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These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987 | Fluoxetine [Med-Health Pharma, LLC] | BioPortfolio

13:38 EST 27th January 2019 | BioPortfolio

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Table 1: Approximate Dose Correspondence Between Symbyax1 and the Combination of Fluoxetine and Olanzapine
   For Symbyax (mg/day) Use in Combination
Olanzapine
(mg/day)
Fluoxetine
(mg/day)
1 Symbyax (olanzapine/fluoxetine hydrochloride) is a fixed-dose combination of fluoxetine and olanzapine.
   3 mg olanzapine/25 mg fluoxetine
2.5
20
   6 mg olanzapine/25 mg fluoxetine
5
20
   12 mg olanzapine/25 mg fluoxetine
10+2.5
20
   6 mg olanzapine/50 mg fluoxetine
5
40+10
   12 mg olanzapine/50 mg fluoxetine
10+2.5
40+10
Table 2: Suicidality per 1000 Patients Treated
Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
Increases Compared to Placebo
<18
14 additional cases
18-24
5 additional cases
Decreases Compared to Placebo
25-64
1 fewer case
≥65
6 fewer cases
Table 3: Most Common Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1,2
Percentage of Patients Reporting Event
Major Depressive
Disorder
OCD Bulimia Panic Disorder
1 Incidence less than 1%.
2 Includes U.S. data for Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-U.S. data for Panic Disorder clinical trials.
3 Denominator used was for males only (N=690 fluoxetine Major Depressive Disorder; N=410 placebo Major Depressive Disorder; N=116 fluoxetine OCD; N=43 placebo OCD; N=14 fluoxetine bulimia; N=1 placebo bulimia; N=162 fluoxetine panic; N=121 placebo panic).
   Body System/ Adverse Reaction
Fluoxetine
(N=1728)
Placebo
(N=975)
Fluoxetine
(N=266)
Placebo
(N=89)
Fluoxetine
(N=450)
Placebo
(N=267)
Fluoxetine
(N=425)
Placebo
(N=342)
   Body as a Whole
      Asthenia
9
5
15
11
21
9
7
7
      Flu syndrome
3
4
10
7
8
3
5
5
   Cardiovascular System
      Vasodilatation
3
2
5
--
2
1
1
--
   Digestive System
      Nausea
21
9
26
13
29
11
12
7
      Diarrhea
12
8
18
13
8
6
9
4
      Anorexia
11
2
17
10
8
4
4
1
      Dry mouth
10
7
12
3
9
6
4
4
      Dyspepsia
7
5
10
4
10
6
6
2
   Nervous System
      Insomnia
16
9
28
22
33
13
10
7
      Anxiety
12
7
14
7
15
9
6
2
      Nervousness
14
9
14
15
11
5
8
6
      Somnolence
13
6
17
7
13
5
5
2
      Tremor
10
3
9
1
13
1
3
1
      Libido decreased
3
--
11
2
5
1
1
2
      Abnormal dreams
1
1
5
2
5
3
1
1
   Respiratory System
      Pharyngitis
3
3
11
9
10
5
3
3
      Sinusitis
1
4
5
2
6
4
2
3
      Yawn
--
--
7
--
11
--
1
--
   Skin and Appendages
      Sweating
8
3
7
--
8
3
2
2
      Rash
4
3
6
3
4
4
2
2
   Urogenital System
      Impotence3
2
--
--
--
7
--
1
--
      Abnormal ejaculation3
--
--
7
--
7
--
2
1
Table 4: Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1, 2
Percentage of Patients Reporting Event
Major Depressive Disorder, OCD,
Bulimia, and Panic Disorder Combined
1 Incidence less than 1%.
2 Includes U.S. data for Major Depressive Disorder, OCD, bulimia, and Panic Disorder clinical trials, plus non-U.S. data for Panic Disorder clinical trials.
Body System/Adverse Reaction
Fluoxetine
(N=2869)
Placebo
(N=1673)
   Body as a Whole
      Headache
21
19
      Asthenia
11
6
      Flu syndrome
5
4
      Fever
2
1
   Cardiovascular System
      Vasodilatation
2
1
   Digestive System
      Nausea
22
9
      Diarrhea
11
7
      Anorexia
10
3
      Dry mouth
9
6
      Dyspepsia
8
4
      Constipation
5
4
      Flatulence
3
2
      Vomiting
3
2
   Metabolic and Nutritional Disorders
      Weight loss
2
1
   Nervous System
      Insomnia
19
10
      Nervousness
13
8
      Anxiety
12
6
      Somnolence
12
5
      Dizziness
9
6
      Tremor
9
2
      Libido decreased
4
1
      Thinking abnormal
2
1
   Respiratory System
      Yawn
3
--
   Skin and Appendages
      Sweating
7
3
      Rash
4
3
      Pruritus
3
2
   Special Senses
      Abnormal vision
2
1
Table 5: Most Common Adverse Reactions Associated with Discontinuation in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1
1 Includes U.S. Major Depressive Disorder, OCD, bulimia, and Panic Disorder clinical trials, plus non-U.S. Panic Disorder clinical trials.
Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Combined
(N=1533)
Major Depressive Disorder
(N=392)
OCD
(N=266)
Bulimia
(N=450)
Panic Disorder
(N=425)
Anxiety (1%)
--
Anxiety (2%)
--
Anxiety (2%)
--
--
--
Insomnia (2%)
--
--
Nervousness (1%)
--
--
Nervousness (1%)
--
--
Rash (1%)
--
--

When using fluoxetine and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax.

Table 6: Outcome Classification (%) on CGI Improvement Scale for Completers in Pool of Two OCD Studies
Fluoxetine
   Outcome Classification
Placebo
20 mg
40 mg
60 mg
      Worse
8%
0%
0%
0%
      No change
64%
41%
33%
29%
      Minimally improved
17%
23%
28%
24%
      Much improved
8%
28%
27%
28%
      Very much improved
3%
8%
12%
19%

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Med-Health Pharma, LLCNorth Las Vegas, NV 89032

SP-60030 Rev03

 

Repackaged By:

Med-Health Pharma, LLCNorth Las Vegas, NV 89032

SP-60030 Rev03

Manufacturer

Med-Health Pharma, LLC

Active Ingredients

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