Olanzapine and Fluoxetine

×

Overview

What is Olanzapine and Fluoxetine?

Olanzapine and fluoxetine HCl capsules USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa , and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac*, Prozac Weekly, and Sarafem).

Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 thieno[2,3-] [1,5]benzodiazepine. The molecular formula is CHNS, which corresponds to a molecular weight of 312.44.

Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3‑[(α,α,α-trifluoro- -tolyl)oxy]propylamine hydrochloride. The molecular formula is CHFNO•HCl, which corresponds to a molecular weight of 345.79. The chemical structures are:

Olanzapine is a yellow crystalline solid, which is practically insoluble in water.

Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.

Olanzapine and fluoxetine capsules USP are available for oral administration in the following strength combinations:

Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol.

What does Olanzapine and Fluoxetine look like?

What are the available doses of Olanzapine and Fluoxetine?

Capsules (mg olanzapine/mg equivalent fluoxetine):

What should I talk to my health care provider before I take Olanzapine and Fluoxetine?

How should I use Olanzapine and Fluoxetine?

Olanzapine and Fluoxetine is indicated for the treatment of:

Adults

[see Clinical Studies

( )]

Children and Adolescents (10 to 17 years of age)

[see Clinical Studies ()]

What interacts with Olanzapine and Fluoxetine?

Sorry No Records found

What are the warnings of Olanzapine and Fluoxetine?

Sorry No Records found

What are the precautions of Olanzapine and Fluoxetine?

Sorry No Records found

What are the side effects of Olanzapine and Fluoxetine?

Sorry No records found

What should I look out for while using Olanzapine and Fluoxetine?

Monoamine Oxidase Inhibitors (MAOI)

Pimozide

Thioridazine

WARNINGS: SUICIDAL THOUGHTS AND BEHAVIORS; AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Suicidal Thoughts and Behaviors

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Olanzapine and Fluoxetine Capsules are not approved for use in children less than 10 years of age .

What might happen if I take too much Olanzapine and Fluoxetine?

Olanzapine and Fluoxetine HCl

Adverse reactions involving overdose of fluoxetine and olanzapine in combination, and olanzapine and fluoxetine HCl, have been reported. An overdose of combination therapy is defined as confirmed or suspected ingestion of a dose of >20 mg olanzapine in combination with a dose of >80 mg fluoxetine. Adverse reactions associated with these reports included somnolence (sedation), impaired consciousness (coma), impaired neurologic function (ataxia, confusion, convulsions, dysarthria), arrhythmias, lethargy, essential tremor, agitation, acute psychosis, hypotension, hypertension, and aggression. Fatalities have been confounded by exposure to additional substances including alcohol, thioridazine, oxycodone, and propoxyphene.

Olanzapine

Fluoxetine

Among 633 adult patients who overdosed on fluoxetine alone, 34 resulted in a fatal outcome, 378 completely recovered, and 15 patients experienced sequelae after overdose, including abnormal accommodation, abnormal gait, confusion, unresponsiveness, nervousness, pulmonary dysfunction, vertigo, tremor, elevated blood pressure, erectile dysfunction, movement disorder, and hypomania. The remaining 206 patients had an unknown outcome. The most common signs and symptoms associated with non-fatal overdose were seizures, somnolence, nausea, tachycardia, and vomiting. The largest known ingestion of fluoxetine in adult patients was 8 grams in a patient who took fluoxetine alone and who subsequently recovered. However, in an adult patient who took fluoxetine alone, an ingestion as low as 520 mg has been associated with lethal outcome, but causality has not been established.

Among pediatric patients (ages 3 months to 17 years), there were 156 cases of overdose involving fluoxetine alone or in combination with other drugs. Six patients died, 127 patients completely recovered, 1 patient experienced renal failure, and 22 patients had an unknown outcome. One of the 6 fatalities was a 9-year-old boy who had a history of OCD, Tourette's Syndrome with tics, attention deficit disorder, and fetal alcohol syndrome. He had been receiving 100 mg of fluoxetine daily for 6 months in addition to clonidine, methylphenidate, and promethazine. Mixed-drug ingestion or other methods of suicide complicated all 6 overdoses in children that resulted in fatalities. The largest ingestion in pediatric patients was 3 grams, which was non-lethal.

Other important adverse reactions reported with fluoxetine overdose (single or multiple drugs) included coma, delirium, ECG abnormalities (such as nodal rhythm, QT-interval prolongation and ventricular tachycardia, including torsades de pointes-type arrhythmias), hypotension, mania, neuroleptic malignant syndrome-like reactions, pyrexia, stupor, and syncope.

How should I store and handle Olanzapine and Fluoxetine?

Store olanzapine and fluoxetine capsules at room temperature, between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from light. Keep container tightly closed and protect from moisture.* Zyprexa, Zyprexa Zydis, Prozac, Prozac Weekly™, and Sarafem are registered trademarks of Eli Lilly and Company..Store olanzapine and fluoxetine capsules at room temperature, between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from light. Keep container tightly closed and protect from moisture.* Zyprexa, Zyprexa Zydis, Prozac, Prozac Weekly™, and Sarafem are registered trademarks of Eli Lilly and Company..Store olanzapine and fluoxetine capsules at room temperature, between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from light. Keep container tightly closed and protect from moisture.* Zyprexa, Zyprexa Zydis, Prozac, Prozac Weekly™, and Sarafem are registered trademarks of Eli Lilly and Company..Store olanzapine and fluoxetine capsules at room temperature, between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from light. Keep container tightly closed and protect from moisture.* Zyprexa, Zyprexa Zydis, Prozac, Prozac Weekly™, and Sarafem are registered trademarks of Eli Lilly and Company..Sterile Water for Injection, USP is supplied in the following:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 3/2014 EN-3490Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By:Cardinal HealthZanesville, OH 43701LA68600712Sterile Water for Injection, USP is supplied in the following:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 3/2014 EN-3490Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By:Cardinal HealthZanesville, OH 43701LA68600712Sterile Water for Injection, USP is supplied in the following:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 3/2014 EN-3490Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By:Cardinal HealthZanesville, OH 43701LA68600712Sterile Water for Injection, USP is supplied in the following:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 3/2014 EN-3490Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By:Cardinal HealthZanesville, OH 43701LA68600712Sterile Water for Injection, USP is supplied in the following:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 3/2014 EN-3490Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By:Cardinal HealthZanesville, OH 43701LA68600712Sterile Water for Injection, USP is supplied in the following:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 3/2014 EN-3490Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By:Cardinal HealthZanesville, OH 43701LA68600712Sterile Water for Injection, USP is supplied in the following:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 3/2014 EN-3490Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By:Cardinal HealthZanesville, OH 43701LA68600712Sterile Water for Injection, USP is supplied in the following:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 3/2014 EN-3490Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By:Cardinal HealthZanesville, OH 43701LA68600712Sterile Water for Injection, USP is supplied in the following:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 3/2014 EN-3490Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By:Cardinal HealthZanesville, OH 43701LA68600712

×

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Although the exact mechanism of olanzapine and fluoxetine HCl is unknown, it has been proposed that the activation of 3 monoaminergic neural systems (serotonin, norepinephrine, and dopamine) is responsible for its enhanced antidepressant effect. In animal studies, olanzapaine and fluoxetine in combination has been shown to produce synergistic increases in norepinephrine and dopamine release in the prefrontal cortex compared with either component alone, as well as increases in serotonin.

Non-Clinical Toxicology

Monoamine Oxidase Inhibitors (MAOI)

Pimozide

Thioridazine

WARNINGS: SUICIDAL THOUGHTS AND BEHAVIORS; AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Suicidal Thoughts and Behaviors

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Olanzapine and Fluoxetine Capsules are not approved for use in children less than 10 years of age .

Caution should be exercised when Propranolol Hydrochloride Extended-Release Capsules, USP, are administered with drugs that have an affect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see in ).

Alcohol

Patients with Major Depressive Disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with Major Depressive Disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in .

Table 1: Suicidality per 1000 Patients Treated

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for Major Depressive Disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms .

Families and caregivers of patients being treated with antidepressants for Major Depressive Disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.

It should be noted that olanzapine and fluoxetine capsules are not approved for use in treating any indications in patients less than 10 years of age c .

The following adverse reactions are discussed in more detail in other sections of the labeling:

×

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

×

Review

×

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

×

Tips

×

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

Disclaimer: