SYMBYAX Capsule (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Eli Lilly and Company
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
BOXED WARNING SECTION
<b>WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS</b> <b><u>Suicidal Thoughts and Behaviors</u> — Antidepressants increased the risk ...
1. Indications and Usage
SYMBYAX is indicated for the treatment of: Acute depressive episodes in Bipolar I Disorder <em>[see Clinical Studies (14.1)]</em>. Treatment resistant depression (Major Depressive Disorder in patient who ...
2. Dosage and Administration
2.1 Depressive Episodes Associated with Bipolar I Disorder Adults Administer SYMBYAX once daily in the evening, generally beginning with the 6 mg/25 mg (mg olanzapine/mg equivalent fluoxetine) capsule. ...
3. Dosage Forms and Strengths
Capsules (mg olanzapine/mg equivalent fluoxetine): 3 mg/25 mg 6 mg/25 mg
4. Contraindications
4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with SYMBYAX or within 5 weeks of stopping treatment with SYMBYAX is contraindicated because of an increased ...
5. Warnings and Precautions
5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with Major Depressive Disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or ...
6. Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults <em>[see Boxed Warning and Warnings ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of SYMBYAX, Fluoxetine, or Olanzapine monotherapy. Because these reactions are reported voluntarily from a population of uncertain ...
7. Drug Interactions
The risks of using SYMBYAX in combination with other drugs have not been extensively evaluated in systematic studies. The drug-drug interactions sections of fluoxetine and olanzapine are applicable to ...
8.1. Pregnancy
Risk Summary Neonates exposed to antipsychotic drugs, including the olanzapine component of SYMBYAX, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery ...
8.2. Lactation
Risk Summary Data from published literature report the presence of olanzapine, fluoxetine, and norfluoxetine in human milk <em>(see Data).</em> There are reports of excess sedation, irritability, poor ...
8.3. Females and Males of Reproductive Potential
Infertility Females Based on the pharmacologic action of olanzapine (dopamine D<sub>2</sub> receptor blockade), treatment with SYMBYAX may result in an increase in serum prolactin levels, which may lead ...
8.4. Pediatric Use
SYMBYAX The safety and efficacy of SYMBYAX in patients 10 to 17 years of age has been established for the acute treatment of Depressive Episodes Associated with Bipolar I Disorder in a single 8-week randomized, ...
8.5. Geriatric Use
SYMBYAX Clinical studies of SYMBYAX did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients. Other reported clinical experience ...
8.6. Hepatic Impairment
In subjects with cirrhosis of the liver, the clearances of fluoxetine and its active metabolite, norfluoxetine, were decreased, thus increasing the elimination half-lives of these substances. A lower or ...
9.3. Dependence
SYMBYAX, as with fluoxetine and olanzapine, has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. While the clinical studies did not reveal any tendency ...
10. Overdosage
SYMBYAX During premarketing clinical studies of olanzapine and fluoxetine in combination, overdose of both fluoxetine and olanzapine were reported in 5 study subjects. Four of the 5 subjects experienced ...
11. Description
SYMBYAX (olanzapine and fluoxetine HCl capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine ...
12.1. Mechanism of Action
The mechanism of action of olanzapine and fluoxetine in the listed indications, is unclear. However, the combined effect of olanzapine and fluoxetine at the monoaminergic neural systems (serotonin, norepinephrine, ...
12.2. Pharmacodynamics
Olanzapine binds with high affinity to the following receptors: serotonin 5HT<sub>2A/2C</sub>, 5HT<sub>6</sub> (K<sub>i</sub>=4, 11, and 5 nM, respectively), dopamine D<sub>1-4</sub> (K<sub>i</sub>=11 ...
12.3. Pharmacokinetics
SYMBYAX Fluoxetine (administered as a 60 mg single dose or 60 mg daily for 8 days) caused a small increase in the mean maximum concentration of olanzapine (16%) following a 5 mg dose, an increase in the ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity, mutagenicity, or fertility studies were conducted with SYMBYAX. The following data are based on findings in studies performed with the individual components, and all dose multiples ...
14. Clinical Studies
Efficacy for SYMBYAX was established for the: Acute treatment of depressive episodes in Bipolar I Disorder in adults, and children and adolescents (10 to 17 years) in 3 short-term, placebo-controlled trials ...
16.1. How Supplied
SYMBYAX capsules are supplied in 3/25 mg, 6/25 mg (mg olanzapine/mg equivalent fluoxetine<sup>a</sup>) strengths. SYMBYAX CAPSULE STRENGTH 3 mg/25 mg 6 mg/25 mg Color Peach &<br />Light Yellow ...
16.2. Storage and Handling
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep tightly closed and protect from moisture.
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling <em>(Medication Guide)</em>. Patients should be advised of the following issues and asked to alert their healthcare provider if these occur ...