in bottles of 2000 capsules

NDC 65841-607-77 in unit-dose blister cartons of 100 (10 x 10) unit dose capsules

Atomoxetine Capsules 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 65841-608-06 in bottles of 30 capsules

NDC 65841-608-14 in bottles of 60 capsules

NDC 65841-608-16 in bottles of 90 capsules

NDC 65841-608-10 in bottles of 1000 capsules

NDC 65841-608-02 in bottles of 2000 capsules

NDC 65841-608-77 in unit-dose blister cartons of 100 (10 x 10) unit dose capsules

Atomoxetine Capsules 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 65841-609-06 in bottles of 30 capsules

NDC 65841-609-14 in bottles of 60 capsules

NDC 65841-609-16 in bottles of 90 capsules

NDC 65841-609-10 in bottles of 1000 capsules

NDC 65841-609-02 in bottles of 2000 capsules

NDC 65841-609-77 in unit-dose blister cartons of 100 (10 x 10) unit dose capsules

Atomoxetine Capsules 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 65841-610-06 in bottles of 30 capsules

NDC 65841-610-14 in bottles of 60 capsules

NDC 65841-610-16 in bottles of 90 capsules

NDC 65841-610-10 in bottles of 1000 capsules

NDC 65841-610-02 in bottles of 2000 capsules

NDC 65841-610-77 in unit-dose blister cartons of 100 (10 x 10) unit dose capsules

Atomoxetine Capsules 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 65841-611-06 in bottles of 30 capsules

NDC 65841-611-14 in bottles of 60 capsules

NDC 65841-611-16 in bottles of 90 capsules

NDC 65841-611-10 in bottles of 1000 capsules

NDC 65841-611-02 in bottles of 2000 capsules

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide.

17.1 General Information

Physicians should instruct their patients to read the Medication Guide before starting therapy with atomoxetine and to reread it each time the prescription is renewed.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with atomoxetine and should counsel them in its appropriate use. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking atomoxetine.

17.2 Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during atomoxetine treatment and when the dose is adjusted. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

17.3 Severe Liver Injury

Patients initiating atomoxetine should be cautioned that severe liver injury may develop. Patients should be instructed to contact their physician immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms [see Warnings and Precautions (5.2)].

17.4 Aggression or Hostility

Patients should be instructed to call their doctor as soon as possible should they notice an increase in aggression or hostility.

17.5 Priapism

Rare postmarketing cases of priapism, defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported for pediatric and adult patients treated with atomoxetine. The parents or guardians of pediatric patients taking atomoxetine and adult patients taking atomoxetine should be instructed that priapism requires prompt medical attention.

17.6 Ocular Irritant

Atomoxetine is an ocular irritant. Atomoxetine capsules are not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.

17.7 Drug-Drug Interaction

Patients should be instructed to consult a physician if they are taking or plan to take any prescription or over-thecounter medicines, dietary supplements, or herbal remedies.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.