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Additional information about the drug Olanzapine


Olanzapine (originally branded Zyprexa ) is an antipsychotic medication used to treat schizophrenia and bipolar disorder. It is usually classed with the atypical antipsychotics, the newer generation of antipsychotics.
Olanzapine is believed to work by antagonizing the dopamine D 2 receptor, an effect it shares with most antipsychotics.
Olanzapine was first patented in 1971.
Contents
1 Medical uses
1.1 Schizophrenia
1.1.1 Comparison
1.2 Bipolar Disorder
1.3 Other uses
1.4 Specific populations
1.4.1 Pregnancy and lactation
1.4.2 In the elderly
2 Adverse effects
2.1 Paradoxical effects
2.2 Metabolic effects
2.3 Animal toxicology
2.4 Discontinuation
3 Overdose
4 Interactions
5 Pharmacology
5.1 Pharmacodynamics
5.2 Pharmacokinetics
5.2.1 Metabolism
6 Society and culture
6.1 Regulatory status
6.2 Controversy and litigation
6.3 Trade names
6.4 Dosage forms
7 Research
8 References
9 External links
Medical uses
Schizophrenia
The first-line psychiatric treatment for schizophrenia is antipsychotic medication; olanzapine is one such medication.
Comparison
National Institute for Health and Care Excellence, the British Association for Psychopharmacology, and the World Federation of Societies for Biological Psychiatry suggest that there is little difference in effectiveness between antipsychotics in prevention of relapse, and recommend that the specific choice of antipsychotic be chosen based on a person’s preference and the drug’s side effect profile.
In a 2013 comparison of 15 antipsychotic drugs in schizophrenia, olanzapine was ranked third in efficacy. It was 5% more effective than risperidone (4th), 24-27% more effective than haloperidol, quetiapine, and aripiprazole, and 33% less effective than clozapine (1st).
A 2014 meta analysis of 9 published trials having minimum duration 6 months and median duration 52 weeks concluded that olanzapine, quetiapine, and risperidone had better effects on cognitive function than amisulpride and haloperidol.
Bipolar Disorder
Olanzapine is recommended by the National Institute of Health and Care Excellence as a first line therapy for the treatment of acute mania in bipolar disorder.
The Network for Mood and Anxiety Treatments (CANMAT) recommends olanzapine as a first line maintenance treatment in bipolar disorder and the combination of olanzapine with fluoxetine as second line treatment for bipolar depression.
A 2014 meta analysis concluded that olanzapine plus fluoxetine was the most effective among nine treatments for bipolar depression included in the analysis.
Other uses
Evidence does not support the use of atypical antipsychotics, including olanzapine, in eating disorders.
Olanzapine has not been rigorously evaluated in generalized anxiety disorder, panic disorder, delusional parasitosis, or post-traumatic stress disorder. Olanzapine is no less effective than lithium or valproate and more effective than placebo in treating bipolar disorder.
Olanzapine has been studied for the treatment of hyperactivity, aggressive behavior, and repetitive behaviors in autism.
Olanzapine is frequently prescribed off-label for the treatment of insomnia, including difficult falling asleep and staying asleep. The daytime sedation experienced with olanzapine is generally comparable to quetiapine and lurasidone, which is a frequent complaint in clinical trials. In some cases, the sedation due to olanzapine impaired the ability of people to wake up at a consistent time every day. There does appear to be some evidence of efficacy for treating insomnia, but long-term studies (especially for safety) are still needed.
Specific populations
Pregnancy and lactation
Olanzapine is associated with the highest placental exposure of any atypical antipsychotic.
In the elderly
Citing an increased risk of stroke, in 2004 the Committee on the Safety of Medicines (CSM) in the UK issued a warning that olanzapine and risperidone, both atypical antipsychotic medications, should not be given to elderly patients with dementia. In the U.S., olanzapine comes with a black box warning for increased risk of death in elderly patients. It is not approved for use in patients with dementia-related psychosis.
Adverse effects
See also: List of adverse effects of olanzapine
The principal side effect of olanzapine is weight gain, which may be profound in some cases and/or associated with derangement in the blood lipid and blood sugar profiles (see section metabolic effects ). A recent meta-analysis of the efficacy and tolerance of 15 antipsychotic drugs (APDs) found that it had the highest propensity for causing weight gain out of the 15 APD compared with a SMD of 0.74 but may include tremors and muscle rigidity.
Several patient groups are at a heightened risk of side effects from olanzapine and antipsychotics in general. Olanzapine may produce non-trivial high blood sugar in people with diabetes mellitus. Likewise, the elderly are at a greater risk of falls and accidental injury. Young males appear to be at heightened risk of dystonic reactions, although these are relatively rare with olanzapine. Most antipsychotics, including olanzapine, may disrupt the body’s natural thermoregulatory systems, thus permitting excursions to dangerous levels when situations (exposure to heat, strenuous exercise) occur.
Other side effects include galactorrhea, amenorrhea, gynecomastia, and erectile dysfunction (impotence).
Paradoxical effects
Olanzapine is used therapeutically to treat serious mental illness. Occasionally, it can have the opposite effect and provoke serious paradoxical reactions in a small subgroup of people, causing unusual changes in personality, thoughts, or behavior; hallucinations and excessive thoughts about suicide have also been linked to olanzapine use.
Metabolic effects
The US Food and Drug Administration requires all atypical antipsychotics to include a warning about the risk of developing hyperglycemia and diabetes, both of which are factors in the metabolic syndrome. These effects may be related to the drugs’ ability to induce weight gain, although there are some reports of metabolic changes in the absence of weight gain.
Despite weight gain, a large multi-center randomized National Institute of Mental Health study found that olanzapine was better at controlling symptoms because patients were more likely to remain on olanzapine than the other drugs. but this has not been substantiated in a blinded experimental setting.
Animal toxicology
Olanzapine has demonstrated carcinogenic effects in multiple studies when exposed chronically to female mice and rats, but not male mice and rats. The tumors found were in either the liver or mammary glands of the animals.
Discontinuation
The British National Formulary recommends a gradual withdrawal when discontinuing anti-psychotic treatment to avoid acute withdrawal syndrome or rapid relapse.
Overdose
Symptoms of an overdose include tachycardia, agitation, dysarthria, decreased consciousness, and coma. Death has been reported after an acute overdose of 450 mg, but also survival after an acute overdose of 2000 mg.
Olanzapine is considered moderately toxic in overdose, more toxic than quetiapine, aripiprazole, and the SSRIs and less toxic than the MAOIs and TCAs.
Interactions
Drugs or agents that increase the activity of the enzyme CYP1A2, notably tobacco smoke, may significantly increase hepatic first-pass clearance of olanzapine; conversely, drugs which inhibit CYP1A2 activity (examples: ciprofloxacin, fluvoxamine ) may reduce olanzapine clearance.
Probenecid increases the total exposure ( area under the curve, or AUC) and maximum plasma concentration (C max ) of olanzapine.
Pharmacology
Pharmacodynamics
See also: Atypical antipsychotic § Pharmacodynamics, and Antipsychotic § Comparison of medications
Olanzapine
Site
K i (nM)
Action
Ref
5-HT 1A
2,063–2,720
Antagonist
5-HT 1B
509–660
ND
5-HT 1D
540–1,582
ND
5-HT 1E
2,010–2,408
ND
5-HT 1F
310
ND
5-HT 2A
1.32–24.2
Inverse agonist
5-HT 2B
11.8–12.0
Inverse agonist
5-HT 2C
6.4–29
Inverse agonist
5-HT 3
202
Antagonist
5-HT 5A
1,212
Full Agonist
5-HT 6
6.0–42
Antagonist
5-HT 7
105–365
Antagonist
α 1A
109–115
Antagonist
α 1B
263
Antagonist
α 2A
192–470
Antagonist
α 2B
82–180
Antagonist
α 2C
29–210
Antagonist
β 1
>10,000
ND
β 2
>10,000
ND
D 1
35–118
Antagonist
D 2
3.00–106
Antagonist
D 2L
31–38
Antagonist
D 2S
21–52
Antagonist
D 3
7.8–91
Antagonist
D 4
1.6–50
Antagonist
D 4.2
17–102
Antagonist
D 4.4
21–60
Antagonist
D 5
74–90
Antagonist
H 1
0.65–4.9
Inverse agonist
H 2
44
Antagonist
H 3
3,713
Antagonist
H 4
>10,000
Antagonist
M 1
2.5–73
Antagonist
M 2
48–622
Antagonist
M 3
13–126
Antagonist
M 4
10–350
Antagonist
M 5
6.0–82
Antagonist
σ 1
>5,000
ND
σ 2
ND
ND
ND
Opioid
>10,000
ND
nACh
>10,000
ND
NMDA ( PCP )
>10,000
ND
SERT
≥3,676
ND
NET
>10,000
ND
DAT
>10,000
ND
VDCC
>10,000
ND
VGSC
>5,000
ND
hERG
6,013
Blocker
Values are K i (nM). The smaller the value, the more strongly the drug binds to the site. All data are for human cloned proteins, except H 3 (guinea pig), σ 1 (guinea pig), opioid (rodent), NMDA / PCP (rat), VDCC, and VGSC.
Olanzapine has a higher affinity for 5-HT 2A serotonin receptors than D 2 dopamine receptors, which is a common property of most atypical antipsychotics, aside from the benzamide antipsychotics such as amisulpride along with the non-benzamides aripiprazole, brexpiprazole, blonanserin, cariprazine, melperone and perospirone.
Olanzapine had the highest affinity of any second-generation antipsychotic towards the P-glycoprotein in one in vitro study.
Olanzapine is a potent antagonist of the muscarinic M 3 receptor,
Additionally, olanzapine also exhibits a relatively low affinity for serotonin 5-HT 1, GABA A, beta-adrenergic receptors, and benzodiazepine binding sites.
The mode of action of olanzapine’s antipsychotic activity is unknown. It may involve antagonism of dopamine and serotonin receptors. Antagonism of dopamine receptors is associated with extrapyramidal effects such as tardive dyskinesia (TD), and with therapeutic effects. Antagonism of muscarinic acetylcholine receptors is associated with anticholinergic side effects such as dry mouth and constipation, in addition it may suppress or reduce the emergence of extrapyramidal effects for the duration of treatment, however it offers no protection against the development of tardive dyskinesia. In common with other second generation (atypical) antipsychotics, olanzapine poses a relatively low risk of extrapyramidal side effects including TD, due to its higher affinity for the 5HT 2A receptor over the D 2 receptor.
Antagonizing H 1 histamine receptors causes sedation and may cause weight gain, although antagonistic actions at serotonin 5-HT 2C and dopamine D 2 receptors have also been associated with weight gain and appetite stimulation.
Pharmacokinetics
Metabolism
Olanzapine is metabolized by the cytochrome P450 (CYP) system; principally by isozyme 1A2 (CYP1A2) and to a lesser extent by CYP2D6. By these mechanisms more than 40% of the oral dose, on average, is removed by the hepatic first-pass effect.
Society and culture
Zyprexa (olanzapine) 10 mg tablets ( AU )
Regulatory status
Olanzapine is approved in the United States by the Food and Drug Administration (FDA) for:
Treatment—in combination with fluoxetine —of depressive episodes associated with bipolar disorder (December 2003).
Long-term treatment of bipolar I disorder (January 2004).
Long-term treatment—in combination with fluoxetine —of resistant depression (March 2009).
Oral formulation: acute and maintenance treatment of schizophrenia in adults, acute treatment of manic or mixed episodes associated with bipolar I disorder (monotherapy and in combination with lithium or sodium valproate )
Intramuscular formulation: acute agitation associated with schizophrenia and bipolar I mania in adults
Oral formulation combined with fluoxetine : treatment of acute depressive episodes associated with bipolar I disorder in adults, or treatment of acute, resistant depression in adults
Treatment of the manifestations of psychotic disorders (September 1996
Short-term treatment of acute manic episodes associated with bipolar I disorder (March 2000).
Short-term treatment of schizophrenia instead of the management of the manifestations of psychotic disorders (March 2000).
Maintaining treatment response in schizophrenic patients who had been stable for approximately eight weeks and were then followed for a period of up to eight months (November 2000).
Controversy and litigation
Eli Lilly has faced many lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa, as well as by various governmental entities, insurance companies, and others. Lilly produced a large number of documents as part of the discovery phase of this litigation, which started in 2004; the documents were ruled to be confidential by a judge and placed under seal, and later themselves became the subject of litigation.
In 2006, Lilly paid $700 million to settle around 8,000 of these lawsuits,
A December 2006 New York Times article based on leaked company documents concluded that the company had engaged in a deliberate effort to downplay olanzapine’s side effects.
Lilly had threatened Egilman with criminal contempt charges regarding the documents he took and provided to reporters; in September 2007 he agreed to pay Lilly $100,000 in return for the company’s agreement to drop the threat of charges.
In September 2008 Judge Weinstein issued an order to make public Lilly’s internal documents about the drug in a different suit brought by insurance companies, pension funds, and other payors.
In March 2008 Lilly settled a suit with the state of Alaska
In 2009, Eli Lilly pleaded guilty to a US federal criminal misdemeanor charge of illegally marketing Zyprexa for off-label use and agreed to pay $1.4 billion.
Trade names
Olanzapine is generic and is available under many trade names worldwide.
List of trade names for olanzapine
A
Aedon, Alonzap, Amulsin, Anzap, Anzatric, Anzorin, Apisco, Apo-Olanzapine, Apo-Olanzapine ODT, Apsico, Arenbil, Arkolamyl
B
Benexafrina, Bloonis
C
Caprilon, Cap-Tiva, Clingozan
D
Deprex, Domus, Dopin
E
Egolanza, Elynza, Emzypine, Epilanz-10, Exzapine
F
Fontanivio, Fordep
G
H
I
Irropia
J
Jolyon-MD
K
Kozylex
L
Lanopin, Lanzapine, Lanzep, Lapenza, Lapozan, Lazap, Lazapir, Lazapix, Lezapin-MD, Lopez
M
Marathon, Meflax, Midax
N
Niolib, Nodoff, Norpen Oro, Nykob, Nyzol
O
Oferta, Oferta-Sanovel, Olace, Oladay, Oladay-F, Olaffar, Olan, Olanap, Olancell, Olandix, Olandoz, Olandus, Olankline, Olanpax, Olanstad, Olanza, Olanza Actavis, Olanza Actavis ODT, Olanzalet, Olanzalux, Olanzamed, Olanzapin 1A Pharma, Olanzapin AbZ, Olanzapin Accord, Olanzapin Actavis, Olanzapin AL, Olanzapin Apotex, Olanzapin Aristo, Olanzapin axcount, Olanzapin beta, Olanzapin Bluefish, Olanzapin Cipla, Olanzapin easypharm, Olanzapin Egis, Olanzapin G.L., Olanzapin Genera, Olanzapin Genericon, Olanzapin Helvepharm, Olanzapin Hennig, Olanzapin Heumann, Olanzapin HEXAL, Olanzapin Krka, Olanzapin Lilly, Olanzapin Mylan, Olanzapin Niolib, Olanzapin Orion, Olanzapin PCD, Olanzapin PharmaS, Olanzapin Ranbaxy, Olanzapin ratiopharm, Olanzapin ReplekFarm, Olanzapin Rth, Olanzapin Sandoz, Olanzapin Spirig HC, Olanzapin Stada, Olanzapin SUN, Olanzapin Teva, Olanzapin Viketo, Olanzapin Zentiva, Olanzapina Accord, Olanzapina Actavis, Olanzapina Actavis PTC, Olanzapina Aldal, Olanzapina Almus, Olanzapina Alter, Olanzapina Angenerico, Olanzapina Anipaz, Olanzapina Apotex, Olanzapina APS, Olanzapina Arrowblue, Olanzapina Aspen, Olanzapina Aurobindo, Olanzapina Basi, Olanzapina Bexalabs, Olanzapina Blixie, Olanzapina Bluefish, Olanzapina Bluepharma, Olanzapina Cantabria, Olanzapina Ceapharma, Olanzapina Ciclum, Olanzapina Cinfa, Olanzapina Cipla, Olanzapina Combix, Olanzapina Doc Generici, Olanzapina Dr. Reddy’s, Olanzapina Eulex, Olanzapina Eurogenerici, Olanzapina Fantex, Olanzapina Farmoz, Olanzapina Flas Pharma Combix, Olanzapina Genedec, Olanzapina Generis, Olanzapina Germed, Olanzapina Glenmark, Olanzapina Green Avet, Olanzapina Helm, Olanzapina Kern Pharma, Olanzapina Krka, Olanzapina La Santé, Olanzapina Labesfal, Olanzapina Leugim, Olanzapina Lilly, Olanzapina LPH, Olanzapina Mabo, Olanzapina Medana, Olanzapina Medis, Olanzapina Medley, Olanzapina Mylan, Olanzapina Nakozap, Olanzapina Nolian, Olanzapina Normon, Olanzapina Ozilormar, Olanzapina Parke-Davis, Olanzapina Pensa, Olanzapina Pensa Pharma, Olanzapina Pharmakern, Olanzapina Polipharma, Olanzapina Polpharma, Olanzapina Qualigen, Olanzapina Ranbaxy, Olanzapina Ratio, Olanzapina Ratiopharm, Olanzapina Reconir, Olanzapina Reddy, Olanzapina Rospaw, Olanzapina Sabacur, Olanzapina Sandoz, Olanzapina Sarb, Olanzapina Stada, Olanzapina Sun, Olanzapina TAD, Olanzapina Technigen, Olanzapina Terapia, Olanzapina Teva, Olanzapina Tevagen, Olanzapina tolife, Olanzapina Torrent, Olanzapina Vegal, Olanzapina Vida, Olanzapina Winthrop, Olanzapina Wynn, Olanzapina Kraz, Olanzapina Zentiva, Olanzapina Zerpi, Olanzapina Zonapir, Olanzapin-Actavis, Olanzapin-CT, Olanzapine 1A Pharma, Olanzapine Accord, Olanzapine Actavis, Olanzapine Adamed, Olanzapine Alter, Olanzapine Alvogen, Olanzapine Apotex, Olanzapine Arrow Génériques, Olanzapine Auro, Olanzapine Aurobindo, Olanzapine Biogaran, Olanzapine Bluefish, Olanzapine CF, Olanzapine Clonmel, Olanzapine Cristers, Olanzapine Dexcel, Olanzapine EG, Olanzapine Egis, Olanzapine Evolugen, Olanzapine Galenicum, Olanzapine Generichealth, Olanzapine Glenmark, Olanzapine GSK, Olanzapine Isomed, Olanzapine Jacobsen, Olanzapine Jubilant, Olanzapine Lekam, Olanzapine Lesvi, Olanzapine Medana, Olanzapine Mylan, Olanzapine Neopharma, Olanzapine Niolib, Olanzapine Nyzol, Olanzapine Odis Mylan, Olanzapine ODT Generichealth, Olanzapine ODT Sanis Health, Olanzapine ODT Teva, Olanzapine ODT-DRLA, Olanzapine Orion, Olanzapine Polpharma, Olanzapine Prasco, Olanzapine Ranbaxy, Olanzapine Ratiopharm, Olanzapine Sandoz, Olanzapine Sanis Health, Olanzapine Sanovel, Olanzapine Stada, Olanzapine Sun, Olanzapine Synthon, Olanzapine Teva, Olanzapine Torrent, Olanzapine Zentiva, Olanzapine Zentiva Lab, Olanzapine Zydus, Olanzapine-DRLA
P
Q
R
S
T
U
V
W
X
Y
Z
Dosage forms
Olanzapine is marketed in a number of countries, with tablets ranging from 2.5 to 20 milligrams. Zyprexa (and generic olanzapine) is available as an orally-disintegrating “wafer” which rapidly dissolves in saliva. It is also available in 10 milligram vials for intramuscular injection.
Research
Olanzapine has been investigated for use as an antiemetic, particularly for the control of chemotherapy-induced nausea and vomiting (CINV). A 2007 study demonstrated its successful potential for this use, achieving a complete response in the acute prevention of nausea and vomiting in 100% of patients treated with moderately and highly-emetogenic chemotherapy, when used in combination with palonosetron and dexamethasone.
Olanzapine has been considered as part of an early psychosis approach for schizophrenia. The Prevention through Risk Identification, Management, and Education (PRIME) study, funded by the National Institute of Mental Health and Eli Lilly, tested the hypothesis that olanzapine might prevent the onset of psychosis in people at very high risk for schizophrenia. The study examined 60 patients with prodromal schizophrenia, who were at an estimated risk of 36–54% of developing schizophrenia within a year, and treated half with olanzapine and half with placebo.

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