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Olanzapine

Olanzapine
Olanzapin is used for short-term treatment of agitation caused by schizophrenia or bipolar disorder. This drug can be used for other diseases treatment based on doctor’s prescription.

Brand: Olanzapine

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: March 2024
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Olanzapine 15 mg
360 pills - 15 mg
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$417.65 $1.16 $248.23 Add to cart
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180 pills - 15 mg
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120 pills - 15 mg
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60 pills - 15 mg
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30 pills - 15 mg $55.49 $1.85 No Add to cart
Olanzapine 7.5 mg
360 pills - 7.5 mg
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$415.53 $1.15 $97.47 Add to cart
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60 pills - 7.5 mg $79.99 $1.33 $5.51 Add to cart
30 pills - 7.5 mg $42.75 $1.43 No Add to cart
Olanzapine 5 mg
360 pills - 5 mg
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$327.69 $0.91 $80.19 Add to cart
270 pills - 5 mg
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180 pills - 5 mg
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90 pills - 5 mg $86.83 $0.96 $15.14 Add to cart
60 pills - 5 mg $60.27 $1.00 $7.71 Add to cart
30 pills - 5 mg $33.99 $1.13 No Add to cart
Olanzapine 2.5 mg
360 pills - 2.5 mg
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$241.43 $0.67 $70.45 Add to cart
270 pills - 2.5 mg
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$183.63 $0.68 $50.28 Add to cart
180 pills - 2.5 mg
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120 pills - 2.5 mg $83.97 $0.70 $19.99 Add to cart
90 pills - 2.5 mg $64.93 $0.72 $13.04 Add to cart
60 pills - 2.5 mg $44.95 $0.75 $7.03 Add to cart
30 pills - 2.5 mg $25.99 $0.87 No Add to cart

Product description

Drug title

Olanzapin

Pharmacological action

Olanzapine is an antipsychotic (neuroleptic).


In preclinical studies it was established affinity to 5-NT2A/2C-, 5-NT3-, 5-NT6-serotonin receptors, D1-, D2-, D3-, D4-, D5-dopamine receptors; m-cholinoblocking effects are caused by M1-5-cholinoreceptor blockade; it also has affinity to α1-adreno- and H1-histamine receptors. In animal experiments, antagonism to serotonin, dopamine and m-cholinoreceptors was detected. In vivo and in vitro olanzapine has a more pronounced affinity and activity towards 5-NT2-serotonin receptors compared to D2-dopamine receptors. According to electrophysiological studies, olanzapine selectively reduces excitability of mesolimbic dopaminergic neurons, and at the same time has a negligible effect on striatal nerve pathways involved in the regulation of motor functions. Olanzapine reduces the conditioned protective reflex (the test that characterizes antipsychotic activity) at doses lower than those that cause catalepsy (a disorder reflecting a side effect on motor function). Unlike other neuroleptics, olanzapine enhances the anti-anxiety effect of the "anxiolytic" test.


Olanzapine provides a statistically reliable response to both productive (delirium, hallucinations, etc.) and negative disorders.


A single administration of 10 mg olanzapine by positron emission tomography (PET) in healthy volunteers revealed a greater affinity of olanzapine for 5 NT2A- than for D2-dopamine receptors. Tomograms of patients with schizophrenia show that the affinity for striatal D2 receptors in patients susceptible to treatment with olanzapine is comparable to the effect in patients susceptible to clozapine and lower than in patients susceptible to treatment with other antipsychotics and risperidone.


Clinical efficacy


In an international, double-blind, comparative study of patients with schizophrenia, schizoaffective or similar disorders of varying severity of depressive symptoms (mean baseline 16. 6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of the mood scale from baseline to the control endpoint found a statistically significant (p=0.001) improvement with olanzapine (-6.0) compared to haloperidol (-3.1).


Patients with manic or mixed episode bipolar disorder compared with placebo and valproic acid (divalproate) showed high efficacy in reducing manic symptoms within 3 weeks. Comparable efficacy results of olanzapine and haloperidol were observed in patients with symptomatic remission of mania and depression after 6-12 weeks.


In co-therapy patients who had taken lithium or valproic acid for at least 2 weeks, an additional 10 mg of olanzapine (co-therapy with lithium or valproic acid) resulted in a significant reduction in mania symptoms compared with lithium or valproic acid monotherapy for 6 weeks.


In a 12-month study of manic episode relapse prevention in patients who achieved remission while taking olanzapine and then randomized to the group taking olanzapine, there was a statistically significant advantage over placebo on the primary criterion of controlling the onset of bipolar relapse and in terms of preventing a relapse of mania or relapse of depression.


In a second 12-month study of the prevention of relapse of manic episodes in patients who had achieved remission by coadministration of olanzapine with lithium medication and then randomized to the olanzapine or lithium monotherapy group. Efficacy from olanzapine was statistically insignificant compared with lithium medication on the main criterion for control of bipolar relapse (olanzapine 30.0%, lithium 38.3%, p=0.055).


In an 18-month co-therapy study of manic or mixed episodes in patients stabilized with olanzapine and mood stabilizing drugs (lithium or valproic acid), long-term co-therapy with olanzapine and lithium or valproic acid was not statistically significant compared with monotherapy with lithium or valproic acid to delay the onset of bipolar relapse as determined by diagnostic signs.

Pharmacokinetics

After oral administration olanzapine is well absorbed, Cmax in plasma is reached after 5-8 hours. Absorption of olanzapine is not dependent on food intake. Studies with different doses in the range of 1-20 mg have shown that plasma concentrations of olanzapine vary linearly and in proportion to the dose.


Olanzapine is metabolized in the liver by conjugation and oxidation processes. The main circulating metabolite is 10-N-glucuronide, which theoretically does not cross the blood-brain barrier. CYP1A2 and CYP2D6 isoenzymes are involved in the formation of N-desmethyl- and 2-hydroxymethylmetabolites of olanzapine. Both metabolites in animal studies had significantly less pronounced in vivo pharmacological activity than olanzapine. The main pharmacological activity of the drug is due to the parent compound, olanzapine, which has the ability to penetrate the blood-brain barrier.


In healthy volunteers after oral administration, the mean T1/2 was 33 h (21-54 h for 5-95%) and the mean clearance of olanzapine from plasma was 26 l/h (12-47 l/h for 5-95%).


However, the degree of change in the elimination half-life and clearance under the influence of each of these factors is significantly inferior to the degree of variation in these parameters between individuals.


The pharmacokinetic parameters in adolescents (13-17 years old) and adults are similar. According to clinical studies, the value of exposure in adolescents is 27% higher than in adults. Demographic differences between the adult and adolescent populations were that adolescents had fewer smokers and lower mean body weights.


No significant differences were found between the mean half-life and plasma clearance values of olanzapine in persons with severe renal impairment compared with persons with normal renal function. About 57% of radioactively labeled olanzapine is excreted with the urine mainly as metabolites.


Smokers with minor liver dysfunction have lower clearance of olanzapine than nonsmokers without liver dysfunction.


At plasma concentrations of olanzapine of 7-1000 ng/ml, its binding to plasma proteins is about 93%. Olanzapine primarily binds to albumin and acidic α1-glycoprotein. No differences in the pharmacokinetics of olanzapine related to race were found in studies involving persons of European, Japanese, and Chinese origin. The activity of CYP2D6 isoenzyme does not affect the metabolism of olanzapine.


Contraindications to use

  • Hypersensitivity to any of the components of the drug;
  • Contraindicated for persons under 18 years of age;
  • lactase deficiency;
  • lactose intolerance;
  • glucose-galactose malabsorption.

Use during pregnancy and lactation

Because of insufficient experience with the use of olanzapine during pregnancy, the drug should be prescribed during pregnancy only if the potential benefit to the patient significantly exceeds the potential risk to the fetus. Patients should be warned that if they become pregnant or plan to become pregnant during treatment with olanzapine, they should inform their treating physician.


Newborns whose mothers have taken antipsychotics (including olanzapine) during the third trimester of pregnancy are at risk of adverse reactions, including extrapyramidal disorders and/or withdrawal syndrome, whose symptoms may vary in severity and duration after birth. Agitation, arterial hyper- and hypotension, tremor, somnolence, respiratory distress syndrome, or eating disorders have been reported. Therefore, neonates should be carefully monitored.


The study found that olanzapine penetrates breast milk. The average dose received by the infant (mg/kg) when reaching equilibrium concentration in the mother was 1.8% of the mother's olanzapine dose (mg/kg). Breastfeeding during therapy with olanzapine is not recommended.


Use in hepatic dysfunction

Reduction of the starting dose to 5 mg daily is recommended in patients with other clinical risk factors, including moderate hepatic impairment.

Use in impaired renal function

Reduction of the initial dose to 5 mg daily is recommended for patients with other clinical risk factors, including severe renal impairment.

Administration in children

Contraindicated in persons under 18 years of age.

Use in elderly patients

Reduction of the starting dose to 5 mg per day is recommended in elderly patients.

Indications of the drug Olanzapine

For the treatment of schizophrenia. Olanzapine is effective in maintaining clinical improvement as part of ongoing therapy in patients with schizophrenia responding to initial treatment;

For the treatment of a moderate to severe manic episode;

to prevent relapse in patients with bipolar disorder in whom it has been effective in treating the manic phase;

Therapeutically resistant depression. In combination with fluoxetine, olanzapine is indicated for the treatment of treatment-resistant depression in adult patients (major depressive episodes with a history of ineffective use of two antidepressants at a dose and duration of therapy adequate for the episode). Olanzapine in monotherapy is not indicated for treatment of therapeutically resistant depression.


Dosing regimen

Oral. Olanzapine can be taken regardless of meals, since food does not affect the absorption of olanzapine.


Schizophrenia


The recommended starting dose of olanzapine is 10 mg once daily. Therapeutic doses of olanzapine range from 5 mg to 20 mg per day. Daily dose should be chosen individually, depending on the clinical condition of the patient. Increasing the dose above the standard daily dose (10 mg) is recommended only after evaluating the clinical picture. When using the drug, the need for continuation of therapy should be assessed regularly.


Bipolar disorder.


For the treatment of a manic episode, the recommended starting dose of olanzapine is 15 mg once daily as monotherapy or 10 mg once daily in combination with lithium or valproic acid. Therapeutic doses of olanzapine range from 5 mg to 20 mg per day. The daily dose should be selected individually, depending on the clinical condition of the patient. Increasing the dose above the standard daily dose is recommended only after evaluating the clinical picture and at intervals of at least 24 hours.


Maintenance therapy for bipolar disorder: patients who have taken olanzapine for treatment of a manic episode should continue maintenance therapy at the same dose. In patients in remission, the recommended initial dose of olanzapine is 10 mg once daily. Thereafter, the daily dose should be adjusted individually; depending on the clinical condition of the patient, ranging from 5 mg to 20 mg per day.


To treat a depressive episode, olanzapine should be prescribed in combination with fluoxetine once daily, in the evening, regardless of meals. Typically, the starting dose is 5 mg olanzapine and 20 mg fluoxetine. Antidepressant activity has been confirmed with olanzapine at a dose of 6-12 mg (mean daily dose, 7.4 mg) and fluoxetine at a dose of 25-30 mg (mean daily dose, 39.3 mg). Doses of both olanzapine and fluoxetine may be changed if necessary. When using the drug, the need for continuation of therapy should be assessed regularly.


Therapeutically resistant depression


Olanzapine should be administered in combination with fluoxetine once daily, in the evening, regardless of meals. The starting dose is usually 5 mg olanzapine and 20 mg fluoxetine. It is allowed to change the dose of both olanzapine and fluoxetine if necessary. Antidepressant activity has been confirmed with the use of olanzapine at a dose of 6-12 mg and fluoxetine at a dose of 25-30 mg. When using the drug, the need for continuation of therapy should be evaluated regularly.


General rules for choosing a daily dose for special groups of patients when administered orally


Reduction of the starting dose to 5 mg daily is recommended in elderly patients or patients with other clinical risk factors, including severe renal failure or moderate hepatic failure. Reduction of the starting dose to 5 mg may be recommended for patients with a combination of factors (female sex, older age, and no smoking habit) that may reduce olanzapine metabolism (see Table 1).


The use of olanzapine has not been studied in persons younger than 13 years of age.